21 CFR 862.2 Regulation of calibrators.
Many devices classified in this part are intended to be used with a
calibrator. A calibrator has a reference value assigned to it which
serves as the basis by which test results of patients are derived or
calculated. The calibrator for a device may be (a) manufactured and
distributed separately from the device with which it is intended to be
used, (b) manufactured and distributed as one of several device
components, such as in a kit of reagents, or (c) built-in as an integral
part of the device. Because of the central role that a calibrator plays
in the measurement process and the critical effect calibrators have on
accuracy of test results, elsewhere in this part, all three of these
types of calibrators ( 862.1150 and 862.3200 of this part) are
classified into class II, notwithstanding the classification of the
device with which it is intended to be used. Thus, a device and its
calibrator may have different classifications, even if the calibrator is
built into the device.
21 CFR 862.3 Effective dates of requirement for premarket approval.
A device included in this part that is classified into class III
(premarket approval) shall not be commercially distributed after the
date shown in the regulation classifying the device unless the
manufacturer has an approval under section 515 of the act (unless an
exemption has been granted under section 520(g)(2) of the act). An
approval under section 515 of the act consists of FDA's issuance of an
order approving an application for premarket approval (PMA) for the
device or declaring completed a product development protocol (PDP) for
the device.
(a) Before FDA requires that a device commercially distributed before
the enactment date of the amendments, or a device that has been found
substantially equivalent to such a device, has an approval under section
515 of the act FDA must promulgate a regulation under section 515(b) of
the act requiring such approval, except as provided in paragraph (b) of
this section. Such a regulation under section 515(b) of the act shall
not be effective during the grace period ending on the 90th day after
its promulgation or on the last day of the 30th full calendar month
after the regulation that classifies the device into class III is
effective, whichever is later. See section 501(f)(2)(B) of the act.
Accordingly, unless an effective date of the requirement for premarket
approval is shown in the regulation for a device classified into class
III in this part, the device may be commercially distributed without
FDA's issuance of an order approving a PMA or declaring completed a PDP
for the device. If FDA promulgates a regulation under section 515(b) of
the act requiring premarket approval for a device, section 501(f)(1)(A)
of the act applies to the device.
(b) Any new, not substantially equivalent, device introduced into
commercial distribution on or after May 28, 1976, including a device
formerly marketed that has been substantially altered, is classified by
statute (section 513(f) of the act) into class III without any grace
period and FDA must have issued an order approving a PMA or declaring
completed a PDP for the device before the device is commercially
distributed unless it is reclassified. If FDA knows that a device being
commercially distributed may be a ''new'' device as defined in this
section because of any new intended use or other reasons, FDA may codify
the statutory classification of the device into class III for such new
use. Accordingly, the regulation for such a class III device states
that as of the enactment date of the amendments, May 28, 1976, the
device must have an approval under section 515 of the act before
commercial distribution.
21 CFR 862.9 Limitations of exemptions from section 510(k) of the act.
FDA's decision to grant an exemption from the requirement of
premarket notification (section 510(k) of the act) for a generic type of
class I device is based upon the existing and reasonably foreseeable
characteristics of commercially distributed devices within that generic
type. Because FDA cannot anticipate every change in intended use or
characteristic that could significantly affect a device's safety or
effectiveness, manufacturers of any commercially distributed class I
device for which FDA has granted an exemption from the requirement of
premarket notification must still submit a premarket notification to FDA
before introducing or delivering for introduction into interstate
commerce for commercial distribution the device when:
(a) The device is intended for a use different from its intended use
before May 28, 1976, or the device is intended for a use different from
the intended use of a preamendments device to which it had been
determined to be substantially equivalent; e.g., the device is intended
for a different medical purpose, or the device is intended for lay use
where the former intended use was by health care professionals only; or
(b) The modified device operates using a different fundamental
scientific technology than that in use in the device before May 28,
1976; e.g., a surgical instrument cuts tissue with a laser beam rather
than with a sharpened metal blade, or an in vitro diagnostic device
detects or identifies infectious agents by using a deoxyribonucleic acid
(DNA) probe or nucleic acid hybridization technology rather than culture
or immunoassay technology.
(53 FR 21448, June 8, 1988)
21 CFR 862.9 Subpart B -- Clinical Chemistry Test Systems
21 CFR 862.1020 Acid phosphatase (total or prostatic) test system.
(a) Identification. An acid phosphatase (total or prostatic) test
system is a device intended to measure the activity of the acid
phosphatase enzyme in plasma and serum.
(b) Classification. Class II.
21 CFR 862.1025 Adrenocorticotropic hormone (ACTH) test system.
(a) Identification. An adrenocorticotropic hormone (ACTH) test
system is a device intended to measure adrenocorticotropic hormone in
plasma and serum. ACTH measurements are used in the differential
diagnosis and treatment of certain disorders of the adrenal glands such
as Cushing's syndrome, adrenocortical insufficiency, and the ectopic
ACTH syndrome.
(b) Classification. Class II.
21 CFR 862.1030 Alanine amino transferase (ALT/SGPT) test system.
(a) Identification. An alanine amino transferase (ALT/SGPT) test
system is a device intended to measure the activity of the enzyme
alanine amino transferase (ALT) (also known as a serum glutamic pyruvic
transaminase or SGPT) in serum and plasma. Alanine amino transferase
measurements are used in the diagnosis and treatment of certain liver
diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.
(b) Classification. Class I.
21 CFR 862.1035 Albumin test system.
(a) Identification. An albumin test system is a device intended to
measure the albumin concentration in serum and plasma. Albumin
measurements are used in the diagnosis and treatment of numerous
diseases involving primarily the liver or kidneys.
(b) Classification. Class II.
21 CFR 862.1040 Aldolase test system.
(a) Identification. An aldolase test system is a device intended to
measure the activity of the enzyme aldolase in serum or plasma.
Aldolase measurements are used in the diagnosis and treatment of the
early stages of acute hepatitis and for certain muscle diseases such as
progressive Duchenne-type muscular dystrophy.
(b) Classification. Class I.
21 CFR 862.1045 Aldosterone test system.
(a) Identification. An aldosterone test system is a device intended
to measure the hormone aldosterone in serum and urine. Aldosterone
measurements are used in the diagnosis and treatment of primary
aldosteronism (a disorder caused by the excessive secretion of
aldosterone by the adrenal gland), hypertension caused by primary
aldosteronism, selective hypoaldosteronism, edematous states, and other
conditions of electrolyte imbalance.
(b) Classification. Class II.
21 CFR 862.1050 Alkaline phosphatase or isoenzymes test system.
(a) Identification. An alkaline phosphatase or isoenzymes test
system is a device intended to measure alkaline phosphatase or its
isoenzymes (a group of enzymes with similar biological activity) in
serum or plasma. Measurements of alkaline phosphatase or its isoenzymes
are used in the diagnosis and treatment of liver, bone, parathyroid, and
intestinal diseases.
(b) Classification. Class II.
21 CFR 862.1060 Delta-aminolevulinic acid test system.
(a) Identification. A delta-aminolevulinic acid test system is a
device intended to measure the level of delta-aminolevulinic acid (a
precursor of porphyrin) in urine. Delta-aminolevulinic acid
measurements are used in the diagnosis and treatment of lead poisoning
and certain porphyrias (diseases affecting the liver, gastrointestinal,
and nervous systems that are accompanied by increased urinary excretion
of various heme compounds including delta-aminolevulinic acid).
(b) Classification. Class I.
21 CFR 862.1065 Ammonia test system.
(a) Identification. An ammonia test system is a device intended to
measure ammonia levels in blood, serum, and plasma, Ammonia measurements
are used in the diagnosis and treatment of severe liver disorders, such
as cirrhosis, hepatitis, and Reye's syndrome.
(b) Classification. Class I.
21 CFR 862.1070 Amylase test system.
(a) Identification. An amylase test system is a device intended to
measure the activity of the enzyme amylase in serum and urine. Amylase
measurements are used primarily for the diagnosis and treatment of
pancreatitis (inflammation of the pancreas).
(b) Classification. Class II.
21 CFR 862.1075 Androstenedione test system.
(a) Identification. An androstenedione test system is a device
intended to measure androstenedione (a substance secreted by the testes,
ovary, and adrenal glands) in serum. Adrostenedione measurements are
used in the diagnosis and treatment of females with excessive levels of
androgen (male sex hormone) production.
(b) Classification. Class I.
21 CFR 862.1080 Androsterone test system.
(a) Identification. An androsterone test system is a device intended
to measure the hormone adrosterone in serum, plasma, and urine.
Androsterone measurements are used in the diagnosis and treatment of
gonadal and adrenal diseases.
(b) Classification. Class I.
21 CFR 862.1085 Angiotensin I and renin test system.
(a) Identification. An angiotensin I and renin test system is a
device intended to measure the level of angiotensin I generated by renin
in plasma. Angiotensin I measurements are used in the diagnosis and
treatment of certain types of hypertension.
(b) Classification. Class II.
21 CFR 862.1090 Angiotensin converting enzyme (A.C.E.) test system.
(a) Identification. An angiotensin converting enzyme (A.C.E.) test
system is a device intended to measure the activity of angiotensin
converting enzyme in serum and plasma. Measurements obtained by this
device are used in the diagnosis and treatment of diseases such as
sarcoidosis, a disease characterized by the formation of nodules in the
lungs, bones, and skin, and Gaucher's disease, a hereditary disorder
affecting the spleen.
(b) Classification. Class II.
21 CFR 862.1095 Ascorbic acid test system.
(a) Identification. An ascorbic acid test system is a device
intended to measure the level of ascorbic acid (vitamin C) in plasma,
serum, and urine. Ascorbic acid measurements are used in the diagnosis
and treatment of ascorbic acid dietary deficiencies.
(b) Classification. Class I.
21 CFR 862.1100 Aspartate amino transferase (AST/SGOT) test system.
(a) Identification. An aspartate amino transferase (AST/SGOT) test
system is a device intended to measure the activity of the enzyme
aspartate amino transferase (AST) (also known as a serum glutamic
oxaloacetic transferase or SGOT) in serum and plasma. Aspartate amino
transferase measurements are used in the diagnosis and treatment of
certain types of liver and heart disease.
(b) Classification. Class II.
21 CFR 862.1110 Bilirubin (total or direct) test system.
(a) Identification. A bilirubin (total or direct) test system is a
device intended to measure the levels of bilirubin (total or direct) in
plasma or serum. Measurements of the levels of bilirubin, an organic
compound formed during the normal and abnormal distruction of red blood
cells, if used in the diagnosis and treatment of liver, hemolytic
hematological, and metabolic disorders, including hepatitis and gall
bladder block.
(b) Classification. Class II.
21 CFR 862.1113 Bilirubin (total and unbound) in the neonate test
system.
(a) Identification. A bilirubin (total and unbound) in the neonate
test system is a device intended to measure the levels of bilirubin
(total and unbound) in the blood (serum) of newborn infants to aid in
indicating the risk of bilirubin encephalopathy (kernicterus).
(b) Classification. Class I.
(54 FR 30206, July 19, 1989)
21 CFR 862.1115 Urinary bilirubin and its conjugates (nonquantitative)
test system.
(a) Identification. A urinary bilirubin and its conjugates
(nonquantitative) test system is a device intended to measure the levels
of bilirubin conjugates in urine. Measurements of urinary bilirubin and
its conjugates (nonquantitative) are used in the diagnosis and treatment
of certain liver diseases.
(b) Classification. Class I.
21 CFR 862.1120 Blood gases (PCO2, PO2) and blood pH test system.
(a) Identification. A blood gases (PCO2, PO2) and blood pH test
system is a device intended to measure certain gases in blood, serum,
plasma or pH of blood, serum, and plasma. Measurements of blood gases
(PCO2, PO2) and blood pH are used in the diagnosis and treatment of
life-threatening acid-base disturbances.
(b) Classification. Class II.
21 CFR 862.1130 Blood volume test system.
(a) Identification. A blood volume test system is a device intended
to measure the circulating blood volume. Blood volume measurements are
used in the diagnosis and treatment of shock, hemorrhage, and
polycythemia vera (a disease characterized by an absolute increase in
erythrocyte mass and total blood volume).
(b) Classification. Class I.
21 CFR 862.1135 C-peptides of proinsulin test system.
(a) Identification. A C-peptides of proinsulin test system is a
device intended to measure C-peptides of proinsulin levels in serum,
plasma, and urine. Measurements of C-peptides of proinsulin are used in
the diagnosis and treatment of patients with abnormal insulin secretion,
including diabetes mellitus.
(b) Classification. Class I.
21 CFR 862.1140 Calcitonin test system.
(a) Identification. A calcitonin test system is a device intended to
measure the thyroid hormone calcitonin (thyrocalcitonin) levels in
plasma and serum. Calcitonin measurements are used in the diagnosis and
treatment of diseases involving the thyroid and parathyroid glands,
including carcinoma and hyperparathyroidism (excessive activity of the
parathyroid gland).
(b) Classification. Class II.
21 CFR 862.1145 Calcium test system.
(a) Identification. A calcium test system is a device intended to
measure the total calcium level in serum. Calcium measurements are used
in the diagnosis and treatment of parathyroid disease, a variety of bone
diseases, chronic renal disease and tetany (intermittent muscular
contractions or spasms).
(b) Classification. Class II.
21 CFR 862.1150 Calibrator.
(a) Identification. A calibrator is a device intended for medical
purposes for use in a test system to establish points of reference that
are used in the determination of values in the measurement of substances
in human specimens. (See also 862.2 in this part.)
(b) Classification. Class II.
21 CFR 862.1155 Human chorionic gonadotropin (HCG) test system.
(a) Human chorionic gonadotropin (HCG) test system intended for the
early detection of pregnancy -- (1) Identification. A human chorionic
gonadotropin (HCG) test system is a device intended for the early
detection of pregnancy is intended to measure HCG, a placental hormone,
in plasma or urine.
(2) Classification. Class II.
(b) Human chorionic gonadotropin (HCG) test system intended for any
uses other than early detection of pregnancy -- (1) Identification. A
human chorionic goadotropin (HCG) test system is a device intended for
any uses other than early detection of pregnancy (such as an aid in the
diagnosis, prognosis, and management of treatment of persons with
certain tumors or carcinomas) is intended to measure HCG, a placental
hormone, in plasma or urine.
(2) Classification. Class III.
(3) Date PMA or notice of completion of a PDP is required. As of the
enactment date of the amendments, May 28, 1976, an approval under
section 515 of the act is required before the device described in
paragraph (b)(1) may be commercially distributed. See 862.3.
21 CFR 862.1160 Bicarbonate/carbon dioxide test system.
(a) Identification. A bicarbonate/carbon dioxide test system is a
device intended to measure bicarbonate/carbon dioxide in plasma, serum,
and whole blood. Bicarbonate/carbon dioxide measurements are used in
the diagnosis and treatment of numerous potentially serious disorders
associated with changes in body acid-base balance.
(b) Classification. Class II.
21 CFR 862.1165 Catecholamines (total) test system.
(a) Identification. A catecholamines (total) test system is a device
intended to determine whether a group of similar compounds (epinephrine,
norepinephrine, and dopamine) are present in urine and plasma.
Catecholamine determinations are used in the diagnosis and treatment of
adrenal medulla and hypertensive disorders, and for
catecholamine-secreting tumors (pheochromo-cytoma, neuroblastoma,
ganglioneuroma, and retinoblastoma).
(b) Classification. Class I.
21 CFR 862.1170 Chloride test system.
(a) Identification. A chloride test system is a device intended to
measure the level of chloride in plasma, serum, sweat, and urine.
Chloride measurements are used in the diagnosis and treatment of
electrolyte and metabolic disorders such as cystic fibrosis and diabetic
acidosis.
(b) Classification. Class II.
21 CFR 862.1175 Cholesterol (total) test system.
(a) Identification. A cholesterol (total) test system is a device
intended to measure cholesterol in plasma and serum. Cholesterol
measurements are used in the diagnosis and treatment of disorders
involving excess cholesterol in the blood and lipid and lipoprotein
metabolism disorders.
(b) Classification. Class I.
21 CFR 862.1177 Cholylglycine test system.
(a) Identification. A cholylglycine test system is a device intended
to measure the bile acid cholylglycine in serum. Measurements obtained
by this device are used in the diagnosis and treatment of liver
disorders, such as cirrhosis or obstructive liver disease.
(b) Classification. Class II.
21 CFR 862.1180 Chymotrypsin test system.
(a) Identification. A chymotrypsin test system is a device intended
to measure the activity of the enzyme chymotrypsin in blood and other
body fluids and in feces. Chymotrypsin measurements are used in the
diagnosis and treatment of pancreatic exocrine insufficiency.
(b) Classification. Class I.
21 CFR 862.1185 Compound S (11-deoxycortisol) test system.
(a) Identification. A compound S (11-dioxycortisol) test system is a
device intended to measure the level of compound S (11-dioxycortisol) in
plasma. Compound S is a steroid intermediate in the biosynthesis of the
adrenal hormone cortisol. Measurements of compound S are used in the
diagnosis and treatment of certain adrenal and pituitary gland disorders
resulting in clinical symptoms of masculinization and hypertension.
(b) Classification. Class I.
21 CFR 862.1187 Conjugated sulfolithocholic acid (SLCG) test system.
(a) Identification. A conjugated sulfolithocholic acid (SLCG) test
system is a device intended to measure the bile acid SLCG in serum.
Measurements obtained by this device are used in the diagnosis and
treatment of liver disorders, such as cirrhosis or obstructive liver
disease.
(b) Classification. Class II.
21 CFR 862.1190 Copper test system.
(a) Identification. A copper test system is a device intended to
measure copper levels in plasma, serum, and urine. Measurements of
copper are used in the diagnosis and treatment of anemia, infections,
inflammations, and Wilson's disease (a hereditary disease primarily of
the liver and nervous system). Test results are also used in monitoring
patients with Hodgkin's disease (a disease primarily of the lymph
system).
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807.
(52 FR 16122, May 6, 1987, as amended at 53 FR 21449, June 8, 1988)
21 CFR 862.1195 Corticoids test system.
(a) Identification. A corticoids test system is a device intended to
measure the levels of corticoids (hormones of the adrenal cortex) in
serum and p lasma. Measurements of corticoids are used in the diagnosis
and treatment of disorders of the cortex of the adrenal glands,
especially those associated with hypertension and electrolyte
disturbances.
(b) Classification. Class I.
21 CFR 862.1200 Corticosterone test system.
(a) Identification. A corticosterone test system is a device
intended to measure corticosterone (a steroid secreted by the adrenal
gland) levels in plasma. Measurements of corticosterone are used in the
diagnosis and treatment of adrenal disorders such as adrenal cortex
disorders and blocks in cortisol synthesis.
(b) Classification. Class I.
21 CFR 862.1205 Cortisol (hydrocortisone and hydroxycorticosterone)
test system.
(a) Identification. A cortisol (hydrocortisone and
hydroxycorticosterone) test system is a device intended to measure the
cortisol hormones secreted by the adrenal gland in plasma and urine.
Measurements of cortisol are used in the diagnosis and treatment of
disorders of the adrenal gland.
(b) Classification. Class II.
21 CFR 862.1210 Creatine test system.
(a) Identification. A creatine test system is a device intended to
measure creatine (a substance synthesized in the liver and pancreas and
found in biological fluids) in plasma, serum, and urine. Measurements
of creatine are used in the diagnosis and treatment of muscle diseases
and endocrine disorders including hyperthyroidism.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807.
(52 FR 16122, May 6, 1987, as amended at 53 FR 21449, June 8, 1988)
21 CFR 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes
test system.
(a) Identification. A creatine phosphokinase/creatine kinase or
isoenzymes test system is a device intended to measure the activity of
the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes
with similar biological activity) in plasma and serum. Measurements of
creatine phosphokinase and its isoenzymes are used in the diagnosis and
treatment of myocardial infarction and muscle diseases such as
progressive, Duchenne-type muscular dystrophy.
(b) Classification. Class II.
21 CFR 862.1225 Creatinine test system.
(a) Identification. A creatinine test system is a device intended to
measure creatinine levels in plasma and urine. Creatinine measurements
are used in the diagnosis and treatment of renal diseases, in monitoring
renal dialysis, and as a calculation basis for measuring other urine
analytes.
(b) Classification. Class II.
21 CFR 862.1230 Cyclic AMP test system.
(a) Identification. A cyclic AMP test system is a device intended to
measure the level of adenosine 3 , 5 -monophosphate (cyclic AMP) in
plasma, urine, and other body fluids. Cyclic AMP measurements are used
in the diagnosis and treatment of endocrine disorders, including
hyperparathyroidism (overactivity of the parathyroid gland). Cyclic AMP
measurements may also be used in the diagnosis and treatment of Graves'
disease (a disorder of the thyroid) and in the differentiation of causes
of hypercalcemia (elevated levels of serum calcium.)
(b) Classification. Class II.
21 CFR 862.1240 Cystine test system.
(a) Identification. A cystine test system is a device intended to
measure the amino acid cystine in urine. Cystine measurements are used
in the diagnosis of cystinuria (occurrence of cystine in urine).
Patients with cystinuria frequently develop kidney calculi (stones).
(b) Classification. Class I.
21 CFR 862.1245 Dehydroepiandrosterone (free and sulfate) test system.
(a) Identification. A dehydroepiandrosterone (free and sulfate) test
system is a device intended to measure dehydroepiandrosterone (DHEA) and
its sulfate in urine, serum, plasma, and amniotic fluid.
Dehydroepiandrosterone measurements are used in the diagnosis and
treatment of DHEA-secreting adrenal carcinomas.
(b) Classification. Class I.
21 CFR 862.1250 Desoxycorticosterone test system.
(a) Identification. A desoxycorticosterone test system is a device
intended to measure desoxycorticosterone (DOC) in plasma and urine. DOC
measurements are used in the diagnosis and treatment of patients with
hypermineralocorticoidism (excess retention of sodium and loss of
potassium) and other disorders of the adrenal gland.
(b) Classification. Class I.
21 CFR 862.1255 2,3-Diphosphoglyceric acid test system.
(a) Identification. A 2,3-diphosphoglyceric acid test system is a
device intended to measure 2,3-diphosphoglyceric acid (2,3-DPG) in
erythrocytes (red blood cells). Measurements of 2,3-diphosphoglyceric
acid are used in the diagnosis and treatment of blood disorders that
affect the delivery of oxygen by erythrocytes to tissues and in
monitoring the quality of stored blood.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807.
(52 FR 16122, May 6, 1987, as amended at 53 FR 21449, June 8, 1988)
21 CFR 862.1260 Estradiol test system.
(a) Identification. An estradiol test system is a device intended to
measure estradiol, an estrogenic steroid, in plasma. Estradiol
measurements are used in the diagnosis and treatment of various hormonal
sexual disorders and in assessing placental function in complicated
pregnancy.
(b) Classification. Class I.
21 CFR 862.1265 Estriol test system.
(a) Identification. An estriol test system is a device intended to
measure estriol, an estrogenic steroid, in plasma, serum, and urine of
pregnant females. Estriol measurements are used in the diagnosis and
treatment of fetoplacental distress in certain cases of high-risk
pregnancy.
(b) Classification. Class I.
21 CFR 862.1270 Estrogens (total, in pregnancy) test system.
(a) Identification. As estrogens (total, in pregnancy) test system
is a device intended to measure total estrogens in plasma, serum, and
urine during pregnancy. The device primarily measures estrone plus
estradiol. Measurements of total estrogens are used to aid in the
diagnosis and treatment of fetoplacental distress in certain cases of
high-risk pregnancy.
(b) Classification. Class I.
21 CFR 862.1275 Estrogens (total, nonpregnancy) test system.
(a) Identification. As estrogens (total, nonpregnancy) test system
is a device intended to measure the level of estrogens (total estrone,
estradiol, and estriol) in plasma, serum, and urine of males and
nonpregnant females. Measurement of estrogens (total, nonpregnancy) is
used in the diagnosis and treatment of numerous disorders, including
infertility, amenorrhea (absence of menses) differentiation of primary
and secondary ovarian malfunction, estrogen secreting testicular and
ovarian tumors, and precocious puberty in females.
(b) Classification. Class I.
21 CFR 862.1280 Estrone test system.
(a) Identification. An estrone test system is a device intended to
measure estrone, an estrogenic steroid, in plasma. Estrone measurements
are used in the diagnosis and treatment of numerous disorders, including
infertility, amenorrhea, differentiation of primary and secondary
ovarian malfunction, estrogen secreting testicular and ovarian tumors,
and precocious puberty in females.
(b) Classification. Class I.
21 CFR 862.1285 Etiocholanolone test system.
(a) Identification. An etiocholanolone test system is a device
intended to measure etiocholanolone in serum and urine. Etiocholanolone
is a metabolic product of the hormone testosterone and is excreted in
the urine. Etiocholanolone measurements are used in the diagnosis and
treatment of disorders of the testes and ovaries.
(b) Classification. Class I.
21 CFR 862.1290 Fatty acids test system.
(a) Identification. A fatty acids test system is a device intended
to measure fatty acids in plasma and serum. Measurements of fatty acids
are used in the diagnosis and treatment of various disorders of lipid
metabolism.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807.
(52 FR 16122, May 6, 1987, as amended at 53 FR 21449, June 8, 1988)
21 CFR 862.1295 Folic acid test system.
(a) Identification. A folic acid test system is a device intended to
measure the vitamin folic acid in plasma and serum. Folic acid
measurements are used in the diagnosis and treatment of megaloblastic
anemia, which is characterized by the presence of megaloblasts (an
abnormal red blood cell series) in the bone marrow.
(b) Classification. Class II.
(52 FR 16122, May 6, 1987; 53 FR 11645, Apr. 8, 1988)
21 CFR 862.1300 Follicle-stimulating hormone test system.
(a) Identification. A follicle-stimulating hormone test system is a
device intended to measure follicle-stimulating hormone (FSH) in plasma,
serum, and urine. FSH measurements are used in the diagnosis and
treatment of pituitary gland and gonadal disorders.
(b) Classification. Class I.
21 CFR 862.1305 Formiminoglutamic acid (FIGLU) test system.
(a) Identification. A formiminoglutamic acid (FIGLU) test system is
a device intended to measure formiminolutamic acid in urine. FIGLU
measurements obtained by this device are used in the diagnosis of
anemias, such as pernicious anemia and congenital hemolytic anemia.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807.
(52 FR 16122, May 6, 1987, as amended at 53 FR 21449, June 8, 1988)
21 CFR 862.1310 Galactose test system.
(a) Identification. A galactose test system is a device intended to
measure galactose in blood and urine. Galactose measurements are used
in the diagnosis and treatment of the hereditary disease galactosemia (a
disorder of galactose metabolism) in infants.
(b) Classification. Class I.
21 CFR 862.1315 Galactose-1-phosphate uridyl transferase test system.
(a) Identification. A galactose-1-phosphate uridyl transferase test
system is a device intended to measure the activity of the enzyme
galactose-1-phosphate uridyl transferase in erythrocytes (red blood
cells). Measurements of galactose-1-phosphate uridyl transferase are
used in the diagnosis and treatment of the hereditary disease
galactosemia (disorder of galactose metabolism) in infants.
(b) Classification. Class II.
21 CFR 862.1320 Gastric acidity test system.
(a) Identification. A gastric acidity test system is a device
intended to measure the acidity of gastric fluid. Measurements of
gastric acidity are used in the diagnosis and treatment of patients with
peptic ulcer, Zollinger-Ellison syndrome (peptic ulcer due to
gastrin-secreting tumor of the pancreas), and related gastric disorders.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807.
(52 FR 16122, May 6, 1987, as amended at 53 FR 21449, June 8, 1988)
21 CFR 862.1325 Gastrin test system.
(a) Identification. A gastrin test system is a device intended to
measure the hormone gastrin in plasma and serum. Measurements of
gastrin are used in the diagnosis and treatment of patients with ulcers,
pernicious anemia, and the Zollinger-Ellison syndrome (peptic ulcer due
to a gastrin-secreting tumor of the pancreas).
(b) Classification. Class I.
21 CFR 862.1330 Globulin test system.
(a) Identification. A globulin test system is a device intended to
measure globulins (proteins) in plasma and serum. Measurements of
globulin are used in the diagnosis and treatment of patients with
numerous illnesses including severe liver and renal disease, multiple
myeloma, and other disorders of blood globulins.
(b) Classification. Class I.
21 CFR 862.1335 Glucagon test system.
(a) Identification. A glucagon test system is a device intended to
measure the pancreatic hormone glucagon in plasma and serum. Glucagon
measurements are used in the diagnosis and treatment of patients with
various disorders of carbohydrate metabolism, including diabetes
mellitus, hypoglycemia, and hyperglycemia.
(b) Classification. Class I.
21 CFR 862.1340 Urinary glucose (nonquantitative) test system.
(a) Identification. A urinary glucose (nonquantitative) test system
is a device intended to measure glucosuria (glucose in urine). Urinary
glucose (nonquantitative) measurements are used in the diagnosis and
treatment of carbohydrate metabolism disorders including diabetes
mellitus, hypoglycemia, and hyperglycemia.
(b) Classification. Class II.
21 CFR 862.1345 Glucose test system.
(a) Identification. A glucose test system is a device intended to
measure glucose quantitatively in blood and other body fluids. Glucose
measurements are used in the diagnosis and treatment of carbohydrate
metabolism disorders including diabetes mellitus, neonatal hypoglycemia,
and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
(b) Classification. Class II.
21 CFR 862.1360 Gamma-glutamyl transpeptidase and isoenzymes test
system.
(a) Identification. A gamma-glutamyl transpeptidase and isoenzymes
test system is a device intended to measure the activity of the enzyme
gamma-glutamyl transpeptidase (GGTP) in plasma and serum.
Gamma-glutamyl transpeptidase and isoenzymes measurements are used in
the diagnosis and treatment of liver diseases such as alcoholic
cirrhosis and primary and secondary liver tumors.
(b) Classification. Class I.
21 CFR 862.1365 Glutathione test system.
(a) Identification. A glutathione test system is a device intended
to measure glutathione (the tripeptide of glycine, cysteine, and
glutamic acid) in erythrocytes (red blood cells). Glutathione
measurements are used in the diagnosis and treatment of certain
drug-induced hemolytic (erythrocyte destroying) anemias due to an
inherited enzyme deficiency.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807.
(52 FR 16122, May 6, 1987, as amended at 53 FR 21449, June 8, 1988)
21 CFR 862.1370 Human growth hormone test system.
(a) Identification. A human growth hormone test system is a device
intended to measure the levels of human growth hormone in plasma. Human
growth hormone measurements are used in the diagnosis and treatment of
disorders involving the anterior lobe of the pituitary gland.
(b) Classification. Class I.
21 CFR 862.1375 Histidine test system.
(a) Identification. A histidine test system is a device intended to
measure free histidine (an amino acid) in plasma and urine. Histidine
measurements are used in the diagnosis and treatment of hereditary
histidinemia characterized by excess histidine in the blood and urine
often resulting in mental retardation and disordered speech development.
(b) Classification. Class I.
21 CFR 862.1377 Urinary homocystine (nonquantitative) test system.
(a) Identification. A urinary homocystine (nonquantitative) test
system is a device intended to identify homocystine (an analogue of the
amino acid cystine) in urine. The identification of urinary homocystine
is used in the diagnosis and treatment of homocystinuria (homosystine in
urine), a heritable metabolic disorder which may cause mental
retardation.
(b) Classification. Class II.
21 CFR 862.1380 Hydroxybutyric dehydrogenase test system.
(a) Identification. A hydroxybutyric dehydrogenase test system is a
device intended to measure the activity of the enzyme
alpha-hydroxybutric dehydrogenase (HBD) in plasma or serum. HBD
measurements are used in the diagnosis and treatment of myocardial
infarction, renal damage (such as rejection of transplants), certain
hematological diseases (such as acute leukemias and megaloblastic
anemias) and, to a lesser degree, liver disease.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807.
(52 FR 16122, May 6, 1987, as amended at 53 FR 21449, June 8, 1988)
21 CFR 862.1385 17-Hydroxycorticosteroids (17-ketogenic steroids) test
system.
(a) Identification. A 17-hydroxycorticosteroids (17-ketogenic
steroids) test system is a device intended to measure corticosteroids
that possess a dihydroxyacetone
moiety on the steroid nucleus in urine. Corticosteroids with this
chemical configuration include cortisol, cortisone 11-desoxycortisol,
desoxycorticosterone, and their tetrahydroderivatives. This group of
hormones is synthesized by the adrenal gland. Measurements of
17-hydroxycorticosteroids (17-ketogenic steroids) are used in the
diagnosis and treatment of various diseases of the adrenal or pituitary
glands and gonadal disorders.
(b) Classification. Class I.
(52 FR 16122, May. 1, 1987; 52 FR 29468, Aug. 7, 1987)
21 CFR 862.1390 5-Hydroxyindole acetic acid/serotonin test system.
(a) Identification. A 5-hydroxyindole acetic acid/serotonin test
system is a device intended to measure 5-hydroxyindole acetic
acid/serotonin in urine. Measurements of 5-hydroxyindole acetic
acid/serotonin are used in the diagnosis and treatment of carcinoid
tumors of endocrine tissue.
(b) Classification. Class I.
21 CFR 862.1395 17-Hydroxyprogesterone test system.
(a) Identification. A 17-hydroxyprogesterone test system is a device
intended to measure 17-hydroxyprogesterone (a steroid) in plasma and
serum. Measurements of 17-hydroxyprogesterone are used in the diagnosis
and treatment of various disorders of the adrenal glands or the ovaries.
(b) Classification. Class I.
21 CFR 862.1400 Hydroxyproline test system.
(a) Identification. A hydroxyproline test system is a device
intended to measure the amino acid hydroxyproline in urine.
Hydroxyproline measurements are used in the diagnosis and treatment of
various collagen (connective tissue) diseases, bone disease such as
Paget's disease, and endocrine disorders such as hyperparathyroidism and
hyperthyroidism.
(b) Classification. Class I.
21 CFR 862.1405 Immunoreactive insulin test system.
(a) Identification. An immunoreactive insulin test system is a
device intended to measure immunoreactive insulin in serum and plasma.
Immunoreactive insulin measurements are used in the diagnosis and
treatment of various carbohydrate metabolism disorders, including
diabetes mellitus, and hypoglycemia.
(b) Classification. Class I.
21 CFR 862.1410 Iron (non-heme) test system.
(a) Identification. An iron (non-heme) test system is a device
intended to measure iron (non-heme) in serum and plasma. Iron
(non-heme) measurements are used in the diagnosis and treatment of
diseases such as iron deficiency anemia, hemochromatosis (a disease
associated with widespread deposit in the tissues of two iron-containing
pigments, hemosiderin and hemofuscin, and characterized by pigmentation
of the skin), and chronic renal disease.
(b) Classification. Class I.
21 CFR 862.1415 Iron-binding capacity test system.
(a) Identification. An iron-binding capacity test system is a device
intended to measure iron-binding capacity in serum. Iron-binding
capacity measurements are used in the diagnosis and treatment of anemia.
(b) Classification. Class I.
21 CFR 862.1420 Isocitric dehydrogenase test system.
(a) Identification. An isocitric dehydrogenase test system is a
device intended to measure the activity of the enzyme isocitric
dehydrogenase in serum and plasma. Isocitric dehydrogenase measurements
are used in the diagnosis and treatment of liver disease such as viral
hepatitis, cirrhosis, or acute inflammation of the biliary tract;
pulmonary disease such as pulmonary infarction (local arrest or sudden
insufficiency of the blood supply to the lungs), and diseases associated
with pregnancy.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807.
(52 FR 16122, May 6, 1987, as amended at 53 FR 21449, June 8, 1988)
21 CFR 862.1430 17-Ketosteroids test system.
(a) Identification. A 17-ketosteroids test system is a device
intended to measure 17-ketosteroids in urine. Measurements of
17-ketosteroids are used in the diagnosis and treatment of disorders of
the adrenal cortex and gonads and of other endocrine disorders,
including hypertension, diabetes, and hypothyroidism.
(b) Classification. Class I.
21 CFR 862.1435 Ketones (nonquantitative) test system.
(a) Identification. A ketones (nonquantitative) test system is a
device intended to identify ketones in urine and other body fluids.
Identification of ketones is used in the diagnosis and treatment of
acidosis (a condition characterized by abnormally high acidity of body
fluids) or ketosis (a condition characterized by increased production of
ketone bodies such as acetone) and for monitoring patients on ketogenic
diets and patients with diabetes.
(b) Classification. Class I.
21 CFR 862.1440 Lactate dehydrogenase test system.
(a) Identification. A lactate dehydrogenase test system is a device
intended to measure the activity of the enzyme lactate dehydrogenase in
serum. Lactate dehydrogenase measurements are used in the diagnosis and
treatment of liver diseases such as acute viral hepatitis, cirrhosis,
and metastatic carcinoma of the liver, cardiac diseases such as
myocardial infarction, and tumors of the lung or kidneys.
(b) Classification. Class II.
21 CFR 862.1445 Lactate dehydrogenase isoenzymes test system.
(a) Identification. A lactate dehydrogenase isoenzymes test system
is a device intended to measure the activity of lactate dehydrogenase
isoenzymes (a group of enzymes with similar biological activity) in
serum. Measurements of lactate dehydrogenase isoenzymes are used in the
diagnosis and treatment of liver diseases, such as viral hepatitis, and
myocardial infarction.
(b) Classification. Class II.
21 CFR 862.1450 Lactic acid test system.
(a) Identification. A lactic acid test system is a device intended
to measure lactic acid in whole blood and plasma. Lactic acid
measurements that evaluate the acid-base status are used in the
diagnosis and treatment of lactic acidosis (abnormally high acidity of
the blood).
(b) Classification. Class I.
21 CFR 862.1455 Lecithin/sphingomyelin ratio in amniotic fluid test
system.
(a) Identification. A lecithin/sphingomyelin ratio in amniotic fluid
test system is a device intended to measure the lecithin/sphingomyelin
ratio in amniotic fluid. Lecithin and sphingomyelin are phospholipids
(fats or fat-like substances containing phosphorus). Measurements of
the lecithin/sphingomyelin ratio in amniotic fluid are used in
evaluating fetal maturity.
(b) Classification. Class II.
21 CFR 862.1460 Leucine aminopeptidase test system.
(a) Identification. A leucine aminopeptidase test system is a device
intended to measure the activity of the enzyme leucine amino-peptidase
in serum, plasma, and urine. Leucine aminopeptidase measurements are
used in the diagnosis and treatment of liver diseases such as viral
hepatitis and obstructive jaundice.
(b) Classification. Class I.
21 CFR 862.1465 Lipase test system.
(a) Identification. A lipase test system is a device intended to
measure the activity of the enzymes lipase in serum. Lipase
measurements are used in diagnosis and treatment of diseases of the
pancreas such as acute pancreatitis and obstruction of the pancreatic
duct.
(b) Classification. Class I.
21 CFR 862.1470 Lipid (total) test system.
(a) Identification. A lipid (total) test system is a device intended
to measure total lipids (fats or fat-like substances) in serum and
plasma. Lipid (total) measurements are used in the diagnosis and
treatment of various diseases involving lipid metabolism and
atherosclerosis.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807.
(52 FR 16122, May 6, 1987, as amended at 53 FR 21449, June 8, 1988)
21 CFR 862.1475 Lipoprotein test system.
(a) Identification. A lipoprotein test system is a device intended
to measure lipoprotein in serum and plasma. Lipoprotein measurements
are used in the diagnosis and treatment of lipid disorders (such as
diabetes mellitus), atherosclerosis, and various liver and renal
diseases.
(b) Classification. Class I.
21 CFR 862.1485 Luteinizing hormone test system.
(a) Identification. A luteinizing hormone test system is a device
intended to measure luteinizing hormone in serum and urine. Luteinizing
hormone measurements are used in the diagnosis and treatment of gonadal
dysfunction.
(b) Classification. Class I.
21 CFR 862.1490 Lysozyme (muramidase) test system.
(a) Identification. A lysozyme (muramidase) test system is a device
intended to measure the activity of the bacteriolytic enzyme lysozyme
(muramidase) in serum, plasma, leukocytes, and urine. Lysozyme
measurements are used in the diagnosis and treatment of monocytic
leukemia and kidney disease.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807.
(52 FR 16122, May 6, 1987, as amended at 53 FR 21449, June 8, 1988)
21 CFR 862.1495 Magnesium test system.
(a) Identification. A magnesium test system is a device intended to
measure magnesium levels in serum and plasma. Magnesium measurements
are used in the diagnosis and treatment of hypomagnesemia (abnormally
low plasma levels of magnesium) and hypermagnesemia (abnormally high
plasma levels of magnesium).
(b) Classification. Class I.
21 CFR 862.1500 Malic dehydrogenase test system.
(a) Identification. A malic dehydrogenase test system is a device
that is intended to measure the activity of the enzyme malic
dehydrogenase in serum and plasma. Malic dehydrogenase measurements are
used in the diagnosis and treatment of muscle and liver diseases,
myocardial infarctions, cancer, and blood disorders such as myelogenous
(produced in the bone marrow) leukemia.
(b) Classification. Class I.
21 CFR 862.1505 Mucopolysaccharides (nonquantitative) test system.
(a) Identification. A mucopolysaccharides (nonquantitative) test
system is a device intended to measure the levels of mucopolysaccharides
in urine. Mucopolysaccharide measurements in urine are used in the
diagnosis and treatment of various inheritable disorders that affect
bone and connective tissues, such as Hurler's, Hunter's, Sanfilippo's,
Scheie's Morquio's and Maroteaux-Lamy syndromes.
(b) Classification. Class I.
21 CFR 862.1509 Methylmalonic acid (nonquantitative) test system.
(a) Identification. A methylmalonic acid (nonquantitative) test
system is a device intended to identify methylmalonic acid in urine.
The identification of methylmalonic acid in urine is used in the
diagnosis and treatment of methylmalonic aciduria, a heritable metabolic
disorder which, if untreated, may cause mental retardation.
(b) Classification. Class II.
21 CFR 862.1510 Nitrite (nonquantitative) test system.
(a) Identification. A nitrite (nonquantitative) test system is a
device intended to identify nitrite in urine. Nitrite identification is
used in the diagnosis and treatment of uninary tract infection of
bacterial origin.
(b) Classification. Class I.
21 CFR 862.1515 Nitrogen (amino-nitrogen) test system.
(a) Identification. A nitrogen (amino-nitrogen) test system is a
device intended to measure amino acid nitrogen levels in serum, plasma,
and urine. Nitrogen (amino-nitrogen) measurements are used in the
diagnosis and treatment of certain forms of severe liver disease and
renal disorders.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807.
(52 FR 16122, May 6, 1987, as amended at 53 FR 21449, June 8, 1988)
21 CFR 862.1520 5'-Nucleotidase test system.
(a) Identification. A 5'-nucleotidase test system is a device
intended to measure the activity of the enzyme 5'-nucleotidase in serum
and plasma. Measurements of 5'-nucleotidase are used in the diagnosis
and treatment of liver diseases and in the differentiations between
liver and bone diseases in the presence of elevated serum alkaline
phosphatase activity.
(b) Classification. Class I.
21 CFR 862.1530 Plasma oncometry test system.
(a) Identification. A plasma oncometry test system is a device
intended to measure plasma oncotic pressure. Plasma oncotic pressure is
that portion of the total fluid pressure contributed by proteins and
other molecules too large to pass through a specified membrane.
Measurements of plasma oncotic pressure are used in the diagnosis and
treatment of dehydration and circulatory disorders related to low serum
protein levels and increased capillary permeability, such as edema and
shock.
(b) Classification. Class I.
21 CFR 862.1535 Ornithine carbamyl transferase test system.
(a) Identification. An ornithine carbamyl transferase test system is
a device intended to measure the activity of the enzyme ornithine
carbamyl transferase (OCT) in serum. Ornithine carbamyl transferase
measurements are used in the diagnosis and treatment of liver diseases,
such as infectious hepatitis, acute cholecystitis (inflammation of the
gall bladder), cirrhosis, and liver metastases.
(b) Classification. Class I.
21 CFR 862.1540 Osmolality test system.
(a) Identification. An osmolality test system is a device intended
to measure ionic and nonionic solute concentration in body fluids, such
as serum and urine. Osmolality measurement is used as an adjunct to
other tests in the evaluation of a variety of diseases, including kidney
diseases (e.g., chronic progressive renal failure), diabetes insipidus,
other endocrine and metabolic disorders, and fluid imbalances.
(b) Classification. Class I.
21 CFR 862.1542 Oxalate test system.
(a) Identification. An oxalate test system is a device intended to
measure the concentration of oxalate in urine. Measurements of oxalate
are used to aid in the diagnosis or treatment of urinary stones or
certain other metabolic disorders.
(b) Classification. Class I.
21 CFR 862.1545 Parathyroid hormone test system.
(a) Identification. A parathyroid hormone test system is a device
intended to measure the levels of parathyroid hormone in serum and
plasma. Measurements of parathyroid hormone levels are used in the
differential diagnosis of hypercalcemia (abnormally high levels of
calcium in the blood) and hypocalcemia (abnormally low levels of calcium
in the blood) resulting from disorders of calcium metabolism.
(b) Classification. Class II.
21 CFR 862.1550 Urinary pH (nonquantitative) test system.
(a) Identification. A urinary pH (nonquantitative) test system is a
device intended to estimate the pH of urine. Estimations of pH are used
to evaluate the acidity or alkalinity of urine as it relates to numerous
renal and metabolic disorders and in the monitoring of patients with
certain diets.
(b) Classification. Class I.
21 CFR 862.1555 Phenylalanine test system.
(a) Identification. A phenylalanine test system is a device intended
to measure free phenylalanine (an amino acid) in serum, plasma, and
urine. Measurements of phenylalanine are used in the diagnosis and
treatment of congenital phenylketonuria which, if untreated, may cause
mental retardation.
(b) Classification. Class II.
21 CFR 862.1560 Urinary phenylketones (nonquantitative) test system.
(a) Identification. A urinary phenylketones (nonquantitative) test
system is a device intended to identify phenylketones (such as
phenylpyruvic acid) in urine. The identification of urinary
phenylketones is used in the diagnosis and treatment of congenital
phenylketonuria which, if untreated, may cause mental retardation.
(b) Classification. Class I.
21 CFR 862.1565 6-Phosphogluconate dehydrogenase test system.
(a) Identification. A 6-phosphogluconate dehydrogenase test system
is a device intended to measure the activity of the enzyme
6-phosphogluconate dehydrogenase (6 PGD) in serum and erythrocytes.
Measurements of 6-phosphogluconate dehydrogenase are used in the
diagnosis and treatment of certain liver diseases (such as hepatitis)
and anemias.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807.
(52 FR 16122, May 6, 1987, as amended at 53 FR 21449, June 8, 1988)
21 CFR 862.1570 Phosphohexose isomerase test system.
(a) Identification. A phosphohexose isomerase test system is a
device intended to measure the activity of the enzyme phosphohexose
isomerase in serum. Measurements of phosphohexose isomerase are used in
the diagnosis and treatment of muscle diseases such as muscular
dystrophy, liver diseases such as hepatitis or cirrhosis, and metastatic
carcinoma.
(b) Classification. Class I.
21 CFR 862.1575 Phospholipid test system.
(a) Identification. A phospholipid test system is a device intended
to measure phospholipids in serum and plasma. Measurements of
phospholipids are used in the diagnosis and treatment of disorders
involving lipid (fat) metabolism.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807.
(52 FR 16122, May 6, 1987, as amended at 53 FR 21449, June 8, 1988)
21 CFR 862.1580 Phosphorus (inorganic) test system.
(a) Identification. A phosphorus (inorganic) test system is a device
intended to measure inorganic phosphorus in serum, plasma, and urine.
Measurements of phosphorus (inorganic) are used in the diagnosis and
treatment of various disorders, including parathyroid gland and kidney
diseases, and vitamin D imbalance.
(b) Classification. Class I.
21 CFR 862.1585 Human placental lactogen test system.
(a) Identification. A human placental lactogen test system is a
device intended to measure the hormone human placental lactogen (HPL),
(also known as human chorionic somatomammotrophin (HCS)), in maternal
serum and maternal plasma. Measurements of human placental lactogen are
used in the diagnosis and clinical management of high-risk pregnancies
involving fetal distress associated with placental insufficiency.
Measurements of HPL are also used in pregnancies complicated by
hypertension, proteinuria, edema, post-maturity, placental
insufficiency, or possible miscarriage.
(b) Classification. Class II.
21 CFR 862.1590 Porphobilinogen test system.
(a) Identification. A porphobilinogen test system is a device
intended to measure porphobilinogen (one of the derivatives of
hemoglobin which can make the urine a red color) in urine. Measurements
obtained by this device are used in the diagnosis and treatment of
porphyrias (primarily inherited diseases associated with disturbed
porphyrine metabolism), lead poisoning, and other diseases characterized
by alterations in the heme pathway.
(b) Classification. Class I.
21 CFR 862.1595 Porphyrins test system.
(a) Identification. A porphyrins test system is a device intended to
measure porphyrins (compounds formed during the biosynthesis of heme, a
constituent of hemoglobin, and related compounds) in urine and feces.
Measurements obtained by this device are used in the diagnosis and
treatment of lead poisoning, porphyrias (primarily inherited diseases
associated with disturbed porphyrin metabolism), and other diseases
characterized by alterations in the heme pathway.
(b) Classification. Class I.
21 CFR 862.1600 Potassium test system.
(a) Identification. A potassium test system is a device intended to
measure potassium in serum, plasma, and urine. Measurements obtained by
this device are used to monitor electrolyte balance in the diagnosis and
treatment of diseases conditions characterized by low or high blood
potassium levels.
(b) Classification. Class II.
21 CFR 862.1605 Pregnanediol test system.
(a) Identification. A pregnanediol test system is a device intended
to measure pregnanediol (a major urinary metabolic product of
progesterone) in urine. Measurements obtained by this device are used
in the diagnosis and treatment of disorders of the ovaries or placenta.
(b) Classification. Class I.
21 CFR 862.1610 Pregnanetriol test system.
(a) Identification. A pregnanetriol test system is a device intended
to measure pregnanetriol (a precursor in the biosynthesis of the adrenal
hormone cortisol) in urine. Measurements obtained by this device are
used in the diagnosis and treatment of congenital adrenal hyperplasia
(congenital enlargement of the adrenal gland).
(b) Classification. Class I.
21 CFR 862.1615 Pregnenolone test system.
(a) Identification. A pregnenolone test system is a device intended
to measure pregnenolone (a precursor in the biosynthesis of the adrenal
hormone cortisol and adrenal androgen) in serum and plasma.
Measurements obtained by this device are used in the diagnosis and
treatment of diseases of the adrenal cortex or the gonads.
(b) Classification. Class I.
21 CFR 862.1620 Progesterone test system.
(a) Identification. A progesterone test system is a device intended
to measure progesterone (a female hormone) in serum and plasma.
Measurements obtained by this device are used in the diagnosis and
treatment of disorders of the ovaries or placenta.
(b) Classification. Class I.
21 CFR 862.1625 Prolactin (lactogen) test system.
(a) Identification. A prolactin (lactogen) test system is a device
intended to measure the anterior pituitary polypeptide hormone prolactin
in serum and plasma. Measurements obtained by this device are used in
the diagnosis and treatment of disorders of the anterior pituitary gland
or of the hypothalamus portion of the brain.
(b) Classification. Class I.
21 CFR 862.1630 Protein (fractionation) test system.
(a) Identification. A protein (fractionation) test system is a
device intended to measure protein fractions in blood, urine,
cerebrospinal fluid, and other body fluids. Protein fractionations are
used as a aid in recognizing abnormal proteins in body fluids and
genetic variants of proteins produced in diseases with tissue
destruction.
(b) Classification. Class I.
21 CFR 862.1635 Total protein test system.
(a) Identification. A total protein test system is a device intended
to measure total protein(s) in serum or plasma. Measurements obtained
by this device are used in the diagnosis and treatment of a variety of
diseases involving the liver, kidney, or bone marrow as well as other
metabolic or nutritional disorders.
(b) Classification. Class II.
21 CFR 862.1640 Protein-bound iodine test system.
(a) Identification. A protein-bound iodine test system is a device
intended to measure protein-bound iodine in serum. Measurements of
protein-bound iodine obtained by this device are used in the diagnosis
and treatment of thyroid disorders.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807.
(52 FR 16122, May 6, 1987, as amended at 53 FR 21449, June 8, 1988)
21 CFR 862.1645 Urinary protein or albumin (nonquantitative) test
system.
(a) Identification. A urinary protein or albumin (nonquantitative)
test system is a device intended to identify proteins or albumin in
urine. Identification of urinary protein or albumin (nonquantitative)
is used in the diagnosis and treatment of disease conditions such as
renal or heart diseases or thyroid disorders, which are characterized by
proteinuria or albuminuria.
(b) Classification. Class I.
21 CFR 862.1650 Pyruvate kinase test system.
(a) Identification. A pyruvate kinase test system is a device
intended to measure the activity of the enzyme pyruvate kinase in
erythrocytes (red blood cells). Measurements obtained by this device
are used in the diagnosis and treatment of various inherited anemias due
to pyruvate kinase deficiency or of acute leukemias.
(b) Classification. Class I.
21 CFR 862.1655 Pyruvic acid test system.
(a) Identification. A pyruvic acid test system is a device intended
to measure pyruvic acid (an intermediate compound in the metabolism of
carbohydrate) in plasma. Measurements obtained by this device are used
in the evaluation of electrolyte metabolism and in the diagnosis and
treatment of acid-base and electrolyte disturbances or anoxia (the
reduction of oxygen in body tissues).
(b) Classification. Class I.
21 CFR 862.1660 Quality control material (assayed and unassayed).
(a) Identification. A quality control material (assayed and
unassayed) for clinical chemistry is a device intended for medical
purposes for use in a test system to estimate test precision and to
detect systematic analytical deviations that may arise from reagent or
analytical instrument variation. A quality control material (assayed
and unassayed) may be used for proficiency testing in interlaboratory
surveys. This generic type of device includes controls (assayed and
unassayed) for blood gases, electrolytes, enzymes, multianalytes (all
kinds), single (specified) analytes, or urinalysis controls.
(b) Classification. Class I.
21 CFR 862.1665 Sodium test system.
(a) Identification. A sodium test system is a device intended to
measure sodium in serum, plasma, and urine. Measurements obtained by
this device are used in the diagnosis and treatment of aldosteronism
(excessive secretion of the hormone aldosterone), diabetes insipidus
(chronic excretion of large amounts of dilute urine, accompanied by
extreme thirst), adrenal hypertension, Addison's disease (caused by
destruction of the adrenal glands), dehydration, inappropriate
antidiuretic hormone secretion, or other diseases involving electrolyte
imbalance.
(b) Classification. Class II.
21 CFR 862.1670 Sorbitol dehydrogenase test system.
(a) Identification. A sorbitol dehydrogenase test system is a device
intended to measure the activity of the enzyme sorbitol dehydrogenase in
serum. Measurements obtained by this device are used in the diagnosis
and treatment of liver disorders such as cirrhosis or acute hepatitis.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807.
(52 FR 16122, May 6, 1987, as amended at 53 FR 21449, June 8, 1988)
21 CFR 862.1675 Blood specimen collection device.
(a) Identification. A blood specimen collection device is a device
intended for medical purposes to collect and to handle blood specimens
and to separate serum from nonserum (cellular) components prior to
further testing. This generic type device may include blood collection
tubes, vials, systems, serum separators, blood collection trays, or
vacuum sample tubes.
(b) Classification. Class II.
21 CFR 862.1680 Testosterone test system.
(a) Identification. A testosterone test system is a device intended
to measure testosterone (a male sex hormone) in serum, plasma, and
urine. Measurement of testosterone are used in the diagnosis and
treatment of disorders involving the male sex hormones (androgens),
including primary and secondary hypogonadism, delayed or precocious
puberty, impotence in males and, in females hirsutism (excessive hair)
and virilization (masculinization) due to tumors, polycystic ovaries,
and adrenogenital syndromes.
(b) Classification. Class I.
(52 FR 16122, May 6, 1987; 53 FR 11645, Apr. 8, 1988)
21 CFR 862.1685 Thyroxine-binding globulin test system.
(a) Identification. A thyroxine-binding globulin test system is a
device intended to measure thyroxine (thyroid)-binding globulin (TBG), a
plasma protein which binds thyroxine, in serum and plasma. Measurements
obtained by this device are used in the diagnosis and treatment of
thyroid diseases.
(b) Classification. Class II.
21 CFR 862.1690 Thyroid stimulating hormone test system.
(a) Identification. A thyroid stimulating hormone test system is a
device intended to measure thyroid stimulating hormone, also known as
thyrotrophin and thyrotrophic hormone, in serum and plasma.
Measurements of thyroid stimulating hormone produced by the anterior
pituitary are used in the diagnosis of thyroid or pituitary disorders.
(b) Classification. Class II.
21 CFR 862.1695 Free thyroxine test system.
(a) Identification. A free thyroxine test system is a device
intended to measure free (not protein bound) thyroxine (thyroid hormone)
in serum or plasma. Levels of free thyroxine in plasma are thought to
reflect the amount of thyroxine hormone available to the cells and may
therefore determine the clinical metabolic status of thyroxine.
Measurements obtained by this device are used in the diagnosis and
treatment of thyroid diseases.
(b) Classification. Class II.
21 CFR 862.1700 Total thyroxine test system.
(a) Identification. A total thyroxine test system is a device
intended to measure total (free and protein bound) thyroxine (thyroid
hormone) in serum and plasma. Measurements obtained by this device are
used in the diagnosis and treatment of thyroid diseases.
(b) Classification. Class II.
21 CFR 862.1705 Triglyceride test system.
(a) Identification. A triglyceride test system is a device intended
to measure triglyceride (neutral fat) in serum and plasma. Measurements
obtained by this device are used in the diagnosis and treatment of
patients with diabetes mellitus, nephrosis, liver obstruction, other
diseases involving lipid metabolism, or various endocrine disorders.
(b) Classification. Class I.
21 CFR 862.1710 Total triiodothyronine test system.
(a) Identification. A total triiodothyronine test system is a device
intended to measure the hormone triiodothyronine in serum and plasma.
Measurements obtained by this device are used in the diagnosis and
treatment of thyroid diseases such as hyperthyroidism.
(b) Classification. Class II.
21 CFR 862.1715 Triiodothyronine uptake test system.
(a) Identification. A triiodothyronine uptake test system is a
device intended to measure the total amount of binding sites available
for binding thyroid hormone on the thyroxine-binding proteins,
thyroid-binding globulin, thyroxine-binding prealbumin, and albumin of
serum and plasma. The device provides an indirect measurement of
thyrkoxine levels in serum and plasma. Measurements of triiodothyronine
uptake are used in the diagnosis and treatment of thyroid disorders.
(b) Classification. Class II.
21 CFR 862.1720 Triose phosphate isomerase test system.
(a) Identification. A triose phosphate isomerase test system is a
device intended to measure the activity of the enzyme triose phosphate
isomerase in erythrocytes (red blood cells). Triose phosphate isomerase
is an enzyme important in glycolysis (the energy-yielding conversion of
glucose to lactic acid in various tissues). Measurements obtained by
this device are used in the diagnosis and treatment of congenital triose
phosphate isomerase enzyme deficiency, which causes a type of hemolytic
anemia.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807.
(52 FR 16122, May 6, 1987, as amended at 53 FR 21449, June 8, 1988)
21 CFR 862.1725 Trypsin test system.
(a) Identification. A trypsin test system is a device intended to
measure the activity of trypsin (a pancreatic enzyme important in
digestion for the breakdown of proteins) in blood and other body fluids
and in feces. Measurements obtained by this device are used in the
diagnosis and treatment of pancreatic disease.
(b) Classification. Class I.
21 CFR 862.1730 Free tyrosine test system.
(a) Identification. A free tyrosine test system is a device intended
to measure free tyrosine (an amono acid) in serum and urine.
Measurements obtained by this device are used in the diagnosis and
treatment of diseases such as congenital tyrosinemia (a disease that can
cause liver/kidney disorders) and as an adjunct to the measurement of
phenylalanine in detecting congenital phenylketonuria (a disease that
can cause brain damage).
(b) Classification. Class I.
21 CFR 862.1770 Urea nitrogen test system.
(a) Identification. A urea nitrogen test system is a device intended
to measure urea nitrogen (an end-product of nitrogen metabolism) in
whole blood, serum, plasma, and urine. Measurements obtained by this
device are used in the diagnosis and treatment of certain renal and
metabolic diseases.
(b) Classification. Class II.
21 CFR 862.1775 Uric acid test system.
(a) Identification. A uric acid test system is a device intended to
measure uric acid in serum, plasma, and urine. Measurements obtained by
this device are used in the diagnosis and treatment of numerous renal
and metabolic disorders, including renal failure, gout, leukemia,
psoriasis, starvation or other wasting conditions, and of patients
receiving cytotoxic drugs.
(b) Classification. Class I.
21 CFR 862.1780 Urinary calculi (stones) test system.
(a) Identification. A urinary calculi (stones) test system is a
device intended for the analysis of urinary calculi. Analysis of
urinary calculi is used in the diagnosis and treatment of calculi of the
urinary tract.
(b) Classification. Class I.
21 CFR 862.1785 Urinary urobilinogen (nonquantitative) test system.
(a) Identification. A urinary urobilinogen (nonquantitative) test
system is a device intended to detect and estimate urobilinogen (a bile
pigment degradation product of red cell hemoglobin) in urine.
Estimations obtained by this device are used in the diagnosis and
treatment of liver diseases and hemolytic (red cells) disorders.
(b) Classification. Class I.
21 CFR 862.1790 Uroporphyrin test system.
(a) Identification. A uroporphyrin test system is a device intended
to measure uroporphyrin in urine. Measurements obtained by this device
are used in the diagnosis and treatment of porphyrias (primarily
inherited diseases associated with disturbed porphyrin metabolism), lead
poisoning, and other diseases characterized by alterations in the heme
pathway.
(b) Classification. Class I.
21 CFR 862.1795 Vanilmandelic acid test system.
(a) Identification. A vanilmandelic acid test system is a device
intended to measure vanilmandelic acid in urine. Measurements of
vanilmandelic acid obtained by this device are used in the diagnosis and
treatment of neuroblastoma, pheochromocytoma, and certain hypertensive
conditions.
(b) Classification. Class I.
21 CFR 862.1805 Vitamin A test system.
(a) Identification. A vitamin A test system is a device intended to
measure vitamin A in serum or plasma. Measurements obtained by this
device are used in the diagnosis and treatment of vitamin A deficiency
conditions, including night blindness, or skin, eye, or intestinal
disorders.
(b) Classification. Class I.
21 CFR 862.1810 Vitamin B12 test system.
(a) Identification. A vitamin B12 test system is a device intended
to measure vitamin B12 in serum, plasma, and urine. Measurements
obtained by this device are used in the diagnosis and treatment of
anemias of gastrointestinal malabsorption.
(b) Classification. Class II.
21 CFR 862.1815 Vitamin E test system.
(a) Identification. A vitamin E test system is a device intended to
measure vitamin E (tocopherol) in serum. Measurements obtained by this
device are used in the diagnosis and treatment of infants with vitamin E
deficiency syndrome.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807.
(52 FR 16122, May 6, 1987, as amended at 53 FR 21449, June 8, 1988)
21 CFR 862.1820 Xylose test system.
(a) Identification. A xylose test system is a device intended to
measure xylose (a sugar) in serum, plasma, and urine. Measurements
obtained by this device are used in the diagnosis and treatment of
gastrointestinal malabsorption syndrome (a group of disorders in which
there is subnormal absorption of dietary constituents and thus excessive
loss from the body of the nonabsorbed substances).
(b) Classification. Class I.
21 CFR 862.1820 Subpart C -- Clinical Laboratory Instruments
21 CFR 862.2050 General purpose laboratory equipment labeled or
promoted for a specific medical use.
(a) Identification. General purpose laboratory equipment labeled or
promoted for a specific medical use is a device that is intended to
prepare or examine specimens from the human body and that is labeled or
promoted for a specific medical use.
(b) Classification. Class I. The device identified in paragraph (a)
of this section is exempt from the premarket notification procedures in
Subpart E of Part 807 and is exempt from the current good manufacturing
practice regulations in Part 820, with the exception of 820.180, with
respect to general requirements concerning records, and 820.198, with
respect to complaint files.
21 CFR 862.2100 Calculator/data processing module for clinical use.
(a) Identification. A calculator/data processing module for clinical
use is an electronic device intended to store, retrieve, and process
laboratory data.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807.
(52 FR 16122, May 6, 1987, as amended at 53 FR 21449, June 8, 1988)
21 CFR 862.2140 Centrifugal chemistry analyzer for clinical use.
(a) Identification. A centrifugal chemistry analyzer for clinical
use is an automatic device intended to centrifugally mix a sample and a
reagent and spectrophotometrically measure concentrations of the sample
constituents. This device is intended for use in conjunction with
certain materials to measure a variety of analytes.
(b) Classification. Class I.
21 CFR 862.2150 Continuous flow sequential multiple chemistry analyzer
for clinical use.
(a) Identification. A continuous flow sequential multiple chemistry
analyzer for clinical use is a modular analytical instrument intended to
simultaneously perform multiple chemical procedures using the principles
of automated continuous flow systems. This device is intended for use
in conjunction with certain materials to measure a variety of analytes.
(b) Classification. Class I.
21 CFR 862.2160 Discrete photometric chemistry analyzer for clinical
use.
(a) Identification. A discrete photometric chemistry analyzer for
clinical use is a device intended to duplicate manual analytical
procedures by performing automatically various steps such as pipetting,
preparing filtrates, heating, and measuring color intensity. This
device is intended for use in conjunction with certain materials to
measure a variety of analytes. Different models of the device
incorporate various instrumentation such as micro analysis apparatus,
double beam, single, or dual channel photometers, and bichromatic
2-wavelength photometers. Some models of the device may include
reagent-containing components that may also serve as reaction units.
(b) Classification. Class I.
21 CFR 862.2170 Micro chemistry analyzer for clinical use.
(a) Identification. A micro chemistry analyzer for clinical use is a
device intended to duplicate manual analytical procedures by performing
automatically various steps such as pipetting, preparing filtrates,
heating, and measuring color intensity. The distinguishing
characteristic of the device is that it requires only micro volume
samples obtainable from pediatric patients. This device is intended for
use in conjunction with certain materials to measure a variety of
analytes.
(b) Classification. Class I.
21 CFR 862.2230 Chromatographic separation material for clinical use.
(a) Identification. A chromatographic separation material for
clinical use is a device accessory (e.g., ion exchange absorbents, ion
exchagne resins, and ion papers) intended for use in ion exchange
chromatography, a procedure in which a compound is separated from a
solution.
(b) Classification. Class I.
21 CFR 862.2250 Gas liquid chromatography system for clinical use.
(a) Identification. A gas liquid chromatography system for clinical
use is a device intended to separate one or more drugs or compounds from
a mixture. Each of the constituents in a vaporized mixture of compounds
is separated according to its vapor pressure. The device may include
accessories such as columns, gases, column supports, and liquid coating.
(b) Classification. Class I.
21 CFR 862.2260 High pressure liquid chromatography system for clinical
use.
(a) Identification. A high pressure liquid chromatography system for
clinical use is a device intended to separate one or more drugs or
compounds from a solution by processing the mixture of compounds
(solutes) through a column packed with materials of uniform size
(stationary phase) under the influence of a high pressure liquid (mobile
phase). Separation of the solutes occurs either by absorption, sieving,
partition, or selective affinity.
(b) Classification. Class I.
21 CFR 862.2270 Thin-layer chromatography system for clinical use.
(a) Identification. A thin-layer chromatography (TLC) system for
clinical use is a device intended to separate one or more drugs or
compounds from a mixture. The mixture of compounds is absorbed onto a
stationary phase or thin layer of inert material (e.g., cellulose,
alumina, etc.) and eluted off by a moving solvent (moving phase) until
equilibrium occurs between the two phases.
(b) Classification. Class I. Particular components of TLC systems,
i.e., the thin-layer chromatography apparatus, TLC atomizer, TLC
developing tanks, and TLC ultraviolet light, are exempt from the current
good manufacturing practice regulations in Part 820, with the exception
of 820.180, with respect to general requirements concerning records,
and 820.198, with respect to complaint files.
21 CFR 862.2300 Colorimeter, photometer, or spectrophotometer for
clinical use.
(a) Identification. A colorimeter, a photometer, or a
spectrophotometer for clinical use is an instrument intended to measure
radiant energy emitted, transmitted, absorbed, or reflected under
controlled conditions. The device may include a monochromator to
produce light of a specific wavelength.
(b) Classification. Class I.
21 CFR 862.2310 Clinical sample concentrator.
(a) Identification. A clinical sample concentrator is a device
intended to concentrate (by dialysis, evaporation, etc.) serum, urine,
cerebrospinal fluid, and other body fluids before the fluids are
analyzed.
(b) Classification. Class I.
21 CFR 862.2320 Beta or gamma counter for clinical use.
(a) Identification. A beta or gamma counter for clinical use is a
device intended to detect and count beta or gamma radiation emitted by
clinical samples. Clinical samples are prepared by addition of a
radioactive reagent to the sample. These measurements are useful in the
diagnosis and treatment of various disorders.
(b) Classification. Class I.
21 CFR 862.2400 Densitometer/scanner (integrating, reflectance, TLC, or
radiochromatogram) for clinical use.
(a) Identification. A densitometer/scanner (integrating,
reflectance, thin-layer chromatography, or radiochromatogram) for
clinical use is device intended to measure the concentration of a
substance on the surface of a film or other support media by either a
photocell measurement of the light transmission through a given area of
the medium or, in the case of the radiochromatogram scanner, by
measurement of the distribution of a specific radio-active element on a
radiochromatogram.
(b) Classification. Class I.
21 CFR 862.2485 Electrophoresis apparatus for clinical use.
(a) Identification. An electrophoresis apparatus for clinical use is
a device intended to separate molecules or particles, including plasma
proteins, lipoproteins, enzymes, and hemoglobulins on the basis of their
net charge in specified buffered media. This device is used in
conjunction with certain materials to measure a variety of analytes as
an aid in the diagnosis and treatment of certain disorders.
(b) Classification. Class I.
21 CFR 862.2500 Enzyme analyzer for clinical use.
(a) Identification. An enzyme analyzer for clinical use is a device
intended to measure enzymes in plasma or serum by nonkinetic or kinetic
measurement of enzyme-catalyzed reactions. This device is used in
conjunction with certain materials to measure a variety of enzymes as an
aid in the diagnosis and treatment of certain enzyme-related disorders.
(b) Classification. Class I.
21 CFR 862.2540 Flame emission photometer for clinical use.
(a) Identification. A flame emission photometer for clinical use is
a device intended to measure the concentration of sodium, potassium,
lithium, and other metal ions in body fluids. Abnormal variations in
the concentration of these substances in the body are indicative of
certain disorders (e.g., electrolyte imbalance and heavy metal
intoxication) and are, therefore, useful in diagnosis and treatment of
those disorders.
(b) Classification. Class I.
21 CFR 862.2560 Fluorometer for clinical use.
(a) Identification. A fluorometer for clinical use is a device
intended to measure by fluorescence certain analytes. Fluorescence is
the property of certain substances of radiating, when illuminated, a
light of a different wavelength. This device is used in conjunction
with certain materials to measure a variety of analytes.
(b) Classification. Class I.
21 CFR 862.2680 Microtitrator for clinical use.
(a) Identification. A microtitrator for clinical use is a device
intended for use in micronanalysis to measure the concentration of a
substance by reacting it with a measure ''micro'' volume of a known
standardized solution.
(b) Classification. Class I.
21 CFR 862.2700 Nephelometer for clinical use.
(a) Identification. A nephelometer for clinical use is a device
intended to estimate the concentration of particles in a suspension by
measuring their light scattering properties (the deflection of light
rays by opaque particles in their path). The device is used in
conjunction with certain materials to measure the concentration of a
variety of analytes.
(b) Classification. Class I.
21 CFR 862.2720 Plasma oncometer for clinical use.
(a) Identification. A plasma oncometer for clinical use is a device
intended to measure plasma oncotic pressure, which is that portion of
the total plasma osmotic pressure contributed by protein and other
molecules too large to pass through a specified semipermeable membrane.
Because variations in plasma oncotic pressure are indications of certain
disorders, measurements of the variations are useful in the diagnosis
and treatment of these disorders.
(b) Classification. Class I.
21 CFR 862.2730 Osmometer for clinical use.
(a) Identification. An osmometer for clinical use is a device
intended to measure the osmotic pressure of body fluids. Osmotic
pressure is the pressure required to prevent the passage of a solution
with a lesser solute concentration into a solution with greater solute
concentration when the two solutions are separated by a semipermeable
membrane. The concentration of a solution affects its osmotic pressure,
freezing point, and other physiochemical properties. Osmometers
determine osmotic pressure by methods such as the measurement of the
freezing point. Measurements obtained by this device are used in the
diagnosis and treatment of body fluid disorders.
(b) Classification. Class I.
21 CFR 862.2750 Pipetting and diluting system for clinical use.
(a) Identification. A pipetting and diluting system for clinical use
is a device intended to provide an accurately measured volume of liquid
at a specified temperature for use in certain test procedures. This
generic type of device system includes serial, manual, automated, and
semi-automated dilutors, pipettors, dispensers, and pipetting stations.
(b) Classification. Class I.
21 CFR 862.2800 Refractometer for clinical use.
(a) Identification. A refractometer for clinical use is a device
intended to determine the amount of solute in a solution by measuring
the index of refraction (the ratio of the velocity of light in a vacuum
to the velocity of light in the solution). The index of refraction is
used to measure the concentration of certain analytes (solutes), such a
plasma total proteins and urinary total solids. Measurements obtained
by this device are used in the diagnosis and treatment of certain
conditions.
(b) Classification. Class I.
21 CFR 862.2850 Atomic absorption spectrophotometer for clinical use.
(a) Identification. An atomic absorption spectrophotometer for
clinical use is a device intended to identify and measure elements and
metals (e.g., lead and mercury) in human specimens. The metal elements
are identified according to the wavelength and intensity of the light
that is absorbed when the specimen is converted to the atomic vapor
phase. Measurements obtained by this device are used in the diagnosis
and treatment of certain conditions.
(b) Classification. Class I.
21 CFR 862.2860 Mass spectrometer for clinical use.
(a) Identification. A mass spectrometer for clinical use is a device
intended to identify inorganic or organic compounds (e.g., lead,
mercury, and drugs) in human specimens by ionizing the compound under
investigation and separating the resulting ions by means of an
electrical and megnetic field according to their mass.
(b) Classification. Class I.
21 CFR 862.2900 Automated urinalysis system.
(a) Identification. An automated urinalysis system is a device
intended to measure certain of the physical properties and chemical
constituents of urine by procedures that duplicate manual urinalysis
systems. This device is used in conjunction with certain materials to
measure a variety of urinary analytes.
(b) Classification. Class I.
21 CFR 862.2920 Plasma viscometer for clinical use.
(a) Identification. A plasma viscometer for clinical use is a device
intended to measure the viscosity of plasma by determining the time
period required for the plasma to flow a measured distance through a
calibrated glass tube. Measurements obtained by this device are used to
monitor changes in the amount of solids present in plasma in various
disorders.
(b) Classification. Class I.
21 CFR 862.2920 Subpart D -- Clinical Toxicology Test Systems
21 CFR 862.3030 Acetaminophen test system.
(a) Identification. An acetaminophen test system is a device
intended to measure acetaminophen, an analgestic and fever reducing
drug, in serum. Measurements obtained by this device are used in the
diagnosis and treatment of acetaminophen overdose.
(b) Classification. Class II.
21 CFR 862.3035 Amikacin test system.
(a) Identification. An amikacin test system is a device intended to
measure amikacin, an aminoglycoside antibiotic drug, in serum and
plasma. Measurements obtained by this device are used in the diagnosis
and treatment of amikacin overdose and in monitoring levels of amikacin
to ensure appropriate therapy.
(b) Classification. Class II.
21 CFR 862.3040 Alcohol test system.
(a) Identification. An alcohol test system is a device intented to
measure alcohol (e.g., ethanol, methanol, isopropanol, etc.) in human
body fluids (e.g., serum, whole blood, and urine). Measurements
obtained by this device are used in the diagnosis and treatment of
alcohol intoxication and poisoning.
(b) Classification. Class II.
21 CFR 862.3050 Breath-alcohol test system.
(a) Identification. A breath-alcohol test system is a device intened
to measure alcohol in the human breath. Measurements obtained by this
device are used in the diagnosis of alcohol intoxication.
(b) Classification. Class I.
21 CFR 862.3100 Amphetamine test system.
(a) Identification. An amphetamine test system is a device intended
to measure amphetamine, a central nervous system stimulating drug, in
plasma and urine. Measurements obtained by this device are used in the
diagnosis and treatment of amphetamine use or overdose and in monitoring
levels of amphetamine to ensure appropriate therapy.
(b) Classification. Class II.
21 CFR 862.3110 Antimony test system.
(a) Identification. An antimony test system is a device intended to
measure antimony, a heavy metal, in urine, blood, vomitus, and stomach
contents. Measurements obtained by this device are used in the
diagnosis and treatment of antimony poisoning.
(b) Classification. Class I.
21 CFR 862.3120 Arsenic test system.
(a) Identification. An arsenic test system is a device intended to
measure arsenic, a poisonous heavy metal, in urine, vomitus, stomach
contents, nails, hair, and blood. Measurements obtained by this device
are used in the diagnosis and treatment of arsenic poisoning.
(b) Classification. Class I.
21 CFR 862.3150 Barbiturate test system.
(a) Identification. A barbiturate test system is a device intended
to measure barbiturates, a class of hypnotic and sedative drugs, in
serum, urine, and gastric contents. Measurements obtained by this
device are used in the diagnosis and treatment of barbiturate use or
overdose and in monitoring levels of barbiturate to ensure appropriate
therapy.
(b) Classification. Class II.
21 CFR 862.3170 Benzodiazepine test system.
(a) Identification. A benzodiazepine test system is a device
intended to measure any of the benzodiazepine compounds, sedative and
hypnotic drugs, in blood, plasma, and urine. The benzodiazepine
compounds include chlordiazepoxide, diazepam, oxazepam, chlorzepate,
flurazepam, and nitrazepam. Measurements obtained by this device are
used in the diagnosis and treatment of benzodiazepine use or overdose
and in monitoring levels of benzodiazepines to ensure appropriate
therapy.
(b) Classification. Class II.
21 CFR 862.3200 Clinical toxicology calibrator.
(a) Identification. A clinical toxicology calibrator is a device
intended for medical purposes for use in a test system to establish
points of reference that are used in the determination of values in the
measurement of substances in human specimens. A clinical toxicology
calibrator can be a mixture of drugs or a specific material for a
particular drug (e.g., ethanol, lidocaine, etc.). (See also 862.2 in
this part.)
(b) Classification. Class II.
21 CFR 862.3220 Carbon monoxide test system.
(a) Identification. A carbon monoxide test system is a device
intended to measure carbon monoxide or carboxyhemoglobin (carbon
monoxide bound to the hemoglobin in the blood) in blood. Measurements
obtained by this device are used in the diagnosis and treatment of or
confirmation of carbon monoxide poisoning.
(b) Classification. Class I.
21 CFR 862.3240 Cholinesterase test system.
(a) Identification. A cholinesterase test system is a device
intended to measure cholinesterase (an enzyme that catalyzes the
hydrolysis of acetylcholine to choline) in human specimens. There are
two principal types of cholinesterase in human tissues. True
cholinesterase is present at nerve endings and in erythrocytes (red
blood cells) but is not present in plasma. Pseudo cholinesterase is
present in plasma and liver but is not present in erythrocytes.
Measurements obtained by this device are used in the diagnosis and
treatment of cholinesterase inhibition disorders (e.g., insecticide
poisoning and succinylcholine poisoning).
(b) Classification. Class I.
21 CFR 862.3250 Cocaine and cocaine metabolite test system.
(a) Identification. A cocaine and cocaine metabolite test system is
a device intended to measure cocaine and a cocaine metabolite
(benzoylecgonine) in serum, plasma, and urine. Measurements obtained by
this device are used in the diagnosis and treatment of cocaine use or
overdose.
(b) Classification. Class II.
21 CFR 862.3270 Codeine test system.
(a) Identification. A codeine test system is a device intended to
measure codeine (a narcotic pain-relieving drug) in serum and urine.
Measurements obtained by this device are used in the diagnosis and
treatment of codeine use or overdose and in monitoring levels of codeine
to ensure appropriate therapy.
(b) Classification. Class II.
21 CFR 862.3280 Clinical toxicology control material.
(a) Identification. A clinical toxicology control material is a
device intended to provide an estimation of the precision of a device
test system and to detect and monitor systematic deviations from
accuracy resulting from reagent or instrument defects. This generic
type of device includes various single, and multi-analyte control
materials.
(b) Classification. Class I.
21 CFR 862.3300 Digitoxin test system.
(a) Identification. A digitoxin test system is a device intended to
measure digitoxin, a cardiovascular drug, in serum and plasma.
Measurements obtained by this device are used in the diagnosis and
treatment of digitoxin overdose and in monitoring levels of digitoxin to
ensure appropriate therapy.
(b) Classification. Class II.
21 CFR 862.3320 Digoxin test system.
(a) Identification. A digoxin test system is a device intended to
measure digoxin, a cardiovascular drug, in serum and plasma.
Measurements obtained by this device are used in the diagnosis and
treatment of digoxin overdose and in monitoring levels of digoxin to
ensure appropriate therapy.
(b) Classification. Class II.
21 CFR 862.3350 Diphenylhydantoin test system.
(a) Identification. A diphenylhydantoin test system is a device
intended to measure diphenylhydantoin, an antiepileptic drug, in human
specimens. Measurements obtained by this device are used in the
diagnosis and treatment of diphenylhydantoin overdose and in monitoring
levels of diphenylhydantoin to ensure appropriate therapy.
(b) Classification. Class II.
21 CFR 862.3380 Ethosuximide test system.
(a) Identification. An ethosuximide test system is a device intended
to measure ethosuximide, an antiepileptic drug, in human specimens.
Measurements obtained by this device are used in the diagnosis and
treatment of ethosuximide overdose and in monitoring levels of
ethosuximide to ensure appropriate therapy.
(b) Classification. Class II.
21 CFR 862.3450 Gentamicin test system.
(a) Identification. A gentamicin test system is a device intended to
measure gentamicin, an antibiotic drug, in human specimens.
Measurements obtained by this device are used in the diagnosis and
treatment of gentamicin overdose and in monitoring levels of gentamicin
to ensure appropriate therapy.
(b) Classification. Class II.
21 CFR 862.3520 Kanamycin test system.
(a) Identification. A kanamycin test system is a device intended to
measure kanamycin, an antibiotic drug, in plasma and serum.
Measurements obtained by this device are used in the diagnosis and
treatment of kanamycin overdose and in monitoring levels of kanamycin to
ensure appropriate therapy.
(b) Classification. Class II.
21 CFR 862.3550 Lead test system.
(a) Identification. A lead test system is a device intended to
measure lead, a heavy metal, in blood and urine. Measurements obtained
by this device are used in the diagnosis and treatment of lead
poisoning.
(b) Classification. Class II.
21 CFR 862.3555 Lidocaine test system.
(a) Identification. A lidocaine test system is a device intended to
measure lidocaine, an antiarrythmic and anticonvulsant drug, in serum
and plasma. Measurements obtained by this device are used in the
diagnosis and treatment of lidocaine overdose or in monitoring levels of
lidocaine to ensure appropriate therapy.
(b) Classification. Class II.
21 CFR 862.3560 Lithium test system.
(a) Identification. A lithium test system is a device intended to
measure lithium (from the drug lithium carbonate) in serum or plasma.
Measurements of lithium are used to assure that the proper drug dosage
is administered in the treatment of patients with mental disturbances,
such as manic-depressive illness (bipolar disorder).
(b) Classification. Class II.
21 CFR 862.3580 Lysergic acid diethylamide (LSD) test system.
(a) Identification. A lysergic acid diethylamide (LSD) test system
is a device intended to measure lysergic acid diethylamide, a
hallucinogenic drug, in serum, urine, and gastric contents.
Measurements obtained by this device are used in the diagnosis and
treatment of LSD use or overdose.
(b) Classification. Class II.
21 CFR 862.3600 Mercury test system.
(a) Identification. A mercury test system is a device intended to
measure mercury, a heavy metal, in human specimens. Measurements
obtained by this device are used in the diagnosis and treatment of
mercury poisoning.
(b) Classification. Class I.
21 CFR 862.3610 Methamphetamine test system.
(a) Identification. A methamphetamine test system is a device
intended to measure methamphetamine, a central nervous system
stimulating drug, in serum, plasma, and urine. Measurements obtained by
this device are used in the diagnosis and treatment of methamphetamine
use or overdose.
(b) Classification. Class II.
21 CFR 862.3620 Methadone test system.
(a) Identification. A methadone test system is a device intended to
measure methadone, an addictive narcotic pain-relieving drug, in serum
and urine. Measurements obtained by this device are used in the
diagnosis and treatment of methadone use or overdose and to determine
compliance with regulations in methadone maintenance treatment.
(b) Classification. Class II.
21 CFR 862.3630 Methaqualone test system.
(a) Identification. A methaqualone test system is a device intended
to measure methaqualone, a hypnotic and sedative drug, in urine.
Measurements obtained by this device are used in the diagnosis and
treatment of methaqualone use or overdose.
(b) Classification. Class II.
21 CFR 862.3640 Morphine test system.
(a) Identification. A morphine test system is a device intended to
measure morphine, an addictive narcotic pain-relieving drug, and its
analogs in serum, urine, and gastric contents. Measurements obtained by
this device are used in the diagnosis and treatment of morphine use or
overdose and in monitoring levels of morphine and its analogs to ensure
appropriate therapy.
(b) Classification. Class II.
21 CFR 862.3645 Neuroleptic drugs radioreceptor assay test system.
(a) Identification. A neuroleptic drugs radioceptor assay test
system is a device intended to measure in serum or plasma the dopamine
receptor blocking activity of neuroleptic drugs and their active
metabolites. A neuroleptic drug has anti-psychotic action affecting
principally psychomotor activity, is generally without hypnotic effects,
and is a tranquilizer. Measurements obtained by this device are used to
aid in determining whether a patient is taking the prescribed dosage
level of such drugs.
(b) Classification. Class II.
21 CFR 862.3650 Opiate test system.
(a) Identification. An opiate test system is a device intended to
measure any of the addictive narcotic pain-relieving opiate drugs in
blood, serum, urine, gastric contents, and saliva. An opiate is any
natural or synthetic drug that has morphine-like pharmocological
actions. The opiates include drugs such as morphine, morphine
glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements
obtained by this device are used in the diagnosis and treatment of
opiate use or overdose and in monitoring the levels of opiate
administration to ensure appropriate therapy.
(b) Classification. Class II.
21 CFR 862.3660 Phenobarbital test system.
(a) Identification. A phenobarbitol test system is a device intended
to measure phenobarbital, an antiepileptic and sedative-hypnotic drug,
in human specimens. Measurements obtained by this device are used in
the diagnosis and treatment of phenobarbital use or overdose and in
monitoring levels of phenobarbital to ensure appropriate therapy.
(b) Classification. Class II.
21 CFR 862.3670 Phenothiazine test system.
(a) Identification. A phenothiazine test system is a device intended
to measure any of the drugs of the phenothiazine class in human
specimens. Measurements obtained by this device are used in the
diagnosis and treatment of phenothiazine use or overdose.
(b) Classification. Class II.
21 CFR 862.3680 Primidone test system.
(a) Identification. A primidone test system is a device intended to
measure primidone, an antiepileptic drug, in human specimens.
Measurements obtained by this device are used in the diagnosis and
treatment of primidone overdose and in monitoring levels of primidone to
ensure appropriate therapy.
(b) Classification. Class II.
21 CFR 862.3700 Propoxyphene test system.
(a) Identification. A propoxyphene test system is a device intended
to measure propoxyphene, a pain-relieving drug, in serum, plasma, and
urine. Measurements obtained by this device are used in the diagnosis
and treatment of propoxyphene use or overdose or in monitoring levels of
propoxyphene to ensure appropriate therapy.
(b) Classification. Class II.
21 CFR 862.3750 Quinine test system.
(a) Identification. A quinine test system is a device intended to
measure quinine, a fever-reducing and pain-relieving drug intended in
the treatment of malaria, in serum and urine. Measurements obtained by
this device are used in the diagnosis and treatment of quinine overdose
and malaria.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807.
(52 FR 16122, May 6, 1987, as amended at 53 FR 21450, June 8, 1988)
21 CFR 862.3830 Salicylate test system.
(a) Identification. A salicylate test system is a device intended to
measure salicylates, a class of analgesic, antipyretic and
anti-inflammatory drugs that includes aspirin, in human specimens.
Measurements obtained by this device are used in diagnosis and treatment
of salicylate overdose and in monitoring salicylate levels to ensure
appropriate therapy.
(b) Classification. Class II.
21 CFR 862.3850 Sulfonamide test system.
(a) Identification. A sulfonamide test system is a device intended
to measure sulfonamides, any of the antibacterial drugs derived from
sulfanilamide, in human specimens. Measurements obtained by this device
are used in the diagnosis and treatment of sulfonamide overdose and in
monitoring sulfonamide levels to ensure appropriate therapy.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807.
(52 FR 16122, May 6, 1987, as amended at 53 FR 21450, June 8, 1988)
21 CFR 862.3870 Cannabinoid test system.
(a) Identification. A cannabinoid test system is a device intended
to measure any of the cannabinoids, hallucinogenic compounds endogenous
to marihuana, in serum, plasma, saliva, and urine. Cannabinoid
compounds include delta-9-tetrahydrocannabinol, cannabidiol, cannabinol,
and cannabichromene. Measurements obtained by this device are used in
the diagnosis and treatment of cannabinoid use or abuse and in
monitoring levels of cannabinoids during clinical investigational use.
(b) Classification. Class II.
21 CFR 862.3880 Theophylline test system.
(a) Identification. A theophylline test system is a device intended
to measure theophylline (a drug used for stimulation of the muscles in
the cardiovascular, respiratory, and central nervous systems) in serum
and plasma. Measurements obtained by this device are used in the
diagnosis and treatment of theophylline overdose or in monitoring levels
of theophylline to ensure appropriate therapy.
(b) Classification. Class II.
21 CFR 862.3900 Tobramycin test system.
(a) Identification. A tobramycin test system is a device intended to
measure tobramycin, an aminoglycoside antibiotic drug, in plasma and
serum. Measurements obtained by this device are used in the diagnosis
and treatment of tobramycin overdose and in monitoring levels of
tobramycin to ensure appropriate therapy.
(b) Classification. Class II.
21 CFR 862.3910 Tricyclic antidepressant drugs test system.
(a) Identification. A tricyclic antidepressant drugs test system is
a device intended to measure any of the tricyclic antidepressant drugs
in serum. The tricyclic antidepressant drugs include imipramine,
desipramine, amitriptyline, nortriptyline, protriptyline, and doxepin.
Measurements obtained by this device are used in the diagnosis and
treatment of chronic depression to ensure appropriate therapy.
(b) Classification. Class II.
21 CFR 862.3950 Vancomycin test system.
(a) Identification. A vancomycin test system is a device intended to
measure vancomycin, an antibiotic drug, in serum. Measurements obtained
by this device are used in the diagnosis and treatment of vancomycin
overdose and in monitoring the level of vancomycin to ensure appropriate
therapy.
(b) Classification. Class II.
21 CFR 862.3950 Pt. 864
21 CFR 862.3950 PART 864 -- HEMATOLOGY AND PATHOLOGY DEVICES
21 CFR 862.3950 Subpart A -- General Provisions
Sec.
864.1 Scope.
864.3 Effective dates of requirement for premarket approval.
864.9 Limitations of exemptions from section 510(k) of the Federal
Food, Drug, and Cosmetic Act (the act).
21 CFR 862.3950 Subpart B -- Biological Stains
864.1850 Dye and chemical solution stains.
21 CFR 862.3950 Subpart C -- Cell and Tissue Culture Products
864.2220 Synthetic cell and tissue culture media and components.
864.2240 Cell and tissue culture supplies and equipment.
864.2260 Chromosome culture kit.
864.2280 Cultured animal and human cells.
864.2360 Mycoplasma detection media and components.
864.2800 Animal and human sera.
864.2875 Balanced salt solutions or formulations.
21 CFR 862.3950 Subpart D -- Pathology-Instrumentation and Accessories
864.3010 Tissue processing equipment.
864.3250 Specimen transport and storage container.
864.3300 Cytocentrifuge.
864.3400 Device for sealing microsections.
864.3600 Microscopes and accessories.
864.3800 Automated slide stainer.
864.3875 Automated tissue processor.
21 CFR 862.3950 Subpart E -- Specimen Preparation Reagents
864.4010 General purpose reagent.
864.4400 Enzyme preparations.
21 CFR 862.3950 Subpart F -- Automated and Semi-Automated Hematology
Devices
864.5200 Automated cell counter.
864.5220 Automated differential cell counter.
864.5240 Automated blood cell diluting apparatus.
864.5260 Automated cell-locating device.
864.5300 Red cell indices device.
864.5350 Microsedimentation centrifuge.
864.5400 Coagulation instrument.
864.5425 Multipurpose system for in vitro coagulation studies.
864.5600 Automated hematocrit instrument.
864.5620 Automated hemoglobin system.
864.5680 Automated heparin analyzer.
864.5700 Automated platelet aggregation system.
864.5800 Automated sedimentation rate device.
864.5850 Automated slide spinner.
864.5950 Blood volume measuring device.
21 CFR 862.3950 Subpart G -- Manual Hematology Devices
864.6100 Bleeding time device.
864.6150 Capillary blood collection tube.
864.6160 Manual blood cell counting device.
864.6400 Hematocrit measuring device.
864.6550 Occult blood test.
864.6600 Osmotic fragility test.
864.6650 Platelet adhesion test.
864.6675 Platelet aggregometer.
864.6700 Erythrocyte sedimentation rate test.
21 CFR 862.3950 Subpart H -- Hematology Kits and Packages
864.7040 Adenosine triphosphate release assay.
864.7060 Antithrombin III assay.
864.7100 Red blood cell enzyme assay.
864.7140 Activated whole blood clotting time tests.
864.7250 Erythropoietin assay.
864.7275 Euglobulin lysis time tests.
864.7290 Factor deficiency test.
864.7300 Fibrin monomer paracoagulation test.
864.7320 Fibrinogen/fibrin degradation products assay.
864.7340 Fibrinogen determination system.
864.7360 Erythrocytic glucose-6-phosphate dehydrogenase assay.
864.7375 Glutathione reductase assay.
864.7400 Hemoglobin A2assay.
864.7415 Abnormal hemoglobin assay.
864.7425 Carboxyhemoglobin assay.
864.7440 Electrophoretic hemoglobin analysis system.
864.7455 Fetal hemoglobin assay.
864.7470 Glycosylated hemoglobin assay.
864.7490 Sulfhemoglobin assay.
864.7500 Whole blood hemoglobin assays.
864.7525 Heparin assay.
864.7660 Leukocyte alkaline phosphatase test.
864.7675 Leukocyte peroxidase test.
864.7695 Platelet factor 4 radioimmunoassay.
864.7720 Prothrombin consumption test.
864.7735 Prothrombin-proconvertin test and thrombotest.
864.7750 Prothrombin time test.
864.7825 Sickle cell test.
864.7875 Thrombin time test.
864.7900 Thromboplastin generation test.
864.7925 Partial thromboplastin time tests.
21 CFR 862.3950 Subpart I -- Hematology Reagents
864.8100 Bothrops atrox reagent.
864.8150 Calibrator for cell indices.
864.8165 Calibrator for hemoglobin or hematocrit measurement.
864.8175 Calibrator for platelet counting.
864.8185 Calibrator for red cell and white cell counting.
864.8200 Blood cell diluent.
864.8500 Lymphocyte separation medium.
864.8540 Red cell lysing reagent.
864.8625 Hematology quality control mixture.
864.8950 Russell viper venom reagent.
21 CFR 862.3950 Subpart J -- Products Used In Establishments That
Manufacture Blood and Blood Products
864.9050 Blood bank supplies.
864.9100 Empty container for the collection and processing of blood
and blood components.
864.9125 Vacuum-assisted blood collection system.
864.9145 Processing system for frozen blood.
864.9160 Blood group substances of nonhuman origin for in vitro
diagnostic use.
864.9175 Automated blood grouping and antibody test system,
864.9185 Blood grouping view box.
864.9195 Blood mixing devices and blood weighing devices.
864.9205 Blood and plasma warming device.
864.9225 Cell-freezing apparatus and reagents for in vitro diagnostic
use.
864.9245 Automated blood cell separator.
864.9275 Blood bank centrifuge for in vitro diagnostic use.
864.9285 Automated cell-washing centrifuge for immuno-hematology.
864.9300 Automated Coombs test systems.
864.9320 Copper sulfate solution for specific gravity determinations.
864.9400 Stabilized enzyme solution.
864.9550 Lectins and protectins.
864.9575 Environmental chamber for storage of platelet concentrate.
864.9600 Potentiating media for in vitro diagnostic use.
864.9650 Quality control kit for blood banking reagents.
864.9700 Blood storage refrigerator and blood storage freezer.
864.9750 Heat-sealing device.
864.9875 Transfer set.
Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j, 371).
21 CFR 862.3950 Subpart A -- General Provisions
21 CFR 864.1 Scope.
(a) This part sets forth the classification of hematology and
pathology devices intended for human use that are in commercial
distribution.
(b) The identification of a device in a regulation in this part is
not a precise description of every device that is, or will be, subject
to the regulation. A manufacturer who submits a premarket notification
submission for a device under Part 807 may not show merely that the
device is accurately described by the section title and identification
provisions of a regulation in this part, but shall state why the device
is substantially equivalent to other devices, as required by 807.87.
(c) References in this part to regulatory sections of the Code of
Federal Regulations are to Chapter I of Title 21, unless otherwise
noted.
(52 FR 17732, May 11, 1987)
21 CFR 864.3 Effective dates of requirement for premarket approval.
A device included in this part that is classified into class III
(premarket approval) shall not be commercially distributed after the
date shown in the regulation classifying the device unless the
manufacturer has an approval under section 515 of the act (unless an
exemption has been granted under section 520(g)(2) of the act). An
approval under section 515 of the act consists of FDA's issuance of an
order approving an application for premarket approval (PMA) for the
device or declaring completed a product development protocol (PDP) for
the device.
(a) Before FDA requires that a device commercially distributed before
the enactment date of the amendments, or a device that has been found
substantially equivalent to such a device, has an approval under section
515 of the act FDA must promulgate a regulation under section 515(b) of
the act requiring such approval, except as provided in paragraph (b) of
this section. Such a regulation under section 515(b) of the act shall
not be effective during the grace period ending on the 90th day after
its promulgation or on the last day of the 30th full calendar month
after the regulation that classifies the device into class III is
effective, whichever is later. See section 501(f)(2)(B) of the act.
Accordingly, unless an effective date of the requirement for premarket
approval is shown in the regulation for a device classified into class
III in this part, the device may be commercially distributed without
FDA's issuance of an order approving a PMA or declaring completed a PDP
for the device. If FDA promulgates a regulation under section 515(b) of
the act requiring premarket approval for a device, section 501(f)(1)(A)
of the act applies to the device.
(b) Any new, not substantially equivalent, device introduced into
commercial distribution on or after May 28, 1976, including a device
formerly marketed that has been substantially altered, is classified by
statute (section 513(f) of the act) into class III without any grace
period and FDA must have issued an order approving a PMA or declaring
completed a PDP for the device before the device is commercially
distributed unless it is reclassified. If FDA knows that a device being
commercially distributed may be a ''new'' device as defined in this
section because of any new intended use or other reasons, FDA may codify
the statutory classification of the device into class III for such new
use. Accordingly, the regulation for such a class III device states
that as of the enactment date of the amendments, May 28, 1976, the
device must have an approval under section 515 of the act before
commercial distribution.
(52 FR 17732, May 11, 1987)
21 CFR 864.9 Limitations of exemptions from section 510(k) of the
Federal Food, Drug, and Cosmetic Act (the act).
The Food and Drug Administration's (FDA's) decision to grant an
exemption from the requirement of premarket notification (section 510(k)
of the act) for a generic type of class I device is based upon the
existing and reasonably foreseeable characteristics of commercially
distributed devices within that generic type. Because FDA cannot
anticipate every change in intended use or characteristic that could
significantly affect a device's safety or effectiveness, manufacturers
of any commercially distributed class I device for which FDA has granted
an exemption from the requirement of premarket notification must still
submit a premarket notification to FDA before introducing or delivering
for introduction into interstate commerce for commercial distribution
the device when:
(a) The device is intended for a use different from its intended use
before May 28, 1976, or the device is intended for a use different from
the intended use of a preamendments device to which it had been
determined to be substantially equivalent; e.g., the device is intended
for a different medical purpose, or the device is intended for lay use
where the former intended use was by health care professionals only; or
(b) The modified device operates using a different fundamental
scientific technology than that in use in the device before May 28,
1976, e.g., a surgical instrument cuts tissue with a laser beam rather
than with a sharpened metal blade, or an in vitro diagnostic device
detects or identifies infectious agents by using a deoxyribonucleic acid
(DNA) probe or nucleic acid hybridization technology rather than culture
or immunoassay technology.
(54 FR 25043, June 12, 1989)
21 CFR 864.9 Subpart B -- Biological Stains
21 CFR 864.1850 Dye and chemical solution stains.
(a) Identification. Dye and chemical solution stains for medical
purposes are mixtures of synthetic or natural dyes or nondye chemicals
in solutions used in staining cells and tissues for diagnostic
histopathology, cytopathology, or hematology.
(b) Classification. Class I. These devices are exempt from the
premarket notification procedures in Subpart E of Part 807. The devices
are also exempt from the current good manufacturing practice regulations
in Part 820 of this chapter, with the exception of 820.180, with
respect to general requirements concerning records, and 820.198, with
respect to complaint files.
(45 FR 60583, Sept. 12, 1980, as amended at 54 FR 25044, June 12,
1989)
21 CFR 864.1850 Subpart C -- Cell And Tissue Culture Products
21 CFR 864.2220 Synthetic cell and tissue culture media and components.
(a) Identification. Synthetic cell and tissue culture media and
components are substances that are composed entirely of defined
components (e.g., amino acids, vitamins, inorganic salts, etc.) that are
essential for the survival and development of cell lines of humans and
other animals.
(b) Classification. Class I. These devices are exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(45 FR 60583, Sept. 12, 1980, as amended at 54 FR 25044, June 12,
1989)
21 CFR 864.2240 Cell and tissue culture supplies and equipment.
(a) Identification. Cell and tissue culture supplies and equipment
are devices that are used to examine, propagate, nourish, or grow cells
and tissue cultures. These include such articles as slide culture
chambers, perfusion and roller apparatus, cell culture suspension
systems, and tissue culture flasks, disks, tubes, and roller bottles.
(b) Classification. Class I. These devices are exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter. If the devices are not labeled or otherwise represented as
sterile, they are exempt from the current good manufacturing practice
regulations in Part 820 of this chapter, with the exception of 820.180,
with respect to general requirements concerning records, and 820.198,
with respect to complaint files.
(45 FR 60584, Sept. 12, 1980, as amended at 54 FR 25044, June 12,
1989)
21 CFR 864.2260 Chromosome culture kit.
(a) Identification. A chromosome culture kit is a device containing
the necessary ingredients (e.g., Minimum Essential Media (MEM) of
McCoy's 5A culture media, phytohemagglutinin, fetal calf serum,
antibiotics, and heparin) used to culture tissues for diagnosis of
congenital chromosome abnormalities.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(45 FR 60585, Sept. 12, 1980, as amended at 54 FR 25044, June 12,
1989)
21 CFR 864.2280 Cultured animal and human cells.
(a) Identification. Cultured animal and human cells are in vitro
cultivated cell lines from the tissue of humans or other animals which
are used in various diagnostic procedures, particularly diagnostic
virology and cytogenetic studies.
(b) Classification. Class I (general controls).
(45 FR 60585, Sept. 12, 1980)
21 CFR 864.2360 Mycoplasma detection media and components.
(a) Identification. Mycoplasma detection media and components are
used to detect and isolate mycoplasma pleuropneumonia-like organisms
(PPLO), a common microbial contaminant in cell cultures.
(b) Classification. Class I. These devices are exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(45 FR 60586, Sept. 12, 1980, as amended at 54 FR 25044, June 12,
1989)
21 CFR 864.2800 Animal and human sera.
(a) Identification. Animal and human sera are biological products,
obtained from the blood of humans or other animals, that provide the
necessary growth-promoting nutrients in a cell culture system.
(b) Classification. Class I. The devices are exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(45 FR 60586, Sept. 12, 1980, as amended at 54 FR 25044, June 12,
1989)
21 CFR 864.2875 Balanced salt solutions or formulations.
(a) Identification. A balanced salt solution or formulation is a
defined mixture of salts and glucose in a simple medium. This device is
included as a necessary component of most cell culture systems. This
media component controls for pH, osmotic pressure, energy source, and
inorganic ions.
(b) Classification. Class I. These devices are exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(45 FR 60586, Sept. 12, 1980, as amended at 54 FR 25044, June 12,
1989)
21 CFR 864.2875 Subpart D -- Pathology Instrumentation and Accessories
21 CFR 864.3010 Tissue processing equipment.
(a) Identification. Tissue processing equipment consists of devices
used to prepare human tissue specimens for diagnostic histological
examination by processing specimens through the various stages of
decalcifying, infiltrating, sectioning, and mounting on microscope
slides.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter. The device is also exempt from the current good manufacturing
practice regulations in Part 820 of this chapter, with the exception of
820.180, with respect to general requirements concerning records, and
820.198, with respect to complaint files.
(45 FR 60587, Sept. 12, 1980, as amended at 54 FR 25044, June 12,
1989)
21 CFR 864.3250 Specimen transport and storage container.
(a) Identification. A specimen transport and storage container,
which may be empty or prefilled, is a device intended to contain
biological specimens, body waste, or body exudate during storage and
transport in order that the matter contained therein can be destroyed or
used effectively for diagnostic examination. If prefilled, the device
contains a fixative solution or other general purpose reagent to
preserve the condition of a biological specimen added to the container.
(b) Classification. Class I (general controls). If the device is
not intended for over-the-counter (OTC) distribution, it is exempt from
the premarket notification procedures in subpart E of part 807 of this
chapter. If the device is not labeled or otherwise represented as
sterile, it is exempt from the current good manufacturing practice
regulations in Part 820 of this chapter, with the exception of 820.180,
with respect to the general requirements concerning records, and
820.198, with respect to complaint files.
(54 FR 47206, Nov. 13, 1989)
21 CFR 864.3300 Cytocentrifuge.
(a) Identification. A cytocentrifuge is a centrifuge used to
concentrate cells from biological cell suspensions (e.g., cerebrospinal
fluid) and to deposit these cells on a glass microscope slide for
cytological examination.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(45 FR 60588, Sept. 12, 1980, as amended at 54 FR 25044, June 12,
1989)
21 CFR 864.3400 Device for sealing microsections.
(a) Identification. A device for sealing microsections is an
automated instrument used to seal stained cells and microsections for
histological and cytological examination.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(45 FR 60589, Sept. 12, 1980, as amended at 54 FR 25044, June 12,
1989)
21 CFR 864.3600 Microscopes and accessories.
(a) Identification. Microscopes and accessories are optical
instruments used to enlarge images of specimens, preparations, and
cultures for medical purposes. Variations of microscopes and
accessories (through a change in the light source) used for medical
purposes include the following:
(1) Phase contrast microscopes, which permit visualization of
unstained preparations by altering the phase relationship of light that
passes around the object and through the object.
(2) Fluorescense microscopes, which permit examination of specimens
stained with fluorochromes that fluoresce under ultraviolet light.
(3) Inverted stage microscopes, which permit examination of tissue
cultures or other biological specimens contained in bottles or tubes
with the light source mounted above the specimen.
(b) Classification. Class I. These devices are exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter. The devices are also exempt from the current good
manufacturing practice regulations in Part 820 of this chapter, with the
exception of 820.180, with respect to general requirements concerning
records, and 820.198, with respect to complaint files.
(45 FR 60590, Sept. 12, 1980, as amended at 54 FR 25044, June 12,
1989)
21 CFR 864.3800 Automated slide stainer.
(a) Identification. An automated slide stainer is a device used to
stain histology, cytology, and hematology slides for diagnosis.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(45 FR 60591, Sept. 12, 1980, as amended at 54 FR 25044, June 12,
1989)
21 CFR 864.3875 Automated tissue processor.
(a) Identification. An automated tissue processor is an automated
system used to process tissue specimens for examination through
fixation, dehydration, and infiltration.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(45 FR 60591, Sept. 12, 1980, as amended at 54 FR 25045, June 12,
1989)
21 CFR 864.3875 Subpart E -- Specimen Preparation Reagents
21 CFR 864.4010 General purpose reagent.
(a) Identification. A general purpose reagent is a chemical reagent
that has general laboratory application, that is used to collect,
prepare, and examine specimens from the human body for diagnostic
histopathology, cytology, and hematology, and that is not labeled or
otherwise intended for a specific diagnostic application. General
purpose reagents include cytological preservatives, decalcifying
reagents, fixatives and adhesives, tissue processing reagents, isotonic
solutions, and pH buffers.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter. If the device is not labeled or otherwise represented as
sterile, it is exempt from the current good manufacturing practice
regulations in Part 820 of this chapter, with the exception of 820.180,
with respect to general requirements concerning records, and 820.198,
with respect to complaint files.
(45 FR 60592, Sept. 12, 1980, as amended at 54 FR 25045, June 12,
1989)
21 CFR 864.4400 Enzyme preparations.
(a) Identification. Enzyme preparations are products that are used
in the histopathology laboratory for the following purposes:
(1) To disaggregate tissues and cells already in established cultures
for preparation into subsequent cultures (e.g., trypsin);
(2) To disaggregate fluid specimens for cytological examination
(e.g., papain for gastric lavage or trypsin for sputum liquefaction);
(3) To aid in the selective staining of tissue specimens (e.g.,
diastase for glycogen determination).
(b) Classification. Class I. These devices are exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(45 FR 60592, Sept. 12, 1980, as amended at 54 FR 25045, June 12,
1989)
21 CFR 864.4400 Subpart F -- Automated and Semi-Automated Hematology Devices
21 CFR 864.5200 Automated cell counter.
(a) Identification. An automated cell counter is a fully-automated
or semi-automated device used to count red blood cells, white blood
cells, or blood platelets using a sample of the patient's peripheral
blood (blood circulating in one of the body's extremities, such as the
arm). These devices may also measure hemoglobin or hematocrit and may
also calculate or measure one or more of the red cell indices (the
erythrocyte mean corpuscular volume, the mean corpuscular hemoglobin, or
the mean corpuscular hemoglobin concentration). These devices may use
either an electronic particle counting method or an optical counting
method.
(b) Classification. Class II (performance standards).
(45 FR 60593, Sept. 12, 1980)
21 CFR 864.5220 Automated differential cell counter.
(a) Identification. An automated differential cell counter is a
device used to identify and classify one or more of the formed elements
of the blood.
(b) Classification. (1) Class II (performance standards) when the
device is intended to flag or identify specimens containing abnormal
blood cells.
(2) Class III (premarket approval) when the device is intended for
other uses, including to count or classify abnormal cells of the blood.
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval for the device identified in paragraph (b)(2) of this section.
See 864.3.
(45 FR 60596, Sept. 12, 1980, as amended at 55 FR 23511, June 8,
1990)
21 CFR 864.5240 Automated blood cell diluting apparatus.
(a) Identification. An automated blood cell diluting apparatus is a
fully automated or semi-automated device used to make appropriate
dilutions of a blood sample for further testing.
(b) Classification. Class I (general controls).
(45 FR 60596, Sept. 12, 1980)
21 CFR 864.5260 Automated cell-locating device.
(a) Identification. An automated cell-locating device is a device
used to locate blood cells on a peripheral blood smear, allowing the
operator to identify and classify each cell according to type.
(Peripheral blood is blood circulating in one of the body's extremities,
such as the arm.)
(b) Classification. Class II (performance standards).
(45 FR 60597, Sept. 12, 1980)
21 CFR 864.5300 Red cell indices device.
(a) Identification. A red cell indices device, usually part of a
larger system, calculates or directly measures the erythrocyte mean
corpuscular volume (MCV), the mean corpuscular hemoglobin (MCH), and the
mean corpuscular hemoglobin concentration (MCHC). The red cell indices
are used for the differential diagnosis of anemias.
(b) Classification. Class II (performance standards).
(45 FR 60597, Sept. 12, 1980)
21 CFR 864.5350 Microsedimentation centrifuge.
(a) Identification. A microsedimentation centrifuge is a device used
to sediment red cells for the microsedimentation rate test.
(b) Classification. Class I (general controls).
(45 FR 60598, Sept. 12, 1980)
21 CFR 864.5400 Coagulation instrument.
(a) Identification. A coagulation instrument is an automated or
semiautomated device used to determine the onset of clot formation for
in vitro coagulation studies.
(b) Classification. Class II (performance standards).
(45 FR 60598, Sept. 12, 1980)
21 CFR 864.5425 Multipurpose system for in vitro coagulation studies.
(a) Identification. A multipurpose system for in vitro coagulation
studies is a device consisting of one automated or semiautomated
instrument and its associated reagents and controls. The system is used
to perform a series of coagulation studies and coagulation factor
assays.
(b) Classification. Class II (performance standards).
(45 FR 60599, Sept. 12, 1980)
21 CFR 864.5600 Automated hematocrit instrument.
(a) Identification. An automated hematocrit instrument is a fully
automated or semi-automated device which may or may not be part of a
larger system. This device measures the packed red cell volume of a
blood sample to distinguish normal from abnormal states, such as anemia
and erythrocytosis (an increase in the number of red cells).
(b) Classification. Class II (performance standards).
(45 FR 60600, Sept. 12, 1980)
21 CFR 864.5620 Automated hemoglobin system.
(a) Identification. An automated hemoglobin system is a fully
automated or semi-automated device which may or may not be part of a
larger system. The generic type of device consists of the reagents,
calibrators, controls, and instrumentation used to determine the
hemoglobin content of human blood.
(b) Classification. Class II (performance standards).
(45 FR 60601, Sept. 12, 1980)
21 CFR 864.5680 Automated heparin analyzer.
(a) Identification. An automated heparin analyzer is a device used
to determine the heparin level in a blood sample by mixing the sample
with protamine (a heparin-neutralizing substance) and determining
photometrically the onset of air-activated clotting. The analyzer also
determines the amount of protamine necessary to neutralize the heparin
in the patient's circulation.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 864.3.
(45 FR 60601, Sept. 12, 1980, as amended at 52 FR 17733, May 11,
1987)
21 CFR 864.5700 Automated platelet aggregation system.
(a) Identification. An automated platelet aggregation system is a
device used to determine changes in platelet shape and platelet
aggregation following the addition of an aggregating reagent to a
platelet-rich plasma.
(b) Classification. Class II (performance standards).
(45 FR 60602, Sept. 12, 1980)
21 CFR 864.5800 Automated sedimentation rate device.
(a) Identification. An automated sedimentation rate device is an
instrument that measures automatically the erythrocyte sedimentation
rate in whole blood. Because an increased sedimentation rate indicates
tissue damage or inflammation, the erythrocyte sedimentation rate device
is useful in monitoring treatment of a disease.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(45 FR 60602, Sept. 12, 1980, as amended at 54 FR 25045, June 12,
1989)
21 CFR 864.5850 Automated slide spinner.
(a) Identification. An automated slide spinner is a device that
prepares automatically a blood film on a microscope slide using a small
amount of peripheral blood (blood circulating in one of the body's
extremities, such as the arm).
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(45 FR 60603, Sept. 12, 1980, as amended at 54 FR 25045, June 12,
1989)
21 CFR 864.5950 Blood volume measuring device.
(a) Identification. A blood volume measuring device is a manual,
semiautomated, or automated system that is used to calculate the red
cell mass, plasma volume, and total blood volume.
(b) Classification. Class II (performance standards).
(45 FR 60603, Sept. 12, 1980)
21 CFR 864.5950 Subpart G -- Manual Hematology Devices
21 CFR 864.6100 Bleeding time device.
(a) Identification. A bleeding time device is a device, usually
employing two spring-loaded blades, that produces two small incisions in
the patient's skin. The length of time required for the bleeding to
stop is a measure of the effectiveness of the coagulation system,
primarily the platelets.
(b) Classification. Class II (performance standards).
(45 FR 60604, Sept. 12, 1980)
21 CFR 864.6150 Capillary blood collection tube.
(a) Identification. A capillary blood collection tube is a plain or
heparinized glass tube of very small diameter used to collect blood by
capillary action.
(b) Classification. Class I. If the device is not intended for
over-the-counter (OTC) distribution, it is exempt from the premarket
notification procedures in Subpart E of Part 807 of this chapter.
(45 FR 60604, Sept. 12, 1980, as amended at 54 FR 25045, June 12,
1989)
21 CFR 864.6160 Manual blood cell counting device.
(a) Identification. A manual blood cell counting device is a device
used to count red blood cells, white blood cells, or blood platelets.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(45 FR 60605, Sept. 12, 1980, as amended at 54 FR 25045, June 12,
1989)
21 CFR 864.6400 Hematocrit measuring device.
(a) Identification. A hematocrit measuring device is a system
consisting of instruments, tubes, racks, and a sealer and a holder. The
device is used to measure the packed red cell volume in blood to
determine whether the patient's total red cell volume is normal or
abnormal. Abnormal states include anemia (an abnormally low total red
cell volume) and erythrocytosis (an abnormally high total red cell
mass). The packed red cell volume is produced by centrifuging a given
volume of blood.
(b) Clasification. Class II (performance standards).
(45 FR 60606, Sept. 12, 1980)
21 CFR 864.6550 Occult blood test.
(a) Identification. An occult blood test is a device used to detect
occult blood in urine or feces. (Occult blood is blood present in such
small quantities that it can be detected only by chemical tests of
suspected material, or by microscopic or spectroscopic examination.)
(b) Classification. Class II (performance standards).
(45 FR 60606, Sept. 12, 1980)
21 CFR 864.6600 Osmotic fragility test.
(a) Identification. An osmotic fragility test is a device used to
determine the resistance of red blood cells to hemolysis (destruction)
in varying concentrations of hypotonic saline solutions.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(45 FR 60607, Sept. 12, 1980, as amended at 54 FR 25045, June 12,
1989)
21 CFR 864.6650 Platelet adhesion test.
(a) Identification. A platelet adhesion test is a device used to
determine in vitro platelet function.
(b) Classification. Class II (performance standards).
(45 FR 60608, Sept. 12, 1980)
21 CFR 864.6675 Platelet aggregometer.
(a) Identification. A platelet aggregometer is a device, used to
determine changes in platelet shape and platelet aggregation following
the addition of an aggregating reagent to a platelet rich plasma.
(b) Classification. Class II (performance standards).
(45 FR 60608, Sept. 12, 1980)
21 CFR 864.6700 Erythrocyte sedimentation rate test.
(a) Identification. An erythrocyte sedimentation rate test is a
device that measures the length of time required for the red cells in a
blood sample to fall a specified distance or a device that measures the
degree of sedimentation taking place in a given length of time. An
increased rate indicates tissue damage or inflammation.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(45 FR 60608, Sept. 12, 1980, as amended at 54 FR 25045, June 12,
1989)
21 CFR 864.6700 Subpart H -- Hematology Kits and Packages
21 CFR 864.7040 Adenosine triphosphate release assay.
(a) Identification. An adenosine triphosphate release assay is a
device that measures the release of adenosine triphosphate (ATP) from
platelets following aggregation. This measurement is made on
platelet-rich plasma using a photometer and a luminescent firefly
extract. Simultaneous measurements of platelet aggregation and ATP
release are used to evaluate platelet function disorders.
(b) Classification. Class I (general controls).
(45 FR 60609, Sept. 12, 1980)
21 CFR 864.7060 Antithrombin III assay.
(a) Identification. An antithrombin III assay is a device that is
used to determine the plasma level of antithrombin III (a substance
which acts with the anticoagulant heparin to prevent coagulation). This
determination is used to monitor the administration of heparin in the
treatment of thrombosis. The determination may also be used in the
diagnosis of thrombophilia (a congenital deficiency of antithrombin
III).
(b) Classification. Class II (performance standards).
(45 FR 60609, Sept. 12, 1980)
21 CFR 864.7100 Red blood cell enzyme assay.
(a) Identification. Red blood cell enzyme assay is a device used to
measure the activity in red blood cells of clinically important
enzymatic reactions and their products, such as pyruvate kinase or
2,3-diphosphoglycerate. A red blood cell enzyme assay is used to
determine the enzyme defects responsible for a patient's hereditary
hemolytic anemia.
(b) Classification. Class II (performance standards).
(45 FR 60610, Sept. 12, 1980)
21 CFR 864.7140 Activated whole blood clotting time tests.
(a) Identification. An activated whole blood clotting time tests is
a device, used to monitor heparin therapy for the treatment of venous
thrombosis or pulmonary embolism by measuring the coagulation time of
whole blood.
(b) Classification. Class II (performance standards).
(45 FR 60611, Sept. 12, 1980)
21 CFR 864.7250 Erythropoietin assay.
(a) Identification. A erythropoietin assay is a device that measures
the concentration of erythropoietin (an enzyme that regulates the
production of red blood cells) in serum or urine. This assay provides
diagnostic information for the evaluation of erythrocytosis (increased
total red cell mass) and anemia.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 864.3.
(45 FR 60612, Sept. 12, 1980, as amended at 52 FR 17733, May 11,
1987)
21 CFR 864.7275 Euglobulin lysis time tests.
(a) Identification. A euglobulin lysis time test is a device that
measures the length of time required for the lysis (dissolution) of a
clot formed from fibrinogen in the euglobulin fraction (that fraction of
the plasma responsible for the formation of plasmin, a clot lysing
enzyme). This test evaluates natural fibrinolysis (destruction of a
blood clot after bleeding has been arrested). The test also will detect
accelerated fibrinolysis.
(b) Classification. Class II (performance standards).
(45 FR 60612, Sept. 12, 1980)
21 CFR 864.7290 Factor deficiency test.
(a) Identification. A factor deficiency test is a device used to
diagnose specific coagulation defects, to monitor certain types of
therapy, to detect coagulation inhibitors, and to detect a carrier state
(a person carrying both a recessive gene for a coagulation factor
deficiency such as hemophilia and the corresponding normal gene).
(b) Classification. Class II (performance standards).
(45 FR 60613, Sept. 12, 1980)
21 CFR 864.7300 Fibrin monomer paracoagulation test.
(a) Identification. A fibrin monomer paracoagulation test is a
device used to detect fibrin monomer in the diagnosis of disseminated
intravascular coagulation (nonlocalized clotting within a blood vessel)
or in the differential diagnosis between disseminated intravascular
coagulation and primary fibrinolysis (dissolution of the fibrin in a
blood clot).
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 864.3.
(45 FR 60614, Sept. 12, 1980, as amended at 52 FR 17733, May 11,
1987)
21 CFR 864.7320 Fibrinogen/fibrin degradation products assay.
(a) Identification. A fibrinogen/fibrin degradation products assay
is a device used to detect and measure fibrinogen degradation products
and fibrin degradation products (protein fragments produced by the
enzymatic action of plasmin on fibrinogen and fibrin) as an aid in
detecting the presence and degree of intravascular coagulation and
fibrinolysis (the dissolution of the fibrin in a blood clot) and in
monitoring therapy for disseminated intravascular coagulation
(nonlocalized clotting in the blood vessels).
(b) Classification. Class II (performance standards).
(45 FR 60615, Sept. 12, 1980)
21 CFR 864.7340 Fibrinogen determination system.
(a) Identification. A fibrinogen determination system is a device
that consists of the instruments, reagents, standards, and controls used
to determine the fibrinogen levels in disseminated intravascular
coagulation (nonlocalized clotting within the blood vessels) and primary
fibrinolysis (the dissolution of fibrin in a blood clot).
(b) Classification. Class II (performance standards).
(45 FR 60615, Sept. 12, 1980)
21 CFR 864.7360 Erythrocytic glucose-6-phosphate dehydrogenase assay.
(a) Identification. An erythrocytic glucose-6-phosphate
dehydrogenase assay is a device used to measure the activity of the
enzyme glucose-6-phosphate dehydrogenase or of glucose-6-phosphate
dehydrogenase isoenzymes. The results of this assay are used in the
diagnosis and treatment of nonspherocytic congenital hemolytic anemia or
drug-induced hemolytic anemia associated with a glucose-6-phosphate
dehydrogenase deficiency. This generic device includes assays based on
fluorescence, electrophoresis, methemoglobin reduction, catalase
inhibition, and ultraviolet kinetics.
(b) Classification. Class II (performance standards).
(45 FR 60616, Sept. 12, 1980)
21 CFR 864.7375 Glutathione reductase assay.
(a) Identification. A glutathione reductase assay is a device used
to determine the activity of the enzyme glutathione reductase in serum,
plasma, or erythrocytes by such techniques as fluorescence and
photometry. The results of this assay are used in the diagnosis of
liver disease, glutathione reductase deficiency, or riboflavin
deficiency.
(b) Classification. Class II (performance standards).
(45 FR 60616, Sept. 12, 1980)
21 CFR 864.7400 Hemoglobin A2 assay.
(a) Identification. A hemoglobin A2 assay is a device used to
determine the hemoglobin A2 content of human blood. The measurement of
hemoglobin A2 is used in the diagnosis of the thalassemias (hereditary
hemolytic anemias characterized by decreased synthesis of one or more
types of hemoglobin polypeptide chains).
(b) Classification. Class II (performance standards).
(45 FR 60617, Sept. 12, 1980)
21 CFR 864.7415 Abnormal hemoglobin assay.
(a) Identification. An abnormal hemoglobin assay is a device
consisting of the reagents, apparatus, instrumentation, and controls
necessary to isolate and identify abnormal genetically determined
hemoglobin types.
(b) Classification. Class II (performance standards).
(45 FR 60618, Sept. 12, 1980)
21 CFR 864.7425 Carboxyhemoglobin assay.
(a) Identification. A carboxyhemoglobin assay is a device used to
determine the carboxyhemoglobin (the compound formed when hemoglobin is
exposed to carbon monoxide) content of human blood as an aid in the
diagnosis of carbon monoxide poisoning. This measurement may be made
using methods such as spectroscopy, colorimetry, spectrophotometry, and
gasometry.
(b) Classification. Class II (performance standards).
(45 FR 60619, Sept. 12, 1980)
21 CFR 864.7440 Electrophoretic hemoglobin analysis system.
(a) Identification. An electrophoretic hemoglobin analysis system is
a device that electrophoretically separates and identifies normal and
abnormal hemoglobin types as an aid in the diagnosis of anemia or
erythrocytosis (increased total red cell mass) due to a hemoglobin
abnormality.
(b) Classification. Class II (performance standards).
(45 FR 60620, Sept. 12, 1980)
21 CFR 864.7455 Fetal hemoglobin assay.
(a) Identification. A fetal hemoglobin assay is a device that is
used to determine the presence and distribution of fetal hemoglobin
(hemoglobin F) in red cells or to measure the amount of fetal hemoglobin
present. The assay may be used to detect fetal red cells in the
maternal circulation or to detect the elevated levels of fetal
hemoglobin exhibited in cases of hemoglobin abnormalities such as
thalassemia (a hereditary hemolytic anemia characterized by a decreased
synthesis of one or more types of hemoglobin polypeptide chains). The
hemoglobin determination may be made by methods such as electrophoresis,
alkali denaturation, column chromatography, or radial immunodiffusion.
(b) Classification. Class II (performance standards).
(45 FR 60620, Sept. 12, 1980)
21 CFR 864.7470 Glycosylated hemoglobin assay.
(a) Identification. A glycosylated hemoglobin assay is a device used
to measure the glycosylated hemoglobins (A1a, A1b, and A1c) in a
patient's blood by a column chromatographic procedure. Measurement of
glycosylated hemoglobin is used to assess the level of control of a
patient's diabetes and to determine the proper insulin dosage for a
patient. Elevated levels of glycosylated hemoglobin indicate
uncontrolled diabetes in a patient.
(b) Classification. Class II (performance standards).
(45 FR 60621, Sept. 12, 1980)
21 CFR 864.7490 Sulfhemoglobin assay.
(a) Identification. A sulfhemoglobin assay is a device consisting of
the reagents, calibrators, controls, and instrumentation used to
determine the sulfhemoglobin (a compound of sulfur and hemoglobin)
content of human blood as an aid in the diagnosis of sulfhemoglobinemia
(presence of sulfhemoglobin in the blood due to drug administration or
exposure to a poison). This measurement may be made using methods such
as spectroscopy, colorimetry, spectrophotometry, or gasometry.
(b) Classification. Class II (performance standards).
(45 FR 60621, Sept. 12, 1980)
21 CFR 864.7500 Whole blood hemoglobin assays.
(a) Identification. A whole blood hemoglobin assay is a device
consisting or reagents, calibrators, controls, or photometric or
spectrophotometric instrumentation used to measure the hemoglobin
content of whole blood for the detection of anemia. This generic device
category does not include automated hemoglobin systems.
(b) Classification. Class II (performance standards).
(45 FR 60622, Sept. 12, 1980)
21 CFR 864.7525 Heparin assay.
(a) Identification. A heparin assay is a device used to determine
the level of the anticoagulant heparin in the patient's circulation.
These assays are quantitative clotting time procedures using the effect
of heparin on activated coagulation factor X (Stuart factor) or
procedures based on the neutralization of heparin by protamine sulfate
(a protein that neutralizes heparin).
(b) Classification. Class II (performance standards).
(45 FR 60623, Sept. 12, 1980)
21 CFR 864.7660 Leukocyte alkaline phosphatase test.
(a) Identification. A leukocyte alkaline phosphatase test is a
device used to identify the enzyme leukocyte alkaline phosphatase in
neutrophilic granulocytes (granular leukocytes stainable by neutral
dyes). The cytochemical identification of alkaline phosphatase depends
on the formation of blue granules in cells containing alkaline
phosphatase. The results of this test are used to differentiate chronic
granulocytic leukemia (a malignant disease characterized by excessive
overgrowth of granulocytes in the bone marrow) and reactions that
resemble true leukemia, such as those occuring in severe infections and
polycythemia (increased total red cell mass).
(b) Classification. Class I (general controls.
(45 FR 60623, Sept. 12, 1980)
21 CFR 864.7675 Leukocyte peroxidase test.
(a) Identification. A leukocyte peroxidase test is a device used to
distinguish certain myeloid cells derived from the bone marrow, i.e.,
neutrophils, eosinophils, and monocytes, from lymphoid cells of the
lymphatic system and erythroid cells of the red blood cell series on the
basis of their peroxidase activity as evidenced by staining. The
results of this test are used in the differential diagnosis of the
leukemias.
(b) Classification. Class I (general controls).
(45 FR 60624, Sept. 12, 1980)
21 CFR 864.7695 Platelet factor 4 radioimmunoassay.
(a) Identification. A platelet factor 4 radioimmunoassay is a device
used to measure the level of platelet factor 4, a protein released
during platelet activation by radioimmunoassay. This device measures
platelet activiation, which may indicate a coagulation disorder, such as
myocardial infarction or coronary artery disease.
(b) Classification. Class II (performance standards).
(45 FR 60625, Sept. 12, 1980; 46 FR 14890, Mar. 3, 1981)
21 CFR 864.7720 Prothrombin consumption test.
(a) Identification. A prothrombin consumption tests is a device that
measures the patient's capacity to generate thromboplastin in the
coagulation process. The test also is an indirect indicator of
qualitative or quantitative platelet abnormalities. It is a screening
test for thrombocytopenia (decreased number of blood platelets) and
hemophilia A and B.
(b) Classification. Class II (performance standards).
(45 FR 60625, Sept. 12, 1980)
21 CFR 864.7735 Prothrombin-proconvertin test and thrombotest.
(a) Identification. The prothrombin-proconvertin test and
thrombotest are devices used in the regulation of coumarin therapy
(administration of a coumarin anticoagulant such as sodium warfarin in
the treatment of venous thrombosis and pulmonary embolism) and as a
diagnostic test in conjunction with, or in place of, the Quick
prothrombin time test to detect coagulation disorders.
(b) Classification. Class II (performance standards).
(45 FR 60626, Sept. 12, 1980)
21 CFR 864.7750 Prothrombin time test.
(a) Identification. A prothrombin time test is a device used as a
general screening procedure for the detection of possible clotting
factor deficiencies in the extrinsic coagulation pathway, which involves
the reaction between coagulation factors III and VII, and to monitor
patients receiving coumarin therapy (the administration of one of the
coumarin anticoagulants in the treatment of venous thrombosis or
pulmonary embolism).
(b) Classification. Class II (performance standards).
(45 FR 60626, Sept. 12, 1980)
21 CFR 864.7825 Sickle cell test.
(a) Identification. A sickle cell test is a device used to determine
the sickle cell hemoglobin content of human blood to detect sickle cell
trait or sickle cell diseases.
(b) Classification. Class II (performance standards).
(45 FR 60627, Sept. 12, 1980)
21 CFR 864.7875 Thrombin time test.
(a) Identification. A thrombin time test is a device used to measure
fibrinogen concentration and detect fibrin or fibrinogen split products
for the evaluation of bleeding disorders.
(b) Classification. Class II (performance standards).
(45 FR 60628, Sept. 12, 1980)
21 CFR 864.7900 Thromboplastin generation test.
(a) Identification. A thromboplastin generation test is a device
used to detect and identify coagulation factor deficiencies and
coagulation inhibitors.
(b) Classification. Class I (general controls).
(45 FR 60628, Sept. 12, 1980)
21 CFR 864.7925 Partial thromboplastin time tests.
(a) Identification. A partial thromboplastin time test is a device
used for primary screening for coagulation abnormalities, for evaluation
of the effect of therapy on procoagulant disorders, and as an assay for
coagulation factor deficiencies of the intrinsic coagulation pathway.
(b) Classification. Class II (performance standards).
(45 FR 60629, Sept. 12, 1980)
21 CFR 864.7925 Subpart I -- Hematology Reagents
21 CFR 864.8100 Bothrops atrox reagent.
(a) Identification. A Bothrops atrox reagent is a device made from
snake venom and used to determine blood fibrinogen levels to aid in the
evaluation of disseminated intravascular coagulation (nonlocalized
clotting in the blood vessels) in patients receiving heparin therapy
(the administration of the anticoagulant heparin in the treatment of
thrombosis) or as an aid in the classification of dysfibrinogenemia
(presence in the plasma of functionally defective fibrinogen).
(b) Classification. Class II (performance standards).
(45 FR 60629, Sept. 12, 1980)
21 CFR 864.8150 Calibrator for cell indices.
(a) Identification. A calibrator for cell indices is a device that
approximates whole blood or certain blood cells and that is used to set
an instrument intended to measure mean cell volume (MCV), mean
corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin
concentration (MCHC), or other cell indices. It is a suspension of
particles or cells whose size, shape, concentration, and other
characteristics have been precisely and accurately determined.
(b) Classification. Class II (performance standards).
(45 FR 60631, Sept. 12, 1980)
21 CFR 864.8165 Calibrator for hemoglobin or hematocrit measurement.
(a) Identification. A calibrator for hemoglobin or hematocrit
measurement is a device that approximates whole blood, red blood cells,
or a hemoglobin derivative and that is used to set instruments intended
to measure hemoglobin, the hematocrit, or both. It is a material whose
characteristics have been precisely and accurately determined.
(b) Classification. Class II (performance standards).
(45 FR 60632, Sept. 12, 1980)
21 CFR 864.8175 Calibrator for platelet counting.
(a) Identification. A calibrator for platelet counting is a device
that resembles platelets in plasma or whole blood and that is used to
set a platelet counting instrument. It is a suspension of particles or
cells whose size, shape concentration, and other characteristics have
been precisely and accurately determined.
(b) Classification. Class II (performance standards).
(45 FR 60633, Sept. 12, 1980)
21 CFR 864.8185 Calibrator for red cell and white cell counting.
(a) Identification. A calibrator for red cell and white cell
counting is a device that resembles red or white blood cells and that is
used to set instruments intended to count red cells, white cells, or
both. It is a suspension of particles or cells whose size, shape,
concentration, and other characteristics have been precisely and
accurately determined.
(b) Classification. Class II (performance standards).
(45 FR 60634, Sept. 12, 1980)
21 CFR 864.8200 Blood cell diluent.
(a) Identification. A blood cell diluent is a device used to dilute
blood for further testing, such as blood cell counting.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(45 FR 60635, Sept. 12, 1980, as amended at 54 FR 25045, June 12,
1989)
21 CFR 864.8500 Lymphocyte separation medium.
(a) Identification. A lymphocyte separation medium is a device used
to isolate lymphocytes from whole blood.
(b) Classification. Class I (general controls).
(45 FR 60636, Sept. 12, 1980)
21 CFR 864.8540 Red cell lysing reagent.
(a) Identification. A red cell lysing reagent is a device used to
lyse (destroy) red blood cells for hemoglobin determinations or aid in
the counting of white blood cells.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(45 FR 60636, Sept. 12, 1980, as amended at 54 FR 25045, June 12,
1989)
21 CFR 864.8625 Hematology quality control mixture.
(a) Identification. A hematology quality control mixture is a device
used to ascertain the accuracy and precision of manual, semiautomated,
and automated determinations of cell parameters such as white cell count
(WBC), red cell count (RBC), platelet count (PLT), hemoglobin,
hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular
hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).
(b) Classification. Class II (performance standards).
(45 FR 60637, Sept. 12, 1980)
21 CFR 864.8950 Russell viper venom reagent.
(a) Identification. Russell viper venom reagent is a device used to
determine the cause of an increase in the prothrombin time.
(b) Classification. Class I (general controls).
(45 FR 60637, Sept. 12, 1980)
21 CFR 864.8950 Subpart J -- Products Used In Establishments That Manufacture Blood and Blood Products
21 CFR 864.9050 Blood bank supplies.
(a) Identification. Blood bank supplies are general purpose devices
intended for in vitro use in blood banking. This generic type of device
includes products such as blood bank pipettes, blood grouping slides,
blood typing tubes, blood typing racks, and cold packs for antisera
reagents. The device does not include articles that are licensed by the
Center for Biologics Evaluation and Research of the Food and Drug
Administration.
(b) Classification. Class I (general controls).
(45 FR 60638, Sept. 12, 1980, as amended at 53 FR 11253, Apr. 6,
1988)
21 CFR 864.9100 Empty container for the collection and processing of
blood and blood components.
(a) Identification. An empty container for the collection and
processing of blood and blood components is a device intended for
medical purposes that is an empty plastic bag or plastic or glass bottle
used to collect, store, or transfer blood and blood components for
further processing.
(b) Classification. Class II (performance standards).
(45 FR 60638, Sept. 12, 1980)
21 CFR 864.9125 Vacuum-assisted blood collection system.
(a) Identification. A vacuum-assisted blood collection system is a
device intended for medical purposes that uses a vacuum to draw blood
for subsequent reinfusion.
(b) Classification. Class I (general controls).
(45 FR 60639, Sept. 12, 1980)
21 CFR 864.9145 Processing system for frozen blood.
(a) Identification. A processing system for frozen blood is a device
used to glycerolize red blood cells prior to freezing to minimize
hemolysis (disruption of the red cell membrane accompanied by the
release of hemoglobin) due to freezing and thawing of red blood cells
and to deglycerolize and wash thawed cells for subsequent reinfusion.
(b) Classification. Class II (performance standards).
(45 FR 60639, Sept. 12, 1980)
21 CFR 864.9160 Blood group substances of nonhuman origin for in vitro
diagnostic use.
(a) Identification. Blood group substances of nonhuman origin for in
vitro diagnostic use are materials, such as blood group specific
substances prepared from nonhuman sources (e.g., pigs, cows, and horses)
used to detect, identify, or neutralize antibodies to various human
blood group antigens. This generic type of device does not include
materials that are licensed by the Center for Biologics Evaluation and
Research of the Food and Drug Administration.
(b) Classification. Class II (performance standards).
(45 FR 60640, Sept. 12, 1980, as amended at 53 FR 11253, Apr. 6,
1988)
21 CFR 864.9175 Automated blood grouping and antibody test system.
(a) Identification. An automated blood grouping and antibody test
system is a device used to group erythrocytes (red blood cells) and to
detect antibodies to blood group antigens.
(b) Classification. Class II (performance standards).
(45 FR 60641, Sept. 12, 1980)
21 CFR 864.9185 Blood grouping view box.
(a) Identification. A blood grouping view box is a device with a
glass or plastic viewing surface, which may be illuminated and heated,
that is used to view cell reactions in antigen-antibody testing.
(b) Classification. Class I (general controls).
(45 FR 60641, Sept. 12, 1980)
21 CFR 864.9195 Blood mixing devices and blood weighing devices.
(a) Identification. A blood mixing device is a device intended for
medical purposes that is used to mix blood or blood components by
agitation. A blood weighing device is a device intended for medical
purposes that is used to weigh blood or blood components as they are
collected.
(b) Classification. Class I (general controls).
(45 FR 60642, Sept. 12, 1980)
21 CFR 864.9205 Blood and plasma warming device.
(a) Nonelectromagnetic blood or plasma warming device -- (1)
Identification. A nonelectromagnetic blood and plasma warming device is
a device that warms blood or plasma, by means other than electromagnetic
radiation, prior to administration.
(2) Classification. Class II (performance standards).
(b) Electromagnetic blood and plasma warming device -- (1)
Identification. An electromagnetic blood and plasma warming device is a
device that employs electromagnetic radiation (radiowaves or microwaves)
to warm a bag or bottle of blood or plasma prior to administration.
(2) Classfication. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval for the device described in paragraph (b)(1). See 864.3.
(45 FR 60642, Sept. 12, 1980, as amended at 52 FR 17733, May 11,
1987)
21 CFR 864.9225 Cell-freezing apparatus and reagents for in vitro
diagnostic use.
(a) Identification. Cell-freezing apparatus and reagents for in
vitro diagnostic use are devices used to freeze human red blood cells
for in vitro diagnostic use.
(b) Classification. Class I (general controls).
(45 FR 60643, Sept. 12, 1980)
21 CFR 864.9245 Automated blood cell separator.
(a) Identification. An automated blood cell separator is a device
that automatically removes whole blood from a donor, separates the blood
into components (red blood cells, white blood cells, plasma, and
platelets), retains one or more of the components, and returns the
remainder of the blood to the donor. The components obtained are
transfused or used to prepare blood products for administration. These
devices operate on either a centrifugal separation principle or a
filtration principle. The separation bowls of centrifugal blood cell
separators may be reusable or disposable.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 864.3.
(45 FR 60645, Sept. 12, 1980, as amended at 52 FR 17733, May 11,
1987)
21 CFR 864.9275 Blood bank centrifuge for in vitro diagnostic use.
(a) Identification. A blood bank centrifuge for in vitro diagnostic
use is a device used only to separate blood cells for further diagnostic
testing.
(b) Classification. Class I (general controls).
(45 FR 60645, Sept. 12, 1980)
21 CFR 864.9285 Automated cell-washing centrifuge for
immuno-hematology.
(a) Identification. An automated cell-washing centrifuge for
immuno-hematology is a device used to separate and prepare cells and
sera for further in vitro diagnostic testing.
(b) Classification. Class II (performance standards).
(45 FR 60646, Sept. 12, 1980)
21 CFR 864.9300 Automated Coombs test systems.
(a) Identification. An automated Coombs test system is a device used
to detect and identify antibodies in patient sera or antibodies bound to
red cells. The Coombs test is used for the diagnosis of hemolytic
disease of the newborn, and autoimmune hemolytic anemia. The test is
also used in crossmatching and in investigating transfusion reactions
and drug-induced red cell sensitization.
(b) Classification. Class II (performance standards).
(45 FR 60646, Sept. 12, 1980)
21 CFR 864.9320 Copper sulfate solution for specific gravity
determinations.
(a) Identification. A copper sulfate solution for specific gravity
determinations is a device used to determine whether the hemoglobin
content of a potential donor's blood meets the required level (12.5
grams per 100 milliliters of blood for women and 13.5 grams per 100
milliliters of blood for men).
(b) Classification. Class I (general controls).
(45 FR 60647, Sept. 12, 1980)
21 CFR 864.9400 Stabilized enzyme solution.
(a) Identification. A stabilized enzyme solution is a reagent
intended for medical purposes that is used to enhance the reactivity of
red blood cells with certain antibodies, including antibodies that are
not detectable by other techniques. These enzyme solutions include
papain, bromelin, ficin, and trypsin.
(b) Classification. Class II (performance standards).
(45 FR 60647, Sept. 12, 1980)
21 CFR 864.9550 Lectins and protectins.
(a) Identification. Lectins and protectins are proteins derived from
plants and lower animals that cause cell agglutination in the presence
of certain antigens. These substances are used to detect blood group
antigens for in vitro diagnostic purposes.
(b) Classification. Class II (performance standards).
(45 FR 60648, Sept. 12, 1980)
21 CFR 864.9575 Environmental chamber for storage of platelet
concentrate.
(a) Identification. An environmental chamber for storage of platelet
concentrate is a device used to hold platelet-rich plasma within a
preselected temperature range.
(b) Classification. Class II (performance standards).
(45 FR 60648, Sept. 12, 1980)
21 CFR 864.9600 Potentiating media for in vitro diagnostic use.
(a) Identification. Potentiating media for in vitro diagnostic use
are media, such as bovine albumin, that are used to suspend red cells
and to enhance cell reactions for antigen-antibody testing.
(b) Classification. Class II (performance standards).
(45 FR 60649, Sept. 12, 1980)
21 CFR 864.9650 Quality control kit for blood banking reagents.
(a) Identification. A quality control kit for blood banking reagents
is a device that consists of sera, cells, buffers, and antibodies used
to determine the specificity, potency, and reactivity of the cells and
reagents used for blood banking.
(b) Classification. Class II (performance standards).
(45 FR 60649, Sept. 12, 1980)
21 CFR 864.9700 Blood storage refrigerator and blood storage freezer.
(a) Identification. A blood storage refrigerator and a blood storage
freezer are devices intended for medical purposes that are used to
preserve blood and blood products by storing them at cold or freezing
temperatures.
(b) Classification. Class II (performance standards).
(45 FR 60650, Sept. 12, 1980)
21 CFR 864.9750 Heat-sealing device.
(a) Identification. A heat-sealing device is a device intended for
medical purposes that uses heat to seal plastic bags containing blood or
blood components.
(b) Classification. Class I (general controls).
(45 FR 60650, Sept. 12, 1980)
21 CFR 864.9875 Transfer set.
(a) Identification. A transfer set is a device intended for medical
purposes that consists of a piece of tubing with suitable adaptors used
to transfer blood or plasma from one container to another.
(b) Classification. Class II (performance standards).
(45 FR 60651, Sept. 12, 1980)
21 CFR 864.9875 Pt. 866
21 CFR 864.9875 PART 866 -- IMMUNOLOGY AND MICROBIOLOGY DEVICES
21 CFR 864.9875 Subpart A -- General Provisions
Sec.
866.1 Scope.
866.3 Effective dates of requirement for premarket approval.
866.9 Limitations of exemptions from section 510(k) of the Federal
Food, Drug, and Cosmetic Act (the act).
21 CFR 864.9875 Subpart B -- Diagnostic Devices
866.1620 Antimicrobial susceptibility test disc.
866.1640 Antimicrobial susceptibility test powder.
866.1700 Culture medium for antimicrobial susceptibility tests.
21 CFR 864.9875 Subpart C -- Microbiology Devices
866.2050 Staphylococcal typing bacteriophage.
866.2120 Anaerobic chamber.
866.2160 Coagulase plasma.
866.2170 Automated colony counter.
866.2180 Manual colony counter.
866.2300 Multipurpose culture medium.
866.2320 Differential culture medium.
866.2330 Enriched culture medium.
866.2350 Microbiological assay culture medium.
866.2360 Selective culture medium.
866.2390 Transport culture medium.
866.2410 Culture medium for pathogenic Neisseria spp.
866.2420 Oxidase screening test for gonorrhea.
866.2440 Automated medium dispensing and stacking device.
866.2450 Supplement for culture media.
866.2480 Quality control kit for culture media.
866.2500 Microtiter diluting and dispensing device.
866.2540 Microbiological incubator.
866.2560 Microbial growth monitor.
866.2580 Gas-generating device.
866.2600 Wood's fluorescent lamp.
866.2660 Microorganism differentiation and identification device.
866.2850 Automated zone reader.
866.2900 Microbiological specimen collection and transport device.
21 CFR 864.9875 Subpart D -- Serological Reagents
866.3010 Acinetobacter calcoaceticus serological reagents.
866.3020 Adenovirus serological reagents.
866.3035 Arizona spp. serological reagents.
866.3040 Aspergillus spp. serological reagents.
866.3060 Blastomyces dermatitidis serological reagents.
866.3065 Bordetella spp. serological reagents.
866.3085 Brucella spp. serological reagents.
866.3110 Campylobacter fetus serological reagents.
866.3120 Chlamydia serological reagents.
866.3125 Citrobacter spp. serological reagents.
866.3135 Coccidioides immitis serological reagents.
866.3140 Corynebacterium spp. serological reagents.
866.3145 Coxsackievirus serological reagents.
866.3165 Cryptococcus neoformans serological reagents.
866.3175 Cytomegalovirus serological reagents.
866.3200 Echinococcus spp. serological reagents.
866.3205 Echovirus serological reagents.
866.3220 Entamoeba histolytica serological reagents.
866.3235 Epstein-Barr virus serological reagents.
866.3240 Equine encephalomyelitis virus serological reagents.
866.3250 Erysipelothrix rhusiopathiae serological reagents.
866.3255 Escherichia coli serological reagents.
866.3270 Flavobacterium spp. serological reagents.
866.3280 Francisella tularensis serological reagents.
866.3290 Gonococcal antibody test (GAT).
866.3300 Haemophilus spp. serological reagents.
866.3305 Herpes simplex virus serological reagents.
866.3320 Histoplasma capsulatum serological reagents.
866.3330 Influenza virus serological reagents.
866.3340 Klebsiella spp. serological reagents.
866.3350 Leptospira spp. serological reagents.
866.3355 Listeria spp. serological reagents.
866.3360 Lymphocytic choriomeningitis virus serological reagents.
866.3370 Mycobacterium tuberculosis immunofluorescent reagents.
866.3375 Mycoplasma spp. serological reagents.
866.3380 Mumps virus serological reagents.
866.3390 Neisseria spp. direct serological test reagents.
866.3400 Parainfluenza virus serological reagents.
866.3405 Poliovirus serological reagents.
866.3410 Proteus spp. (Weil-Felix) serological reagents.
866.3415 Pseudomonas spp. serological reagents.
866.3460 Rabiesvirus immunofluorescent reagents.
866.3470 Reovirus serological reagents.
866.3480 Respiratory syncytial virus serological reagents.
866.3490 Rhinovirus serological reagents.
866.3500 Rickettsia serological reagents.
866.3510 Rubella virus serological reagents.
866.3520 Rubeola (measles) virus serological reagents.
866.3550 Salmonella spp. serological reagents.
866.3600 Schistosoma spp. serological reagents.
866.3630 Serratia spp. serological reagents.
866.3660 Shigella spp. serological reagents.
866.3680 Sporothrix schenckii serological reagents.
866.3700 Staphylococcus aureus serological reagents.
866.3720 Streptococcus spp. exoenzyme reagents.
866.3740 Streptococcus spp. serological reagents.
866.3780 Toxoplasma gondii serological reagents.
866.3820 Treponema pallidum nontreponemal test reagents.
866.3830 Treponema pallidum treponemal test reagents.
866.3850 Trichinella spiralis serological reagents.
866.3870 Trypanosoma spp. serological reagents.
866.3900 Varicella-zoster virus serological reagents.
866.3930 Vibrio cholerae serological reagents.
21 CFR 864.9875 Subpart E -- Immunology Laboratory Equipment and
Reagents
866.4100 Complement reagent.
866.4500 Immunoelectrophoresis equipment.
866.4520 Immunofluorometer equipment.
866.4540 Immunonephelometer equipment.
866.4600 Ouchterlony agar plate.
866.4800 Radial immunodiffusion plate.
866.4830 Rocket immunoelectrophoresis equipment.
866.4900 Support gel.
21 CFR 864.9875 Subpart F -- Immunological Test Systems
866.5040 Albumin immunological test system.
866.5060 Prealbumin immunological test system.
866.5065 Human allotypic marker immunological test system.
866.5080 Alpha-1-antichymotrypsin immunological test system.
866.5090 Antimitochondrial antibody immunological test system.
866.5100 Antinuclear antibody immunological test system.
866.5110 Antiparietal antibody immunological test system.
866.5120 Antismooth muscle antibody immunological test system.
866.5130 Alpha-1-antitrypsin immunological test system.
866.5150 Bence-Jones proteins immunological test system.
866.5160 Beta-globulin immunological test system.
866.5170 Breast milk immunological test system.
866.5200 Carbonic anhydrase B and C immunological test system.
866.5210 Ceruloplasmin immunological test system.
866.5220 Cohn fraction II immunological test system.
866.5230 Colostrum immunological test system.
866.5240 Complement components immunological test system.
866.5250 Complement C1 inhibitor (inactivator) immunological test
system.
866.5260 Complement C3b inactivator immunological test system.
866.5270 C-reactive protein immunological test system.
866.5320 Properidin factor B immunological test system.
866.5330 Factor XIII, A, S, immunological test system.
866.5340 Ferritin immunological test system.
866.5350 Fibrinopeptide A immunological test system.
866.5360 Cohn fraction IV immunological test system.
866.5370 Cohn fraction V immunological test system.
866.5380 Free secretory component immunological test system.
866.5400 Alpha-globulin immunological test system.
866.5420 Alpha-1-glycoproteins immunological test system.
866.5425 Alpha-2-glycoproteins immunological test system.
866.5430 Beta-2-glycoprotein I immunological test system.
866.5440 Beta-2-glycoprotein III immunological test system.
866.5460 Haptoglobin immunological test system.
866.5470 Hemoglobin immunological test system.
866.5490 Hemopexin immunological test system.
866.5500 Hypersensitivity pneumonitis immunological test system.
866.5510 Immunoglobulins A, G, M, D, and E immunological test system.
866.5520 Immunoglobulin G (Fab fragment specific) immunological test
system.
866.5530 Immunoglobulin G (Fc fragment specific) immunological test
system.
866.5540 Immunoglobulin G (Fd fragment specific) immunological test
system.
866.5550 Immunoglobulin (light chain specific) immunological test
system.
866.5560 Lactic dehydrogenase immunological test system.
866.5570 Lactoferrin immunological test system.
866.5580 Alpha-1-lipoprotein immunological test system.
866.5590 Lipoprotein X immunological test system.
866.5600 Low-density lipoprotein immunological test system.
866.5620 Alpha-2-macroglobulin immunological test system.
866.5630 Beta-2-microglobulin immunological test system.
866.5640 Infectious mononucleosis immunological test system.
866.5660 Multiple autoantibodies immunological test system.
866.5680 Myoglobin immunological test system.
866.5700 Whole human plasma or serum immunological test system.
866.5715 Plasminogen immunological test system.
866.5735 Prothrombin immunological test system.
866.5750 Radioallergosorbent (RAST) immunological test system.
866.5765 Retinol-binding protein immunological test system.
866.5775 Rheumatoid factor immunological test system.
866.5800 Seminal fluid (sperm) immunological test system.
866.5820 Systemic lupus erythematosus immunological test system.
866.5860 Total spinal fluid immunological test system.
866.5870 Thyroid autoantibody immunological test system.
866.5880 Transferrin immunological test system.
866.5890 Inter-alpha trypsin inhibitor immunological test system.
21 CFR 864.9875 Subpart G -- Tumor Associated Antigen Immunological
Test Systems
866.6010 Carcinoembryonic antigen (CEA) immunological test system as
an aid in the detection and management of cancer.
Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j, 371).
Source: 47 FR 50823, Nov. 9, 1982, unless otherwise noted.
21 CFR 864.9875 Subpart A -- General Provisions
21 CFR 866.1 Scope.
(a) This part sets forth the classification of immunology and
microbiology devices intended for human use that are in commercial
distribution.
(b) The indentification of a device in a regulation in this part is
not a precise description of every device that is, or will be, subject
to the regulation. A manufacturer who submits a premarket notification
submission for a device under Part 807 may not show merely that the
device is accurately described by the section title and identification
provisions of a regulation in this part, but shall state why the device
is substantially equivalent to other devices, as required by 807.87.
(c) To avoid duplicative listings, an immunology and microbiology
device that has two or more types of uses (e.g., used both as a
diagnostic device and as a microbiology device) is listed only in one
subpart.
(d) References in this part to regulatory sections of the Code of
Federal Regulations are to Chapter I of Title 21, unless otherwise
noted.
(52 FR 17733, May 11, 1987)
21 CFR 866.3 Effective dates of requirement for premarket approval.
A device included in this part that is classified into class III
(Premarket approval) shall not be commercially distributed after the
date shown in the regulation classifying the device unless the
manufacturer has an approval under section 515 of the act (unless an
exemption has been granted under section 520(g)(2) of the act). An
approval under section 515 of the act consists of FDA's issuance of an
order approving an application for premarket approval (PMA) for the
device or declaring completed a product development protocol (PDP) for
the device.
(a) Before FDA requires that a device commercially distributed before
the enactment date of the amendments, or a device that has been found
substantially equivalent to such a device, has an approval under section
515 of the act FDA must promulgate a regulation under section 515(b) of
the act requiring such approval, except as provided in paragraphs (b)
and (c) of this section. Such a regulation under section 515(b) of the
act shall not be effective during the grace period ending on the 90th
day after its promulgation or on the last day of the 30th full calendar
month after the regulation that classifies the device into class III is
effective, whichever is later. See section 501(f)(2)(B) of the act.
Accordingly, unless an effective date of the requirement for premarket
approval is shown in the regulation for a device classified into class
III in this part, the device may be commercially distributed without
FDA's issuance of an order approving a PMA or declaring completed a PDP
for the device. If FDA promulgates a regulation under section 515(b) of
the act requiring premarket approval for a device, section 501(f)(1)(A)
of the act applies to the device.
(b) Any new, not substantially equivalent, device introduced into
commercial distribution on or after May 28, 1976, including a device
formerly marketed that has been substantially altered, is classified by
statute (section 513(f) of the act) into class III without any grace
period and FDA must have issued an order approving a PMA or declaring
completed a PDP for the device before the device is commercially
distributed unless it is reclassified. If FDA knows that a device being
commercially distributed may be a ''new'' device as defined in this
section because of any new intended use or other reasons, FDA may codify
the statutory classification of the device into class III for such new
use. Accordingly, the regulation for such a class III device states
that as of the enactment date of the amendments, May 28, 1976, the
device must have an approval under section 515 of the act before
commercial distribution.
(c) A device identified in a regulation in this part that is
classified into class III and that is subject to the transitional
provisions of section 520(l) of the act is automatically classified by
statute into class III and must have an approval under section 515 of
the act before being commercially distributed. Accordingly, the
regulation for such a class III transitional device states that as of
the enactment date of the amendments, May 28, 1976, the device must have
an approval under section 515 of the act before commercial distribution.
(52 FR 17733, May 11, 1987; 52 FR 22577, June 12, 1987)
21 CFR 866.9 Limitations of exemptions from section 510(k) of the
Federal Food, Drug, and Cosmetic Act (the act).
The Food and Drug Administration's (FDA's) decision to grant an
exemption from the requirement of premarket notification (section 510(k)
of the act) for a generic type of class I device is based upon the
existing and reasonably foreseeable characteristics of commercially
distributed devices within that generic type. Because FDA cannot
anticipate every change in intended use or characteristic that could
significantly affect a device's safety or effectiveness, manufacturers
of any commercially distributed class I device for which FDA has granted
an exemption from the requirement of premarket notification must still
submit a premarket notification to FDA before introducing or delivering
for introduction into interstate commerce for commercial distribution
the device when:
(a) The device is intended for a use different from its intended use
before May 28, 1976, or the device is intended for a use different from
the intended use of a preamendments device to which it had been
determined to be substantially equivalent; e.g., the device is intended
for a different medical purpose, or the device is intended for lay use
where the former intended use was by health care professionals only; or
(b) The modified device operates using a different fundamental
scientific technology than that in use in the device before May 28, 1976
e.g., a surgical instrument cuts tissue with a laser beam rather than
with a sharpened metal blade, or an in vitro diagnostic device detects
or identifies infectious agents by using a deoxyribonucleic acid (DNA)
probe or nucleic acid hybridization technology rather than culture or
immunoassay technology.
(54 FR 25045, June 12, 1989)
21 CFR 866.9 Subpart B -- Diagnostic Devices
21 CFR 866.1620 Antimicrobial susceptibility test disc.
(a) Identification. An antimicrobial susceptibility test disc is a
device that consists of antimicrobic-impregnated paper discs used to
measure by a disc-agar diffusion technique or a disc-broth elution
technique the in vitro susceptibility of most clinically important
bacterial pathogens to antimicrobial agents. In the disc-agar diffusion
technique, bacterial susceptibility is ascertained by directly measuring
the magnitude of a zone of bacterial inhibition around the disc on an
agar surface. The disc-broth elution technique is associated with an
automated rapid susceptibility test system and employs a fluid medium in
which susceptibility is ascertained by photometrically measuring changes
in bacterial growth resulting when antimicrobial material is eluted from
the disc into the fluid medium. Test results are used to determine the
antimicrobial agent of choice in the treatment of bacterial diseases.
(b) Classification. Class II (performance standards).
21 CFR 866.1640 Antimicrobial susceptibility test powder.
(a) Identification. An antimicrobial susceptibility test powder is a
device that consists of an antimicrobial drug powder packaged in vials
in specified amounts and intended for use in clinical laboratories for
determining in vitro susceptibility of bacterial pathogens to these
therapeutic agents. Test results are used to determine the
antimicrobial agent of choice in the treatment of bacterial diseases.
(b) Classification. Class II (performance standards).
21 CFR 866.1700 Culture medium for antimicrobial susceptibility tests.
(a) Identification. A culture medium for antimicrobial
susceptibility tests is a device intended for medical purposes that
consists of any medium capable of supporting the growth of many of the
bacterial pathogens that are subject to antimicrobial susceptibility
tests. The medium should be free of components known to be antagonistic
to the common agents for which susceptibility tests are performed in the
treatment of disease.
(b) Classification. Class II (performance standards).
21 CFR 866.1700 Subpart C -- Microbiology Devices
21 CFR 866.2050 Staphylococcal typing bacteriophage.
(a) Identification. A staphylococcal typing bacteriophage is a
device consisting of a bacterial virus intended for medical purposes to
identify pathogenic staphylococcal bacteria through use of the
bacteria's susceptibility to destruction by the virus. Test results are
used principally for the collection of epidemiological information.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25045, June 12, 1989)
21 CFR 866.2120 Anaerobic chamber.
(a) Identification. An anaerobic chamber is a device intended for
medical purposes to maintain an anaerobic (oxygen free) environment. It
is used to isolate and cultivate anaerobic microorganisms.
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in Subpart E of Part
807. The device also is exempt from the good manufacturing practice
regulation in Part 820, with the exception of 820.180, with respect to
general requirements concerning records, and 820.198, with respect to
complaint files.
21 CFR 866.2160 Coagulase plasma.
(a) Identification. Coagulase plasma is a device that consists of
freeze-dried animal or human plasma that is intended for medical
purposes to perform coagulase tests primarily on staphylococcal
bacteria. When reconstituted, the fluid plasma is clotted by the action
of the enzyme coagulase which is produced by pathogenic staphylococci.
Test results are used primarily as an aid in the diagnosis of disease
caused by pathogenic bacteria belonging to the genus Staphylococcus and
provide epidemiological information on disease caused by these
microorganisms.
(b) Classification. Class II (performance standards).
21 CFR 866.2170 Automated colony counter.
(a) Identification. An automated colony counter is a mechanical
device intended for medical purposes to determine the number of
bacterial colonies present on a bacteriological culture medium contained
in a petri plate. The number of colonies counted is used in the
diagnosis of disease as a measure of the degree of bacterial infection.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25045, June 12, 1989)
21 CFR 866.2180 Manual colony counter.
(a) Identification. A manual colony counter is a device intended for
medical purposes that consists of a printed grid system superimposed on
an illuminated screen. Petri plates containing bacterial colonies to be
counted are placed on the screen for better viewing and ease of
counting. The number of colonies counted is used in the diagnosis of
disease as a measure of the degree of bacterial infection.
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in Subpart E of Part
807. The device also is exempt from the good manufacturing practice
regulation in Part 820, with the exception of 820.180, with respect to
general requirements concerning records, and 820.198, with respect to
complaint files.
21 CFR 866.2300 Multipurpose culture medium.
(a) Identification. A multipurpose culture medium is a device that
consists primarily of liquid or solid biological materials intended for
medical purposes for the cultivation and identification of several types
of pathogenic microorganisms without the need of additional nutritional
supplements. Test results aid in the diagnosis of disease and also
provide epidemiological information on diseases caused by these
microorganisms.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989)
21 CFR 866.2320 Differential culture medium.
(a) Identification. A differential culture medium is a device that
consists primarily of liquid biological materials intended for medical
purposes to cultivate and identify different types of pathogenic
microorganisms. The identification of these microorganisms is
accomplished by the addition of a specific biochemical component(s) to
the medium. Microorganisms are identified by a visible change (e.g., a
color change) in a specific biochemical component(s) which indicates
that specific metabolic reactions have occurred. Test results aid in
the diagnosis of disease and also provide epidemiological information on
diseases caused by these microorganisms.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989)
21 CFR 866.2330 Enriched culture medium.
(a) Identification. An enriched culture medium is a device that
consists primarily of liquid or solid biological materials intended for
medical purposes to cultivate and identify fastidious microorganisms
(those having complex nutritional requirements). The device consists of
a relatively simple basal medium enriched by the addition of such
nutritional components as blood, blood serum, vitamins, and extracts of
plant or animal tissues. The device is used in the diagnosis of disease
caused by pathogenic microorganisms and also provides epidemiological
information on these diseases.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989)
21 CFR 866.2350 Microbiological assay culture medium.
(a) Identification. A microbiological assay culture medium is a
device that consists primarily of liquid or solid biological materials
intended for medical purposes to cultivate selected test microorganisms
in order to measure by microbiological procedures the concentration in a
patient's serum of certain substances, such as amino acids,
antimicrobial agents, and vitamins. The concentration of these
substances is measured by their ability to promote or inhibit the growth
of the test organism in the innoculated medium. Test results aid in the
diagnosis of disease resulting from either deficient or excessive
amounts of these substances in a patient's serum. Tests results may
also be used to monitor the effects of the administration of certain
antimicrobial drugs.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 this chapter.
(47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989)
21 CFR 866.2360 Selective culture medium.
(a) Identification. A selective culture medium is a device that
consists primarily of liquid or solid biological materials intended for
medical purposes to cultivate and identify certain pathogenic
microorganisms. The device contains one or more components that
suppress the growth of certain microorganisms while either promoting or
not affecting the growth of other microorganisms. The device aids in
the diagnosis of disease caused by pathogenic microorganisms and also
provides epidemiological information on these diseases.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989)
21 CFR 866.2390 Transport culture medium.
(a) Identification. A transport culture medium is a device that
consists of a semisolid, usually non-nutrient, medium that maintains the
viability of suspected pathogens contained in patient specimens while in
transit from the specimen collection area to the laboratory. The device
aids in the diagnosis of disease caused by pathogenic microorganisms and
also provides epidemiological information on these diseases.
(b) Classification. Class I (general controls).
21 CFR 866.2410 Culture medium for pathogenic Neisseria spp.
(a) Identification. A culture medium for pathogenic Neisseria spp.
is a device that consists primarily of liquid or solid biological
materials used to cultivate and identify pathogenic Neisseria spp. The
identification aids in the diagnosis of disease caused by bacteria
belonging to the genus Neisseria, such as epidemic cerebrospinal
meningitis, other meningococcal disease, and gonorrhea, and also
provides epidemiological information on these microorganisms.
(b) Classification. Class II (performance standards).
21 CFR 866.2420 Oxidase screening test for gonorrhea.
(a) Identification. An oxidase screening test for gonorrhea is an in
vitro device that consists of the articles intended to identify by
chemical reaction, cytochrome oxidase, an oxidizing enzyme that is
associated with certain bacteria including Neisseria gonorrhoeae. A
sample of a male's urethral discharge is obtained on a swab which is
placed into a wetting agent containing an ingredient that will react
with cytochrome oxidase. When cytochrome oxidase is present, the swab
turns a dark purple color within 3 minutes. Because it is unlikely that
cytochrome oxidase-positive organisms other than Neisseria gonorrhoeae
are present in the urethral discharge of males, the identification of
cytochrome oxidase with this device indicates presumptive infection of
the patient with the causative agent of gonorrhea.
(b) Classification. Class III (premarket approval) (transitional
device).
(c) Date PMA or notice of completion of a PDP is required. As of May
28, 1976, an approval under section 515 of the act is required before
this device may be commercially distributed. See 866.3.
(47 FR 50823, Nov. 9, 1982, as amended at 52 FR 17734, May 11, 1987)
21 CFR 866.2440 Automated medium dispensing and stacking device.
(a) Identification. An automated medium dispensing and stacking
device is a device intended for medical purposes to dispense a
microbiological culture medium into petri dishes and then mechanically
stack the petri dishes.
(b) Classification. Class I (general controls). This device is
exempt from the premarket notification procedures in Subpart E of Part
807. This device also is exempt from the good manufacturing practice
regulation in Part 820, with the exception of 820.180, with respect to
general requirements concerning records, and 820.198, with respect to
complaint files.
21 CFR 866.2450 Supplement for culture media.
(a) Identification. A supplement for culture media is a device, such
as a vitamin or sugar mixture, that is added to a solid or liquid basal
culture medium to produce a desired formulation and that is intended for
medical purposes to enhance the growth of fastidious microorganisms
(those having complex nutritional requirements). This device aids in
the diagnosis of diseases caused by pathogenic microorganisms.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989)
21 CFR 866.2480 Quality control kit for culture media.
(a) Identification. A quality control kit for culture media is a
device that consists of paper discs (or other suitable materials), each
impregnated with a specified, freeze-dried, viable microorganism,
intended for medical purposes to determine if a given culture medium is
able to support the growth of that microorganism. The device aids in
the diagnosis of disease caused by pathogenic microorganisms and also
provides epidemiological information on these diseases.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989)
21 CFR 866.2500 Microtiter diluting and dispensing device.
(a) Identification. A microtiter diluting and dispensing device is a
mechanical device intended for medical purposes to dispense or serially
dilute very small quantities of biological or chemical reagents for use
in various diagnostic procedures.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989)
21 CFR 866.2540 Microbiological incubator.
(a) Identification. A microbiological incubator is a device with
various chambers or water-filled compartments in which controlled
environmental conditions, particularly temperature, are maintained. It
is intended for medical purposes to cultivate microorganisms and aid in
the diagnosis of disease.
(b) Classification. Class I (general controls). This device is
exempt from premarket notification procedures in Subpart E of Part 807.
The device also is exempt from the good manufacturing practice
regulation in Part 820 with the exception of 820.180, with respect to
general requirements concerning records, and 820.198, with respect to
complaint files.
21 CFR 866.2560 Microbial growth monitor.
(a) Identification. A microbial growth monitor is a device intended
for medical purposes that measures the concentration of bacteria
suspended in a liquid medium by measuring changes in light scattering
properties, optical density, electrical impedance, or by making direct
bacterial counts. The device aids in the diagnosis of disease caused by
pathogenic microorganisms.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989)
21 CFR 866.2580 Gas-generating device.
(a) Identification. A gas-generating device is a device intended for
medical purposes that produces predetermined amounts of selected gases
to be used in a closed chamber in order to establish suitable
atmospheric conditions for cultivation of microorganisms with special
atmospheric requirements. The device aids in the diagnosis of disease.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989)
21 CFR 866.2600 Wood's fluorescent lamp.
(a) Identification. A Wood's fluorescent lamp is a device intended
for medical purposes to detect fluorescent materials (e.g., fluorescein
pigment produced by certain microorganisms) as an aid in the
identification of these microorganisms. The device aids in the
diagnosis of disease.
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in Subpart E of Part
807. The device also is exempt from the good manufacturing practice
regulation in Part 820 with the exception of 820.180, with respect to
general requirements concerning records, and 820.198 with respect to
complaint files.
21 CFR 866.2660 Microorganism differentiation and identification
device.
(a) Identification. A microorganism differentiation and
identification device is a device intended for medical purposes that
consists of one or more components, such as differential culture media,
biochemical reagents, and paper discs or paper strips impregnated with
test reagents, that are usually contained in individual compartments and
used to differentiate and identify selected microorganisms. The device
aids in the diagnosis of disease.
(b) Classification. Class I (general controls).
21 CFR 866.2850 Automated zone reader.
(a) Identification. An automated zone reader is a mechanical device
intended for medical purposes to measure zone diameters of microbial
growth inhibition (or exhibition), such as those observed on the surface
of certain culture media used in disc-agar diffusion antimicrobial
susceptibility tests. The device aids in decisionmaking respecting the
treatment of disease.
(b) Classification. Class I (general controls).
21 CFR 866.2900 Microbiological specimen collection and transport
device.
(a) Identification. A microbiological specimen collection and
transport device is a specimen collecting chamber intended for medical
purposes to preserve the viability or integrity of microorganisms in
specimens during storage of specimens after their collection and during
their transport from the collecting area to the laboratory. The device
may be labeled or otherwise represented as sterile. The device aids in
the diagnosis of disease caused by pathogenic microorganisms.
(b) Classification. Class I (general controls).
21 CFR 866.2900 Subpart D -- Serological Reagents
21 CFR 866.3010 Acinetobacter calcoaceticus serological reagents.
(a) Identification. Acinetobacter calcoaceticus serological reagents
are devices that consist of Acinetobacter calcoaceticus antigens and
antisera used to identify this bacterium from cultured isolates derived
from clinical specimens. The identification aids in the diagnosis of
disease caused by the bacterium Acinetobacter calcoaceticus and provides
epidemiological information on disease caused by this microorganism.
This organism becomes pathogenic in patients with burns or with
immunologic deficiency, and infection can result in sepsis (blood
poisoning).
(b) Classification. Class I. These devices are exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989)
21 CFR 866.3020 Adenovirus serological reagents.
(a) Identification. Adenovirus serological reagents are devices that
consist of antigens and antisera used in serological tests to identify
antibodies to adenovirus in serum. Additionally, some of these reagents
consist of adenovirus antisera conjugated with a fluorescent dye and are
used to identify adenoviruses directly from clinical specimens. The
identification aids in the diagnosis of disease caused by adenoviruses
and provides epidemiological information on these diseases. Adenovirus
infections may cause pharyngitis (inflammation of the throat), acute
respiratory diseases, and certain external diseases of the eye (e.g.,
conjunctivitis).
(b) Classification. Class I. These devices are exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989)
21 CFR 866.3035 Arizona spp. serological reagents.
(a) Identification. Arizona spp. serological reagents are devices
that consist of antisera and antigens used to identify Arizona spp. in
cultured isolates derived from clinical specimens. The identification
aids in the diagnosis of disease caused by bacteria belonging to the
genus Arizona and provides epidemiological information on diseases
caused by these microorganisms. Arizona spp. can cause gastroenteritis
(food poisoning) and sepsis (blood poisoning).
(b) Classification. Class I. These devices are exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989)
21 CFR 866.3040 Aspergillus spp. serological reagents.
(a) Identification. Aspergillus spp. serological reagents are
devices that consist of antigens and antisera used in various
serological tests to identify antibodies to Aspergillus spp. in serum.
The identification aids in the diagnosis of aspergillosis caused by
fungi belonging to the genus Aspergillus. Aspergillosis is a disease
marked by inflammatory granulomatous (tumor-like) lessions in the skin,
ear, eyeball cavity, nasal sinuses, lungs, and occasionally the bones.
(b) Classification. Class I (general controls).
21 CFR 866.3060 Blastomyces dermatitidis serological reagents.
(a) Identification. Blastomyces dermatitidis serological reagents
are devices that consist of antigens and antisera used in serological
tests to identify antibodies to Blastomyces determatitidis in serum.
The identification aids in the diagnosis of blastomycosis caused by the
fungus Blastomyces dermatitidis. Blastomycosis is a chronic
granulomatous (tumor-like) disease, which may be limited to the skin or
lung or may be widely disseminated in the body resulting in lesions of
the bones, liver, spleen, and kidneys.
(b) Classification. Class II (performance standards).
21 CFR 866.3065 Bordetella spp. serological reagents.
(a) Identification. Bordetella spp. serological reagents are
devices that consist of antigens and antisera, including antisera
conjugated with a fluorescent dye, used in serological tests to identify
Bordetella spp. from cultured isolates or directly from clinical
specimens. The identification aids in the diagnosis of diseases caused
by bacteria belonging to the genus Bordetella and provides
epidemiological information on these diseases. Bordetella spp. cause
whooping cough (Bordetella pertussis) and other similiarly contagious
and acute respiratory infections characterized by pneumonitis
(inflammation of the lungs).
(b) Classification. Class I. These devices are exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989)
21 CFR 866.3085 Brucella spp. serological reagents.
(a) Identification. Brucella spp. serological reagents are devices
that consist of antigens and antisera used for serological
identification of Brucella spp. from cultured isolates derived from
clinical specimens or to identify antibodies to Brucella spp. in serum.
Additionally, some of these reagents consist of antisera conjugated
with a fluorescent dye (immunofluorescent reagents) used to identify
Brucella spp. directly from clinical specimens or cultured isolates
derived from clinical specimens. The identification aids in the
diagnosis of brucellosis (e.g., undulant fever, Malta fever) caused by
bacteria belonging to the genus Brucella and provides epidemiological
information on diseases caused by these microorganisms.
(b) Classification. Class II (performance standards).
21 CFR 866.3110 Campylobacter fetus serological reagents.
(a) Identification. Campylobacter fetus serological reagents are
devices that consist of antisera conjugated with a fluorescent dye used
to identify Campylobacter fetus from clinical specimens or cultured
isolates derived from clinical specimens. The identification aids in
the diagnosis of diseases caused by this bacterium and provides
epidemiological information on these diseases. Campylobacter fetus is a
frequent cause of abortion in sheep and cattle and is sometimes
responsible for endocarditis (inflammation of certain membranes of the
heart) and enteritis (inflammation of the intestines) in humans.
(b) Classification. Class I (general controls).
21 CFR 866.3120 Chlamydia serological reagents.
(a) Identification. Chlamydia serological reagents are devices that
consist of antigens and antisera used in serological tests to identify
antibodies to chlamydia in serum. Additionally, some of these reagents
consist of chlamydia antisera conjugated with a fluorescent dye used to
identify chlamydia directly from clinical specimens or cultured isolates
derived from clinical specimens. The identification aids in the
diagnosis of disease caused by bacteria belonging to the genus Chlamydia
and provides epidemiological information on these diseases. Chlamydia
are the causative agents of psittacosis (a form of pneumonia),
lymphogranuloma venereum (a venereal disease), and trachoma (a chronic
disease of the eye and eyelid).
(b) Classification. Class I (general controls).
21 CFR 866.3125 Citrobacter spp. serological reagents.
(a) Identification. Citrobacter spp. serological reagents are
devices that consist of antigens and antisera used in serological tests
to identify Citrobacter spp. from cultured isolates derived from
clinical specimens. The identification aids in the diagnosis of disease
caused by bacteria belonging to the genus Citrobacter and provides
epidemiological information on diseases caused by these microorganisms.
Citrobacter spp. have occasionally been associated with urinary tract
infections.
(b) Classification. Class I. These devices are exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989)
21 CFR 866.3135 Coccidioides immitis serological reagents.
(a) Identification. Coccidioides immitis serological reagents are
devices that consist of antigens and antisera used in serological tests
to identify antibodies to Coccidioides immitis in serum. The
identification aids in the diagnosis of coccidioidomycosis caused by a
fungus belonging to the genus Coccidioides and provides epidemiological
information on diseases caused by this microorganism. An infection with
Coccidioides immitis produces symptoms varying in severity from those
accompanying the common cold to those of influenza.
(b) Classification. Class II (performance standards).
21 CFR 866.3140 Corynebacterium spp. serological reagents.
(a) Identification. Corynebacterium spp. serological reagents are
devices that consist of antisera conjugated with a fluorescent dye used
to identify Corynebacterium spp. from clinical specimens. The
identification aids in the diagnosis of disease caused by bacteria
belonging to the genus Corynebacterium and provides epidemiological
information on diseases caused by these microorganisms. The principal
human pathogen of this genus, Corynebacterium diphtheriae, causes
diphtheria. However, many other types of corynebacteria form part of
the normal flora of the human respiratory tract, other mucus membranes,
and skin, and are either nonpathogenic or have an uncertain role.
(b) Classification. Class I (general controls).
21 CFR 866.3145 Coxsackievirus serological reagents.
(a) Identification. Coxsackievirus serological reagents are devices
that consist of antigens and antisera used in serological tests to
identify antibodies to coxsackievirus in serum. Additionally, some of
these reagents consist of coxsackievirus antisera conjugated with a
fluorescent dye that are used to identify coxsackievirus from clinical
specimens or from tissue culture isolates derived from clinical
specimens. The identification aids in the diagnosis of coxsackievirus
infections and provides epidemiological information on diseases caused
by these viruses. Coxsackieviruses produce a variety of infections,
including common colds, meningitis (inflammation of brain and spinal
cord membranes), herpangina (brief fever accompanied by ulcerated
lesions of the throat), and myopericarditis (inflammation of heart
tissue).
(b) Classification. Class I (general controls).
21 CFR 866.3165 Cryptococcus neoformans serological reagents.
(a) Identification. Cryptococcus neoformans serological reagents are
devices that consist of antigens used in serological tests to identify
antibodies to Cryptococcus neoformans in serum. Additionally, some of
these reagents consist of antisera conjugated with a fluorescent dye
(immunofluorescent reagents) and are used to identify Cryptococcus
neoformans directly from clinical specimens or from cultured isolates
derived from clinical specimens. The identification aids in the
diagnosis of cryptococcosis and provides epidemiological information on
this type of disease. Cryptococcosis infections are found most often as
chronic meningitis (inflammation of brain membranes) and, if not
treated, are usually fatal.
(b) Classification. Class II (performance standards).
21 CFR 866.3175 Cytomegalovirus serological reagents.
(a) Identification. Cytomegalovirus serological reagents are devices
that consist of antigens and antisera used in serological tests to
identify antibodies to cytomegalovirus in serum. The identification
aids in the diagnosis of diseases caused by cytomegaloviruses
(principally cytomegalic inclusion disease) and provides epidemiological
information on these diseases. Cytomegalic inclusion disease is a
generalized infection of infants and is caused by intrauterine or early
postnatal infection with the virus. The disease may cause severe
congenital abnormalities, such as microcephaly (abnormal smallness of
the head), motor disability, and mental retardation. Cytomegalovirus
infection has also been associated with acquired hemolytic anemia, acute
and chronic hepatitis, and an infectious mononucleosis-like syndrome.
(b) Classification. Class II (performance standards).
21 CFR 866.3200 Echinococcus spp. serological reagents.
(a) Identification. Echinococcus spp. serological reagents are
devices that consist of Echinococcus spp. antigens and antisera used in
serological tests to identify antibodies to Echinococcus spp. in serum.
The identification aids in the diagnosis of echinococcosis, caused by
parasitic tapeworms belonging to the genus Echinococcus and provides
epidemiological information on this disease. Echinococcosis is
characterized by the development of cysts in the liver, lung, kidneys,
and other organs formed by the larva of the infecting organisms.
(b) Classification. Class I (general controls).
21 CFR 866.3205 Echovirus serological reagents.
(a) Identification. Echovirus serological reagents are devices that
consist of antigens and antisera used in serological tests to identify
antibodies to echovirus in serum. Additionally, some of these reagents
consist of echovirus antisera conjugated with a fluorescent dye used to
identify echoviruses from clinical specimens or from tissue culture
isolates derived from clinical specimens. The identification aids in
the diagnosis of echovirus infections and provides epidemiological
information on diseases caused by these viruses. Echoviruses cause
illnesses such as meningitis (inflammation of the brain and spinal cord
membranes), febrile illnesses (accompanied by fever) with or without
rash, and the common cold.
(b) Classification. Class I. These devices are exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989)
21 CFR 866.3220 Entamoeba histolytica serological reagents.
(a) Identification. Entamoeba histolytica serological reagents are
devices that consist of antigens and antisera used in serological tests
to identify antibodies to Entamoeba histolytica in serum. Additionally,
some of these reagents consist of antisera conjugated with a fluorescent
dye (immunofluorescent reagents) used to identify Entamoeba histolytica
directly from clinical specimens. The identification aids in the
diagnosis of amebiasis caused by the microscopic protozoan parasite
Entamoeba histolytica and provides epidemiological information on
diseases caused by this parasite. The parasite may invade the skin,
liver, intestines, lungs, and diaphragm, causing disease conditions such
as indolent ulcers, an amebic hepatitis, amebic dysentery, and pulmonary
lesions.
(b) Classification. Class II (performance standards).
(47 FR 50823, Nov. 9, 1982; 47 FR 56846, Dec. 21, 1982)
21 CFR 866.3235 Epstein-Barr virus serological reagents.
(a) Identification. Epstein-Barr virus serological reagents are
devices that consist of antigens and antisera used in serological tests
to identify antibodies to Epstein-Barr virus in serum. The
identification aids in the diagnosis of Epstein-Barr virus infections
and provides epidemiological information on diseases caused by these
viruses. Epstein-Barr viruses are thought to cause infectious
mononucleosis and have been associated with Burkitt's lymphoma (a tumor
of the jaw in African children and young adults) and postnasal carcinoma
(cancer).
(b) Classification. Class I (general controls).
21 CFR 866.3240 Equine encephalomyelitis virus serological reagents.
(a) Identification. Equine encephalomyelitis virus serological
reagents are devices that consist of antigens and antisera used in
serological tests to identify antobodies to equine encephalomyelitis
virus in serum. The identification aids in the diagnosis of diseases
caused by equine encephalomyelitis viruses and provides epidemiological
information on these viruses. Equine encephalomyelitis viruses are
transmitted to humans by the bite of insects, such as mosquitos and
ticks, and may cause encephalitis (inflammation of the brain), rash,
acute arthritis, or hepatitis.
(b) Classification. Class I (general controls).
21 CFR 866.3250 Erysipelothrix rhusiopathiae serological reagents.
(a) Identification. Erysipelothrix rhusiopathiae serological
reagents are devices that consist of antigens and antisera used in
serological tests to identify Erysipelothrix rhusiopathiae from cultured
isolates derived from clinical specimens. The identification aids in
the diagnosis of disease caused by this bacterium belonging to the genus
Erysipelothrix. This organism is responsible for a variety of
inflammations of the skin following skin abrasions from contact with
fish, shellfish, or poultry.
(b) Classification. Class I. These devices are exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989)
21 CFR 866.3255 Escherichia coli serological reagents.
(a) Identification. Escherichia coli serological reagents are
devices that consist of antigens and antisera used in serological tests
to identify Escherichia coli from cultured isolates derived from
clinical specimens. Additionally, some of these reagents consist of
Escherichia coli antisera conjugated with a fluorescent dye used to
identify Escherichia coli directly from clinical specimens or cultured
isolates derived from clinical specimens. The identification aids in
the diagnosis of diseases caused by this bacterium belonging to the
genus Escherichia, and provides epidemiological information on diseases
caused by this microorganism. Although Escherichia coli constitutes the
greater part of the microorganisms found in the intestinal tract in
humans and is usually nonpathogenic, those strains which are pathogenic
may cause urinary tract infections or epidemic diarrheal disease,
especially in children.
(b) Classification. Class I. These devices are exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989)
21 CFR 866.3270 Flavobacterium spp. serological reagents.
(a) Identification. Flavobacterium spp. serological reagents are
devices that consist of antigens and antisera used in serological tests
to identify Flavobacteriuim spp. from cultured isolates derived from
clinical specimens. The identification aids in the diagnosis of disease
caused by bacteria belonging to the genus Flavobacterium and provides
epidemiological information on diseases caused by these microorganisms.
Most members of this genus are found in soil and water and, under
certain conditions, may become pathogenic to humans. Flavobacterium
meningosepticum is highly virulent for the newborn, in whom it may cause
epidemics of septicemia (blood poisoning) and meningitis (inflammation
of the membranes of the brain) and is usually attributable to
contaminated hospital equipment.
(b) Classification. Class I. These devices are exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989)
21 CFR 866.3280 Francisella tularensis serological reagents.
(a) Identification. Francisella tularensis serological reagents are
devices that consist of antigens and antisera used in serological tests
to identify antibodies to Francisella tularensis in serum or to identify
Francisella tularensis in cultured isolates derived from clinical
specimens. Additionally, some of these reagents consist of antisera
conjugated with a fluorescent dye (immunofluorescent reagents) used to
identify Francisella tularensis directly from clinical specimens. The
identification aids in the diagnosis of tularemia caused by Francisella
tularensis and provides epidemiological information on this disease.
Tularemia is a desease principally of rodents, but may be transmitted to
humans through handling of infected animals, animal products, or by the
bites of fleas and ticks. The disease takes on several forms depending
upon the site of infection, such as skin lesions, lymph node
enlargements, or pulmonary infection.
(b) Classification. Class II (performance standards).
21 CFR 866.3290 Gonococcal antibody test (GAT).
(a) Identification. A gonococcal antibody test (GAT) is an in vitro
device that consists of the reagents intended to identify by
immunochemical techniques, such as latex agglutination, indirect
fluorescent antibody, or radioimmunoassay, antibodies to Neisseria
gonorrhoeae in sera of asymptomatic females at low risk of infection.
Identification of antibodies with this device may indicate past or
present infection of the patient with Neisseria gonorrhoeae.
(b) Classification. Class III (premarket approval) (transitional
device).
(c) Date PMA or notice of completion of a PDP is required. As of May
28, 1976, an approval under section 515 of the act is required before
this device may be commercially distributed. See 866.3.
(47 FR 50823, Nov. 9, 1982, as amended at 52 FR 17734, May 11, 1987)
21 CFR 866.3300 Haemophilus spp. serological reagents.
(a) Identification. Haemophilus spp. serological reagents are
devices that consist of antigens and antisera, including antisera
conjugated with a fluorescent dye, that are used in serological tests to
identify Haemophilus spp. directly from clinical specimens or tissue
culture isolates derived from clinical specimens. The identification
aids in the diagnosis of diseases caused by bacteria belonging to the
genus Haemophilus and provides epidemiological information on diseases
cause by these microorganisms. Diseases most often caused by
Haemophilus spp. include pneumonia, pharyngitis, sinusitis, vaginitis,
chancroid venereal disease, and a contagious form of conjunctivitis
(inflammation of eyelid membranes).
(b) Classification. Class II (performance standards).
21 CFR 866.3305 Herpes simplex virus serological reagents.
(a) Identification. Herpes simplex virus serological reagents are
devices that consist of antigens and antisera used in various
serological tests to identify antibodies to herpes simplex virus in
serum. Additionally, some of the reagents consist of herpes simplex
virus antisera conjugated with a fluorescent dye (immunofluorescent
reagents) used to identify herpes simplex virus directly from clinical
specimens or tissue culture isolates derived from clinical specimens.
The identification aids in the diagnosis of diseases caused by herpes
simplex viruses and provides epidemiological information on these
diseases. Herpes simplex viral infections range from common and mild
lesions of the skin and mucous membranes to a severe form of
encephalitis (inflammation of the brain). Neonatal herpes virus
infections range from an mild infection to a severe generalized disease
with a fatal outcome.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 866.3.
(47 FR 50823, Nov. 9, 1982, as amended at 52 FR 17734, May 11, 1987)
21 CFR 866.3320 Histoplasma capsulatum serological reagents.
(a) Identification. Histoplasma capsulatum serological reagents are
devices that consist of antigens and antisera used in serological tests
to identify antibodies to Histoplasma capsulatum in serum.
Additionally, some of these reagents consist of Histoplasma capsulatum
antisera conjugated with a fluorescent dye (immunofluorescent reagents)
used to identify Histoplasma capsulatum from clinical specimens or
cultured isolates derived from clinical specimens. The identification
aids in the diagnosis of histoplasmosis caused by this fungus belonging
to the genus Histoplasma and provides epidemiological information on the
diseases caused by this fungus. Histoplasmosis usually is a mild and
often asymptomatic respiratory infection, but in a small number of
infected individuals the lesions may spread to practically all tissues
and organs.
(b) Classification. Class II (performance standards).
21 CFR 866.3330 Influenza virus serological reagents.
(a) Identification. Influenza virus serological reagents are devices
that consist of antigens and antisera used in serological tests to
identify antibodies to influenza in serum. The identification aids in
the diagnosis of influenza (flu) and provides epidemiological
information on influenza. Influenza is an acute respiratory tract
disease, which is often epidemic.
(b) Classification. Class I. These devices are exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989)
21 CFR 866.3340 Klebsiella spp. serological reagents.
(a) Identification. Klebsiella spp. serological reagents are
devices that consist of antigens and antisera, including antisera
conjugated with a fluorescent dye (immunofluorescent reagents), that are
used in serological tests to identify Klebsiella spp. from cultured
isolates derived from clinical specimens. The identification aids in
the diagnosis of diseases caused by bacteria belonging to the genus
Klebsiella and provides epidemiological information on these diseases.
These organisms can cause serious urinary tract and pulmonary
infections, particularly in hospitalized patients.
(b) Classification. Class I. These devices are exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989)
21 CFR 866.3350 Leptospira spp. serological reagents.
(a) Identification. Leptospira spp. serological reagents are
devices that consist of antigens and antisera used in serological tests
to identify antibodies to Leptospira spp. in serum or identify
Leptospira spp. from cultured isolates derived from clinical specimens.
Additionally, some of these antisera are conjugated with a fluorescent
dye (immunofluorescent reagents) and used to identify Leptospira spp.
directly from clinical specimens. The identification aids in the
diagnosis of leptospirosis caused by bacteria belonging to the genus
Leptospira and provides epidemiological information on this disease.
Leptospira infections range from mild fever-producing illnesses to
severe liver and kidney involvement producing hemorrhage and dysfunction
of these organs.
(b) Classification. Class II (performance standards).
21 CFR 866.3355 Listeria spp. serological reagents.
(a) Identification. Listeria spp. serological reagents are devices
that consist of antigens and antisera used in serological tests to
identify Listeria spp. from cultured isolates derived from clinical
specimens. Additionally, some of these reagents consist of Listeria
spp. antisera conjugated with a fluorescent dye (immunofluorescent
reagents) used to identify Listeria spp. directly from clinical
specimens. The identification aids in the diagnosis of listeriosis, a
disease caused by bacteria belonging to the genus Listeria, and provides
epidemiological information on diseases caused by these microorganisms.
Listeria monocytogenes, the most common human pathogen of this genus,
causes meningitis (inflammation of the brain membranes) and
meningoencephalitis (inflammation of the brain and brain membranes) and
is often fatal if untreated. A second form of human listeriosis is an
intrauterine infection in pregnant women that results in a high
mortality rate for infants before or after birth.
(b) Classification. Class I (general controls).
21 CFR 866.3360 Lymphocytic choriomeningitis virus serological
reagents.
(a) Identification. Lymphocytic choriomeningitis virus serological
reagents are devices that consist of antigens and antisera used in
serological tests to identify antibodies to lymphocytic choriomeningitis
virus in serum. The identification aids in the diagnosis of lymphocytic
choriomeningitis virus infections and provides epidemiological
information on diseases caused by these viruses. Lymphocytic
choriomeningitis viruses usually cause a mild cerebral meningitis
(inflammation of membranes that envelop the brain) and occasionally a
mild pneumonia, but in rare instances may produce severe and even fatal
illnesses due to complications from cerebral meningitis and pneumonia.
(b) Classification. Class I (general controls).
21 CFR 866.3370 Mycobacterium tuberculosis immunofluorescent reagents.
(a) Identification. Mycobacterium tuberculosis immunofluorescent
reagents are devices that consist of antisera conjugated with a
fluorescent dye used to identify Mycobacterium tuberculosis directly
from clinical specimens. The identification aids in the diagnosis of
tuberculosis and provides epidemiological information on this disease.
Mycobacterium tuberculosis is the common causative organism in human
tuberculosis, a chronic infectious disease characterized by formation of
tubercles (small rounded nodules) and tissue necrosis (destruction),
usually occurring in the lung.
(b) Classification. Class I (general controls).
21 CFR 866.3375 Mycoplasma spp. serological reagents.
(a) Identification. Mycoplasma spp. serological reagents are
devices that consist of antigens and antisera used in serological tests
to identify antibodies to Mycoplasma spp. in serum. Additionally, some
of these reagents consist of Mycoplasma spp. antisera conjugated with a
fluorescent dye (immunofluorescent reagents) used to identify Mycoplasma
spp. directly from clinical specimens. The identification aids in the
diagnosis of disease caused by bacteria belonging to the genus
Mycoplasma and provides epidemiological information on diseases caused
by these microorganisms. Mycoplasma spp. are associated with
inflammatory conditions of the urinary and respiratory tracts, the
genitals, and the mouth. The effects in humans of infection with
Mycoplasma pneumoniae range from inapparent infection to mild or severe
upper respiratory disease, ear infection, and bronchial pneumonia.
(b) Classification. Class I (general controls).
21 CFR 866.3380 Mumps virus serological reagents.
(a) Identification. Mumps virus serological reagents consist of
antigens and antisera used in serological tests to identify antibodies
to mumps virus in serum. Additionally, some of these reagents consist
of antisera conjugated with a fluorescent dye (immunofluorescent
reagents) used in serological tests to identify mumps viruses from
tissue culture isolates derived from clinical specimens. The
identification aids in the diagnosis of mumps and provides
epidemiological information on mumps. Mumps is an acute contagious
disease, particularly in children, characterized by an enlargement of
one or both of the parotid glands (glands situated near the ear),
although other organs may also be involved.
(b) Classification. Class I (general controls).
21 CFR 886.3390 Neisseria spp. direct serological test reagents.
(a) Identification. Neisseria spp. direct serological test reagents
are devices that consist of antigens and antisera used in serological
tests to identify Neisseria spp. from cultured isolates. Additionally,
some of these reagents consist of Neisseria spp. antisera conjugated
with a fluorescent dye (immunofluorescent reagents) which may be used to
detect the presence of Neisseria spp. directly from clinical specimens.
The identification aids in the diagnosis of disease caused by bacteria
belonging to the genus Neisseria, such as epidemic cerebrospinal
meningitis, meningococcal disease, and gonorrhea, and also provides
epidemiological information on diseases caused by these microorganisms.
The device does not include products for the detection of gonorrhea in
humans by indirect methods, such as detection of antibodies or of
oxidase produced by gonococcal organisms.
(b) Classification. Class II (performance standards).
21 CFR 866.3400 Parainfluenza virus serological reagents.
(a) Identification. Parainfluenza virus serological reagents are
devices that consist of antigens and antisera used in serological tests
to identify antibodies to parainfluenza virus in serum. The
identification aids in the diagnosis of parainfluenza virus infections
and provides epidemiological information on diseases caused by these
viruses. Parainfluenza viruses cause a variety of respiratory illnesses
ranging from the common cold to pneumonia.
(b) Classification. Class I. These devices are exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989)
21 CFR 866.3405 Poliovirus serological reagents.
(a) Identification. Poliovirus serological reagents are devices that
consist of antigens and antisera used in serological tests to identify
antibodies to poliovirus in serum. Additionally, some of these reagents
consist of poliovirus antisera conjugated with a fluorescent dye
(immunofluorescent reagents) used to identify polioviruses from clinical
specimens or from tissue culture isolates derived from clinical
specimens. The identification aids in the diagnosis of poliomyelitis
(polio) and provides epidemiological information on this disease.
Poliomyelitis is an acute infectious disease which in its serious form
affects the central nervous system resulting in atrophy (wasting away)
of groups of muscles, ending in contraction and permanent deformity.
(b) Classification. Class I (general controls).
21 CFR 866.3410 Proteus spp. (Weil-Felix) serological reagents.
(a) Identification. Proteus spp. (Weil-Felix) serological reagents
are devices that consist of antigens and antisera, including antisera
conjugated with a fluorescent dye (immunofluorescent reagents), derived
from the bacterium Proteus vulgaris used in agglutination tests (a
specific type of antigen-antibody reaction) for the detection of
antibodies to rickettsia (virus-like bacteria) in serum. Test results
aid in the diagnosis of diseases caused by bacteria belonging to the
genus Rickettsiae and provide epidemiological information on these
diseases. Rickettsia are generally transmitted by arthropods (e.g.,
ticks and mosquitoes) and produce infections in humans characterized by
rash and fever (e.g., typhus fever, spotted fever, Q fever, and trench
fever).
(b) Classification. Class I. These devices are exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989)
21 CFR 866.3415 Pseudomonas spp. serological reagents.
(a) Identification. Pseudomonas spp. serological reagents are
devices that consist of antigens and antisera, including antisera
conjugated with a fluorescent dye (immunofluorescent reagents), used to
identify Pseudomonas spp. from clinical specimens or from cultured
isolates derived from clinical specimens. The identification aids in
the diagnosis of disease caused by bacteria belonging to the genus
Pseudomonas. Pseudomonas aeruginosa is a major cause of
hospital-acquired infections, and has been associated with urinary tract
infections, eye infections, burn and wound infections, blood poisoning,
abscesses, and meningitis (inflammation of brain membranes).
Pseudomonas pseudomallei causes melioidosis, a chronic pneumonia.
(b) Classification. Class II (performance standards).
21 CFR 866.3460 Rabiesvirus immunofluorescent reagents.
(a) Identification. Rabiesvirus immunofluorescent reagents are
devices that consist of rabiesvirus antisera conjugated with a
fluorescent dye used to identify rabiesvirus in specimens taken from
suspected rabid animals. The identification aids in the diagnosis of
rabies in patients exposed by animal bites and provides epidemiological
information on rabies. Rabies is an acute infectious disease of the
central nervous system which, if undiagnosed, may be fatal. The disease
is commonly transmitted to humans by a bite from a rabid animal.
(b) Classification. Class II (performance standards).
21 CFR 866.3470 Reovirus serological reagents.
(a) Identification. Reovirus serological reagents are devices that
consist of antigens and antisera used in serological tests to identify
antibodies to reovirus in serum. The identification aids in the
diagnosis of reovirus infections and provides epidemiological
information on diseases caused by these viruses. Reoviruses are thought
to cause only mild respiratory and gastrointestinal illnesses.
(b) Classification. Class I. These devices are exempt from
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989)
21 CFR 866.3480 Respiratory syncytial virus serological reagents.
(a) Identification. Respiratory syncytial virus serological reagents
are devices that consist of antigens and antisera used in serological
tests to identify antibodies to respiratory syncytial virus in serum.
Additionally, some of these reagents consist of respiratory syncytial
virus antisera conjugated with a fluorescent dye (immunofluorescent
reagents) and used to identify respiratory syncytial viruses from
clinical specimens or from tissue culture isolates derived from clinical
specimens. The identification aids in the diagnosis of respiratory
syncytial virus infections and provides epidemiological information on
diseases caused by these viruses. Respiratory syncytial viruses cause a
number of respiratory tract infections, including the common cold,
pharyngitis, and infantile bronchopneumonia.
(b) Classification. Class I (general controls).
21 CFR 866.3490 Rhinovirus serological reagents.
(a) Identification. Rhinovirus serological reagents are devices that
consist of antigens and antisera used in serological tests to identify
antibodies to rhinovirus in serum. The identification aids in the
diagnosis of rhinovirus infections and provides epidemiological
information on diseases caused by these viruses. Rhinoviruses cause
common colds.
(b) Classification. Class I. These devices are exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989)
21 CFR 866.3500 Rickettsia serological reagents.
(a) Identification. Rickettsia serological reagents are devices that
consist of antigens and antisera used in serological tests to identify
antibodies to rickettsia in serum. Additionally, some of these reagents
consist of rickettsial antisera conjugated with a fluorescent dye
(immunofluorescent reagents) used to identify rickettsia directly from
clinical specimens. The identification aids in the diagnosis of
diseases caused by virus-like bacteria belonging to the genus
Rickettsiae and provides epidemiological information on these diseases.
Rickettsia are generally transmitted by arthropods (e.g., ticks and
mosquitoes) and produce infections in humans characterized by rash and
fever (e.g., typhus fever, spotted fever, Q fever, and trench fever).
(b) Classification. Class I (general controls).
21 CFR 866.3510 Rubella virus serological reagents.
(a) Identification. Rubella virus serological reagents are devices
that consist of antigens and antisera used in serological tests to
identify antibodies to rubella virus in serum. The identification aids
in the diagnosis of rubella (German measles) or confirmation of a
person's immune status from past infections or immunizations and
provides epidemiological information on German measles. Newborns
infected in the uterus with rubella virus may be born with multiple
congenital defects (rubella syndrome).
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 866.3.
(47 FR 50823, Nov. 9, 1982, as amended at 52 FR 17734, May 11, 1987)
21 CFR 866.3520 Rubeola (measles) virus serological reagents.
(a) Identification. Rubeola (measles) virus serological reagents are
devices that consist of antigens and antisera used in serological tests
to identify antibodies to rubeola virus in serum. The identification
aids in the diagnosis of measles and provides epidemiological
information on the disease. Measles is an acute, highly infectious
disease of the respiratory and reticuloendothelial tissues, particularly
in children, characterized by a confluent and blotchy rash.
(b) Classification. Class I. These devices are exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989)
21 CFR 866.3550 Salmonella spp. serological reagents.
(a) Identification. Salmonella spp. serological reagents are
devices that consist of antigens and antisera used in serological tests
to identify Salmonella spp. from cultured isolates derived from
clinical specimens. Additionally, some of these reagents consist of
antisera conjugated with a fluorescent dye (immunofluorescent reagents)
used to identify Salmonella spp. directly from clinical specimens or
cultured isolates derived from clinical specimens. The identification
aids in the diagnosis of salmonellosis caused by bacteria belonging to
the genus Salmonella and provides epidemiological information on this
disease. Salmonellosis is characterized by high grade fever (''enteric
fever''), severe diarrhea, and cramps.
(b) Classification. Class II (performance standards).
21 CFR 866.3600 Schistosoma spp. serological reagents.
(a) Identification. Schistosoma spp. serological reagents are
devices that consist of antigens and antisera used in serological tests
to identify antibodies to Schistosoma spp. in serum. The
identification aids in the diagnosis of schistosomiasis caused by
parasitic flatworms of the genus Schistosoma. Schistosomiasis is
characterized by a variety of acute and chronic infections. Acute
infection is marked by fever, allergic symptoms, and diarrhea. Chronic
effects are usually severe and are caused by fibrous degeneration of
tissue around deposited eggs of the parasite in the liver, lungs, and
central nervous system. Schistosomes can also cause schistosome
dermatitis (e.g., swimmer's itch), a skin disease marked by intense
itching.
(b) Classification. Class I (general controls).
21 CFR 866.3630 Serratia spp. serological reagents.
(a) Identification. Serratia spp. serological reagents are devices
that consist of antigens and antisera used in serological tests to
identify Serratia spp. from cultured isolates. The identification aids
in the diagnosis of disease caused by bacteria belonging to the genus
Serratia and provides epidemiological information on these diseases.
Serratia spp. are occasionally associated with gastroenteritis (food
poisoning) and wound infections.
(b) Classification. Class I. These devices are exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(47 FR 50823, Nov. 9, 1982 as amended at 54 FR 25047, June 12, 1989)
21 CFR 866.3660 Shigella spp. serological reagents.
(a) Identification. Shigella spp. serological reagents are devices
that consist of antigens and antisera, including antisera conjugated
with a fluorescent dye (immunofluorescent reagents), used in serological
tests to identify Shigella spp. from cultured isolates. The
identification aids in the diagnosis of shigellosis caused by bacteria
belonging to the genus Shigella and provides epidemiological information
on this disease. Shigellosis is characterized by abdominal pain,
cramps, diarrhea, and fever.
(b) Classification. Class II (performance standards).
21 CFR 866.3680 Sporothrix schenckii serological reagents.
(a) Identification. Sporothrix schenckii serological reagents are
devices that consist of antigens and antisera used in serological tests
to identify antibodies to Sporothrix schenckii in serum. The
identification aids in the diagnosis of sporothrichosis caused by a
fungus belonging to the genus Sporothrix and provides epidemiological
information on this disease. Sporothrichosis is a chronic tumorlike
infection primarily of the skin.
(b) Classification. Class I (general controls).
21 CFR 866.3700 Staphylococcus aureus serological reagents.
(a) Identification. Staphylococcus aureus serological reagents are
devices that consist of antigens and antisera used in serological tests
to identify enterotoxin (toxin affecting the intestine) producing
staphylococci from cultured isolates. The identification aids in the
diagnosis of disease caused by this bacterium belonging to the genus
Staphylococcus and provides epidemiological information on these
diseases. Certain strains of Staphylococcus aureus produce an
enterotoxin while growing in meat, dairy, or bakery products. After
ingestion, this enterotoxin is absorbed in the gut and causes
destruction of the intestinal lining (gastroenteritis).
(b) Classification. Class I. These devices are exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989)
21 CFR 866.3720 Streptococcus spp. exoenzyme reagents.
(a) Identification. Streptococcus spp. exoenzyme reagents are
devices used to identify antibodies to Streptococcus spp. exoenzyme in
serum. The identification aids in the diagnosis of disease caused by
bacteria belonging to the genus Streptococcus and provides
epidemiological information on these diseases. Pathogenic streptococci
are associated with infections, such as sore throat, impetigo (an
infection characterized by small pustules on the skin), urinary tract
infections, rheumatic fever, and kidney disease.
(b) Classification. Class II (performance standards).
21 CFR 866.3740 Streptococcus spp. serological reagents.
(a) Identification. Streptococcus spp. serological reagents are
devices that consist of antigens and antisera (excluding streptococcal
exoenzyme reagents made from enzymes secreted by streptococci) used in
serological tests to identify Streptococcus spp. from cultured isolates
derived from clinical specimens. The identification aids in the
diagnosis of diseases caused by bacteria belonging to the genus
Streptococcus and provides epidemiological information on these
diseases. Pathogenic streptococci are associated with infections, such
as sore throat, impetigo (an infection characterized by small pustules
on the skin), urinary tract infections, rheumatic fever, and kidney
disease.
(b) Classification. Class I (general controls).
21 CFR 866.3780 Toxoplasma gondii serological reagents.
(a) Identification. Toxoplasma gondii serological reagents are
devices that consist of antigens and antisera used in serological tests
to identify antibodies to Toxoplasma gondii in serum. Additionally,
some of these reagents consist of antisera conjugated with a fluorescent
dye (immunofluorescent reagents) used to identify Toxoplasma gondii from
clinical specimens. The identification aids in the diagnosis of
toxoplasmosis caused by the parasitic protozoan Toxoplasma gondii and
provides epidemiological information on this disease. Congenital
toxoplasmosis is characterized by lesions of the central nervous system,
which if undetected and untreated may lead to brain defects, blindness,
and death of an unborn fetus. The disease is characterized in children
by inflammation of the brain and spinal cord.
(b) Classification. Class II (performance standards).
21 CFR 866.3820 Treponema pallidum nontreponemal test reagents.
(a) Identification. Treponema pallidum nontreponemal test reagents
are devices that consist of antigens derived from nontreponemal sources
(sources not directly associated with treponemal organisms) and control
sera (standardized sera with which test results are compared) used in
serological tests to identify reagin, an antibody-like agent, which is
produced from the reaction of treponema microorganisms with body
tissues. The identification aids in the diagnosis of syphilis caused by
microorganisms belonging to the genus Treponema and provides
epidemiological information on syphilis.
(b) Classification. Class II (performance standards).
21 CFR 866.3830 Treponema pallidum treponemal test reagents.
(a) Identification. Treponema pallidum treponemal test reagents are
devices that consist of the antigens, antisera and all control reagents
(standardized reagents with which test results are compared) which are
derived from treponemal sources and that are used in the fluorescent
treponemal antibody absorption test (FTA-ABS), the Treponema pallidum
immobilization test (T.P.I.), and other treponemal tests used to
identify antibodies to Treponema pallidum directly from infecting
treponemal organisms in serum. The identification aids in the diagnosis
of syphilis caused by bacteria belonging to the genus Treponema and
provides epidemiological information on syphilis.
(b) Classification. Class II (performance standards).
21 CFR 866.3850 Trichinella spiralis serological reagents.
(a) Identification. Trichinella spiralis serological reagents are
devices that consist of antigens and antisera used in serological tests
to identify antibodies to Trichinella spiralis in serum. The
identification aids in the diagnosis of trichinosis caused by parasitic
roundworms belonging to the genus Trichinella and provides
epidemiological information on trichinosis. Trichinosis is caused by
ingestion of undercooked, infested meat, especially pork, and
characterized by fever, muscle weakness, and diarrhea.
(b) Classification. Class I (general controls).
21 CFR 866.3870 Trypanosoma spp. serological reagents.
(a) Identification. Trypanosoma spp. serological reagents are
devices that consist of antigens and antisera used in serological tests
to identify antibodies to Trypanosoma spp. in serum. The
identification aids in the diagnosis of trypanosomiasis, a disease
caused by parasitic protozoans belonging to the genus Trypanosoma.
Trypanosomiasis in adults is a chronic disease characterized by fever,
chills, headache, and vomiting. Central nervous system involvement
produces typical sleeping sickness syndrome: physical exhaustion,
inability to eat, tissue wasting, and eventual death. Chagas disease,
an acute form of trypanosomiasis in children, most seriously affects the
central nervous system and heart muscle.
(b) Classification. Class I (general controls).
21 CFR 866.3900 Varicella-zoster virus serological reagents.
(a) Identification. Varicella-zoster virus serological reagents are
devices that consist of antigens and antisera used in serological tests
to identify antibodies to varicella-zoster in serum. The identification
aids in the diagnosis of diseases caused by varicella-zoster viruses and
provides epidemiological information on these diseases. Varicella
(chicken pox) is a mild, highly infectious disease, chiefly of children.
Zoster (shingles) is the recurrent form of the disease, occurring in
adults who were previously infected with varicella-zoster viruses.
Zoster is the response (characterized by a rash) of the partially immune
host to a reactivation of varicella viruses present in latent form in
the patient's body.
(b) Classification. Class II (performance standards).
21 CFR 866.3930 Vibrio cholerae serological reagents.
(a) Identification. Vibrio cholerae serological reagents are devices
that are used in the agglutination (an antigen-antibody clumping
reaction) test to identify Vibrio cholerae from cultured isolates
derived from clinical specimens. The identification aids in the
diagnosis of cholera caused by the bacterium Vibrio cholerae and
provides epidemiological information on cholera. Cholera is an acute
infectious disease characterized by severe diarrhea with extreme fluid
and electrolyte (salts) depletion, and by vomiting, muscle cramps, and
prostration. If untreated, the severe dehydration may lead to shock,
renal failure, cardiovascular collapse, and death.
(b) Classification. Class II (performance standards).
21 CFR 866.3930 Subpart E -- Immunology Laboratory Equipment and Reagents
21 CFR 866.4100 Complement reagent.
(a) Identification. A complement reagent is a device that consists
of complement, a naturally occurring serum protein from any warm-blooded
animal such as guinea pigs, that may be included as a component part of
serological test kits used in the diagnosis of disease.
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in Subpart E of Part
807.
21 CFR 866.4500 Immunoelectrophoresis equipment.
(a) Identification. Immunoelectrophoresis equipment for clinical use
with its electrical power supply is a device used for separating protein
molecules. Immunoelectrophoresis is a procedure in which a complex
protein mixture is placed in an agar gel and the various proteins are
separated on the basis of their relative mobilities under the influence
of an electric current. The separated proteins are then permitted to
diffuse through the agar toward a multispecific antiserum, allowing
precipitation and visualization of the separate complexes.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989)
21 CFR 866.4520 Immunofluorometer equipment.
(a) Identification. Immunofluorometer equipment for clinical use
with its electrical power supply is a device used to measure the
fluorescence of fluorochrome-labeled antigen-antibody complexes. The
concentration of these complexes may be measured by means of reflected
light. A beam of light is passed through a solution in which a
fluorochrome has been selectively attached to serum protein antibody
molecules in suspension. The amount of light emitted by the
fluorochrome label is detected by a photodetector, which converts light
energy into electrical energy. The amount of electrical energy
registers on a readout system such as a digital voltmeter or a recording
chart. This electrical readout is called the fluorescence value and is
used to measure the concentration of antigen-antibody complexes.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989)
21 CFR 866.4540 Immunonephelometer equipment.
(a) Identification. Immunonephelometer equipment for clinical use
with its electrical power supply is a device that measures light
scattering from antigen-antibody complexes. The concentration of these
complexes may be measured by means of reflected light. A beam of light
passed through a solution is scattered by the particles in suspension.
The amount of light is detected by a photodetector, which converts light
energy into electrical energy. The amount of electrical energy
registers on a readout system such as a digital voltmeter or a recording
chart. This electrical readout is called the light-scattering value and
is used to measure the concentration of antigen-antibody complexes.
This generic type of device includes devices with various kinds of light
sources, such as laser equipment.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989)
21 CFR 866.4600 Ouchterlony agar plate.
(a) Identification. An ouchterlony agar plate for clinical use is a
device containing an agar gel used to examine antigen-antibody
reactions. In immunodiffusion, antibodies and antigens migrate toward
each other through gel which originally contained neither of these
reagents. As the reagents come in contact with each other, they combine
to form a precipitate that is trapped in the gel matrix and is
immobilized.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989)
21 CFR 866.4800 Radial immunodiffusion plate.
(a) Identification. A radial immunodiffusion plate for clinical use
is a device that consists of a plastic plate to which agar gel
containing antiserum is added. In radial immunodiffusion, antigens
migrate through gel which originally contains specific antibodies. As
the reagents come in contact with each other, they combine to form a
precipitate that is trapped in the gel matrix and immobilized.
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in Subpart E of Part
807.
21 CFR 866.4830 Rocket immunoelectrophoresis equipment.
(a) Identification. Rocket immunoelectrophoresis equipment for
clinical use is a device used to perform a specific test on proteins by
using a procedure called rocket immunoelectrophoresis. In this
procedure, an electric current causes the protein in solution to migrate
through agar gel containing specific antisera. The protein precipitates
with the antisera in a rocket-shaped pattern, giving the name to the
device. The height of the peak (or the area under the peak) is
proportional to the concentration of the protein.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989)
21 CFR 866.4900 Support gel.
(a) Identification. A support gel for clinical use is a device that
consists of an agar or agarose preparation that is used while measuring
various kinds of, or parts of, protein molecules by various
immunochemical techniques, such as immunoelectrophoresis,
immunodiffusion, or chromatography.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989)
21 CFR 866.4900 Subpart F -- Immunological Test Systems
21 CFR 866.5040 Albumin immunological test system.
(a) Identification. An albumin immunological test system is a device
that consists of the reagents used to measure by immunochemical
techniques the albumin (a plasma protein) in serum and other body
fluids. Measurement of albumin aids in the diagnosis of kidney and
intestinal diseases.
(b) Classification. Class II (performance standards).
21 CFR 866.5060 Prealbumin immunological test system.
(a) Identification. A prealbumin immunological test system is a
device that consists of the reagents used to measure by immunochemical
techniques the prealbumin (a plasma protein) in serum and other body
fluids. Measurement of prealbumin levels in serum may aid in the
assessment of the patient's nutritional status.
(b) Classification. Class I (general controls).
21 CFR 866.5065 Human allotypic marker immunological test system.
(a) Identification. A human allotypic marker immunological test
system is a device that consists of the reagents used to identify by
immunochemical techniques the inherited human protein allotypic markers
(such as nGm, nA2m, and Km allotypes) in serum and other body fluids.
The identification may be used while studying population genetics.
(b) Classification. Class I (general controls).
21 CFR 866.5080 Alpha-1-antichymotrypsin immunological test system.
(a) Identification. An alpha-1-antichymotrypsin immunological test
system is a device that consists of the reagents used to measure by
immunochemical techniques alpha-1-antichymotrypsin (a protein) in serum,
other body fluids, and tissues. Alpha-1-antichymotrypsin helps protect
tissues against proteolytic (protein-splitting) enzymes released during
infection.
(b) Classification. Class II (performance standards).
21 CFR 866.5090 Antimitochondrial antibody immunological test system.
(a) Identification. An antimitochondrial antibody immunological test
system is a device that consists of the reagents used to measure by
immunochemical techniques the antimitochondrial antibodies in human
serum. The measurements aid in the diagnosis of diseases that produce a
spectrum of autoantibodies (antibodies produced against the body's own
tissue), such as primary biliary cirrhosis (degeneration of liver
tissue) and chronic active hepatitis (inflammation of the liver).
(b) Classification. Class II (performance standards).
21 CFR 866.5100 Antinuclear antibody immunological test system.
(a) Identification. An antinuclear antibody immunological test
system is a device that consists of the reagents used to measure by
immunochemical techniques the autoimmune antibodies in serum, other body
fluids, and tissues that react with cellular nuclear constituents
(molecules present in the nucleus of a cell, such as ribonucleic acid,
deoxyribonucleic acid, or nuclear proteins). The measurements aid in
the diagnosis of systemic lupus erythematosus (a multisystem autoimmune
disease in which antibodies attack the victim's own tissues), hepatitis
(a liver disease), rheumatoid arthritis, Sjogren's syndrome (arthritis
with inflammation of the eye, eyelid, and salivary glands), and systemic
sclerosis (chronic hardening and shrinking of many body tissues).
(b) Classification. Class II (performance standards).
21 CFR 866.5110 Antiparietal antibody immunological test system.
(a) Identification. An antiparietal antibody immunological test
system is a device that consists of the reagents used to measure by
immunochemical techniques the specific antibody for gastric parietal
cells in serum and other body fluids. Gastric parietal cells are those
cells located in the stomach that produce a protein that enables vitamin
B12 to be absorbed by the body. The measurements aid in the diagnosis
of vitamin B12 deficiency (or pernicious anemia), atrophic gastritis
(inflammation of the stomach), and autoimmune connective tissue diseases
(diseases resulting when the body produces antibodies against its own
tissues).
(b) Classification. Class II (performance standards).
21 CFR 866.5120 Antismooth muscle antibody immunological test system.
(a) Identification. An antismooth muscle antibody immunological test
system is a device that consists of the reagents used to measure by
immunochemical techniques the antismooth muscle antibodies (antibodies
to nonstriated, involuntary muscle) in serum. The measurements aid in
the diagnosis of chronic hepatitis (inflammation of the liver) and
autoimmune connective tissue diseases (diseases resulting from
antibodies produced against the body's own tissues).
(b) Classification Class II (performance standards).
21 CFR 866.5130 Alpha-1-antitrypsin immunological test system.
(a) Identification. An alpha-1-antitrypsin immunological test system
is a device that consists of the reagents used to measure by
immunochemical techniques the alpha-1-antitrypsin (a plasma protein) in
serum, other body fluids, and tissues. The measurements aid in the
diagnosis of several conditions including juvenile and adult cirrhosis
of the liver. In addition, alpha-1-antitrypsin deficiency has been
associated with pulmonary emphysema.
(b) Classification. Class II (performance standards).
21 CFR 866.5150 Bence-Jones proteins immunological test system.
(a) Identification. A Bence-Jones proteins immunological test system
is a device that consists of the reagents used to measure by
immunochemical techniques the Bence-Jones proteins in urine and plasma.
Immunoglobulin molecules normally consist of pairs of polypeptide chains
(subunits) of unequal size (light chains and heavy chains) bound
together by several disulfide bridges. In some cancerous conditions,
there is a proliferation of one plasma cell (antibody-producing cell)
with excess production of light chains of one specific kind (monoclonal
light chains). These free homogeneous light chains not associated with
an immunoglobulin molecule can be found in urine and plasma, and have
been called Bence-Jones proteins. Measurement of Bence-Jones proteins
and determination that they are monoclonal aid in the diagnosis of
multiple myeloma (malignant proliferation of plasma cells),
Waldenstrom's macroglobulinemia (increased production of large
immunoglobulins by spleen and bone marrow cells), leukemia (cancer of
the blood-forming organs), and lymphoma (cancer of the lymphoid tissue).
(b) Classification. Class II (performance standards).
21 CFR 866.5160 Beta-globulin immunological test system.
(a) Identification. A beta-globulin immunological test system is a
device that consists of reagents used to measure by immunochemical
techniques beta globulins (serum protein) in serum and other body
fluids. Beta-globulin proteins include beta-lipoprotein, transferrin,
glycoproteins, and complement, and are rarely associated with specific
pathologic disorders.
(b) Classification. Class I (general controls).
21 CFR 866.5170 Breast milk immunological test system.
(a) Identification. A breast milk immunological test system is a
device that consists of the reagents used to measure by immunochemical
techniques the breast milk proteins.
(b) Classification. Class I (general controls).
21 CFR 866.5200 Carbonic anhydrase B and C immunological test system.
(a) Identification. A carbonic anhydrase B and C immunological test
system is a device that consists of the reagents used to measure by
immunochemical techniques specific carbonic anhydrase protein molecules
in serum and other body fluids. Measurements of carbonic anhydrase B
and C aid in the diagnosis of abnormal hemoglobin metabolism.
(b) Classification. Class I (general controls).
21 CFR 866.5210 Ceruloplasmin immunological test system.
(a) Identification. A ceruloplasmin immunological test system is a
device that consists of the reagents used to measure by immunochemical
techniques the ceruloplasmin (copper-transporting serum protein) in
serum, other body fluids, or tissues. Measurements of ceruloplasmin aid
in the diagnosis of copper metabolism disorders.
(b) Classification. Class II (performance standards).
21 CFR 866.5220 Cohn fraction II immunological test system.
(a) Identification. A Cohn fraction II immunological test system is
a device that consists of the reagents that contain or are used to
measure that fraction of plasma containing protein gamma globulins,
predominantly of the IgG class. The device may be used as a
coprecipitant in radioimmunoassay methods, as raw material for the
purification of IgG subclasses, and to reduce nonspecific adsorption of
plasma proteins in immunoassay techniques. Measurement of these
proteins aids in the diagnosis of any disease concerned with abnormal
levels of IgG gamma globulins such as agammaglobulinemia or multiple
myeloma.
(b) Classification. Class I (general controls).
21 CFR 866.5230 Colostrum immunological test system.
(a) Identification. A colostrum immunological test system is a
device that consists of the reagents used to measure by immunochemical
techniques the specific proteins in colostrum. Colostrum is a substance
excreted by the mammary glands during pregnancy and until production of
breast milk begins 1 to 5 days after childbirth.
(b) Classification. Class I (general controls).
21 CFR 866.5240 Complement components immunological test system.
(a) Identification. A complement components immunological test
system is a device that consists of the reagents used to measure by
immunochemical techniques complement components C1q, C1r, C1s, C2, C3,
C4, C5, C6, C7, C8, and C9, in serum, other body fluids, and tissues.
Complement is a group of serum proteins which destroy infectious agents.
Measurements of these proteins aids in the diagnosis of immunologic
disorders, especially those associated with deficiencies of complement
components.
(b) Classification. Class II (performance standards).
(47 FR 50823, Nov. 9, 1982, as amended at 53 FR 11253, Apr. 6, 1988)
21 CFR 866.5250 Complement C1 inhibitor (inactivator) immunological
test system.
(a) Identification. A complement C1 inhibitor (inactivator)
immunological test system is a device that consists of the reagents used
to measure by immunochemical techniques the complement C1 inhibitor (a
plasma protein) in serum. Complement C1 inhibitor occurs normally in
plasma and blocks the action of the C1 component of complement (a group
of serum proteins which destroy infectious agents). Measurement of
complement C1 inhibitor aids in the diagnosis of hereditary
angioneurotic edema (increased blood vessel permeability causing
swelling of tissues) and a rare form of angioedema associated with
lymphoma (lymph node cancer).
(b) Classification. Class II (performance standards).
21 CFR 866.5260 Complement C3b inactivator immunological test system.
(a) Identification. A complement C3b inactivator immunological test
system is a device that consists of the reagents used to measure by
immunochemical techniques the complement C3b inactivator (a plasma
protein) in serum. Complement is a group of serum proteins that destroy
infectious agents. Measurement of complement C3b inactivator aids in
the diagnosis of inherited antibody dysfunction.
(b) Classification. Class II (performance standards).
21 CFR 866.5270 C-reactive protein immunological test system.
(a) Identification. A C-reactive protein immunological test system
is a device that consists of the reagents used to measure by
immunochemical techniques the C-reactive protein in serum and other body
fluids. Measurement of C-reactive protein aids in evaluation of the
amount of injury to body tissues.
(b) Classification. Class II (performance standards).
21 CFR 866.5320 Properdin factor B immunological test system.
(a) Identification. A properdin factor B immunological test system
is a device that consists of the reagents used to measure by
immunochemical techniques properdin factor B in serum and other body
fluids. The deposition of properdin factor B in body tissues or a
corresponding depression in the amount of properdin factor B in serum
and other body fluids is evidence of the involvement of the alternative
to the classical pathway of activation of complement (a group of plasma
proteins which cause the destruction of cells which are foreign to the
body). Measurement of properdin factor B aids in the diagnosis of
several kidney diseases, e.g., chronic glomerulonephritis (inflammation
of the glomeruli of the kidney), lupus nephritis (kidney disease
associated with a multisystem autoimmune disease, systemic lupus
erythematosus), as well as several skin diseases, e.g., dermititis
herpetiformis (presence of vesicles on the skin that burn and itch), and
pemphigus vulgaris (large vesicles on the skin). Other diseases in
which the alternate pathway of complement activation has been implicated
include rheumatoid arthritis, sickle cell anemia, and gram-negative
bacteremia.
(b) Classification. Class II (performance standards).
21 CFR 866.5330 Factor XIII, A, S, immunological test system.
(a) Identification. A factor XIII, A, S, immunological test system
is a device that consists of the reagents used to measure by
immunochemical techniques the factor XIII (a bloodclotting factor), in
platelets (A) or serum (S). Measurements of factor XIII, A, S, aid in
the diagnosis and treatment of certain bleeding disorders resulting from
a deficiency of this factor.
(b) Classification. Class I (general controls).
21 CFR 866.5340 Ferritin immunological test system.
(a) Identification. A ferritin immunological test system is a device
that consists of the reagents used to measure by immunochemical
techniques the ferritin (an iron-storing protein) in serum and other
body fluids. Measurements of ferritin aid in the diagnosis of diseases
affecting iron metabolism, such as hemochromatosis (iron overload) and
iron deficiency amemia.
(b) Classification. Class II (performance standards).
21 CFR 866.5350 Fibrinopeptide A immunological test system.
(a) Identification. A fibrinopeptide A immunological test system is
a device that consists of the reagents used to measure by immunochemical
techniques the fibrinopeptide A (a blood-clotting factor) in plasma and
other body fluids. Measurement of fibrinopeptide A may aid in the
diagnosis and treatment of certain blood-clotting disorders.
(b) Classification. Class II (performance standards).
21 CFR 866.5360 Cohn fraction IV immunological test system.
(a) Identification. A Cohn fraction IV immunological test system is
a device that consists of or measures that fraction of plasma proteins,
predominantly alpha- and beta-globulins, used as a raw material for the
production of pure alpha- or beta-globulins. Measurement of specific
alpha- or beta-globulins aids in the diagnosis of many diseases, such as
Wilson's disease (an inherited disease affecting the liver and brain),
Tangier's disease (absence of alpha-1-lipoprotein), malnutrition, iron
deficiency anemia, red blood cell disorders, and kidney disease.
(b) Classification. Class I (general controls).
(47 FR 50823, Nov. 9, 1982; 47 FR 56846, Dec. 21, 1982)
21 CFR 866.5370 Cohn fraction V immunological test system.
(a) Identification. A Cohn fraction V immunological test system is a
device that consists of or measures that fraction of plasma containing
predominantly albumin (a plasma protein). This test aids in the
diagnosis of diseases where albumin levels may be depressed, e.g.,
nephrosis (disease of the kidney), proteinuria (protein in the urine),
gastroenteropathy (disease of the stomach and small intestine),
rheumatoid arthritis, and viral hepatitis.
(b) Classification. Class I (general controls).
21 CFR 866.5380 Free secretory component immunological test system.
(a) Identification. A free secretory component immunological test
system is a device that consists of the reagents used to measure by
immunochemical techniques free secretory component (normally a portion
of the secretory IgA antibody molecule) in body fluids. Measurement of
free secretory component (protein molecules) aids in the diagnosis or
repetitive lung infections and other hypogammaglobulinemic conditions
(low antibody levels).
(b) Classification. Class II (performance standards).
21 CFR 866.5400 Alpha-globulin immunological test system.
(a) Identification. An alpha-globulin immunological test system is a
device that consists of the reagents used to measure by immunochemical
techniques the alpha-globulin (a serum protein) in serum and other body
fluids. Measurement of alpha-globulin may aid in the diagnosis of
inflammatory lesions, infections, severe burns, and a variety of other
conditions.
(b) Classification. Class I (general controls).
21 CFR 866.5420 Alpha-1-glycoproteins immunological test system.
(a) Identification. An alpha-1-glycoproteins immunological test
system is a device that consists of the reagents used to measure by
immunochemical techniques alpha-1-glycoproteins (a group of plasma
proteins found in the alpha-1 group when subjected to electrophoresis)
in serum and other body fluids. Measurement of specific
alpha-1-glycoproteins may aid in the diagnosis of collagen (connective
tissue) disorders, tuberculosis, infections, extensive malignancy, and
diabetes.
(b) Classification. Class I (general controls).
21 CFR 866.5425 Alpha-2-glycoproteins immunological test system.
(a) Identification. An alpha-2-glycoproteins immunolgical test
system is a device that consists of the reagents used to measure by
immunochemical techniques the alpha-2-glycoproteins (a group of plasma
proteins found in the alpha-2 group when subjected to electrophoresis)
in serum and other body fluids. Measurement of alpha-2-glycoproteins
aids in the diagnosis of some cancers and genetically inherited
deficiencies of these plasma proteins.
(b) Classification. Class I (general controls).
21 CFR 866.5430 Beta-2-glycoprotein I immunological test system.
(a) Identification. A beta-2-glycoprotein I immunological test
system is a device that consists of the reagents used to measure by
immunochemical techniques the beta-2-glycoprotein I (a serum protein) in
serum and other body fluids. Measurement of beta-2-glycoprotein I aids
in the diagnosis of an inherited deficiency of this serum protein.
(b) Classification. Class I (general controls).
21 CFR 866.5440 Beta-2-glycoprotein III immunological test system.
(a) Identification. A beta-2-glycoprotein III immunological test
system is a device that consists of the reagents used to measure by
immunochemical techniques the beta-2-glycoprotein III (a serum protein)
in serum and other body fluids. Measurement of beta-2-glycoprotein III
aids in the diagnosis of an inherited deficiency of this serum protein
and a variety of other conditions.
(b) Classification. Class I (general controls).
21 CFR 866.5460 Haptoglobin immunological test system.
(a) Identification. A haptoglobin immunological test system is a
device that consists of the reagents used to measure by immunochemical
techniques the haptoglobin (a protein that binds hemoglobin, the
oxygen-carrying pigment in red blood cells) in serum. Measurement of
haptoglobin may aid in the diagnosis of hemolytic diseases (diseases in
which the red blood cells rupture and release hemoglobin) related to the
formation of hemoglobin-haptoglobin complexes and certain kidney
diseases.
(b) Classification. Class II (performance standards).
21 CFR 866.5470 Hemoglobin immunological test system.
(a) Indentification. A hemoglobin immunological test system is a
device that consists of the reagents used to measure by immunochemical
techniques the different types of free hemoglobin (the oxygen-carrying
pigment in red blood cells) in blood, urine, plasma, or other body
fluids. Measurements of free hemoglobin aid in the diagnosis of various
hematologic disorders, such as sickle cell anemia, Fanconi's anemia (a
rare inherited disease), aplastic anemia (bone marrow does not produce
enough blood cells), and leukemia (cancer of the blood-forming organs).
(b) Classification. Class II (performance standards).
21 CFR 866.5490 Hemopexin immunological test system.
(a) Indentification. A hemopexin immunological test system is a
device that consists of the reagents used to measure by immunochemical
techniques the hemopexin (a serum protein that binds heme, a component
of hemoglobin) in serum. Measurement of hemopexin aids in the diagnosis
of various hematologic disorders, such as hemolytic anemia (anemia due
to shortened in vivo survival of mature red blood cells and inability of
the bone marrow to compensate for their decreased life span) and sickle
cell anemia.
(b) Classification. Class II (performance standards).
21 CFR 866.5500 Hypersensitivity pneumonitis immunological test system.
(a) Identification. A hypersensitivity pneumonitis immunological
test system is a device that consists of the reagents used to measure by
immunochemical techniques the immunoglobulin antibodies in serum which
react specifically with organic dust derived from fungal or animal
protein sources. When these antibodies react with such dusts in the
lung, immune complexes precipitate and trigger an inflammatory reaction
(hypersensitivity pneumonitis). Measurement of these immunoglobulin G
antibodies aids in the diagnosis of hypersensitivity pneumonitis and
other allergic respiratory disorders.
(b) Classification. Class II (performance standards).
21 CFR 866.5510 Immunoglobulins A, G, M, D, and E immunological test
system.
(a) Identification. An immunoglobulins A, G, M, D, and E
immunological test system is a device that consists of the reagents used
to measure by immunochemical techniques the immunoglobulins A, G, M, D,
an E (serum antibodies) in serum. Measurement of these immunoglobulins
aids in the diagnosis of abnormal protein metabolism and the body's lack
of ability to resist infectious agents.
(b) Classification. Class II (performance standards).
21 CFR 866.5520 Immunoglobulin G (Fab fragment specific) immunological
test system.
(a) Identification. An immunoglobulin G (Fab fragment specific)
immunological test system is a device that consists of the reagents used
to measure by immunochemical techniques the Fab antigen-binding fragment
resulting from breakdown of immunoglobulin G antibodies in urine, serum,
and other body fluids. Measurement of Fab fragments of immunoglobulin G
aids in the diagnosis of lymphoproliferative disorders, such as multiple
myeloma (tumor of bone marrow cells), Waldenstrom's macroglobulinemia
(increased immunoglobulin production by the spleen and bone marrow
cells), and lymphoma (tumor of the lymphoid tissues).
(b) Classification. Class II (performance standards).
21 CFR 866.5530 Immunoglobulin G (Fc fragment specific) immunological
test system.
(a) Identification. An immunoglobulin G (Fc fragment specific)
immunological test system is a device that consists of the reagents used
to measure by immunochemical techniques the Fc (carbohydrate containing)
fragment of immunoglobulin G (resulting from breakdown of immunoglobulin
G antibodies) in urine, serum, and other body fluids. Measurement of
immunoglobulin G Fc fragments aids in the diagnosis of plasma cell
antibody-forming abnormalities, e.g., gamma heavy chain disease.
(b) Classification. Class II (performance standards).
21 CFR 866.5540 Immunoglobulin G (Fd fragment specific) immunological
test system.
(a) Identification. An immunoglobulin G (Fd fragment specific)
immunological test system is a device that consists of the reagents used
to measure by immunochemical techniques the amino terminal
(antigen-binding) end (Fd fragment) of the heavy chain (a subunit) of
the immunoglobulin antibody molecule in serum. Measurement of
immunoglobulin G Fd fragments aids in the diagnosis of plasma
antibody-forming cell abnormalities.
(b) Classification. Class I (general controls).
21 CFR 866.5550 Immunoglobulin (light chain specific) immunological
test system.
(a) Identification. An immunoglobulin (light chain specific)
immunological test system is a device that consists of the reagents used
to measure by immunochemical techniques both kappa and lambda types of
light chain portions of immunoglobulin molecules in serum, other body
fluids, and tissues. In some disease states, an excess of light chains
are produced by the antibody-forming cells. These free light chains,
unassociated with gamma globulin molecules, can be found in a patient's
body fluids and tissues. Measurement of the various amounts of the
different types of light chains aids in the diagnosis of multiple
myeloma (cancer of antibody-forming cells), lymphocytic neoplasms
(cancer of lymphoid tissue), Waldenstrom's macroglobulinemia (increased
production of large immunoglobulins), and connective tissue diseases
such as rheumatoid arthritis or systemic lupus erythematosus.
(b) Classification. Class II (performance standards).
21 CFR 866.5560 Lactic dehydrogenase immunological test system.
(a) Identification. A lactic dehydrogenase immunological test system
is a device that consists of the reagents used to measure by
immunochemical techniques the activity of the lactic dehydrogenase
enzyme in serum. Increased levels of lactic dehydrogenase are found in
a variety of conditions, including megaloblastic anemia (decrease in the
number of mature red blood cells), myocardial infarction (heart
disease), and some forms of leukemia (cancer of the blood-forming
organs). However, the diagnostic usefulness of this device is limited
because of the many conditions known to cause increased lactic
dehydrogenase levels.
(b) Classification. Class I (general controls).
21 CFR 866.5570 Lactoferrin immunological test system.
(a) Identification. A lactoferrin immunological test system is a
device that consists of the reagents used to measure by immunochemical
techniques the lactoferrin (an iron-binding protein with the ability to
inhibit the growth of bacteria) in serum, breast milk, other body
fluids, and tissues. Measurement of lactoferrin may aid in the
diagnosis of an inherited deficiency of this protein.
(b) Classification. Class I (general controls).
21 CFR 866.5580 Alpha-1-lipoprotein immunological test system.
(a) Identification. An alpha-1-lipoprotein immunological test system
is a device that consists of the reagents used to measure by
immunochemical techniques the alpha-1-lipoprotein (high-density
lipoprotein) in serum and plasma. Measurement of alpha-1-lipoprotein
may aid in the diagnosis of Tangier disease (a hereditary disorder of
fat metabolism).
(b) Classification. Class II (performance standards).
21 CFR 866.5590 Lipoprotein X immunological test system.
(a) Identification. A lipoprotein X immunological test system is a
device that consists of the reagents used to measure by immunochemical
techniques lipoprotein X (a high-density lipoprotein) in serum and other
body fluids. Measurement of lipoprotein X aids in the diagnosis of
obstructive liver disease.
(b) Classification. Class I (general controls).
21 CFR 866.5600 Low-density lipoprotein immunological test system.
(a) Identification. A low-density lipoprotein immunological test
system is a device that consists of the reagents used to measure by
immunochemical techniques the low-density lipoprotein in serum and other
body fluids. Measurement of low-density lipoprotein in serum may aid in
the diagnosis of disorders of lipid (fat) metabolism and help to
identify young persons at risk from cardiovascular diseases.
(b) Classification. Class II (performance standards).
21 CFR 866.5620 Alpha-2-macroglobulin immunological test system.
(a) Identification. An alpha-2-macroglobulin immunological test
system is a device that consists of the reagents used to measure by
immunochemical techniques the alpha-2-macroglobulin (a serum protein) in
plasma. Measurement of alpha-2-macroglobulin may aid in the diagnosis
of blood-clotting or clot lysis disorders.
(b) Classification. Class II (performance standards).
21 CFR 866.5630 Beta-2-microglobulin immunological test system.
(a) Identification. A beta-2-microglobulin immunological test system
is a device that consists of the reagents used to measure by
immunochemical techniques beta-2-microglobulin (a protein molecule) in
serum, urine, and other body fluids. Measurement of
beta-2-microglobulin aids in the diagnosis of active rheumatoid
arthritis and kidney disease.
(b) Classification. Class II (performance standards).
21 CFR 866.5640 Infectious mononucleosis immunological test system.
(a) Identification. An infectious mononucleosis immunological test
system is a device that consists of the reagents used to measure by
immunochemical techniques heterophile antibodies frequently associated
with infectious mononucleosis in serum, plasma, and other body fluids.
Measurements of these antibodies aid in the diagnosis of infectious
mononucleosis.
(b) Classification. Class II (performance standards).
(47 FR 50823, Nov. 9, 1982; 47 FR 56846, Dec. 21, 1982)
21 CFR 866.5660 Multiple autoantibodies immunological test system.
(a) Identification. A multiple autoantibodies immunological test
system is a device that consists of the reagents used to measure by
immunochemical techniques the autoantibodies (antibodies produced
against the body's own tissues) in serum and other body fluids.
Measurement of multiple autoantibodies aids in the diagnosis of
autoimmune disorders (disease produced when the body's own tissues are
injured by autoantibodies).
(b) Classification. Class II (performance standards).
21 CFR 866.5680 Myoglobin immunological test system.
(a) Identification. A myoglobin immunological test system is a
device that consists of the reagents used to measure by immunochemical
techniques the myoglobin (an oxygen storage protein found in muscle) in
serum and other body fluids. Measurement of myoglobin aids in the rapid
diagnosis of heart or renal disease.
(b) Classification. Class II (performance standards).
21 CFR 866.5700 Whole human plasma or serum immunological test system.
(a) Identification. A whole human plasma or serum immunological test
system is a device that consists of reagents used to measure by
immunochemical techniques the proteins in plasma or serum. Measurements
of proteins in plasma or serum aid in the diagnosis of any disease
concerned with abnormal levels of plasma or serum proteins, e.g.,
agammaglobulinemia, allergies, multiple myeloma, rheumatoid vasculitis,
or hereditary angioneurotic edema.
(b) Classification. Class I (general controls).
21 CFR 866.5715 Plasminogen immunological test system.
(a) Identification. A plasminogen immunological test system is a
device that consists of the reagents used to measure by immunochemical
techniques the plasminogen (an inactive substance from which plasmin, a
blood-clotting factor, is formed) in serum, other body fluids, and
tissues. Measurement of plasminogen levels may aid in the diagnosis of
fibrinolytic (blood-clotting) disorders.
(b) Classification. Class I (general controls).
21 CFR 866.5735 Prothrombin immunological test system.
(a) Identification. A prothrombin immunological test system is a
device that consists of the reagents used to measure by immunochemical
techniques the prothrombin (clotting factor II) in serum. Measurements
of the amount of antigenically competent (ability to react with protein
antibodies) prothrombin aid in the diagnosis of blood-clotting
disorders.
(b) Classification. Class I (general controls).
21 CFR 866.5750 Radioallergosorbent (RAST) immunological test system.
(a) Identification. A radioallergosorbent immunological test system
is a device that consists of the reagents used to measure by
immunochemical techniques the allergen antibodies (antibodies which
cause an allergic reaction) specific for a given allergen. Measurement
of specific allergen antibodies may aid in the diagnosis of asthma,
allergies, and other pulmonary disorders.
(b) Classification. Class II (performance standards).
21 CFR 866.5765 Retinol-binding protein immunological test system.
(a) Identification. A retinol-binding protein immunological test
system is a device that consists of the reagents used to measure by
immunochemical techniques the retinol-binding protein that binds and
transports vitamin A in serum and urine. Measurement of this protein
may aid in the diagnosis of kidney disease and in monitoring patients
with kidney transplants.
(b) Classification. Class I (general controls).
21 CFR 866.5775 Rheumatoid factor immunological test system.
(a) Identification. A rheumatoid factor immunological test system is
a device that consists of the reagents used to measure by immunochemical
techniques the rheumatoid factor (antibodies to immunoglobulins) in
serum, other body fluids, and tissues. Measurement of rheumatoid factor
may aid in the diagnosis of rheumatoid arthritis.
(b) Classification. Class II (performance standards).
21 CFR 866.5800 Seminal fluid (sperm) immunological test system.
(a) Identification. A seminal fluid (sperm) immunological test
system is a device that consists of the reagents used for legal purposes
to identify and differentiate animal and human semen. The test results
may be used as court evidence in alleged instances of rape and other
sex-related crimes.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(54 FR 25047, June 12, 1989)
21 CFR 866.5820 Systemic lupus erythematosus immunological test system.
(a) Identification. A systemic lupus erythematosus (SLE)
immunological test system is a device that consists of the reagents used
to measure by immunochemical techniques the autoimmune antibodies in
serum and other body fluids that react with cellular nuclear
double-stranded deoxyribonucleic acid (DNA) or other nuclear
constituents that are specifically diagnostic of SLE. Measurement of
nuclear double-stranded DNA antibodies aids in the diagnosis of SLE (a
multisystem autoimmune disease in which tissues are attacked by the
person's own antibodies).
(b) Classification. Class II (performance standards).
21 CFR 866.5860 Total spinal fluid immunological test system.
(a) Identification. A total spinal fluid immunological test system
is a device that consists of the reagents used to measure by
immunochemical techniques the total protein in cerebrospinal fluid.
Measurement of spinal fluid proteins may aid in the diagnosis of
multiple sclerosis and other diseases of the nervous system.
(b) Classification. Class II (performance standards).
21 CFR 866.5870 Thyroid autoantibody immunological test system.
(a) Identification. A thyroid autoantibody immunological test system
is a device that consists of the reagents used to measure by
immunochemical techniques the thyroid autoantibodies (antibodies
produced against the body's own tissues). Measurement of thyroid
autoantibodies may aid in the diagnosis of certain thyroid disorders,
such as Hashimoto's disease (chronic lymphocytic thyroiditis), nontoxic
goiter (enlargement of thyroid gland), Grave's disease (enlargement of
the thyroid gland with protrusion of the eyeballs), and cancer of the
thyroid.
(b) Classification. Class II (performance standards).
21 CFR 866.5880 Transferrin immunological test system.
(a) Identification. A transferrin immunological test system is a
device that consists of the reagents used to measure by immunochemical
techniques the transferrin (an iron-binding and transporting serum
protein) in serum, plasma, and other body fluids. Measurement of
transferrin levels aids in the diagnosis of malnutrition, acute
inflammation, infection, and red blood cell disorders, such as iron
deficiency anemia.
(b) Classification. Class II (performance standards).
21 CFR 866.5890 Inter-alpha trypsin inhibitor immunological test
system.
(a) Identification. An inter-alpha trypsin inhibitor immunological
test system is a device that consists of the reagents used to measure by
immunochemical techniques the inter-alpha trypsin inhibitor (a protein)
in serum and other body fluids. Measurement of inter-alpha trypsin
inhibitor may aid in the diagnosis of acute bacterial infection and
inflammation.
(b) Classification. Class I (general controls).
(47 FR 50823, Nov. 9, 1982, as amended at 53 FR 11253, Apr. 6, 1988)
21 CFR 866.5890 Subpart G -- Tumor Associated Antigen Immunological Test Systems
21 CFR 866.6010 Carcinoembryonic antigen (CEA) immunological test
system as an aid in the detection and management of cancer.
(a) Identification. A carcinoembryonic antigen (CEA) immunological
test system as an aid in the detection and management of cancer is a
device that consists of the reagents intended to measure by
immunochemical techniques, such as enzyme immunoassay or
radioimmunoassay, CEA in blood, plasma, other body fluids, and tissues.
Measurement of CEA levels may aid in the detection and management of
cancer.
(b) Classification. Class III (premarket approval) (transitional
device).
(c) Date PMA or notice of completion of a PDP is required. As of May
28, 1976, an approval under section 515 of the act is required before
this device may be commercially distributed. See 866.3.
(47 FR 50823, Nov. 9, 1982, as amended at 52 FR 17734, May 11, 1987)
21 CFR 866.6010 Pt. 868
21 CFR 866.6010 PART 868 -- ANESTHESIOLOGY DEVICES
21 CFR 866.6010 Subpart A -- General Provisions
Sec.
868.1 Scope.
868.3 Effective dates of requirement for premarket approval.
868.9 Limitations of exemptions from section 510(k) of the Federal
Food, Drug, and Cosmetic Act (the act).
21 CFR 866.6010 Subpart B -- Diagnostic Devices
868.1030 Manual algesimeter.
868.1040 Powered algesimeter.
868.1075 Argon gas analyzer.
868.1100 Arterial blood sampling kit.
868.1120 Indwelling blood oxyhemoglobin concentration analyzer.
868.1150 Indwelling blood carbon dioxide partial pressure (PCO2)
analyzer.
868.1170 Indwelling blood hydrogen ion concentration (pH) analyzer.
868.1200 Indwelling blood oxygen partial pressure (PO2) analyzer.
868.1400 Carbon dioxide gas analyzer.
868.1430 Carbon monoxide gas analyzer.
868.1500 Enflurane gas analyzer.
868.1575 Gas collection vessel.
868.1620 Halothane gas analyzer.
868.1640 Helium gas analyzer.
868.1670 Neon gas analyzer.
868.1690 Nitrogen gas analyzer.
868.1700 Nitrous oxide gas analyzer.
868.1720 Oxygen gas analyzer.
868.1730 Oxygen uptake computer.
868.1750 Pressure plethysmograph.
868.1760 Volume plethysmograph.
868.1780 Inspiratory airway pressure meter.
868.1800 Rhinoanemometer.
868.1840 Diagnostic spirometer.
868.1850 Monitoring spirometer.
868.1860 Peak-flow meter for spirometry.
868.1870 Gas volume calibrator.
868.1880 Pulmonary-function data calculator.
868.1890 Predictive pulmonary-function value calculator.
868.1900 Diagnostic pulmonary-function interpretation calculator.
868.1910 Esophageal stethoscope.
868.1920 Esophageal stethoscope with electrical conductors.
868.1930 Stethoscope head.
868.1965 Switching valve (ploss).
868.1975 Water vapor analyzer.
21 CFR 866.6010 Subpart C -- Monitoring Devices
868.2025 Ultrasonic air embolism monitor.
868.2300 Bourdon gauge flowmeter.
868.2320 Uncompensated thorpe tube flowmeter.
868.2340 Compensated thorpe tube flowmeter.
868.2350 Gas calibration flowmeter.
868.2375 Breathing frequency monitor.
868.2450 Lung water monitor.
868.2480 Cutaneous carbon dioxide (PcCO2) monitor.
868.2500 Cutaneous oxygen monitor.
868.2550 Pneumotachometer.
868.2600 Airway pressure monitor.
868.2610 Gas pressure gauge.
868.2620 Gas pressure calibrator.
868.2700 Pressure regulator.
868.2775 Electrical peripheral nerve stimulator.
868.2875 Differential pressure transducer.
868.2885 Gas flow transducer.
868.2900 Gas pressure transducer.
21 CFR 866.6010 Subparts D-E -- (Reserved)
21 CFR 866.6010 Subpart F -- Therapeutic Devices
868.5090 Emergency airway needle.
868.5100 Nasopharyngeal airway.
868.5110 Oropharyngeal airway.
868.5120 Anesthesia conduction catheter.
868.5130 Anesthesia conduction filter.
868.5140 Anesthesia conduction kit.
868.5150 Anesthesia conduction needle.
868.5160 Gas machine for anesthesia or analgesia.
868.5170 Laryngotracheal topical anesthesia applicator.
868.5180 Rocking bed.
868.5220 Blow bottle.
868.5240 Anesthesia breathing circuit.
868.5250 Breathing circuit circulator.
868.5260 Breathing circuit bacterial filter.
868.5270 Breathing system heater.
868.5280 Breathing tube support.
868.5300 Carbon dioxide absorbent.
868.5310 Carbon dioxide absorber.
868.5320 Reservoir bag.
868.5330 Breathing gas mixer.
868.5340 Nasal oxygen cannula.
868.5350 Nasal oxygen catheter.
868.5365 Posture chair for cardiac or pulmonary treatment.
868.5375 Heat and moisture condenser (artificial nose).
868.5400 Electroanesthesia apparatus.
868.5420 Ether hook.
868.5430 Gas-scavenging apparatus.
868.5440 Portable oxygen generator.
868.5450 Respiratory gas humidifier.
868.5460 Therapeutic humidifier for home use.
868.5470 Hyperbaric chamber.
868.5530 Flexible laryngoscope.
868.5540 Rigid laryngoscope.
868.5550 Anesthetic gas mask.
868.5560 Gas mask head strap.
868.5570 Nonrebreathing mask.
868.5580 Oxygen mask.
868.5590 Scavenging mask.
868.5600 Venturi mask.
868.5610 Membrane lung for long-term pulmonary support.
868.5620 Breathing mouthpiece.
868.5630 Nebulizer.
868.5640 Medicinal nonventilatory nebulizer (atomizer).
868.5650 Esophageal obturator.
868.5655 Portable liquid oxygen unit.
868.5665 Powered percussor.
868.5675 Rebreathing device.
868.5690 Incentive spirometer.
868.5700 Nonpowered oxygen tent.
868.5710 Electrically powered oxygen tent.
868.5720 Bronchial tube.
868.5730 Tracheal tube.
868.5740 Tracheal/bronchial differential ventilation tube.
868.5750 Inflatable tracheal tube cuff.
868.5760 Cuff spreader.
868.5770 Tracheal tube fixation device.
868.5780 Tube introduction forceps.
868.5790 Tracheal tube stylet.
868.5795 Tracheal tube cleaning brush.
868.5800 Tracheostomy tube and tube cuff.
868.5810 Airway connector.
868.5820 Dental protector.
868.5830 Autotransfusion apparatus.
868.5860 Pressure tubing and accessories.
868.5870 Nonrebreathing valve.
868.5880 Anesthetic vaporizer.
868.5895 Continuous ventilator.
868.5905 Noncontinuous ventilator (IPPB).
868.5915 Manual emergency ventilator.
868.5925 Powered emergency ventilator.
868.5935 External negative pressure ventilator.
868.5955 Intermittent mandatory ventilation attachment.
868.5965 Positive end expiratory pressure breathing attachment.
868.5975 Ventilator tubing.
868.5995 Tee drain (water trap).
21 CFR 866.6010 Subpart G -- Miscellaneous
868.6100 Anesthetic cabinet, table, or tray.
868.6175 Cardiopulmonary emergency cart.
868.6225 Nose clip.
868.6250 Portable air compressor.
868.6400 Calibration gas.
868.6700 Anesthesia stool.
868.6810 Tracheobronchial suction catheter.
868.6820 Patient position support.
868.6885 Medical gas yoke assembly.
Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j, 371).
Source: 42 FR 31142, July 16, 1982, unless otherwise noted.
21 CFR 866.6010 Subpart A -- General Provisions
21 CFR 868.1 Scope.
(a) This part sets forth the classification of anesthesiology devices
intended for human use that are in commercial distribution.
(b) The identification of a device in a regulation in this part is
not a precise description of every device that is, or will be, subject
to the regulation. A manufacturer who submits a premarket notification
submission for a device under Part 807 may not show merely that the
device is accurately described by the section title and identification
provisions of a regulation in this part, but shall state why the device
is substantially equivalent to other devices, as required by 807.87.
(c) To avoid duplicative listings, an anesthesiology device that has
two or more types of uses (e.g., used both as a diagnostic device and as
a therapeutic device) is listed only in one subpart.
(d) References in this part to regulatory sections of the Code of
Federal Regulations are to Chapter I of Title 21, unless otherwise
noted.
(52 FR 17734, May 11, 1987)
21 CFR 868.3 Effective dates of requirement for premarket approval.
A device included in this part that is classified into class III
(premarket approval) shall not be commercially distributed after the
date shown in the regulation classifying the device unless the
manufacturer has an approval under section 515 of the act (unless an
exemption has been granted under section 520(g)(2) of the act). An
approval under section 515 of the act consists of FDA's issuance of an
order approving an application for premarket approval (PMA) for the
device or declaring completed a product development protocol (PDP) for
the device.
(a) Before FDA requires that a device commercially distributed before
the enactment date of the amendments, or a device that has been found
substantially equivalent to such a device, has an approval under section
515 of the act FDA must promulgate a regulation under section 515(b) of
the act requiring such approval, except as provided in paragraph (b) of
this section. Such a regulation under section 515(b) of the act shall
not be effective during the grace period ending on the 90th day after
its promulgation or on the last day of the 30th full calendar month
after the regulation that classifies the device into class III is
effective, whichever is later. See section 501(f)(2)(B) of the act.
Accordingly, unless an effective date of the requirement for premarket
approval is shown in the regulation for a device classified into class
III in this part, the device may be commercially distributed without
FDA's issuance of an order approving a PMA or declaring completed a PDP
for the device. If FDA promulgates a regulation under section 515(b) of
the act requiring premarket approval for a device, section 501(f)(1)(A)
of the act applies to the device.
(b) Any new, not substantially equivalent, device introduced into
commercial distribution on or after May 28, 1976, including a device
formerly marketed that has been substantially altered, is classified by
statute (section 513(f) of the act) into class III without any grace
period and FDA must have issued an order approving a PMA or declaring
completed a PDP for the device before the device is commercially
distributed unless it is reclassified. If FDA knows that a device being
commercially distributed may be a ''new'' device as defined in this
section because of any new intended use or other reasons, FDA may codify
the statutory classification of the device into class III for such new
use. Accordingly, the regulation for such a class III device states
that as of the enactment date of the amendments, May 28, 1976, the
device must have an approval under section 515 of the act before
commercial distribution.
(52 FR 17734, May 11, 1987)
21 CFR 868.9 Limitations of exemptions from section 510(k) of the
Federal Food, Drug, and Cosmetic Act (the act).
The Food and Drug Administration's (FDA's) decision to grant an
exemption from the requirement of premarket notification (section 510(k)
of the act) for a generic type of class I device is based upon the
existing and reasonably foreseeable characteristics of commercially
distributed devices within that generic type. Because FDA cannot
anticipate every change in intended use or characteristic that could
significantly affect a device's safety or effectiveness, manufacturers
of any commercially distributed class I device for which FDA has granted
an exemption from the requirement of premarket notification must still
submit a premarket notification to FDA before introducing or delivering
for introduction into interstate commerce for commercial distribution
the device when:
(a) The device is intended for a use different from its intended use
before May 28, 1976, or the device is intended for a use different from
the intended use of a preamendments device to which it had been
determined to be substantially equivalent; e.g., the device is intended
for a different medical purpose, or the device is intended for lay use
where the former intended use was by health care professionals only; or
(b) The modified device operates using a different fundamental
scientific technology than that in use in the device before May 28,
1976, e.g., a surgical instrument cuts tissue with a laser beam rather
than with a sharpened metal blade, or an in vitro diagnostic device
detects or identifies infectious agents by using a deoxyribonucleic acid
(DNA) probe or nucleic acid hybridization technology rather than culture
or immunoassay technology.
(54 FR 25047, June 12, 1989)
21 CFR 868.9 Subpart B -- Diagnostic Devices
21 CFR 868.1030 Manual algesimeter.
(a) Identification. A manual algesimeter is a mechanical device
intended to determine a patient's sensitivity to pain after
administration of an anesthetic agent, e.g., by pricking with a sharp
point.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter. The device is also exempt from the current good manufacturing
practice regulations in Part 820 of this chapter, with the exception of
820.180, with respect to general requirements concerning records, and
820.198, with respect to complaint files.
(54 FR 25048, June 12, 1989)
21 CFR 868.1040 Powered algesimeter.
(a) Identification. A powered algesimeter is a device using
electrical stimulation intended to determine a patient's sensitivity to
pain after administration of an anesthetic agent.
(b) Classification. Class II (performance standards).
21 CFR 868.1075 Argon gas analyzer.
(a) Identification. An argon gas analyzer is a device intended to
measure the concentration of argon in a gas mixture to aid in
determining the patient's ventilatory status. The device may use
techniques such as mass spectrometry or thermal conductivity.
(b) Classification. Class II (performance standards).
21 CFR 868.1100 Arterial blood sampling kit.
(a) Identification. An arterial blood sampling kit is a device, in
kit form, used to obtain arterial blood samples from a patient for blood
gas determinations. The kit may include a syringe, needle, cork, and
heparin.
(b) Classification. Class II (performance standards).
21 CFR 868.1120 Indwelling blood oxyhemoglobin concentration analyzer.
(a) Identification. An indwelling blood oxyhemoglobin concentration
analyzer is a photoelectric device used to measure, in vivo, the
oxygen-carrying capacity of hemoglobin in blood to aid in determining
the patient's physiological status.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 868.3.
(47 FR 31142, July 16, 1982, as amended at 52 FR 17735, May 11, 1987;
52 FR 22577, June 12, 1987)
21 CFR 868.1150 Indwelling blood carbon dioxide partial pressure (PCO2)
analyzer.
(a) Identification. An indwelling blood carbon dioxide partial
pressure PCO analyzer is a device that consists of a catheter-tip PCO
transducer (e.g., PCO electrode) and that is used to measure, in vivo,
the partial pressure of carbon dioxide in blood to aid in determining
the patient's circulatory, ventilatory, and metabolic status.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 868.3.
(47 FR 31142, July 16, 1982; 47 FR 40410, Sept. 14, 1982, as amended
at 52 FR 17735, May 11, 1987)
21 CFR 868.1170 Indwelling blood hydrogen ion concentration (pH)
analyzer.
(a) Identification. An indwelling blood hydrogen ion concentration
(pH) analyzer is a device that consists of a catheter-tip pH electrode
and that is used to measure, in vivo, the hydrogen ion concentration
(pH) in blood to aid in determining the patient's acid-base balance.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 868.3.
(47 FR 31142, July 16, 1982, as amended at 52 FR 17735, May 11, 1987)
21 CFR 868.1200 Indwelling blood oxygen partial pressure (PO2)
analyzer.
(a) Identification. An indwelling blood oxygen partial pressure (PO
) analyzer is a device that consists of a catheter-tip PO transducer
(e.g., PO electrode) and that is used to measure, in vivo, the partial
pressure of oxygen in blood to aid in determining the patient's
circulatory, ventilatory, and metabolic status.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 868.3.
(47 FR 31142, July 16, 1982; 47 FR 40410, Sept. 14, 1982, as amended
at 52 FR 17735, May 11, 1987)
21 CFR 868.1400 Carbon dioxide gas analyzer.
(a) Identification. A carbon dioxide gas analyzer is a device
intended to measure the concentration of carbon dioxide in a gas mixture
to aid in determining the patient's ventilatory, circulatory, and
metabolic status. The device may use techniques such as chemical
titration, absorption of infrared radiation, gas chromatography, or mass
spectrometry.
(b) Classification. Class II (performance standards).
21 CFR 868.1430 Carbon monoxide gas analyzer.
(a) Identification. A carbon monoxide gas analyzer is a device
intended to measure the concentration of carbon monoxide in a gas
mixture to aid in determining the patient's ventilatory status. The
device may use techniques such as infrared absorption or gas
chromatography.
(b) Classification. Class II (performance standards).
21 CFR 868.1500 Enflurane gas analyzer.
(a) Identification. An enflurane gas analyzer is a device intended
to measure the concentration of enflurane anesthetic in a gas mixture.
(b) Classification. Class II (performance standards).
21 CFR 868.1575 Gas collection vessel.
(a) Identification. A gas collection vessel is a container-like
device intended to collect a patient's exhaled gases for subsequent
analysis. It does not include a sampling pump.
(b) Classification. Class II (performance standards).
21 CFR 868.1620 Halothane gas analyzer.
(a) Identification. A halothane gas analyzer is a device intended to
measure the concentration of halothane anesthetic in a gas mixture. The
device may use techniques such as mass spectrometry or absorption of
infrared or ultraviolet radiation.
(b) Classification. Class II (performance standards).
21 CFR 868.1640 Helium gas analyzer.
(a) Identification. A helium gas analyzer is a device intended to
measure the concentration of helium in a gas mixture during pulmonary
function testing. The device may use techniques such as thermal
conductivity, gas chromatography, or mass spectrometry.
(b) Classification. Class II (performance standards).
21 CFR 868.1670 Neon gas analyzer.
(a) Identification. A neon gas analyzer is a device intended to
measure the concentration of neon in a gas mixture exhaled by a patient.
The device may use techniques such as mass spectrometry or thermal
conductivity.
(b) Classification. Class II (performance standards).
21 CFR 868.1690 Nitrogen gas analyzer.
(a) Identification. A nitrogen gas analyzer is a device intended to
measure the concentration of nitrogen in respiratory gases to aid in
determining a patient's ventilatory status. The device may use
techniques such as gas chromatography or mass spectrometry.
(b) Classification. Class II (performance standards).
21 CFR 868.1700 Nitrous oxide gas analyzer.
(a) Identification. A nitrous oxide gas analyzer is a device
intended to measure the concentration of nitrous oxide anesthetic in a
gas mixture. The device may use techniques such as infrared absorption
or mass spectrometry.
(b) Classification. Class II (performance standards).
21 CFR 868.1720 Oxygen gas analyzer.
(a) Identification. An oxygen gas analyzer is a device intended to
measure the concentration of oxygen in respiratory gases by techniques
such as mass spectrometry, polarography, thermal conductivity, or gas
chromatography. This generic type of device also includes paramagnetic
analyzers.
(b) Classification. Class II (performance standards).
21 CFR 868.1730 Oxygen uptake computer.
(a) Identification. An oxygen uptake computer is a device intended
to compute the amount of oxygen consumed by a patient and may include
components for determining expired gas volume and composition.
(b) Classification. Class II (performance standards).
21 CFR 868.1750 Pressure plethysmograph.
(a) Identification. A pressure plethysmograph is a device used to
determine a patient's airway resistance and lung volumes by measuring
pressure changes while the patient is in an airtight box.
(b) Classification. Class II (performance standards).
21 CFR 868.1760 Volume plethysmograph.
(a) Identification. A volume plethysmograph is an airtight box, in
which a patient sits, that is used to determine the patient's lung
volume changes.
(b) Classification. Class II (performance standards).
21 CFR 868.1780 Inspiratory airway pressure meter.
(a) Identification. An inspiratory airway pressure meter is a device
used to measure the amount of pressure produced in a patient's airway
during maximal inspiration.
(b) Classification. Class II (performance standards).
21 CFR 868.1800 Rhinoanemometer.
(a) Identification. A rhinoanemometer is a device used to quantify
the amount of nasal congestion by measuring the airflow through, and
differential pressure across, a patient's nasal passages.
(b) Classification. Class II (performance standards).
21 CFR 868.1840 Diagnostic spirometer.
(a) Identification. A diagnostic spirometer is a device used in
pulmonary function testing to measure the volume of gas moving in or out
of a patient's lungs.
(b) Classification. Class II (performance standards).
21 CFR 868.1850 Monitoring spirometer.
(a) Identification. A monitoring spirometer is a device used to
measure continuously a patient's tidal volume (volume of gas inhaled by
the patient during each respiration cycle) or minute volume (the tidal
volume multiplied by the rate of respiration for 1 minute) for the
evaluation of the patient's ventilatory status.
(b) Classification. Class II (performance standards).
21 CFR 868.1860 Peak-flow meter for spirometry.
(a) Identification. A peak-flow meter for spirometry is a device
used to measure a patient's maximum ventilatory flow rate.
(b) Classification. Class II (performance standards).
21 CFR 868.1870 Gas volume calibrator.
(a) Identification. A gas volume calibrator is a device that is
intended for medical purposes and that is used to calibrate the output
of gas volume measurement instruments by delivering a known gas volume.
(b) Classification. Class II (performance standards).
21 CFR 868.1880 Pulmonary-function data calculator.
(a) Identification. A pulmonary-function data calculator is a device
used to calculate pulmonary-function values based on actual physical
data obtained during pulmonary-function testing.
(b) Classification. Class II (performance standards).
21 CFR 868.1890 Predictive pulmonary-function value calculator.
(a) Identification. A predictive pulmonary-function value calculator
is a device used to calculate normal pulmonary-function values based on
empirical equations.
(b) Classification. Class II (performance standards).
21 CFR 868.1900 Diagnostic pulmonary-function interpretation
calculator.
(a) Identification. A diagnostic pulmonary-function interpretation
calculator is a device that interprets pulmonary study data to determine
clinical significance of pulmonary-function values.
(b) Classification. Class II (performance standards).
21 CFR 868.1910 Esophageal stethoscope.
(a) Identification. An esophageal stethoscope is a nonpowered device
that is inserted into a patient's esophagus to enable the user to listen
to heart and breath sounds.
(b) Classification. Class I (general controls).
21 CFR 868.1920 Esophageal stethoscope with electrical conductors.
(a) Identification. An esophageal stethoscope with electrical
conductors is a device that is inserted into the esophagus to listen to
a patient's heart and breath sounds and to monitor electrophysiological
signals. The device may also incorporate a thermistor for temperature
measurement.
(b) Classification. Class II (performance standards).
21 CFR 868.1930 Stethoscope head.
(a) Identification. A stethoscope head is a weighted chest piece
used during anesthesia to listen to a patient's heart, breath, and other
physiological sounds.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(47 FR 31142, July 16, 1982, as amended at 54 FR 25048, June 12,
1989)
21 CFR 868.1965 Switching valve (ploss).
(a) Identification. A switching valve (ploss) is a three-way valve
located between a stethoscope placed over the heart, a blood pressure
cuff, and an earpiece. The valve allows the user to eliminate one sound
channel and listen only to a patient's heart or korotkoff (blood
pressure) sounds through the other channel.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter. The device is also exempt from the current good manufacturing
practice regulations in Part 820 of this chapter, with the exception of
820.180, with respect to general requirements concerning records, and
820.198, with respect to complaint files.
(47 FR 31142, July 16, 1982, as amended at 54 FR 25048, June 12,
1989)
21 CFR 868.1975 Water vapor analyzer.
(a) Identification. A water vapor analyzer is a device intended to
measure the concentration of water vapor in a patient's expired gases by
using techniques such as mass spectrometry.
(b) Classification. Class II (performance standards).
21 CFR 868.1975 Subpart C -- Monitoring Devices
21 CFR 868.2025 Ultrasonic air embolism monitor.
(a) Identification. An ultrasonic air embolism monitor is a device
used to detect air bubbles in a patient's blood stream. It may use
Doppler or other ultrasonic principles.
(b) Classification. Class II (performance standards).
21 CFR 868.2300 Bourdon gauge flowmeter.
(a) Identification. A bourdon gauge flowmeter is a device intended
for medical purposes that is used in conjunction with respiratory
equipment to sense gas pressure. The device is calibrated to indicate
gas flow rate when the outflow is open to the atmosphere.
(b) Classification. Class II (performance standards).
21 CFR 868.2320 Uncompensated thorpe tube flowmeter.
(a) Identification. An uncompensated thorpe tube flowmeter is a
device intended for medical purposes that is used to indicate and
control gas flow rate accurately. The device includes a vertically
mounted tube and is calibrated when the outlet of the flowmeter is open
to the atmosphere.
(b) Classification. Class II (performance standards).
21 CFR 868.2340 Compensated thorpe tube flowmeter.
(a) Identification. A compensated thorpe tube flowmeter is a device
intended for medical purposes that is used to control and measure gas
flow rate accurately. The device includes a vertically mounted tube,
with the outlet of the flowmeter calibrated to a reference pressure.
(b) Classification. Class II (performance standards).
21 CFR 868.2350 Gas calibration flowmeter.
(a) Identification. A gas calibration flowmeter is a device intended
for medical purposes that is used to calibrate flowmeters and accurately
measure gas flow.
(b) Classification. Class II (performance standards).
21 CFR 868.2375 Breathing frequency monitor.
(a) Identification. A breathing (ventilatory) frequency monitor is a
device intended to measure or monitor a patient's respiratory rate. The
device may provide an audible or visible alarm when the respiratory rate
is outside predetermined limits.
(b) Classification. Class II (performance standards).
21 CFR 868.2450 Lung water monitor.
(a) Identification. A lung water monitor is a device used to monitor
the trend of fluid volume changes in a patient's lung by measuring
changes in thoracic electrical impedance (resistance to alternating
current) by means of electrodes placed on the patient's chest.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 868.3.
(47 FR 31142, July 16, 1982, as amended at 52 FR 17735, May 11, 1987)
21 CFR 868.2480 Cutaneous carbon dioxide (PcCO2) monitor.
(a) Identification. A cutaneous carbon dioxide (PcCO2) monitor is a
noninvasive heated sensor and a pH-sensitive glass electrode placed on a
patient's skin, which is intended to monitor relative changes in a
hemodynamically stable patient's cutaneous carbon dioxide tension as an
adjunct to arterial carbon dioxide tension measurement.
(b) Classification. Class II (performance standards).
(54 FR 27160, June 28, 1989)
21 CFR 868.2500 Cutaneous oxygen monitor.
(a) Cutaneous oxygen monitor for an infant patient who is not under
gas anesthesia -- (1) Identification. A cutaneous oxygen monitor for an
infant patient who is not under gas anesthesia is a device that uses a
noninvasive sensor (e.g., a Clark-type polarographic electrode) placed
on the patient's skin and that is intended to monitor relative changes
in the cutaneous oxygen tension in an infant patient who is not under
gas anesthesia.
(2) Classification. Class II (performance standards).
(b) Cutaneous oxygen monitor for all other uses -- (1)
Identification. A cutaneous oxygen monitor for all other uses is a
device that uses a noninvasive sensor (e.g., a Clark-type polarographic
electrode) placed on the patient's skin and that is intended to monitor
relative changes in the cutaneous oxygen tension in a noninfant patient
or in any patient, including an infant, who is under gas anesthesia.
(2) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval for the device described in paragraph (b)(1). See 868.3.
(47 FR 31142, July 16, 1982, as amended at 52 FR 17735, May 11, 1987)
21 CFR 868.2550 Pneumotachometer.
(a) Identification. A pneumotachometer is a device intended for
medical purposes that is used to determine gas flow by measuring the
pressure differential across a known resistance. The device may use a
set of capillaries or a metal screen for the resistive element.
(b) Classification. Class II (performance standards).
21 CFR 868.2600 Airway pressure monitor.
(a) Identification. An airway pressure monitor is a device used to
measure the pressure in a patient's upper airway. The device may
include a pressure gauge and an alarm.
(b) Classification. Class II (performance standards).
21 CFR 868.2610 Gas pressure gauge.
(a) Identification. A gas pressure gauge (e.g., bourdon tube
pressure gauge) is a device intended for medical purposes that is used
to measure gas pressure in a medical gas delivery system.
(b) Classification. Class II (performance standards).
21 CFR 868.2620 Gas pressure calibrator.
(a) Identification. A gas pressure calibrator is a device intended
for medical purposes that is used to calibrate pressure-measuring
instruments by generating a known gas pressure.
(b) Classification. Class II (performance standards).
21 CFR 868.2700 Pressure regulator.
(a) Identification. A pressure regulator is a device, often called a
pressure-reducing valve, that is intended for medical purposes and that
is used to convert a medical gas pressure from a high variable pressure
to a lower, more constant working pressure. This device includes
mechanical oxygen regulators.
(b) Classification. Class II (performance standards).
21 CFR 868.2775 Electrical peripheral nerve stimulator.
(a) Identification. An electrical peripheral nerve stimulator
(neuromuscular blockade monitor) is a device used to apply an electrical
current to a patient to test the level of pharmacological effect of
anesthetic drugs and gases.
(b) Classification. Class II (performance standards).
21 CFR 868.2875 Differential pressure transducer.
(a) Identification. A differential pressure transducer is a
two-chambered device intended for medical purposes that is often used
during pulmonary function testing. It generates an electrical signal
for subsequent display or processing that is proportional to the
difference in gas pressures in the two chambers.
(b) Classification. Class II (performance standards).
21 CFR 868.2885 Gas flow transducer.
(a) Identification. A gas flow transducer is a device intended for
medical purposes that is used to convert gas flow rate into an
electrical signal for subsequent display or processing.
(b) Classification. Class II (performance standards).
21 CFR 868.2900 Gas pressure transducer.
(a) Identification. A gas pressure transducer is a device intended
for medical purposes that is used to convert gas pressure into an
electrical signal for subsequent display or processing.
(b) Classification. Class II (performance standards).
21 CFR 868.2900 Subparts D-E -- (Reserved)
21 CFR 868.2900 Subpart F -- Therapeutic Devices
21 CFR 868.5090 Emergency airway needle.
(a) Identification. An emergency airway needle is a device intended
to puncture a patient's cricothyroid membrane to provide an emergency
airway during upper airway obstruction.
(b) Classification. Class II (performance standards).
21 CFR 868.5100 Nasopharyngeal airway.
(a) Identification. A nasopharyngeal airway is a device used to aid
breathing by means of a tube inserted into a patient's pharynx through
the nose to provide a patent airway.
(b) Classification. Class II (performance standards).
21 CFR 868.5110 Oropharyngeal airway.
(a) Identification. An oropharyngeal airway is a device inserted
into a patient's pharynx through the mouth to provide a patent airway.
(b) Classification. Class II (performance standards).
21 CFR 868.5120 Anesthesia conduction catheter.
(a) Identification. An anesthesia conduction catheter is a flexible
tubular device used to inject local anesthetics into a patient and to
provide continuous regional anesthesia.
(b) Classification. Class II (performance standards).
21 CFR 868.5130 Anesthesia conduction filter.
(a) Identification. An anesthesia conduction filter is a microporous
filter used while administering to a patient injections of local
anesthetics to minimize particulate (foreign material) contamination of
the injected fluid.
(b) Classification. Class II (performance standards).
21 CFR 868.5140 Anesthesia conduction kit.
(a) Identification. An anesthesia conduction kit is a device used to
administer to a patient conduction, regional, or local anesthesia. The
device may contain syringes, needles, and drugs.
(b) Classification. Class II (performance standards).
21 CFR 868.5150 Anesthesia conduction needle.
(a) Identification. An anesthesia conduction needle is a device used
to inject local anesthetics into a patient to provide regional
anesthesia.
(b) Classification. Class II (performance standards).
21 CFR 868.5160 Gas machine for anesthesia or analgesia.
(a) Gas machine for anesthesia -- (1) Identification. A gas machine
for anesthesia is a device used to administer to a patient, continuously
or intermittently, a general inhalation anesthetic and to maintain a
patient's ventilation. The device may include a gas flowmeter,
vaporizer, ventilator, breathing circuit with bag, and emergency air
supply.
(2) Classification. Class II (performance standards).
(b) Gas machine for analgesia -- (1) Identification. A gas machine
for analgesia is a device used to administer to a patient an analgesic
agent, such as a nitrous oxide-oxygen mixture (maximum concentration of
70 percent nitrous oxide).
(2) Classification. Class II (performance standards).
21 CFR 868.5170 Laryngotracheal topical anesthesia applicator.
(a) Identification. A laryngotracheal topical anesthesia applicator
is a device used to apply topical anesthetics to a patient's
laryngotracheal area.
(b) Classification. Class II (performance standards).
21 CFR 868.5180 Rocking bed.
(a) Identification. A rocking bed is a device intended for temporary
use to help patient ventilation (breathing) by repeatedly tilting the
patient, thereby using the weight of the abdominal contents to move the
diaphragm.
(b) Classification. Class II (performance standards).
21 CFR 868.5220 Blow bottle.
(a) Identification. A blow bottle is a device that is intended for
medical purposes to induce a forced expiration from a patient. The
patient blows into the device to move a column of water from one bottle
to another.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter. If the device is not labeled or otherwise represented as
sterile, it is exempt from the current good manufacturing practice
regulations in Part 820 of this chapter, with the exception of 820.180,
with respect to general requirements concerning records, and 820.198,
with respect to complaint files.
(47 FR 31142, July 16, 1982, as amended at 54 FR 25048, June 12,
1989)
21 CFR 868.5240 Anesthesia breathing circuit.
(a) Identification. An anesthesia breathing circuit is a device that
is intended to administer medical gases to a patient during anesthesia.
It provides both an inhalation and exhalation route and may include a
connector, adaptor, and Y-piece.
(b) Classification. Class II (performance standards).
21 CFR 868.5250 Breathing circuit circulator.
(a) Identification. A breathing circuit circulator is a turbine
device that is attached to a closed breathing circuit and that is
intended to circulate anesthetic gases continuously by maintaining the
unidirectional valves in an open position and reducing mechanical dead
space and resistance in the breathing circuit.
(b) Classification. Class II (performance standards).
21 CFR 868.5260 Breathing circuit bacterial filter.
(a) Identification. A breathing circuit bacterial filter is a device
that is intended to remove microbiological and particulate matter from
the gases in the breathing circuit.
(b) Classification. Class II (performance standards).
21 CFR 868.5270 Breathing system heater.
(a) Identification. A breathing system heater is a device that is
intended to warm breathing gases before they enter a patient's airway.
The device may include a temperature controller.
(b) Classification. Class II (performance standards).
21 CFR 868.5280 Breathing tube support.
(a) Identification. A breathing tube support is a device that is
intended to support and anchor a patient's breathing tube(s).
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(47 FR 31142, July 16, 1982, as amended at 54 FR 25048, June 12,
1989)
21 CFR 868.5300 Carbon dioxide absorbent.
(a) Identification. A carbon dioxide absorbent is a device intended
for medical purposes that consists of an absorbent material (e.g., soda
lime) that is intended to remove carbon dioxide from the gases in the
breathing circuit.
(b) Classification. Class II (performance standards).
21 CFR 868.5310 Carbon dioxide absorber.
(a) Identification. A carbon dioxide absorber is a device that is
intended for medical purposes and that is used in a breathing circuit as
a container for carbon dioxide absorbent. It may include a canister and
water drain.
(b) Classification. Class II (performance standards).
21 CFR 868.5320 Reservoir bag.
(a) Identification. A reservoir bag is a device, usually made of
conductive rubber, intended for use in a breathing circuit as a
reservoir for breathing gas and to assist, control, or monitor a
patient's ventilation.
(b) Classification. Class II (performance standards).
21 CFR 868.5330 Breathing gas mixer.
(a) Identification. A breathing gas mixer is a device intended for
use in conjunction with a respiratory support apparatus to control the
mixing of gases that are to be breathed by a patient.
(b) Classification. Class II (performance standards).
21 CFR 868.5340 Nasal oxygen cannula.
(a) Identification. A nasal oxygen cannula is a two-pronged device
used to administer oxygen to a patient through both nostrils.
(b) Classification. Class I (general controls).
21 CFR 868.5350 Nasal oxygen catheter.
(a) Identification. A nasal oxygen catheter is a device intended to
be inserted through a patient's nostril to administer oxygen.
(b) Classification. Class I (general controls).
21 CFR 868.5365 Posture chair for cardiac or pulmonary treatment.
(a) Identification. A posture chair for cardiac or pulmonary
treatment is a device intended to assist in the rehabilitation and
mobilization of patients with chronic heart or lung disease.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(47 FR 31142, July 16, 1982, as amended at 54 FR 25048, June 12,
1989)
21 CFR 868.5375 Heat and moisture condenser (artificial nose).
(a) Identification. A heat and moisture condenser (artificial nose)
is a device intended to be positioned over a tracheotomy (a surgically
created opening in the throat) or tracheal tube (a tube inserted into
the trachea) to warm and humidify gases breathed in by a patient.
(b) Classification. Class II (performance standards).
21 CFR 868.5400 Electroanesthesia apparatus.
(a) Identification. An electroanesthesia apparatus is a device used
for the induction and maintenance of anesthesia during surgical
procedures by means of an alternating or pulsed electric current that is
passed through electrodes fixed to a patient's head.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 868.3.
(47 FR 31142, July 16, 1982, as amended at 52 FR 17735, May 11, 1987)
21 CFR 868.5420 Ether hook.
(a) Identification. An ether hook is a device that fits inside a
patient's mouth and that is intended to deliver vaporized ether.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter. If the device is not labeled or otherwise represented as
sterile, it is exempt from the current good manufacturing practice
regulations in Part 820 of this chapter, with the exception of 820.180,
with respect to general requirements concerning records, and 820.198,
with respect to complaint files.
(47 FR 31142, July 16, 1982, as amended at 54 FR 25048, June 12,
1989)
21 CFR 868.5430 Gas-scavenging apparatus.
(a) Identification. A gas-scavenging apparatus is a device intended
to collect excess anesthetic, analgesic, or trace gases or vapors from a
patient's breathing system, ventilator, or extracorporeal
pump-oxygenator, and to conduct these gases out of the area by means of
an exhaust system.
(b) Classification. Class II (performance standards).
21 CFR 868.5440 Portable oxygen generator.
(a) Identification. A portable oxygen generator is a device that is
intended to release oxygen for respiratory therapy by means of either a
chemical reaction or physical means (e.g., a molecular sieve).
(b) Classification. Class II (performance standards).
21 CFR 868.5450 Respiratory gas humidifier.
(a) Identification. A respiratory gas humidifier is a device that is
intended to add moisture to, and sometimes to warm, the breathing gases
for administration to a patient. Cascade, gas, heated, and prefilled
humidifiers are included in this generic type of device.
(b) Classification. Class II (performance standards).
21 CFR 868.5460 Therapeutic humidifier for home use.
(a) Identification. A therapeutic humidifier for home use is a
device that adds water vapor to breathing gases and that is intended for
respiratory therapy or other medical purposes. The vapor produced by
the device pervades the area surrounding the patient, who breathes the
vapor during normal respiration.
(b) Classification. Class II (performance standards).
(47 FR 31142, July 16, 1982; 47 FR 40410, Sept. 14, 1982)
21 CFR 868.5470 Hyperbaric chamber.
(a) Identification. A hyperbaric chamber is a device that is
intended to increase the environmental oxygen pressure to promote the
movement of oxygen from the environment to a patient's tissue by means
of pressurization that is greater than atmospheric pressure. This
device does not include topical oxygen chambers for extremities (
878.5650).
(b) Classification. Class II (performance standards).
21 CFR 868.5530 Flexible laryngoscope.
(a) Identification. A flexible laryngoscope is a fiberoptic device
used to examine and visualize a patient's upper airway and aid placement
of a tracheal tube.
(b) Classification. Class II (performance standards).
(47 FR 41107, Sept. 17, 1982)
21 CFR 868.5540 Rigid laryngoscope.
(a) Identification. A rigid laryngoscope is a device used to examine
and visualize a patient's upper airway and aid placement of a tracheal
tube.
(b) Classification. Class II (performance standards).
(47 FR 41107, Sept. 17, 1982)
21 CFR 868.5550 Anesthetic gas mask.
(a) Identification. An anesthetic gas mask is a device, usually made
of conductive rubber, that is positioned over a patient's nose or mouth
to direct anesthetic gases to the upper airway.
(b) Classification. Class II (performance standards).
(47 FR 41107, Sept. 17, 1982)
21 CFR 868.5560 Gas mask head strap.
(a) Identification. A gas mask head strap is a device used to hold
an anesthetic gas mask in position on a patient's face.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(47 FR 41107, Sept. 17, 1982, as amended at 54 FR 25048, June 12,
1989)
21 CFR 868.5570 Nonrebreathing mask.
(a) Identification. A nonrebreathing mask is a device fitting over a
patient's face to administer oxygen. It utilizes one-way valves to
prevent the patient from rebreathing previously exhaled gases.
(b) Classification. Class II (performance standards).
21 CFR 868.5580 Oxygen mask.
(a) Identification. An oxygen mask is a device placed over a
patient's nose, mouth, or tracheostomy to administer oxygen or aerosols.
(b) Classification. Class II (performance standards).
21 CFR 868.5590 Scavenging mask.
(a) Identification. A scavenging mask is a device positioned over a
patient's nose to deliver anesthetic or analgesic gases to the upper
airway and to remove excess and exhaled gas. It is usually used during
dentistry.
(b) Classification. Class II (performance standards).
21 CFR 868.5600 Venturi mask.
(a) Identification. A venturi mask is a device containing an
air-oxygen mixing mechanism that dilutes 100 percent oxygen to a
predetermined concentration and delivers the mixed gases to a patient.
(b) Classification. Class II (performance standards).
21 CFR 868.5610 Membrane lung for long-term pulmonary support.
(a) Identification. A membrane lung for long-term pulmonary support
is a device used to provide to a patient extracorporeal blood
oxygenation for longer than 24 hours.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 868.3.
(47 FR 31142, July 16, 1982, as amended at 52 FR 17735, May 11, 1987)
21 CFR 868.5620 Breathing mouthpiece.
(a) Identification. A breathing mouthpiece is a rigid device that is
inserted into a patient's mouth and that connects with diagnostic or
therapeutic respiratory devices.
(b) Classification. Class I (general controls).
21 CFR 868.5630 Nebulizer.
(a) Identification. A nebulizer is a device intended to spray
liquids in aerosol form into gases that are delivered directly to the
patient for breathing. Heated, ultrasonic, gas, venturi, and refillable
nebulizers are included in this generic type of device.
(b) Classification. Class II (performance standards).
21 CFR 868.5640 Medicinal nonventilatory nebulizer (atomizer).
(a) Identification. A medicinal nonventilatory nebulizer (atomizer)
is a device that is intended to spray liquid medication in aerosol form
into the air that a patient will breathe.
(b) Classification. Class I (general controls).
21 CFR 868.5650 Esophageal obturator.
(a) Identification. An esophageal obturator is a device inserted
through a patient's mouth to aid ventilation of the patient during
emergency resuscitation by occluding (blocking) the esophagus, thereby
permitting positive pressure ventilation through the trachea. The
device consists of a closed-end semirigid esophageal tube that is
attached to a face mask.
(b) Classification. Class II (performance standards).
21 CFR 868.5655 Portable liquid oxygen unit.
(a) Identification. A portable liquid oxygen unit is a portable,
thermally insulated container of liquid oxygen that is intended to
supplement gases to be inhaled by a patient, is sometimes accompanied by
tubing and an oxygen mask. An empty portable liquid oxygen unit is a
device, while the oxygen contained therein is a drug.
(b) Classification. Class II (performance standards).
21 CFR 868.5665 Powered percussor.
(a) Identification. A powered percussor is a device that is intended
to transmit vibration through a patient's chest wall to aid in freeing
mucus deposits in the lung in order to improve bronchial drainage and
that may be powered by electricity or compressed gas.
(b) Classification. Class II (performance standards).
21 CFR 868.5675 Rebreathing device.
(a) Identification. A rebreathing device is a device that enables a
patient to rebreathe exhaled gases. It may be used in conjunction with
pulmonary function testing or for increasing minute ventilation.
(b) Classification. Class I (general controls). If the device is
not labeled or otherwise represented as sterile, it is exempt from the
good manufacturing practice regulation in Part 820, with the exception
of 820.180, with respect to general requirements concerning records,
and 820.198, with respect to complaint files.
21 CFR 868.5690 Incentive spirometer.
(a) Identification. An incentive spirometer is a device that
indicates a patient's breathing volume or flow and that provides an
incentive to the patient to improve his or her ventilation.
(b) Classification. Class II (performance standards).
21 CFR 868.5700 Nonpowered oxygen tent.
(a) Identification. A nonpowered oxygen tent is a device that
encloses a patient's head and upper body to contain oxygen delivered to
the patient for breathing. This generic type of device includes infant
oxygen hoods.
(b) Classification. Class I (general controls).
21 CFR 868.5710 Electrically powered oxygen tent.
(a) Identification. An electrically powered oxygen tent is a device
that encloses a patient's head and, by means of an electrically powered
unit, administers breathing oxygen and controls the temperature and
humidity of the breathing gases. This generic type device includes the
pediatric aerosol tent.
(b) Classification. Class II (performance standards).
21 CFR 868.5720 Bronchial tube.
(a) Identification. A bronchial tube is a device used to
differentially intubate a patient's bronchus (one of the two main
branches of the trachea leading directly to the lung) in order to
isolate a portion of lung distal to the tube.
(b) Classification. Class II (performance standards).
21 CFR 868.5730 Tracheal tube.
(a) Identification. A tracheal tube is a device inserted into a
patient's trachea via the nose or mouth and used to maintain an open
airway.
(b) Classification. Class II (performance standards).
21 CFR 868.5740 Tracheal/bronchial differential ventilation tube.
(a) Identification. A tracheal/bronchial differential ventilation
tube is a device used to isolate the left or the right lung of a patient
for anesthesia or pulmonary function testing.
(b) Classification. Class II (performance standards).
21 CFR 868.5750 Inflatable tracheal tube cuff.
(a) Identification. An inflatable tracheal tube cuff is a device
used to provide an airtight seal between a tracheal tube and a patient's
trachea.
(b) Classification. Class II (performance standards).
21 CFR 868.5760 Cuff spreader.
(a) Identification. A cuff spreader is a device used to install
tracheal tube cuffs on tracheal or tracheostomy tubes.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter. If the device is not labeled or otherwise represented as
sterile, it is exempt from the current good manufacturing practice
regulations in Part 820 of this chapter, with the exception of 820.180,
with respect to general requirements concerning records, and 820.198,
with respect to complaint files.
(47 FR 31142, July 16, 1982, as amended at 54 FR 25048, June 12,
1989)
21 CFR 868.5770 Tracheal tube fixation device.
(a) Identification. A tracheal tube fixation device is a device used
to hold a tracheal tube in place, usually by means of straps or pinch
rings.
(b) Classification. Class II (performance standards).
21 CFR 868.5780 Tube introduction forceps.
(a) Identification. Tube introduction forceps (e.g., Magill forceps)
are a right-angled device used to grasp a tracheal tube and place it in
a patient's trachea.
(b) Classification. Class II (performance standards).
21 CFR 868.5790 Tracheal tube stylet.
(a) Identification. A tracheal tube stylet is a device used
temporarily to make rigid a flexible tracheal tube to aid its insertion
into a patient.
(b) Classification. Class II (performance standards).
21 CFR 868.5795 Tracheal tube cleaning brush.
(a) Identification. A tracheal tube cleaning brush is a device
consisting of a brush with plastic bristles intended to clean tracheal
cannula devices after their removal from patients.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807. If the
device is not labeled or otherwise represented as sterile, it is exempt
from the current good manufacturing practice regulations in Part 820,
with the exception of 820.180, with respect to general requirements
concerning records, and 820.198, with respect to complaint files.
(51 FR 40388, Nov. 6, 1986)
21 CFR 868.5800 Tracheostomy tube and tube cuff.
(a) Identification. A tracheostomy tube and tube cuff is a device
intended to be placed into a surgical opening of the trachea to
facilitate ventilation to the lungs. The cuff may be a separate or
integral part of the tracheostomy tube and is, when inflated, intended
to establish a seal between the tracheal wall and the tracheostomy tube.
The cuff is used to prevent the patient's aspiration of substances,
such as blood or vomit, or to provide a means for positive-pressure
ventilation of the patient. This device is made of either stainless
steel or plastic.
(b) Classification. Class II.
(51 FR 40389, Nov. 6, 1986)
21 CFR 868.5810 Airway connector.
(a) Identification. An airway connector is a device intended to
connect a breathing gas source to a tracheal tube, tracheostomy tube, or
mask.
(b) Classification. Class II (performance standards).
21 CFR 868.5820 Dental protector.
(a) Identification. A dental protector is a device intended to
protect a patient's teeth during manipulative procedures within a
patient's oral cavity.
(b) Classification. Class II (performance standards).
21 CFR 868.5830 Autotransfusion apparatus.
(a) Identification. An autotransfusion apparatus is a device used to
collect and reinfuse the blood lost by a patient due to surgery or
trauma.
(b) Classification. Class II (performance standards).
21 CFR 868.5860 Pressure tubing and accessories.
(a) Identification. Pressure tubing and accessories are flexible or
rigid devices intended to deliver pressurized medical gases.
(b) Classification. Class II (performance standards).
21 CFR 868.5870 Nonrebreathing valve.
(a) Identification. A nonrebreathing valve is a one-way valve that
directs breathing gas flow to the patient and vents exhaled gases into
the atmosphere.
(b) Classification. Class II (performance standards).
21 CFR 868.5880 Anesthetic vaporizer.
(a) Identification. An anesthetic vaporizer is a device used to
vaporize liquid anesthetic and deliver a controlled amount of the vapor
to the patient.
(b) Classification. Class II (performance standards).
21 CFR 868.5895 Continuous ventilator.
(a) Identification. A continuous ventilator (respirator) is a device
intended to mechanically control or assist patient breathing by
delivering a predetermined percentage of oxygen in the breathing gas.
Adult, pediatric, and neonatal ventilators are included in this generic
type of device.
(b) Classification. Class II (performance standards).
21 CFR 868.5905 Noncontinuous ventilator (IPPB).
(a) Identification. A noncontinuous ventilator (intermittent
positive pressure breathing-IPPB) is a device intended to deliver
intermittently an aerosol to a patient's lungs or to assist a patient's
breathing.
(b) Classification. Class II (performance standards).
21 CFR 868.5915 Manual emergency ventilator.
(a) Identification. A manual emergency ventilator is a device,
usually incorporating a bag and valve, intended to provide emergency
respiratory support by means of a face mask or a tube inserted into a
patient's airway.
(b) Classification. Class II (performance standards).
21 CFR 868.5925 Powered emergency ventilator.
(a) Identification. A powered emergency ventilator is a demand valve
or inhalator intended to provide emergency respiratory support by means
of a face mask or a tube inserted into a patient's airway.
(b) Classification. Class II (performance standards).
21 CFR 868.5935 External negative pressure ventilator.
(a) Identification. An external negative pressure ventilator (e.g.,
iron lung, cuirass) is a device chamber that is intended to support a
patient's ventilation by alternately applying and releasing external
negative pressure over the diaphragm and upper trunk of the patient.
(b) Classification. Class II (performance standards).
21 CFR 868.5955 Intermittent mandatory ventilation attachment.
(a) Identification. An intermittent mandatory ventilation (IMV)
attachment is a device attached to a mechanical ventilator that allows
spontaneous breathing by a patient while providing mechanical
ventilation at a preset rate.
(b) Classification. Class II (performance standards).
21 CFR 868.5965 Positive end expiratory pressure breathing attachment.
(a) Identification. A positive end expiratory pressure (PEEP)
breathing attachment is a device attached to a ventilator that is used
to elevate pressure in a patient's lungs above atmospheric pressure at
the end of exhalation.
(b) Classification. Class II (performance standards).
21 CFR 868.5975 Ventilator tubing.
(a) Identification. Ventilator tubing is a device intended for use
as a conduit for gases between a ventilator and a patient during
ventilation of the patient.
(b) Classification. Class II (performance standards).
21 CFR 868.5995 Tee drain (water trap).
(a) Identification. A tee drain (water trap) is a device intended to
trap and drain water that collects in ventilator tubing during
respiratory therapy, thereby preventing an increase in breathing
resistance.
(b) Classification. Class II (perfomance standards).
21 CFR 868.5995 Subpart G -- Miscellaneous
21 CFR 868.6100 Anesthetic cabinet, table, or tray.
(a) Identification. An anesthetic cabinet, table, or tray is a
device intended to store anesthetic equipment and drugs. The device is
usually constructed to eliminate build-up of static electrical charges.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(47 FR 31142, July 16, 1982, as amended at 54 FR 25048, June 12,
1989)
21 CFR 868.6175 Cardiopulmonary emergency cart.
(a) Identification. A cardiopulmonary emergency cart is a device
intended to store and transport resuscitation supplies for emergency
treatment. The device does not include any equipment used in
cardiopulmonary resuscitation.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter. The device is also exempt from the current good manufacturing
practice regulations in Part 820 of this chapter, with the exception of
820.180, with respect to general requirements concerning records, and
820.198, with respect to complaint files.
(47 FR 31142, July 16, 1982, as amended at 54 FR 25048, June 12,
1989)
21 CFR 868.6225 Nose clip.
(a) Identification. A nose clip is a device intended to close a
patient's external nares (nostrils) during diagnostic or therapeutic
procedures.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter. The device is also exempt from the current good manufacturing
practice regulations in Part 820 of this chapter, with the exception of
820.180, with respect to general requirements concerning records, and
820.198, with respect to complaint files.
(47 FR 31142, July 16, 1982, as amended at 54 FR 25048, June 12,
1989)
21 CFR 868.6250 Portable air compressor.
(a) Identification. A portable air compressor is a device intended
to provide compressed air for medical purposes, e.g., to drive
ventilators and other respiratory devices.
(b) Classification. Class II (performance standards).
21 CFR 868.6400 Calibration gas.
(a) Identification. A calibration gas is a device consisting of a
container of gas of known concentration intended to calibrate medical
gas concentration measurement devices.
(b) Classification. Class II (performance standards).
21 CFR 868.6700 Anesthesia stool.
(a) Identification. An anesthesia stool is a device intended for use
as a stool for the anesthesiologist in the operating room.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(47 FR 31142, July 16, 1982, as amended at 54 FR 25049, June 12,
1989)
21 CFR 868.6810 Tracheobronchial suction catheter.
(a) Identification. A tracheobronchial suction catheter is a device
used to aspirate liquids or semisolids from a patient's upper airway.
(b) Classification. Class I (general controls).
21 CFR 868.6820 Patient position support.
(a) Identification. A patient position support is a device intended
to maintain the position of an anesthetized patient during surgery.
(b) Classification. Class II (performance standards).
21 CFR 868.6885 Medical gas yoke assembly.
(a) Identification. A medical gas yoke assembly is a device intended
to connect medical gas cylinders to regulators or needle valves to
supply gases for anesthesia or respiratory therapy. The device may
include a particulate filter.
(b) Classification. Class II (performance standards).
21 CFR 868.6885 Pt. 870
21 CFR 868.6885 PART 870 -- CARDIOVASCULAR DEVICES
21 CFR 868.6885 Subpart A -- General Provisions
Sec.
870.1 Scope.
870.3 Effective dates of requirement for premarket approval.
870.9 Limitations of exemptions from section 510(k) of the Federal
Food, Drug, and Cosmetic Act (the act).
21 CFR 868.6885 Subpart B -- Cardiovascular Diagnostic Devices
870.1025 Arrhythmia detector and alarm.
870.1100 Blood pressure alarm.
870.1110 Blood pressure computer.
870.1120 Blood pressure cuff.
870.1130 Noninvasive blood pressure measurement system.
870.1140 Venous blood pressure manometer.
870.1200 Diagnostic intravascular catheter.
870.1210 Continuous flush catheter.
870.1220 Electrode recording catheter or electrode recording probe.
870.1230 Fiberoptic oximeter catheter.
870.1240 Flow-directed catheter.
870.1250 Percutaneous catheter.
870.1270 Intracavitary phonocatheter system.
870.1280 Steerable catheter.
870.1290 Steerable catheter control system.
870.1300 Catheter cannula.
870.1310 Vessel dilator for percutaneous catheterization.
870.1330 Catheter guide wire.
870.1340 Catheter introducer.
870.1350 Catheter balloon repair kit.
870.1360 Trace microsphere.
870.1370 Catheter tip occluder.
870.1380 Catheter stylet.
870.1390 Trocar.
870.1425 Programmable diagnostic computer.
870.1435 Single-function, preprogrammed diagnostic computer.
870.1450 Densitometer.
870.1650 Angiographic injector and syringe.
870.1660 Indicator injector.
870.1670 Syringe actuator for an injector.
870.1750 External programmable pacemaker pulse generator.
870.1800 Withdrawal-infusion pump.
870.1875 Stethoscope.
870.1915 Thermodilution probe.
21 CFR 868.6885 Subpart C -- Cardiovascular Monitoring Devices
870.2050 Biopotential amplifier and signal conditioner.
870.2060 Transducer signal amplifier and signal conditioner.
870.2100 Cardiovascular blood flowmeter.
870.2120 Extravascular blood flow probe.
870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
870.2310 Apex cardiograph (vibrocardiograph).
870.2320 Ballistocardiograph.
870.2330 Echocardiograph.
870.2340 Electrocardiograph.
870.2350 Electrocardiograph lead switching adaptor.
870.2360 Electrocardiograph electrode.
870.2370 Electrocardiograph surface electrode tester.
870.2390 Phonocardiograph.
870.2400 Vectorcardiograph.
870.2450 Medical cathode-ray tube display.
870.2600 Signal isolation system.
870.2620 Line isolation monitor.
870.2640 Portable leakage current alarm.
870.2675 Oscillometer.
870.2700 Oximeter.
870.2710 Ear oximeter.
870.2750 Impedance phlebograph.
870.2770 Impedance plethysmograph.
870.2780 Hydraulic, pneumatic, or photoelectric plethysmographs.
870.2800 Medical magnetic tape recorder.
870.2810 Paper chart recorder.
870.2840 Apex cardiographic transducer.
870.2850 Extravascular blood pressure transducer.
870.2860 Heart sound transducer.
870.2870 Catheter tip pressure transducer.
870.2880 Ultrasonic transducer.
870.2890 Vessel occlusion transducer.
870.2900 Patient transducer and electrode cable (including
connector).
870.2910 Radiofrequency physiological signal transmitter and
receiver.
870.2920 Telephone electrocardiograph transmitter and receiver.
21 CFR 868.6885 Subpart D -- Cardiovascular Prosthetic Devices
870.3250 Vascular clip.
870.3260 Vena cava clip.
870.3300 Arterial embolization device.
870.3375 Cardiovascular intravascular filter.
870.3450 Vascular graft prosthesis of less than 6 millimeters
diameter.
870.3460 Vascular graft prosthesis of 6 millimeters and greater
diameter.
870.3470 Intracardiac patch or pledget made of polypropylene,
polyethylene terephthalate, or polytetrafluoroethylene.
870.3535 Intra-aortic balloon and control system.
870.3545 Ventricular bypass (assist) device.
870.3600 External pacemaker pulse generator.
870.3610 Implantable pacemaker pulse generator.
870.3620 Pacemaker lead adaptor.
870.3630 Pacemaker generator function analyzer.
870.3640 Indirect pacemaker generator function analyzer.
870.3650 Pacemaker polymeric mesh bag.
870.3670 Pacemaker charger.
870.3680 Cardiovascular permanent or temporary pacemaker electrode.
870.3690 Pacemaker test magnet.
870.3700 Pacemaker programmers.
870.3710 Pacemaker repair or replacement material.
870.3720 Pacemaker electrode function tester.
870.3730 Pacemaker service tools.
870.3800 Annuloplasty ring.
870.3850 Carotid sinus nerve stimulator.
870.3925 Replacement heart valve.
870.3935 Prosthetic heart valve holder.
870.3945 Prosthetic heart valve sizer.
21 CFR 868.6885 Subpart E -- Cardiovascular Surgical Devices
870.4075 Endomyocardial biopsy device.
870.4200 Cardiopulmonary bypass accessory equipment.
870.4205 Cardiopulmonary bypass bubble detector.
870.4210 Cardiopulmonary bypass vascular catheter, cannula, or
tubing.
870.4220 Cardiopulmonary bypass heart-lung machine console.
870.4230 Cardiopulmonary bypass defoamer.
870.4240 Cardiopulmonary bypass heat exchanger.
870.4250 Cardiopulmonary bypass temperature controller.
870.4260 Cardiopulmonary bypass arterial line blood filter.
870.4270 Cardiopulmonary bypass cardiotomy suction line blood filter.
870.4280 Cardiopulmonary prebypass filter.
870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or
fitting.
870.4300 Cardiopulmonary bypass gas control unit.
870.4310 Cardiopulmonary bypass coronary pressure gauge.
870.4320 Cardiopulmonary bypass pulsatile flow generator.
870.4330 Cardiopulmonary bypass on-line blood gas monitor.
870.4340 Cardiopulmonary bypass level sensing monitor and/or control.
870.4350 Cardiopulmonary bypass oxygenator.
870.4360 Nonroller-type cardiopulmonary bypass blood pump.
870.4370 Roller-type cardiopulmonary bypass blood pump.
870.4380 Cardiopulmonary bypass pump speed control.
870.4390 Cardiopulmonary bypass pump tubing.
870.4400 Cardiopulmonary bypass blood reservoir.
870.4410 Cardiopulmonary bypass in-line blood gas sensor.
870.4420 Cardiopulmonary bypass cardiotomy return sucker.
870.4430 Cardiopulmonary bypass intracardiac suction control.
870.4450 Vascular clamp.
870.4475 Surgical vessel dilator.
870.4500 Cardiovascular surgical instruments.
870.4875 Intraluminal artery stripper.
870.4885 External vein stripper.
21 CFR 868.6885 Subpart F -- Cardiovascular Therapeutic Devices
870.5050 Patient care suction apparatus.
870.5150 Embolectomy catheter.
870.5175 Septostomy catheter.
870.5200 External cardiac compressor.
870.5225 External counter-pulsating device.
870.5300 DC-defibrillator (including paddles).
870.5325 Defibrillator tester.
870.5550 External transcutaneous cardiac pacemaker (noninvasive).
870.5800 Compressible limb sleeve.
870.5900 Thermal regulating system.
870.5925 Automatic rotating tourniquet.
Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j, 371).
Source: 45 FR 7907-7971, Feb. 5, 1980, unless otherwise noted.
21 CFR 868.6885 Subpart A -- General Provisions
21 CFR 870.1 Scope.
(a) This part sets forth the classification of cardiovascular devices
intended for human use that are in commercial distribution.
(b) The identification of a device in a regulation in this part is
not a precise description of every device that is, or will be, subject
to the regulation. A manufacturer who submits a premarket notification
submission for a device under Part 807 may not show merely that the
device is accurately described by the section title and identification
provisions of a regulation in this part, but shall state why the device
is substantially equivalent to other devices, as required by 807.87.
(c) To avoid duplicative listings, a cardiovascular device that has
two or more types of uses (e.g., used both as a diagnostic device and as
a therapeutic device) is listed only in one subpart.
(d) References in this part to regulatory sections of the Code of
Federal Regulations are to Chapter I of Title 21, unless otherwise
noted.
(52 FR 17735, May 11, 1987)
21 CFR 870.3 Effective dates of requirement for premarket approval.
A device included in this part that is classified into class III
(premarket approval) shall not be commercially distributed after the
date shown in the regulation classifying the device unless the
manufacturer has an approval under section 515 of the act (unless an
exemption has been granted under section 520(g)(2) of the act). An
approval under section 515 of the act consists of FDA's issuance of an
order approving an application for premarket approval (PMA) for the
device or declaring completed a product development protocol (PDP) for
the device.
(a) Before FDA requires that a device commercially distributed before
the enactment date of the amendments, or a device that has been found
substantially equivalent to such a device, has an approval under section
515 of the act FDA must promulgate a regulation under section 515(b) of
the act requiring such approval, except as provided in paragraph (b) of
this section. Such a regulation under section 515(b) of the act shall
not be effective during the grace period ending on the 90th day after
its promulgation or on the last day of the 30th full calendar month
after the regulation that classifies the device into class III is
effective, whichever is later. See section 501(f)(2)(B) of the act.
Accordingly, unless an effective date of the requirement for premarket
approval is shown in the regulation for a device classified into class
III in this part, the device may be commercially distributed without
FDA's issuance of an order approving a PMA or declaring completed a PDP
for the device. If FDA promulgates a regulation under section 515(b) of
the act requiring premarket approval for a device, section 501(f)(1)(A)
of the act applies to the device.
(b) Any new, not substantially equivalent, device introduced into
commercial distribution on or after May 28, 1976, including a device
formerly marketed that has been substantially altered, is classified by
statute (section 513(f) of the act) into class III without any grace
period and FDA must have issued an order approving a PMA or declaring
completed a PDP for the device before the device is commercially
distributed unless it is reclassified. If FDA knows that a device being
commercially distributed may be a ''new'' device as defined in this
section because of any new intended use or other reasons, FDA may codify
the statutory classification of the device into class III for such new
use. Accordingly, the regulation for such a class III device states
that as of the enactment date of the amendments, May 28, 1976, the
device must have an approval under section 515 of the act before
commercial distribution.
(52 FR 17735, May 11, 1987)
21 CFR 870.9 Limitations of exemptions from section 510(k) of the
Federal Food, Drug, and Cosmetic Act (the act).
The Food and Drug Administration's (FDA's) decision to grant an
exemption from the requirement of premarket notification (section 510(k)
of the act) for a generic type of class I device is based upon the
existing and reasonably foreseeable characteristics of commercially
distributed devices within that generic type. Because FDA cannot
anticipate every change in intended use or characteristic that could
significantly affect a device's safety or effectiveness, manufacturers
of any commercially distributed class I device for which FDA has granted
an exemption from the requirement of premarket notification must still
submit a premarket notification to FDA before introducing or delivering
for introduction into interstate commerce for commercial distribution
the device when:
(a) The device is intended for a use different from its intended use
before May 28, 1976, or the device is intended for a use different from
the intended use of a preamendments device to which it had been
determined to be substantially equivalent; e.g., the device is intended
for a different medical purpose, or the device is intended for lay use
where the former intended use was by health care professionals only; or
(b) The modified device operates using a different fundamental
scientific technology than that in use in the device before May 28,
1976; e.g., a surgical instrument cuts tissue with a laser beam rather
than with a sharpened metal blade, or an in vitro diagnostic device
detects or identifies infectious agents by using a deoxyribonucleic acid
(DNA) probe or nucleic acid hybridization technology rather than culture
or immunoassay technology.
(54 FR 25049, June 12, 1989)
21 CFR 870.9 Subpart B -- Cardiovascular Diagnostic Devices
21 CFR 870.1025 Arrhythmia detector and alarm.
(a) Identification. An arrhythmia detector and alarm is a system
that monitors the electrocardiogram and is designed to produce a visible
or audible signal or alarm when an atrial or ventricular arrhythmia,
such as a premature contraction or ventricular fibrillation, exists.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 870.3.
(45 FR 7907-7971, Feb. 5, 1980, as amended at 52 FR 17736, May 11,
1987)
21 CFR 870.1100 Blood pressure alarm.
(a) Identification. A blood pressure alarm is a device that accepts
the signal from a blood pressure transducer amplifier, processes the
signal, and emits an alarm when the blood pressure falls outside a
pre-set upper or lower limit.
(b) Classification. Class II (performance standards).
21 CFR 870.1110 Blood pressure computer.
(a) Identification. A blood pressure computer is a device that
accepts the electrical signal from a blood pressure transducer amplifier
and indicates the systolic, diastolic, or mean pressure based on the
input signal.
(b) Classification. Class II (performance standards).
21 CFR 870.1120 Blood pressure cuff.
(a) Identification. A blood pressure cuff is a device that has an
inflatable bladder in an inelastic sleeve (cuff) with a mechanism for
inflating and deflating the bladder. The cuff is used in conjunction
with another device to determine a subject's blood pressure.
(b) Classification. Class II (performance standards).
21 CFR 870.1130 Noninvasive blood pressure measurement system.
(a) Identification. A noninvasive blood pressure measurement system
is a device that provides a signal from which systolic, diastolic, mean,
or any combination of the three pressures can be derived through the use
of tranducers placed on the surface of the body.
(b) Classification. Class II (performance standards).
21 CFR 870.1140 Venous blood pressure manometer.
(a) Identification. A venous blood pressure manometer is a device
attached to a venous catheter to indicate manometrically the central or
peripheral venous pressure.
(b) Classification. Class II (performance standards).
21 CFR 870.1200 Diagnostic intravascular catheter.
(a) Identification. An intravascular diagnostic catheter is a device
used to record intracardiac pressures, to sample blood, and to introduce
substances into the heart and vessels. Included in this generic device
are right-heart catheters, left-heart catheters, and angiographic
catheters, among others.
(b) Classification. Class II (performance standards).
21 CFR 870.1210 Continuous flush catheter.
(a) Identification. A continuous flush catheter is an attachment to
a catheter-transducer system that permits continuous intravascular
flushing at a slow infusion rate for the purpose of eliminating
clotting, back-leakage, and waveform damping.
(b) Classification. Class II (performance standards).
21 CFR 870.1220 Electrode recording catheter or electrode recording
probe.
(a) Identification. An electrode recording catheter or an electrode
recording probe is a device used to detect an intracardiac
electrocardiogram, or to detect cardiac output or left-to-right heart
shunts. The device may be unipolar or multipolar for electrocardiogram
detection, or may be a platinum-tipped catheter which senses the
presence of a special indicator for cardiac output or left-to-right
heart shunt determinations.
(b) Classification. Class II (performance standards).
21 CFR 870.1230 Fiberoptic oximeter catheter.
(a) Identification. A fiberoptic oximeter catheter is a device used
to estimate the oxygen saturation of the blood. It consists of two
fiberoptic bundles that conduct light at a desired wavelength through
blood and detect the reflected and scattered light at the distal end of
the catheter.
(b) Classification. Class II (performance standards).
21 CFR 870.1240 Flow-directed catheter.
(a) Identification. A flow-directed catheter is a device that
incorporates a gas-filled balloon to help direct the catheter to the
desired position.
(b) Classification. Class II (performance standards).
21 CFR 870.1250 Percutaneous catheter.
(a) Identification. A percutaneous catheter is a device that is
introduced into a vein or artery through the skin using a dilator and a
sheath (introducer) or guide wire.
(b) Classification. Class II (performance standards).
21 CFR 870.1270 Intracavitary phonocatheter system.
(a) Identification. An intracavitary phonocatheter system is a
system that includes a catheter with an acoustic transducer and the
associated device that processes the signal from the transducer; this
device records bioacoustic phenomena from a transducer placed within the
heart, blood vessels, or body cavities.
(b) Classification. Class II (performance standards).
21 CFR 870.1280 Steerable catheter.
(a) Identification. A steerable catheter is a catheter used for
diagnostic and monitoring purposes whose movements are directed by a
steering control unit.
(b) Classification. Class II (performance standards).
21 CFR 870.1290 Steerable catheter control system.
(a) Identification. A steerable catheter control system is a device
that is connected to the proximal end of a steerable guide wire that
controls the motion of the steerable catheter.
(b) Classification. Class II (performance standards).
21 CFR 870.1300 Catheter cannula.
(a) Identification. A catheter cannula is a hollow tube which is
inserted into a vessel or cavity; this device provides a rigid or
semirigid structure which can be connected to a tube or connector.
(b) Classification. Class II (performance standards).
21 CFR 870.1310 Vessel dilator for percutaneous catheterization.
(a) Identification. A vessel dilator for percutaneous
catheterization is a device which is placed over the guide wire to
enlarge the opening in the vessel, and which is then removed before
sliding the catheter over the guide wire.
(b) Classification. Class II (performance standards).
21 CFR 870.1330 Catheter guide wire.
(a) Identification. A catheter guide wire is a coiled wire that is
designed to fit inside a percutaneous catheter for the purpose of
directing the catheter through a blood vessel.
(b) Classification. Class II (performance standards).
21 CFR 870.1340 Catheter introducer.
(a) Identification. A catheter introducer is a sheath used to
facilitate placing a catheter through the skin into a vein or artery.
(b) Classification. Class II (performance standards).
21 CFR 870.1350 Catheter balloon repair kit.
(a) Identification. A catheter balloon repair kit is a device used
to repair or replace the balloon of a balloon catheter. The kit
contains the materials, such as glue and balloons, necessary to effect
the repair or replacement.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 870.3.
(45 FR 7907-7971, Feb. 5, 1980, as amended at 52 FR 17736, May 11,
1987)
21 CFR 870.1360 Trace microsphere.
(a) Identification. A trace microsphere is a radioactively tagged
nonbiodegradable particle that is intended to be injected into an artery
or vein and trapped in the capillary bed for the purpose of studying
blood flow within or to an organ.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 870.3.
(45 FR 7907-7971, Feb. 5, 1980, as amended at 52 FR 17736, May 11,
1987)
21 CFR 870.1370 Catheter tip occluder.
(a) Identification. A catheter tip occluder is a device that is
inserted into certain catheters to prevent flow through one or more
orifices.
(b) Classification. Class II (performance standards).
21 CFR 870.1380 Catheter stylet.
(a) Identification. A catheter stylet is a wire that is run through
a catheter or cannula to render it stiff.
(b) Classification. Class II (performance standards).
21 CFR 870.1390 Trocar.
(a) Identification. A trocar is a sharp-pointed instrument used with
a cannula for piercing a vessel or chamber to facilitate insertion of
the cannula.
(b) Classification. Class II (performance standards).
21 CFR 870.1425 Programmable diagnostic computer.
(a) Identification. A programmable diagnostic computer is a device
that can be programmed to compute various physiologic or blood flow
parameters based on the output from one or more electrodes, transducers,
or measuring devices; this device includes any associated commercially
supplied programs.
(b) Classification. Class II (performance standards).
21 CFR 870.1435 Single-function, preprogrammed diagnostic computer.
(a) Identification. A single-function, preprogrammed diagnostic
computer is a hard-wired computer that calculates a specific
physiological or blood-flow parameter based on information obtained from
one or more electrodes, transducers, or measuring devices.
(b) Classification. Class II (performance standards).
21 CFR 870.1450 Densitometer.
(a) Identification. A densitometer is a device used to measure the
transmission of light through an indicator in a sample of blood.
(b) Classification. Class II (performance standards).
21 CFR 870.1650 Angiographic injector and syringe.
(a) Identification. An angiographic injector and syringe is a device
that consists of a syringe and a high-pressure injector which are used
to inject contrast material into the heart, great vessels, and coronary
arteries to study the heart and vessels by x-ray photography.
(b) Classification. Class II (performance standards).
21 CFR 870.1660 Indicator injector.
(a) Identification. An indicator injector is an electrically or
gas-powered device designed to inject accurately an indicator solution
into the blood stream. This device may be used in conjuction with a
densitometer or thermodilution device to determine cardiac output.
(b) Classification. Class II (performance standards).
21 CFR 870.1670 Syringe actuator for an injector.
(a) Identification. A syringe actuator for an injector is an
electrical device that controls the timing of an injection by an
angiographic or indicator injector and synchronizes the injection with
the electrocardiograph signal.
(b) Classification. Class II (performance standards).
21 CFR 870.1750 External programmable pacemaker pulse generator.
(a) Identification. An external programmable pacemaker pulse
generators is a device that can be programmed to produce one or more
pulses at preselected intervals; this device is used in
electrophysiological studies.
(b) Classification. Class II (performance standards).
21 CFR 870.1800 Withdrawal-infusion pump.
(a) Identification. A withdrawal-infusion pump is a device designed
to inject accurately drugs into the bloodstream and to withdraw blood
samples for use in determining cardiac output.
(b) Classification. Class II (performance standards).
21 CFR 870.1875 Stethoscope.
(a) Manual stethoscope -- (1) Identification. A manual stethoscope
is a mechanical device used to project the sounds associated with the
heart, arteries, and veins and other internal organs.
(2) Classification. Class I (general controls).
(b) Electronic stethoscope -- (1) Identification. An electronic
stethoscope is an electrically amplified device used to project the
sounds associated with the heart, arteries, and veins and other internal
organs.
(2) Classification. Class II (performance standards).
21 CFR 870.1915 Thermodilution probe.
(a) Identification. A thermodilution probe is a device that monitors
cardiac output by use of thermodilution techniques; this device is
commonly attached to a catheter that may have one or more probes.
(b) Classification. Class II (performance standards).
21 CFR 870.1915 Subpart C -- Cardiovascular Monitoring Devices
21 CFR 870.2050 Biopotential amplifier and signal conditioner.
(a) Identification. A biopotential amplifier and signal conditioner
is a device used to amplify or condition an electrical signal of
biologic origin.
(b) Classification. Class II (performance standards).
21 CFR 870.2060 Transducer signal amplifier and conditioner.
(a) Identification. A transducer signal amplifier and conditioner is
a device used to provide the excitation energy for the transducer and to
amplify or condition the signal emitted by the transducer.
(b) Classification. Class II (performance standards).
21 CFR 870.2100 Cardiovascular blood flowmeter.
(a) Identification. A cardiovascular blood flowmeter is a device
that is connected to a flow transducer that energizes the transducer and
processes and displays the blood flow signal.
(b) Classification. Class II (performance standards).
21 CFR 870.2120 Extravascular blood flow probe.
(a) Identification. An extravascular blood flow probe is an
extravascular ultrasonic or electromagnetic probe used in conjunction
with a blood flowmeter to measure blood flow in a chamber or vessel.
(b) Classification. Class II (performance standards).
21 CFR 870.2300 Cardiac monitor (including cardiotachometer and rate
alarm).
(a) Identification. A cardiac monitor (including cardiotachometer
and rate alarm) is a device used to measure the heart rate from an
analog signal produced by an electrocardiograph, vectorcardiograph, or
blood pressure monitor. This device may sound an alarm when the heart
rate falls outside preset upper and lower limits.
(b) Classification. Class II (performance standards).
21 CFR 870.2310 Apex cardiograph (vibrocardiograph).
(a) Identification. An apex cardiograph (vibrocardiograph) is a
device used to amplify or condition the signal from an apex
cardiographic transducer and to produce a visual display of the motion
of the heart; this device also provides any excitation energy required
by the transducer.
(b) Classification. Class II (performance standards).
21 CFR 870.2320 Ballistocardiograph.
(a) Identification. A ballistocardiograph is a device, including a
supporting structure on which the patient is placed, that moves in
response to blood ejection from the heart. The device often provides a
visual display.
(b) Classification. Class II (performance standards).
21 CFR 870.2330 Echocardiograph.
(a) Identification. An echocardiograph is a device that uses
ultrasonic energy to create images of cardiovascular structures. It
includes phased arrays and two-dimensional scanners.
(b) Classification. Class II (performance standards).
21 CFR 870.2340 Electrocardiograph.
(a) Identification. An electrocardiograph is a device used to
process the electrical signal transmitted through two or more
electrocardiograph electrodes and to produce a visual display of the
electrical signal produced by the heart.
(b) Classification. Class II (performance standards).
21 CFR 870.2350 Electrocardiograph lead switching adaptor.
(a) Identification. An electrocardiograph lead switching adaptor is
a passive switching device to which electrocardiograph limb and chest
leads may be attached. This device is used to connect various
combinations of limb and chest leads to the output terminals in order to
create standard lead combinations such as leads I, II, and III.
(b) Classification. Class II (performance standards).
21 CFR 870.2360 Electrocardiograph electrode.
(a) Identification. An electrocardiograph electrode is the
electrical conductor which is applied to the surface of the body to
transmit the electrical signal at the body surface to a processor that
produces an electrocardiogram or vectorcardiogram.
(b) Classification. Class II (performance standards).
21 CFR 870.2370 Electrocardiograph surface electrode tester.
(a) Identification. An electrocardiograph surface electrode tester
is a device used to test the function and application of
electrocardiograph electrodes.
(b) Classification. Class II (performance standards).
21 CFR 870.2390 Phonocardiograph.
(a) Identification. A phonocardiograph is a device used to amplify
or condition the signal from a heart sound transducer. This device
furnishes the excitation energy for the transducer and provides a visual
or audible display of the heart sounds.
(b) Classification. Class II (performance standards).
21 CFR 870.2400 Vectorcardiograph.
(a) Identification. A vectorcardiograph is a device used to process
the electrical signal transmitted through electrocardiograph electrodes
and to produce a visual display of the magnitude and direction of the
electrical signal produced by the heart.
(b) Classification. Class II (performance standards).
21 CFR 870.2450 Medical cathode-ray tube display.
(a) Identification. A medical cathode-ray tube display is a device
designed primarily to display selected biological signals. This device
often incorporates special display features unique to a specific
biological signal.
(b) Classification. Class II (performance standards).
21 CFR 870.2600 Signal isolation system.
(a) Identification. A signal isolation system is a device that
electrically isolates the patient from equipment connected to the
commercial power supply received from a utility company. This isolation
may be accomplished, for example, by transformer coupling, acoustic
coupling, or optical coupling.
(b) Classification. Class II (performance standards).
21 CFR 870.2620 Line isolation monitor.
(a) Identification. A line isolation monitor is a device used to
monitor the electrical leakage current from a power supply electrically
isolated from the commercial power supply received from a utility
company.
(b) Classification. Class II (performance standards).
21 CFR 870.2640 Portable leakage current alarm.
(a) Identification. A portable leakage current alarm is a device
used to measure the electrical leakage current between any two points of
an electrical system and to sound an alarm if the current exceeds a
certain threshold.
(b) Classification. Class II (performance standards).
21 CFR 870.2675 Oscillometer.
(a) Identification. An oscillometer is a device used to measure
physiological oscillations of any kind, e.g., changes in the volume of
arteries.
(b) Classification. Class II (performance standards).
21 CFR 870.2700 Oximeter.
(a) Identification. An oximeter is a device used to transmit
radiation at a known wavelength(s) through blood and to measure the
blood oxygen saturation based on the amount of reflected or scattered
radiation. It may be used alone or in conjunction with a fiberoptic
oximeter catheter.
(b) Classification. Class II (performance standards).
21 CFR 870.2710 Ear oximeter.
(a) Identification. An ear oximeter is an extravascular device used
to transmit light at a known wavelength(s) through blood in the ear.
The amount of reflected or scattered light as indicated by this device
is used to measure the blood oxygen saturation.
(b) Classification. Class II (performance standards).
21 CFR 870.2750 Impedance phlebograph.
(a) Identification. An impedance phlebograph is a device used to
provide a visual display of the venous pulse or drainage by measuring
electrical impedance changes in a region of the body.
(b) Classification. Class II (performance standards).
21 CFR 870.2770 Impedance plethysmograph.
(a) Identification. An impedance plethysmograph is a device used to
estimate peripheral blood flow by measuring electrical impedance changes
in a region of the body such as the arms and legs.
(b) Classification. Class II (performance standards).
21 CFR 870.2780 Hydraulic, pneumatic, or photoelectric plethysmographs.
(a) Identification. A hydraulic, pneumatic, or photoelectric
plethysmograph is a device used to estimate blood flow in a region of
the body using hydraulic, pneumatic, or photoelectric measurement
techniques.
(b) Classification. Class II (performance standards).
21 CFR 870.2800 Medical magnetic tape recorder.
(a) Identification. A medical magnetic tape recorder is a device
used to record and play back signals from, for example, physiological
amplifiers, signal conditioners, or computers.
(b) Classification. Class II (performance standards).
21 CFR 870.2810 Paper chart recorder.
(a) Identification. A paper chart recorder is a device used to print
on paper, and create a permanent record of the signal from, for example,
a physiological amplifier, signal conditioner, or computer.
(b) Classification. Class II (performance standards).
21 CFR 870.2840 Apex cardiographic transducer.
(a) Identification. An apex cardiographic transducer is a device
used to detect motion of the heart (acceleration, velocity, or
displacement) by changes in the mechanical or electrical properties of
the device.
(b) Classification. Class II (performance standards).
21 CFR 870.2850 Extravascular blood pressure transducer.
(a) Identification. An extravascular blood pressure transducer is a
device used to measure blood pressure by changes in the mechanical or
electrical properties of the device. The proximal end of the transducer
is connected to a pressure monitor that produces an analog or digital
electrical signal related to the electrical or mechanical changes
produced in the transducer.
(b) Classification. Class II (performance standards).
21 CFR 870.2860 Heart sound transducer.
(a) Identification. A heart sound transducer is an external
transducer that exhibits a change in mechanical or electrical properties
in relation to sounds produced by the heart. This device may be used in
conjunction with a phonocardiograph to record heart sounds.
(b) Classification. Class II (performance standards).
21 CFR 870.2870 Catheter tip pressure transducer.
(a) Identification. A catheter tip pressure transducer is a device
incorporated into the distal end of a catheter. When placed in the
bloodstream, its mechanical or electrical properties change in relation
to changes in blood pressure. These changes are transmitted to
accessory equipment for processing.
(b) Classification. Class II (performance standards).
21 CFR 870.2880 Ultrasonic transducer.
(a) Identification. An ultrasonic transducer is a device applied to
the skin to transmit and receive ultrasonic energy that is used in
conjunction with an echocardiograph to provide imaging of cardiovascular
structures. This device includes phased arrays and two-dimensional
scanning transducers.
(b) Classification. Class II (performance standards).
21 CFR 870.2890 Vessel occlusion transducer.
(a) Identification. A vessel occlusion transducer is a device used
to provide an electrical signal corresponding to sounds produced in a
partially occluded vessel. This device includes motion, sound, and
ultrasonic transducers.
(b) Classification. Class II (performance standards).
21 CFR 870.2900 Patient transducer and electrode cable (including
connector).
(a) Identification. A patient transducer and electrode cable
(including connector) is an electrical conductor used to transmit
signals from, or power or excitation signals to, patient-connected
electrodes or transducers.
(b) Classification. Class II (performance standards).
21 CFR 870.2910 Radiofrequency physiological signal transmitter and
receiver.
(a) Identification. A radiofrequency physiological signal
transmitter and receiver is a device used to condition a physiological
signal so that it can be transmitted via radiofrequency from one
location to another, e.g., a central monitoring station. The received
signal is reconditioned by the device into its original format so that
it can be displayed.
(b) Classification. Class II (performance standards).
21 CFR 870.2920 Telephone electrocardiograph transmitter and receiver.
(a) Identification. A telephone electrocardiograph transmitter and
receiver is a device used to condition an electrocardiograph signal so
that it can be transmitted via a telephone line to another location.
This device also includes a receiver that reconditions the received
signal into its original format so that it can be displayed. The device
includes devices used to transmit and receive pacemaker signals.
(b) Classification. Class II (performance standards).
21 CFR 870.2920 Subpart D -- Cardiovascular Prosthetic Devices
21 CFR 870.3250 Vascular clip.
(a) Identification. A vascular clip is an implanted extravascular
device designed to occlude, by compression, blood flow in small blood
vessels other than intracranial vessels.
(b) Classification. Class II (performance standards).
21 CFR 870.3260 Vena cava clip.
(a) Identification. A vena cava clip is an implanted extravascular
device designed to occlude partially the vena cava for the purpose of
inhibiting the flow of thromboemboli through that vessel.
(b) Classification. Class II (performance standards).
21 CFR 870.3300 Arterial embolization device.
(a) Identification. An arterial embolization device is an
intravascular implanted device used to control internal hemorrhage or to
halt blood flow in arteries supplying blood to certain types of
abdominal tumors (e.g., nephroma, hepatoma) and arteriovenous
malformations. This device is not used in intracranial arteries.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 870.3.
(45 FR 7907-7971, Feb. 5, 1980, as amended at 52 FR 17736, May 11,
1987)
21 CFR 870.3375 Cardiovascular intravascular filter.
(a) Identification. A cardiovascular intravascular filter is an
implant that is placed in the inferior vena cava for the purpose of
preventing pulmonary thromboemboli (blood clots generated in the lower
limbs and broken loose into the blood stream) from flowing into the
right side of the heart and the pulmonary circulation.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 870.3.
(45 FR 7907-7971, Feb. 5, 1980, as amended at 52 FR 17736, May 11,
1987)
21 CFR 870.3450 Vascular graft prosthesis of less than 6 millimeters
diameter.
(a) Identification. A vascular graft prosthesis of less than 6
millimeters (mm) diameter is a device used to replace sections of small
arteries. This prosthesis is commonly constructed of woven or knitted
materials such as polyethylene terephthalate and polytetrafluoroethylene
and is not made of materials of animal origin, including human umbilical
cords.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 870.3.
(45 FR 7907-7971, Feb. 5, 1980, as amended at 52 FR 17736, May 11,
1987)
21 CFR 870.3460 Vascular graft prosthesis of 6 millimeters and greater
diameter.
(a) Identification. A vascular graft prosthesis of 6 millimeters
(mm) and greater diameter is a device used to replace sections of
arteries. This prosthesis is commonly constructed of woven or knitted
materials such as polyethylene terephthalate and polytetrafluoroethylene
and is not made of materials of animal origin, including human umbilical
cords.
(b) Classification. Class II (performance standards).
21 CFR 870.3470 Intracardiac patch or pledget made of polypropylene,
polyethylene terephthalate, or polytetrafluoroethylene.
(a) Identification. An intracardiac patch or pledget made of
polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is
a fabric device placed in the heart that is used to repair septal
defects, for patch grafting, to repair tissue, and to buttress sutures.
(b) Classification. Class II (performance standards).
21 CFR 870.3535 Intra-aortic balloon and control system
(a) Identification. A intra-aortic balloon and control system is a
device that consists of an inflatable balloon, which is placed in the
aorta to improve cardiovascular functioning during certain
life-threatening emergencies, and a control system for regulating the
inflation and deflation of the balloon. The control system, which
monitors and is synchronized with the electrocardiogram, provides a
means for setting the inflation and deflation of the balloon with the
cardiac cycle.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 870.3.
(45 FR 7907-7971, Feb. 5, 1980, as amended at 52 FR 17736, May 11,
1987)
21 CFR 870.3545 Ventricular bypass (assist) device.
(a) Identification. A ventricular bypass (assist) device is a device
that assists the left or right ventricle in maintaining circulatory
blood flow. The device is either totally or partially implanted in the
body.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 870.3.
(45 FR 7907-7971, Feb. 5, 1980, as amended at 52 FR 17736, May 11,
1987)
21 CFR 870.3600 External pacemaker pulse generator.
(a) Identification. An external pacemaker pulse generator is a
device that has a power supply and electronic circuits that produce a
periodic electrical pulse to stimulate the heart. This device, which is
used outside the body, is used as a temporary substitute for the heart's
intrinsic pacing sytem until a permanent pacemaker can be implanted, or
to control irregular heartbeats in patients following cardiac surgery or
a myocardial infarction. The device may have adjustments for impulse
strength, duration, R-wave sensitivity, and other pacing variables.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 870.3.
(45 FR 7907-7971, Feb. 5, 1980, as amended at 52 FR 17736, May 11,
1987)
21 CFR 870.3610 Implantable pacemaker pulse generator.
(a) Identification. An implantable pacemaker pulse generator is a
device that has a power supply and electronic circuits that produce a
periodic electrical pulse to stimulate the heart. This device is used
as a substitute for the heart's intrinsic pacing system to correct both
intermittent and continuous cardiac rhythm disorders. This device
includes triggered, inhibited, and asynchronous devices implanted in the
human body.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 870.3.
(45 FR 7907-7971, Feb. 5, 1980, as amended at 52 FR 17736, May 11,
1987)
21 CFR 870.3620 Pacemaker lead adaptor.
(a) Identification. A pacemaker lead adaptor is a device used to
adapt a pacemaker lead so that it can be connected to a pacemaker pulse
generator produced by a different manufacturer.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 870.3.
(45 FR 7907-7971, Feb. 5, 1980, as amended at 52 FR 17736, May 11,
1987)
21 CFR 870.3630 Pacemaker generator function analyzer.
(a) Identification. A pacemaker generator function analyzer is a
device that is connected to a pacemaker pulse generator to test any or
all of the generator's parameters, including pulse duration, pulse
amplitude, pulse rate, and sensing threshold.
(b) Classification. Class II (performance standards).
21 CFR 870.3640 Indirect pacemaker generator function analyzer.
(a) Identification. An indirect pacemaker generator function
analyzer is an electrically powered device that is used to determine
pacemaker function or pacemaker battery function by periodically
monitoring an implanted pacemaker's pulse rate and pulse width. The
device is noninvasive, and it detects pacemaker pulse rate and width via
external electrodes in contact with the patient's skin.
(b) Classification. Class II (performance standards).
21 CFR 870.3650 Pacemaker polymeric mesh bag.
(a) Identification. A pacemaker polymeric mesh bag is an implanted
device used to hold a pacemaker pulse generator. The bag is designed to
create a stable implant environment for the pulse generator.
(b) Classification. Class II (performance standards).
21 CFR 870.3670 Pacemaker charger.
(a) Identification. A pacemaker charger is a device used
transcutaneously to recharge the batteries of a rechargeable pacemaker.
(b) Classification. Class II (performance standards).
21 CFR 870.3680 Cardiovascular permanent or temporary pacemaker
electrode.
(a) Temporary pacemaker electrode -- (1) Identification. A temporary
pacemaker electrode is a device consisting of flexible insulated
electrical conductors with one end connected to an external pacemaker
pulse generator and the other end applied to the heart. The device is
used to transmit a pacing electrical stimulus from the pulse generator
to the heart and/or to transmit the electrical signal of the heart to
the pulse generator.
(2) Classification. Class II (performance standards).
(b) Permanent pacemaker electrode -- (1) Identification. A permanent
pacemaker electrode is a device consisting of flexible insulated
electrical conductors with one end connected to an implantable pacemaker
pulse generator and the other end applied to the heart. The device is
used to transmit a pacing electrical stimulus from the pulse generator
to the heart and/or to transmit the electrical signal of the heart to
the pulse generator.
(2) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval for the device described in paragraph (b)(1). See 870.3.
(45 FR 7907-7971, Feb. 5, 1980, as amended at 52 FR 17736, May 11,
1987)
21 CFR 870.3690 Pacemaker test magnet.
(a) Identification. A pacemaker test magnet is a device used to test
an inhibited or triggered type of pacemaker pulse generator and cause an
inhibited or triggered generator to revert to asynchronous operation.
(b) Classification. Class II (performance standards).
21 CFR 870.3700 Pacemaker programmers.
(a) Identification. A pacemaker programmer is a device used to
change noninvasively one or more of the electrical operating
characteristics of a pacemaker.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 870.3.
(45 FR 7907-7971, Feb. 5, 1980, as amended at 52 FR 17736, May 11,
1987)
21 CFR 870.3710 Pacemaker repair or replacement material.
(a) Identification. A pacemaker repair or replacement material is an
adhesive, a sealant, a screw, a crimp, or any other material used to
repair a pacemaker lead or to reconnect a pacemaker lead to a pacemaker
pulse generator.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 870.3.
(45 FR 7907-7971, Feb. 5, 1980, as amended at 52 FR 17736, May 11,
1987)
21 CFR 870.3720 Pacemaker electrode function tester.
(a) Identification. A pacemaker electrode function tester is a
device which is connected to an implanted pacemaker lead that supplies
an accurately calibrated, variable pacing pulse for measuring the
patient's pacing threshold and intracardiac R-wave potential.
(b) Classification. Class II (performance standards).
21 CFR 870.3730 Pacemaker service tools.
(a) Identification. Pacemaker service tools are devices such as
screwdrivers and Allen wrenches, used to repair a pacemaker lead or to
reconnect a pacemaker lead to a pacemaker generator
(b) Classification. Class I. These devices are exempt from the
premarket notification procedures of Subpart E of Part 807 of this
chapter.
(45 FR 7907-7971, Feb. 5, 1980, as amended at 54 FR 25049, June 12,
1989)
21 CFR 870.3800 Annuloplasty ring.
(a) Identification. An annuloplasty ring is a rigid or flexible ring
implanted around the mitral or tricuspid heart valve for reconstructive
treatment of valvular insufficiency.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 870.3.
(45 FR 7907-7971, Feb. 5, 1980, as amended at 52 FR 17736, May 11,
1987)
21 CFR 870.3850 Carotid sinus nerve stimulator.
(a) Identification. A carotid sinus nerve stimulator is an
implantable device used to decrease arterial pressure by stimulating
Hering's nerve at the carotid sinus.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 870.3.
(45 FR 7907-7971, Feb. 5, 1980, as amended at 52 FR 17736, May 11,
1987)
21 CFR 870.3925 Replacement heart valve.
(a) Identification. A replacement heart valve is a device intended
to perform the function of any of the heart's natural valves. This
device includes valves constructed of prosthetic materials, biologic
valves (e.g., porcine valves), or valves constructed of a combination of
prosthetic and biologic materials.
(b) Classification. Class III (premarket approval).
(c) Date premarket approval application (PMA) or notice of completion
of a product development protocol (PDP) is required. A PMA or a notice
of completion of a PDP is required to be filed with the Food and Drug
Administration on or before December 9, 1987 for any replacement heart
valve that was in commercial distribution before May 28, 1976, or that
has on or before December 9, 1987 been found to be substantially
equivalent to a replacement heart valve that was in commercial
distribution before May 28, 1976. Any other replacement heart valve
shall have an approved PMA or a declared completed PDP in effect before
being placed in commercial distribution.
(45 FR 7907-7971, Feb. 5, 1980, as amended at 52 FR 18163, May 13,
1987; 52 FR 23137, June 17, 1987)
21 CFR 870.3935 Prosthetic heart valve holder.
(a) Identification. A prosthetic heart valve holder is a device used
to hold a replacement heart valve while it is being sutured into place.
(b) Classification. Class II (performance standards).
21 CFR 870.3945 Prosthetic heart valve sizer.
(a) Identification. A prosthetic heart valve sizer is a device used
to measure the size of the natural valve opening to determine the size
of the appropriate replacement heart valve.
(b) Classification. Class II (performance standards).
21 CFR 870.3945 Subpart E -- Cardiovascular Surgical Devices
21 CFR 870.4075 Endomyocardial biopsy device.
(a) Identification. An endomyocardial biopsy device is a device used
in a catheterization procedure to remove samples of tissue from the
inner wall of the heart.
(b) Classification. Class II (performance standards).
21 CFR 870.4200 Cardiopulmonary bypass accessory equipment.
(a) Identification. Cardiopulmonary bypass accessory equipment are
devices that have no contact with blood and that are used in the
cardiopulmonary bypass circuit to support, adjoin, or connect
components, or to aid in the setup of the extracorporeal line, e.g., an
oxygenator mounting bracket or system-priming equipment.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(45 FR 7907-7971, Feb. 5, 1980, as amended at 54 FR 25049, June 12,
1989)
21 CFR 870.4205 Cardiopulmonary bypass bubble detector.
(a) Identification. A cardiopulmonary bypass bubble detector is a
device used to detect bubbles in the arterial return line of the
cardiopulmonary bypass circuit.
(b) Classification. Class II (performance standards).
21 CFR 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or
tubing.
(a) Identification. A cardiopulmonary bypass vascular catheter,
cannula, or tubing is a device used in cardiopulmonary surgery to
cannulate the vessels, perfuse the coronary arteries, and to
interconnect the catheters and cannulas with an oxygenator. The device
includes accessory bypass equipment.
(b) Classification. Class II (performance standards).
21 CFR 870.4220 Cardiopulmonary bypass heart-lung machine console.
(a) Identification. A cardiopulmonary bypass heart-lung machine
console is a device that consists of a control panel and the electrical
power and control circuitry for a heart-lung machine. The console is
designed to interface with the basic units used in a gas exchange
system, including the pumps, oxygenator, and heat exchanger.
(b) Classification. Class II (performance standards).
21 CFR 870.4230 Cardiopulmonary bypass defoamer.
(a) Identification. A cardiopulmonary bypass defoamer is a device
used in conjunction with an oxygenator during cardiopulmonary bypass
surgery to remove gas bubbles from the blood.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 870.3.
(45 FR 7907-7971, Feb. 5, 1980, as amended at 52 FR 17737, May 11,
1987)
21 CFR 870.4240 Cardiovascular bypass heat exchanger.
(a) Identification. A cardiopulmonary bypass heat exchanger is a
device, consisting of a heat exchange system used in extracorporeal
circulation to warm or cool the blood or perfusion fluid flowing through
the device.
(b) Classification. Class II (performance standards).
21 CFR 870.4250 Cardiopulmonary bypass temperature controller.
(a) Identification. A cardiopulmonary bypass temperature controller
is a device used to control the temperature of the fluid entering and
leaving a heat exchanger.
(b) Classification. Class II (performance standards).
21 CFR 870.4260 Cardiopulmonary bypass arterial line blood filter.
(a) Identification. A cardiopulmonary bypass arterial line blood
filter is a device used as part of a gas exchange (oxygenator) system to
filter nonbiologic particles and emboli (blood clots or pieces of
foreign material flowing in the bloodstream which will obstruct
circulation by blocking a vessel) out of the blood. It is used in the
arterial return line.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 870.3.
(45 FR 7907-7971, Feb. 5, 1980, as amended at 52 FR 17737, May 11,
1987)
21 CFR 870.4270 Cardiopulmonary bypass cardiotomy suction line blood
filter.
(a) Identification. A cardiopulmonary bypass cardiotomy suction line
blood filter is a device used as part of a gas exchange (oxygenator)
system to filter nonbiologic particles and emboli (a blood clot or a
piece of foreign material flowing in the bloodstream which will obstruct
circulation by blocking a vessel) out of the blood. This device is
intended for use in the cardiotomy suction line.
(b) Classification. Class II (performance standards).
21 CFR 870.4280 Cardiopulmonary prebypass filter.
(a) Identification. A cardiopulmonary prebypass filter is a device
used during priming of the oxygenator circuit to remove particulates or
other debris from the circuit prior to initiating bypass. The device is
not used to filter blood.
(b) Classification. Class II (performance standards).
21 CFR 870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or
fitting.
(a) Identification. A cardiopulmonary bypass adaptor, stopcock,
manifold, or fitting is a device used in cardiovascular diagnostic,
surgical, and therapeutic applications to interconnect tubing,
catheters, or other devices.
(b) Classification. Class II (performance standards).
21 CFR 870.4300 Cardiopulmonary bypass gas control unit.
(a) Identification. A cardiopulmonary bypass gas control unit is a
device used to control and measure the flow of gas into the oxygenator.
The device is calibrated for a specific gas.
(b) Classification. Class II (performance standards).
21 CFR 870.4310 Cardiopulmonary bypass coronary pressure gauge.
(a) Identification. A cardiopulmonary bypass coronary pressure gauge
is a device used in cardiopulmonary bypass surgery to measure the
pressure of the blood perfusing the coronary arteries.
(b) Classification. Class II (performance standards).
21 CFR 870.4320 Cardiopulmonary bypass pulsatile flow generator.
(a) Identification. A cardiopulmonary bypass pulsatile flow
generator is an electrically and pneumatically operated device used to
create pulsatile blood flow. The device is placed in a cardiopulmonary
bypass circuit downstream from the oxygenator.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 870.3.
(45 FR 7907-7971, Feb. 5, 1980, as amended at 52 FR 17737, May 11,
1987)
21 CFR 870.4330 Cardiopulmonary bypass on-line blood gas monitor.
(a) Identification. A cardiopulmonary bypass on-line blood gas
monitor is a device used in conjunction with a blood gas sensor to
measure the level of gases in the blood.
(b) Classification. Class II (performance standards).
21 CFR 870.4340 Cardiopulmonary bypass level sensing monitor and/or
control.
(a) Identification. A cardiopulmonary bypass level sensing monitor
and/or control is a device used to monitor and/or control the level of
blood in the blood reservoir and to sound an alarm when the level falls
below a predetermined value.
(b) Classification. Class II (performance standards).
21 CFR 870.4350 Cardiopulmonary bypass oxygenator.
(a) Identification. A cardiopulmonary bypass oxygenator is a device
used to exchange gases between blood and a gaseous environment to
satisfy the gas exchange needs of a patient during open-heart surgery.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 870.3.
(45 FR 7907-7971, Feb. 5, 1980, as amended at 52 FR 17737, May 11,
1987)
21 CFR 870.4360 Nonroller-type cardiopulmonary bypass blood pump.
(a) Identification. A nonroller-type cardiopulmonary bypass blood
pump is a device that uses a method other than revolving rollers to pump
the blood through the cardiopulmonary bypass circuit during bypass
surgery.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 870.3.
(45 FR 7907-7971, Feb. 5, 1980, as amended at 52 FR 17737, May 11,
1987)
21 CFR 870.4370 Roller-type cardiopulmonary bypass blood pump.
(a) Identification. A roller-type cardiopulmonary bypass blood pump
is a device that uses a revolving roller mechanism to pump the blood
through the cardiopulmonary bypass circuit during bypass surgery.
(b) Classification. Class II (performance standards).
21 CFR 870.4380 Cardiopulmonary bypass pump speed control.
(a) Identification. A cardiopulmonary bypass pump speed control is a
device used that incorporates an electrical system or a mechanical
system, or both, and is used to control the speed of blood pumps used in
cardiopulmonary bypass surgery.
(b) Classification. Class II (performance standards).
21 CFR 870.4390 Cardiopulmonary bypass pump tubing.
(a) Identification. A cardiopulmonary bypass pump tubing is
polymeric tubing which is used in the blood pump head and which is
cyclically compressed by the pump to cause the blood to flow through the
cardiopulmonary bypass circuit.
(b) Classification. Class II (performance standards).
21 CFR 870.4400 Cardiopulmonary bypass blood reservoir.
(a) Identification. A cardiopulmonary bypass blood reservoir is a
device used in conjunction with short-term extracorporeal circulation
devices to hold a reserve supply of blood in the bypass circulation.
(b) Classification. Class II (performance standards), except that a
reservoir that contains a defoamer or filter is classified into the same
class as the defoamer or filter.
21 CFR 870.4410 Cardiopulmonary bypass in-line blood gas sensor.
(a) Identification. A cardiopulmonary bypass in-line blood gas
sensor is a transducer that measures the level of gases in the blood.
(b) Classification. Class II (performance standards).
21 CFR 870.4420 Cardiopulmonary bypass cardiotomy return sucker.
(a) Identification. A cardiopulmonary bypass cardiotomy return
sucker is a device that consists of tubing, a connector, and a probe or
tip that is used to remove blood from the chest or heart during
cardiopulmonary bypass surgery.
(b) Classification. Class II (performance standards).
21 CFR 870.4430 Cardiopulmonary bypass intracardiac suction control.
(a) Identification. A cardiopulmonary bypass intracardiac suction
control is a device which provides the vacuum and control for a
cardiotomy return sucker.
(b) Classification. Class II (performance standards).
21 CFR 870.4450 Vascular clamp.
(a) Identification. A vascular clamp is a surgical instrument used
to occlude a blood vessel temporarily.
(b) Classification. Class II (performance standards).
21 CFR 870.4475 Surgical vessel dilator.
(a) Identification. A surgical vessel dilator is a device used to
enlarge or calibrate a vessel.
(b) Classification. Class II (performance standards).
21 CFR 870.4500 Cardiovascular surgical instruments.
(a) Identification. Cardiovascular surgical instruments are surgical
instruments that have special features for use in cardiovascular
surgery. These devices include, e.g., forceps, retractors, and
scissors.
(b) Classification. Class I. The devices are exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(45 FR 7907-7971, Feb. 5, 1980, as amended at 54 FR 25049, June 12,
1989)
21 CFR 870.4875 Intraluminal artery stripper.
(a) Identification. An intraluminal artery stripper is a device used
to perform an endarterectomy (removal of plaque deposits from
arterisclerotic arteries.)
(b) Classification. Class II (performance standards).
21 CFR 870.4885 External vein stripper.
(a) Identification. An external vein stripper is an extravascular
device used to remove a section of a vein.
(b) Classification. Class II (performance standards).
21 CFR 870.4885 Subpart F -- Cardiovascular Therapeutic Devices
21 CFR 870.5050 Patient care suction apparatus.
(a) Identification. A patient care suction apparatus is a device
used with an intrathoracic catheter to withdraw fluid from the chest
during the recovery period following surgery.
(b) Classification. Class II (performance standards).
21 CFR 870.5150 Embolectomy catheter.
(a) Identification. An embolectomy catheter is a balloon-tipped
catheter that is used to remove thromboemboli, i.e., blood clots which
have migrated in blood vessels from one site in the vascular tree to
another.
(b) Classification. Class II (performance standards).
21 CFR 870.5175 Septostomy catheter.
(a) Identification. A septostomy catheter is a special balloon
catheter that is used to create or enlarge the atrial septal defect
found in the heart of certain infants.
(b) Classification. Class II (performance standards).
21 CFR 870.5200 External cardiac compressor.
(a) Identification. An external cardiac compressor is an external
device that is electrically, pneumatically, or manually powered and is
used to compress the chest periodically in the region of the heart to
provide blood flow during cardiac arrest.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 870.3.
(45 FR 7907-7971, Feb. 5, 1980, as amended at 52 FR 17737, May 11,
1987)
21 CFR 870.5225 External counter-pulsating device.
(a) Identification. An external counter-pulsating device is a
noninvasive device used to assist the heart by applying positive or
negative pressure to one or more of the body's limbs in synchrony with
the heart cycle.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 870.3.
(45 FR 7907-7971, Feb. 5, 1980, as amended at 52 FR 17737, May 11,
1987)
21 CFR 870.5300 DC-defribrillator (including paddles).
(a) Low-energy DC-defibrillator -- (1) Identification. A low-energy
DC-defibrillator is a device that delivers into a 50 ohm test load an
electrical shock of a maximum of 360 joules of energy used for
defibrillating (restoring normal heart rhythm) the atria or ventricles
of the heart or to terminate other cardiac arrhythmias. This generic
type of device includes low energy defibrillators with a maximum
electrical output of less than 360 joules of energy that are used in
pediatric defibrillation or in cardiac surgery. The device may either
synchronize the shock with the proper phase of the electrocardiogram or
may operate asynchronously. The device delivers the electrical shock
through paddles placed either directly across the heart or on the
surface of the body.
(2) Classification. Class II (performance standards).
(b) High-energy DC-defibrillator -- (1) Identification. A
high-energy DC-defibrillator is a device that delivers into a 50 ohm
test load an electrical shock of greater than 360 joules of energy used
for defibrillating the atria or ventricles of the heart or to terminate
other cardiac arrhythmias. The device may either synchronize the shock
with the proper phase of the electrocardiogram or may operate
asynchronously. The device delivers the electrical shock through
paddles placed either directly across the heart or on the surface of the
body.
(2) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval for the device described in paragraph (b)(1). See 870.3.
(45 FR 7907-7971, Feb. 5, 1980, as amended at 52 FR 17737, May 11,
1987)
21 CFR 870.5325 Defibrillator tester.
(a) Identification. A defibrillator tester is a device that is
connected to the output of a defibrillator and is used to measure the
energy delivered by the defibrillator into a standard resistive load.
Some testers also provide waveform information.
(b) Classification. Class II (performance standards).
21 CFR 870.5550 External transcutaneous cardiac pacemaker
(noninvasive).
(a) Identification. An external transcutaneous cardiac pacemaker
(noninvasive) is a device used to supply a periodic electrical pulse
intended to pace the heart. The pulse from the device is usually
applied to the surface of the chest through electrodes such as
defibrillator paddles.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval for the device described in paragraph (b)(1). See 870.3.
(45 FR 7907-7971, Feb. 5, 1980, as amended at 52 FR 17737, May 11,
1987)
21 CFR 870.5800 Compressible limb sleeve.
(a) Identification. A compressible limb sleeve is a device that is
used to prevent pooling of blood in a limb by inflating periodically a
sleeve around the limb.
(b) Classification. Class II (performance standards).
21 CFR 870.5900 Thermal regulation system.
(a) Identification. A thermal regulating system is an external
system consisting of a device that is placed in contact with the patient
and a temperature controller for the device. The system is used to
regulate patient temperature.
(b) Classification. Class II (performance standards).
21 CFR 870.5925 Automatic rotating tourniquet.
(a) Identification. An automatic rotating tourniquet is a device
that prevents blood flow in one limb at a time, which temporarily
reduces the total blood volume, thereby reducing the normal workload of
the heart.
(b) Classification. Class II (performance standards).
21 CFR 870.5925 Pt. 872
21 CFR 870.5925 PART 872 -- DENTAL DEVICES
21 CFR 870.5925 Subpart A -- General Provisions
Sec.
872.1 Scope.
872.3 Effective dates of requirement for premarket approval.
872.9 Limitations of exemptions from section 510(k) of the Federal
Food, Drug, and Cosmetic Act (the act).
21 CFR 870.5925 Subpart B -- Diagnostic Devices
872.1500 Gingival fluid measurer.
872.1720 Pulp tester.
872.1730 Electrode gel for pulp tester.
872.1740 Caries detection device.
872.1800 Extraoral source X-ray system.
872.1810 Intraoral source X-ray system.
872.1820 Dental X-ray exposure alignment device.
872.1830 Cephalometer.
872.1840 Dental X-ray position indicating device.
872.1850 Lead-lined position indicator.
872.1905 Dental X-ray film holder.
21 CFR 870.5925 Subpart C -- (Reserved)
21 CFR 870.5925 Subpart D -- Prosthetic Devices
872.3050 Amalgam alloy.
872.3060 Gold based alloys and precious metal alloys for clinical
use.
872.3080 Mercury and alloy dispenser.
872.3100 Dental amalgamator.
872.3110 Dental amalgam capsule.
872.3130 Preformed anchor.
872.3140 Resin applicator.
872.3150 Articulator.
872.3165 Precision attachment.
872.3200 Resin tooth bonding agent.
872.3220 Facebow.
872.3240 Dental bur.
872.3250 Calcium hydroxide cavity liner.
872.3260 Cavity varnish.
872.3275 Dental cement.
872.3285 Preformed clasp.
872.3300 Hydrophilic resin coating for dentures.
872.3310 Coating material for resin fillings.
872.3330 Preformed crown.
872.3350 Gold or stainless steel cusp.
872.3360 Preformed cusp.
872.3400 Karaya and sodium borate with or without acacia denture
adhesive.
872.3410 Ethylene oxide homopolymer and/or carboxymethyl-cellulose
sodium denture adhesive.
872.3420 Carboxymethylcellulose sodium and cationic polyacrylamide
polymer denture adhesive.
872.3450 Ethylene oxide homopolymer and/or karaya denture adhesive.
872.3480 Polyacrylamide polymer (modified cationic) denture adhesive.
872.3490 Carboxymethylcellulose sodium and/or polyvinylmethylether
maleic acid calcium-sodium double salt denture adhesive.
872.3500 Polyvinylmethylether maleic anhydride (PVM-MA), acid
copolymer, and carboxymethylcellulose sodium (NACMC) denture adhesive.
872.3520 OTC denture cleanser.
872.3530 Mechanical denture cleaner.
872.3540 OTC denture cushion or pad.
872.3560 OTC denture reliner.
872.3570 OTC denture repair kit.
872.3580 Preformed gold denture tooth.
872.3590 Preformed plastic denture tooth.
872.3600 Partially fabricated denture kit.
872.3640 Endosseous implant.
872.3645 Subperiosteal implant material.
872.3660 Impression material.
872.3670 Resin impression tray material.
872.3680 Polytetrafluoroethylene (PTFE) vitreous carbon material.
872.3690 Tooth shade resin material.
872.3700 Dental mercury.
872.3710 Base metal alloy.
872.3730 Pantograph.
872.3740 Retentive and splinting pin.
872.3750 Bracket adhesive resin and tooth conditioner.
872.3760 Denture relining, repairing, or rebasing resin.
872.3765 Pit and fissure sealant and conditioner.
872.3770 Temporary crown and bridge resin.
872.3810 Root canal post.
872.3820 Root canal filling resin.
872.3830 Endodontic paper point.
872.3840 Endodontic silver point.
872.3850 Gutta percha.
872.3890 Endodontic stabilizing splint.
872.3900 Posterior artificial tooth with a metal insert.
872.3910 Backing and facing for an artificial tooth.
872.3920 Porcelain tooth.
872.3930 Tricalcium phosphate granules for dental bone repair.
21 CFR 870.5925 Subpart E -- Surgical Devices
872.4120 Bone cutting instrument and accessories.
872.4130 Intraoral dental drill.
872.4200 Dental handpiece and accessories.
872.4465 Gas-powered jet injector.
872.4475 Spring-powered jet injector.
872.4535 Dental diamond instrument.
872.4565 Dental hand instrument.
872.4600 Intraoral ligature and wire lock.
872.4620 Fiber optic dental light.
872.4630 Dental operating light.
872.4730 Dental injecting needle.
872.4760 Bone plate.
872.4840 Rotary scaler.
872.4850 Ultrasonic scaler.
872.4880 Intraosseous fixation screw or wire.
872.4920 Dental electrosurgical unit and accessories.
21 CFR 870.5925 Subpart F -- Therapeutic Devices
872.5410 Orthodontic appliance and accessories.
872.5470 Orthodontic plastic bracket.
872.5500 Extraoral orthodontic headgear.
872.5525 Preformed tooth positioner.
872.5550 Teething ring.
21 CFR 870.5925 Subpart G -- Miscellaneous Devices
872.6010 Abrasive device and accessories.
872.6030 Oral cavity abrasive polishing agent.
872.6050 Saliva absorber.
872.6070 Ultraviolet activator for polymerization.
872.6080 Airbrush.
872.6100 Anesthetic warmer.
872.6140 Articulation paper.
872.6200 Base plate shellac.
872.6250 Dental chair and accessories.
872.6290 Prophylaxis cup.
872.6300 Rubber dam and accessories.
872.6350 Ultraviolet detector.
872.6390 Dental floss.
872.6475 Heat source for bleaching teeth.
872.6510 Oral irrigation unit.
872.6570 Impression tube.
872.6640 Dental operative unit and accessories.
872.6650 Massaging pick or tip for oral hygiene.
872.6660 Procelain powder for clinical use.
872.6670 Silicate protector.
872.6710 Boiling water sterilizer.
872.6730 Endodontic dry heat sterilizer.
872.6770 Cartridge syringe.
872.6855 Manual toothbrush.
872.6865 Powered toothbrush.
872.6870 Disposable fluoride tray.
872.6880 Preformed impression tray.
872.6890 Intraoral dental wax.
Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j, 371).
Source: 52 FR 30097, Aug. 12, 1987, unless otherwise noted.
21 CFR 870.5925 Subpart A -- General Provisions
21 CFR 872.1 Scope.
(a) This part sets forth the classification of dental devices
intended for human use that are in commercial distribution.
(b) The identification of a device in a regulation in this part is
not a precise description of every device that is, or will be, subject
to the regulation. A manufacturer who submits a premarket notification
submission for a device under Part 807 cannot show merely that the
device is accurately described by the section title and identification
provisions of a regulation in this part, but shall state why the device
is substantially equivalent to other devices, as required by 807.87.
(c) To avoid duplicative listings, a dental device that has two or
more types of uses (e.g., used both as a diagnostic device and as a
therapeutic device) is listed in one subpart only.
(d) References in this part to regulatory sections of the Code of
Federal Regulations are to Chapter I of Title 21 unless otherwise noted.
21 CFR 872.3 Effective dates of requirement for premarket approval.
A device included in this part that is classified into class III
(premarket approval) shall not be commercially distributed after the
date shown in the regulation classifying the device unless the
manufacturer has an approval under section 515 of the act (unless an
exemption has been granted under section 520(g)(2) of the act). An
approval under section 515 of the act consists of FDA's issuance of an
order approving an application for premarket approval (PMA) for the
device or declaring completed a product development protocol (PDP) for
the device.
(a) Before FDA requires that a device commercially distributed before
the enactment date of the amendments, or a device that has been found
substantially equivalent to such a device, has an approval under section
515 of the act, FDA must promulgate a regulation under section 515(b) of
the act requiring such approval, except as provided in paragraphs (b)
and (c) of this section. Such a regulation under section 515(b) of the
act shall not be effective during the grace period ending on the 90th
day after its promulgation or on the last day of the 30th full calendar
month after the regulation that classifies the device into class III is
effective, whichever is later. See section 501(f)(2)(B) of the act.
Accordingly, unless an effective date of the requirement for premarket
approval is shown in the regulation for a device classified into class
III in this part, the device may be commercially distributed without
FDA's issuance of an order approving a PMA or declaring completed a PDP
for the device. If FDA promulgates a regulation under section 515(b) of
the act requiring premarket approval for a device, section 501(f)(1)(A)
of the act applies to the device.
(b) Any new, not substantially equivalent, device introduced into
commercial distribution on or after May 28, 1976, including a device
formerly marketed that has been substantially altered, is classified by
statute (section 513(f) of the act) into class III without any grace
period and FDA must have issued an order approving a PMA or declaring
completed a PDP for the device before the device is commercially
distributed unless it is reclassified. If FDA knows that a device being
commercially distributed may be a ''new'' device as defined in this
section because of any new intended use or other reasons, FDA may codify
the statutory classification of the device into class III for such new
use. Accordingly, the regulation for such a class III device states
that as of the enactment date of the amendments, May 28, 1976, the
device must have an approval under section 515 of the act before
commercial distribution.
(c) A device identified in a regulation in this part that is
classified into class III and that is subject to the transitional
provisions of section 520(1) of the act is automatically classified by
statute into class III and must have an approval under section 515 of
the act before being commercially distributed. Accordingly, the
regulation for such a class III transitional device states that as of
the enactment date of the amendments, May 28, 1976, the device must have
an approval under section 515 of the act before commercial distribution.
21 CFR 872.9 Limitations of exemptions from section 510(k) of the
Federal Food, Drug, and Cosmetic Act (the act).
The Food and Drug Administration's (FDA's) decision to grant an
exemption from the requirement of premarket notification (section 510(k)
of the act) for a generic type of class I device is based upon the
existing and reasonably foreseeable characteristics of commercially
distributed devices within that generic type. Because FDA cannot
anticipate every change in intended use or characteristic that could
significantly affect a device's safety or effectiveness, manufacturers
of any commercially distributed class I device for which FDA has granted
an exemption from the requirement of premarket notification must still
submit a premarket notification to FDA before introducing or delivering
for introduction into interstate commerce for commercial distribution
the device when:
(a) The device is intended for a use different from its intended use
before May 28, 1976, or the device is intended for a use different from
the intended use of a preamendments device to which it had been
determined to be substantially equivalent; e.g., the device is intended
for a different medical purpose, or the device is intended for lay use
where the former intended use was by health care professionals only; or
(b) The modified device operates using a different fundamental
scientific technology than that in use in the device before May 28,
1976; e.g., a surgical instrument cuts tissue with a laser beam rather
than with a sharpened metal blade, or an in vitro diagnostic device
detects or identifies infectious agents by using a deoxyribonucleic acid
(DNA) probe or nucleic acid hybridization technology rather than culture
or immunoassay technology.
(54 FR 13829, Apr. 5, 1989)
21 CFR 872.9 Subpart B -- Diagnostic Devices
21 CFR 872.1500 Gingival fluid measurer.
(a) Identification. A gingival fluid measurer is a gauge device
intended to measure the amount of fluid in the gingival sulcus
(depression between the tooth and gums) to determine if there is a
gingivitis condition.
(b) Classification. Class I.
21 CFR 872.1720 Pulp tester.
(a) Identification. A pulp tester is an AC or battery powered device
intended to evaluate the pulpal vitality of teeth by employing high
frequency current transmitted by an electrode to stimulate the nerve
tissue in the dental pulp.
(b) Classification. Class II.
21 CFR 872.1730 Electrode gel for pulp testers.
(a) Identification. An electrode gel for pulp testers is a device
intended to be applied to the surface of a tooth before use of a pulp
tester to aid conduction of electrical current
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989)
21 CFR 872.1740 Caries detection device.
(a) Identification. The caries detection device is a device intended
to show the existence of decay in a patient's tooth by use of electrical
current.
(b) Classification. Class II.
21 CFR 872.1800 Extraoral source X-ray system.
(a) Identification. An extraoral source X-ray system is an
AC-powered device that produces X-rays and is intended for dental
radiographic examination and diagnosis of diseases of the teeth, jaw,
and oral structures. The X-ray source (a tube) is located outside the
mouth. This generic type of device may include patient and equipment
supports and component parts.
(b) Classification. Class II.
21 CFR 872.1810 Intraoral source X-ray system.
(a) Identification. An intraoral source X-ray system is an
electrically powered device that produces X-rays and is intended for
dental radiographic examination and diagnosis of diseases of the teeth,
jaw, and oral structures. The X-ray source (a tube) is located inside
the mouth. This generic type of device may include patient and
equipment supports and component parts.
(b) Classification. Class II.
21 CFR 872.1820 Dental X-ray exposure alignment device.
(a) Identification. A dental X-ray exposure alignment device is a
device intended to position X-ray film and to align the examination site
with the X-ray beam.
(b) Classification. Class I.
21 CFR 872.1830 Cephalometer.
(a) Identification. A cephalometer is a device used in dentistry
during X-ray procedures. The device is intended to place and to hold a
patient's head in a standard position during dental X-rays.
(b) Classification. Class II.
21 CFR 872.1840 Dental X-ray position indicating device.
(a) Identification. A dental X-ray position indicating device is a
device, such as a collimator, cone, or aperture, that is used in dental
radiographic examination. The device is intended to align the
examination site with the X-ray beam and to restrict the dimensions of
the dental X-ray field by limiting the size of the primary X-ray beam.
(b) Classification. Class II.
21 CFR 872.1850 Lead-lined position indicator.
(a) Identification. A lead-lined position indicator is a cone-shaped
device lined with lead that is attached to a dental X-ray tube and
intended to aid in positioning the tube, to prevent the misfocusing of
the X-rays by absorbing divergent radiation, and to prevent leakage of
radiation.
(b) Classification. Class II.
21 CFR 872.1905 Dental X-ray film holder.
(a) Identification. A dental X-ray film holder is a device intended
to position and to hold X-ray film inside the mouth.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter. If the device is not labeled or otherwise represented as
sterile, it is also exempt from the current good manufacturing practice
regulations in Part 820 of this chapter, with the exceptions of
820.180, with respect to general requirements concerning records, and
820.198, with respect to complaint files.
(52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989)
21 CFR 872.1905 Subpart C -- (Reserved)
21 CFR 872.1905 Subpart D -- Prosthetic Devices
21 CFR 872.3050 Amalgam alloy.
(a) Identification. An amalgam alloy is a device that consists of a
metallic substance intended to be mixed with mercury to form filling
material for treatment of dental caries.
(b) Classification. Class II.
21 CFR 872.3060 Gold-based alloys and precious metal alloys for
clinical use.
(a) Identification. Gold-based alloys and precious metal alloys for
clinical use are mixtures of metals, the major components of which are
gold, silver, or palladium. They also may contain a small quantity of
copper or platinum. The device is intended to fabricate dental
appliances, such as crowns and bridges, for patients.
(b) Classification. Class II
21 CFR 872.3080 Mercury and alloy dispenser.
(a) Identification. A mercury and alloy dispenser is a device with a
spring-activated valve intended to measure and dispense into a mixing
capsule a predetermined amount of dental mercury in droplet form and a
premeasured amount of alloy pellets.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989)
21 CFR 872.3100 Dental amalgamator.
(a) Identification. A dental amalgamator is a device, usually
AC-powered, intended to mix, by shaking, amalgam capsules containing
mercury and dental alloy particles, such as silver, tin, zinc, and
copper. The mixed dental amalgam material is intended for filling
dental caries.
(b) Classification. Class I.
(55 FR 48439, Nov. 20, 1990)
21 CFR 872.3110 Dental amalgam capsule.
(a) Identification. A dental amalgam capsule is a container device
in which silver alloy is intended to be mixed with mercury to form
dental amalgam.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989)
21 CFR 872.3130 Preformed anchor.
(a) Identification. A preformed anchor is a device made of
austenitic alloys or alloys containing 75 percent or greater gold or
metals of the platinum group intended to be incorporated into a dental
appliance, such as a denture, to help stabilize the appliance in the
patient's mouth.
(b) Classification. Class I.
21 CFR 872.3140 Resin applicator.
(a) Identification. A resin applicator is a brushlike device
intended for use in spreading dental resin on a tooth during application
of tooth shade material.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter. If the device is not labeled or otherwise represented as
sterile, it is also exempt from the current good manufacturing practice
regulations in Part 820 of this chapter, with the exceptions of
820.180, with respect to general requirements concerning records, and
820.198, with respect to complaint files.
(52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989)
21 CFR 872.3150 Articulator.
(a) Identification. An articulator is a mechanical device intended
to simulate movements of a patient's upper and lower jaws. Plaster
casts of the patient's teeth and gums are placed in the device to
reproduce the occlusion (bite) and articulation of the patient's jaws.
An articulator is intended to fit dentures or provide orthodontic
treatment.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter. If the device is not labeled or otherwise represented as
sterile, it is also exempt from the current good manufacturing practice
regulations in Part 820 of this chapter, with the exceptions of
820.180, with respect to general requirements concerning records, and
820.198, with respect to complaint files.
(52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989)
21 CFR 872.3165 Precision attachment.
(a) Identification. A precision attachment or preformed bar is a
device made of austenitic alloys or alloys containing 75 percent or
greater gold and metals of the platinum group intended for use in
prosthetic dentistry in conjunction with removable partial dentures.
Various forms of the device are intended to connect a lower partial
denture with another lower partial denture, to connect an upper partial
denture with another upper partial denture, to connect either an upper
or lower partial denture to a tooth or a crown, or to connect a fixed
bridge to a partial denture.
(b) Classification. Class I.
21 CFR 872.3200 Resin tooth bonding agent.
(a) Identification. A resin tooth bonding agent is a device
material, such as methylmethacrylate, intended to be painted on the
interior of a prepared cavity of a tooth to improve retention of a
restoration, such as a filling.
(b) Classification. Class II.
21 CFR 872.3220 Facebow.
(a) Identification. A facebow is a device intended for use in
denture fabrication to determine the spatial relationship between the
upper and lower jaws. This determination is intended for use in placing
denture casts accurately into an articulator ( 872.3150) and thereby
aiding correct placement of artificial teeth into a denture base.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter. If the device is not labeled or otherwise represented as
sterile, it is also exempt from the current good manufacturing practice
regulations in Part 820 of this chapter, with the exceptions of
820.180, with respect to general requirements concerning records, and
820.198, with respect to complaint files.
(52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989)
21 CFR 872.3240 Dental bur.
(a) Identification. A dental bur is a rotary cutting device made
from carbon steel or tungsten carbide intended to cut hard structures in
the mouth, such as teeth or bone. It is also intended to cut hard
metals, plastics, porcelains, and similar materials intended for use in
the fabrication of dental devices.
(b) Classification. Class I.
21 CFR 872.3250 Calcium hydroxide cavity liner.
(a) Identification. A calcium hydroxide cavity liner is a device
material intended to be applied to the interior of a prepared cavity
before insertion of restorative material, such as amalgam, to protect
the pulp of a tooth.
(b) Classification. Class II.
21 CFR 872.3260 Cavity varnish.
(a) Identification. Cavity varnish is a device that consists of a
compound intended to coat a prepared cavity of a tooth before insertion
of restorative materials. The device is intended to prevent penetration
of restorative materials, such as amalgam, into the dentinal tissue.
(b) Classification. Class II.
21 CFR 872.3275 Dental cement.
(a) Zinc oxide-eugenol -- (1) Identification. Zinc oxide-eugenol is
a device composed of zinc oxide-eugenol intended to serve as a temporary
tooth filling or as a base cement to affix a temporary tooth filling, to
affix dental devices such as crowns or bridges, or to be applied to a
tooth to protect the tooth pulp.
(2) Classification. Class I.
(b) Dental cement other than zinc oxide-eugenol -- (1)
Identification. Dental cement other than zinc oxide-eugenol is a device
composed of various materials other than zinc oxide-eugenol intended to
serve as a temporary tooth filling or as a base cement to affix a
temporary tooth filling, to affix dental devices such as crowns or
bridges, or to be applied to a tooth to protect the tooth pulp.
(2) Classification. Class II.
21 CFR 872.3285 Preformed clasp.
(a) Identification. A preformed clasp or a preformed wire clasp is a
prefabricated device made of austenitic alloys or alloys containing 75
percent or greater gold and metals of the platinum group intended to be
incorporated into a dental appliance, such as a partial denture, to help
stabilize the appliance in the patient's mouth by fastening the
appliance to an adjacent tooth.
(b) Classification. Class I.
21 CFR 872.3300 Hydrophilic resin coating for dentures.
(a) Identification. A hydrophilic resin coating for dentures is a
device that consists of a water-retaining polymer that is intended to be
applied to the base of a denture before the denture is inserted into the
patient's mouth to improve denture retention and comfort.
(b) Classification. Class II.
21 CFR 872.3310 Coating material for resin fillings.
(a) Identification. A coating material for resin fillings is a
device intended to be applied to the surface of a restorative resin
dental filling to attain a smooth, glaze-like finish on the surface of
the filling.
(b) Classification. Class II.
21 CFR 872.3330 Preformed crown.
(a) Identification. A preformed crown is a prefabricated device made
of plastic or austenitic alloys or alloys containing 75 percent or
greater gold and metals of the platinum group intended to be affixed
temporarily to a tooth after removal of, or breakage of, the natural
crown (that portion of the tooth that normally protrudes above the
gums). It is intended for use as a functional restoration until a
permanent crown is constructed. The device also may be intended for use
as a functional restoration for a badly decayed deciduous (baby) tooth
until the adult tooth erupts.
(b) Classification. Class I.
21 CFR 872.3350 Gold or stainless steel cusp.
(a) Identification. A gold or stainless steel cusp is a
prefabricated device made of austenitic alloys or alloys containing 75
percent or greater gold and metals of the platinum group or stainless
steel intended to provide a permanent cusp (a projection on the chewing
surface of a tooth) to achieve occlusal harmony (a proper bite) between
the teeth and a removable denture.
(b) Classification. Class I.
21 CFR 872.3360 Preformed cusp.
(a) Identification. A performed cusp is a prefabricated device made
of plastic or austenitic alloys or alloys containing 75 percent or
greater gold and metals of the platinum group intended to be used as a
temporary cusp (a projection on the chewing surface of a tooth) to
achieve occlusal harmony (a proper bite) before permanent restoration of
a tooth.
(b) Classification. Class I.
21 CFR 872.3400 Karaya and sodium borate with or without acacia denture
adhesive.
(a) Identification. A karaya and sodium borate with or without
acacia denture adhesive is a device composed of karaya and sodium borate
with or without acacia intended to be applied to the base of a denture
before the denture is inserted into patient's mouth to improve denture
retention and comfort.
(b) Classification. (1) Class I if the device contains less than 12
percent by weight of sodium borate.
(2) Class III if the device contains 12 percent or more by weight of
sodium borate.
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval of the device described in paragraph (b)(2). See 872.3.
21 CFR 872.3410 Ethylene oxide homopolymer and/or
carboxymethylcellulose sodium denture adhesive.
(a) Identification. An ethylene oxide homopolymer and/or
carboxymethylcellulose sodium denture adhesive is a device containing
ethylene oxide homopolymer and/or carboxymethylcellulose sodium intended
to be applied to the base of a denture before the denture is inserted in
a patient's mouth to improve denture retention and comfort.
(b) Classification. Class I.
21 CFR 872.3420 Carboxymethylcellulose sodium and cationic
polyacrylamide polymer denture adhesive.
(a) Identification. A carboxymethylcellulose sodium and cationic
polyacrylamide polymer denture adhesive is a device composed of
carboxymethylcellulose sodium and cationic polyacrylamide polymer
intended to be applied to the base of a denture before the denture is
inserted in a patient's mouth to improve denture retention and comfort.
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 872.3.
21 CFR 872.3450 Ehtylene oxide homopolymer and/or karaya denture
adhesive.
(a) Identification. Ethylene oxide homopolymer and/or karaya denture
adhesive is a device composed of ethylene oxide homopolymer and/or
karaya intended to be applied to the base of a denture before the
denture is inserted in a patient's mouth to improve denture retention
and comfort.
(b) Classification. Class I.
21 CFR 872.3480 Polyacrylamide polymer (modified cationic) denture
adhesive.
(a) Identification. A polyacrylamide polymer (modified cationic)
denture adhesive is a device composed of polyacrylamide polymer
(modified cationic) intended to be applied to the base of a denture
before the denture is inserted in a patient's mouth to improve denture
retention and comfort.
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 872.3.
21 CFR 872.3490 Carboxymethylcellulose sodium and/or
polyvinylmethylether maleic acid calcium-sodium double salt denture
adhesive.
(a) Identification. A carboxymethylcellulose sodium and/or
polyvinylmethylether maleic acid calcium-sodium double salt denture
adhesive is a device composed of carboxymethylcellulose sodium and/or
polyvinylmethylether maleic acid calcium-sodium double salt intended to
be applied to the base of a denture before the denture is inserted in a
patient's mouth to improve denture retention and comfort.
(b) Classification. Class I.
21 CFR 872.3500 Polyvinylmethylether maleic anhydride (PVM-MA), acid
copolymer, and carboxymethylcellulose sodium (NACMC) denture adhesive.
(a) Identification. Polyvinylmethylether maleic anhydride (PVM-MA),
acid copolymer, and carboxymethylcellulose sodium (NACMC) denture
adhesive is a device composed of polyvinylmethylether maleic anhydride,
acid copolymer, and carboxymethylcellulose sodium intended to be applied
to the base of a denture before the denture is inserted in a patient's
mouth to improve denture retention and comfort.
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 872.3.
21 CFR 872.3520 OTC denture cleanser.
(a) Identification. An OTC denture cleanser is a device that
consists of material in the form of a powder, tablet, or paste that is
intended to remove debris from removable prosthetic dental appliances,
such as bridges or dentures. The dental appliance is removed from the
patient's mouth when the appliance is cleaned.
(b) Classification. Class I.
21 CFR 872.3530 Mechanical denture cleaner.
(a) Identification. A mechanical denture cleaner is a device,
usually AC-powered, that consists of a container for mechanically
agitating a denture cleansing solution. The device is intended to clean
a denture by submersion in the agitating cleansing solution in the
container.
(b) Classification. Class I.
(55 FR 48439, Nov. 20, 1990)
21 CFR 872.3540 OTC denture cushion or pad.
(a) Identification. An OTC denture cushion or pad is a prefabricated
or noncustom made disposable device that is intended to improve the fit
of a loose or uncomfortable denture, and may be available for purchase
over-the-counter.
(b) Classification. (1) Class I if the OTC denture cushion or pad is
made of wax-impregnated cotton cloth that the patient applies to the
base or inner surface of a denture before inserting the denture into the
mouth. The device is intended to be discarded following 1 day's use.
(2) Class III if the OTC denture cushion or pad is made of a material
other than wax-impregnated cotton cloth or if the intended use of the
device differs from that described in paragraph (b) of this section.
(c) Data PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval of the device described in paragraph (b)(2). See 872.3.
21 CFR 872.3560 OTC denture reliner.
(a) Identification. An OTC denture reliner is a device consisting of
a material such as plastic resin that is intended to be applied as a
permanent coating or lining on the base or tissue-contacting surface of
a denture. The device is intended to replace a worn denture lining and
may be available for purchase over the counter.
(b) Classification. Class III.
(c) Data PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 872.3.
21 CFR 872.3570 OTC denture repair kit.
(a) Identification. An OTC denture repair kit is a device consisting
of a material, such as a resin monomer system of powder and liquid
glues, that is intended to be applied permanently to a denture to mend
cracks or breaks. The device may be available for purchase over-the
counter.
(b) Classification. Class III.
(c) Data PMA or notice of completion of PDP is required. No
effective date has been established of the requirement for premarket
approval. See 872.3.
21 CFR 872.3580 Preformed gold denture tooth.
(a) Identification. A preformed gold denture tooth is a device
composed of austenitic alloys or alloys containing 75 percent or greater
gold and metals of the platinum group intended for use as a tooth or a
portion of a tooth in a fixed or removable partial denture.
(b) Classification. Class I.
21 CFR 872.3590 Preformed plastic dentue tooth.
(a) Identification. A preformed plastic denture tooth is a
prefabricated device, composed of materials such as methyl methacrylate,
that is intended for use as a tooth in a denture.
(b) Classification. Class II.
21 CFR 872.3600 Partially fabricated denture kit.
(a) Identification. A partially fabricated denture kit is a device
composed of connected preformed teeth that is intended for use in
construction of a denture. A denture base is constructed using the
patient's mouth as a mold, by partially polymerizing the resin denture
base materials while the materials are in contact with the oral tissues.
After the denture base is constructed, the connected preformed teeth
are chemically bonded to the base.
(b) Classification. Class III.
(c) Data PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 872.3.
21 CFR 872.3640 Endosseous implant.
(a) Identification. An endosseous implant is a device made of a
material such as titanium intended to be surgically placed in the bone
of the upper or lower jaw arches to provide support for prosthetic
devices, such as artificial teeth, and to restore the patient's chewing
function.
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 872.3.
21 CFR 872.3645 Subperiosteal implant material.
(a) Identification. Subperiosteal implant material is a device
composed of titanium or cobalt chrome molybdenum intended to construct
custom prosthetic devices which are surgically implanted into the lower
or upper jaw between the periosteum (connective tissue covering the
bone) and supporting bony structures. The device is intended to provide
support for prostheses, such as dentures.
(b) Classification. Class II.
21 CFR 872.3660 Impression material.
(a) Identification. Impression material is a device composed of
materials such as alginate or polysulfide intended to be placed on a
preformed impression tray and used to reproduce the structure of a
patient's teeth and gums. The device is intended to provide models for
study and for production of restorative prosthetic devices, such as gold
inlays and dentures.
(b) Classification. Class II.
21 CFR 872.3670 Resin impression tray material.
(a) Identification. Resin impression tray material is a device
intended for use in a two-step dental mold fabricating process. The
device consists of a resin material, such as methyl methacrylate, and is
used to form a custom impression tray for use in cases in which a
preformed impression tray is not suitable, such as the fabrication of
crowns, bridges, or full dentures. A preliminary plaster or stone model
of the patient's teeth and gums is made. The resin impression tray
material is applied to this preliminary study model to form a custom
tray. This tray is then filled with impression material and inserted
into the patient's mouth to make an impression, from which a final, more
precise, model of the patient's mouth is cast.
(b) Classification. Class I. If the device is not labeled or
otherwise represented as sterile, it is exempt from the current good
manufacturing practice regulations in Part 820, with the exception of
820.180, with respect to general requirements concerning records, and
820.198, with respect to complaint files.
21 CFR 872.3680 Polytetrafluoroethylene (PTFE) vitreous carbon
materials.
(a) Identification. Polytetrafluoroethylene (PTFE) vitreous carbon
material is a device composed of polytetrafluoroethylene (PTFE) vitreous
carbon intended for use in maxillofacial alveolar ridge augmentation
(building up the upper or lower jaw area that contains the sockets in
which teeth are rooted) or intended to coat metal surgical implants to
be placed in the alveoli (sockets in which the teeth are rooted) or the
temporomandibular joints (the joint between the upper and lower jaws).
(b) Classification. Class II.
(52 FR 30097, Aug. 12, 1987; 52 FR 34456, Sept. 11, 1987)
21 CFR 872.3690 Tooth shade resin material.
(a) Identification. Tooth shade resin material is a device composed
of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA)
intended to restore carious lesions or structural defects in teeth.
(b) Classification. Class II.
21 CFR 872.3700 Dental mercury.
(a) Identification. Dental mercury is a device composed of mercury
intended for use as a component of amalgam alloy in the restoration of a
dental cavity or a broken tooth.
(b) Classification. Class I.
21 CFR 872.3710 Base metal alloy.
(a) Identification. A base metal alloy is a device composed of a
material, such as a mixture of nickel and chromium, intended for use in
fabrication of a custom-made dental device, such as porcelain veneer for
a tooth.
(b) Classification. Class II.
21 CFR 872.3730 Pantograph.
(a) Identification. A pantograph is a device intended to be attached
to a patient's head to duplicate lower jaw movements to aid in
construction of restorative and prosthetic dental devices. A marking
pen is attached to the lower jaw component of the device and, as the
patient's mouth opens, the pen records on graph paper the angle between
the upper and the lower jaw.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807. If the
device is not labeled or otherwise represented as sterile, it is exempt
from the current good manufacturing practice regulations in Part 820,
with the exception of 820.180, with respect to general requirements
concerning records, and 820.198, with respect to complaint files.
21 CFR 872.3740 Retentive and splinting pin.
(a) Identification. A retentive and splinting pin is a device made
of austenitic alloys or alloys containing 75 percent or greater gold and
metals of the platinum group intended to be placed permanently in a
tooth to provide retention and stabilization for a restoration, such as
a crown, or to join two or more teeth together.
(b) Classification. Class I.
21 CFR 872.3750 Bracket adhesive resin and tooth conditioner.
(a) Identification. A bracket adhesive resin and tooth conditioner
is a device composed of an adhesive compound, such as
polymethylmethacrylate, intended to cement an orthodontic bracket to a
tooth surface.
(b) Classification. Class II.
21 CFR 872.3760 Denture relining, repairing, or rebasing resin.
(a) Identification. A denture relining, repairing, or rebasing resin
is a device composed of materials such as methylmethacrylate, intended
to reline a denture surface that contacts tissue, to repair a fractured
denture, or to form a new denture base. This device is not available
for over-the-counter (OTC) use.
(b) Classification. Class II.
21 CFR 872.3765 Pit and fissure sealant and conditioner.
(a) Identification. A pit and fissure sealant and conditioner is a
device composed of resin, such as polymethylmethacrylate, intended for
use primarily in young children to seal pit and fissure depressions
(faults in the enamel) in the biting surfaces of teeth to prevent
cavities.
(b) Classification. Class II.
21 CFR 872.3770 Temporary crown and bridge resin.
(a) Identification. A temporary crown and bridge resin is a device
composed of a material, such as polymethylmethacrylate, intended to make
a temporary prosthesis, such as a crown or bridge, for use until a
permanent restoration is fabricated.
(b) Classification. Class II.
21 CFR 872.3810 Root canal post.
(a) Identification. A root canal post is a device made of austenitic
alloys or alloys containing 75 percent or greater gold and metals of the
platinum group intended to be cemented into the root canal of a tooth to
stabilize and support a restoration.
(b) Classification. Class I.
21 CFR 872.3820 Root canal filling resin.
(a) Identification. A root canal filling resin is a device composed
of material, such as methylmethacrylate, intended for use during
endodontic therapy to fill the root canal of a tooth.
(b) Classification. (1) Class II if chloroform is not used as an
ingredient in the device.
(2) Class III if chloroform is used as an ingredient in the device.
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval of the device described in paragraph (b)(2). See 872.3.
21 CFR 872.3830 Endodontic paper point.
(a) Identification. An endodontic paper point is a device made of
paper intended for use during endodontic therapy to dry, or apply
medication to, the root canal of a tooth.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989)
21 CFR 872.3840 Endodontic silver point.
(a) Identification. An endodontic silver point is a device made of
silver intended for use during endodontic therapy to fill permanently
the root canal of a tooth.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989)
21 CFR 872.3850 Gutta percha.
(a) Identification. Gutta percha is a device made from coagulated
sap of certain tropical trees intended to fill the root canal of a
tooth. The gutta percha is softened by heat and inserted into the root
canal, where it hardens as it cools.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989)
21 CFR 872.3890 Endodontic stabilizing splint.
(a) Identification. An endodontic stabilizing splint is a device
made of a material, such as titanium, intended to be inserted through
the root canal into the upper or lower jaw bone to stabilize a tooth.
(b) Classification. Class II.
21 CFR 872.3900 Posterior artificial tooth with a metal insert.
(a) Identification. A posterior artificial tooth with a metal insert
is a porcelain device with an insert made of austenitic alloys or alloys
containing 75 percent or greater gold and metals of the platinum group
intended to replace a natural tooth. The device is attached to
surrounding teeth by a bridge and is intended to provide both an
improvement in appearance and functional occlusion (bite).
(b) Classification. Class I.
21 CFR 872.3910 Backing and facing for an artificial tooth.
(a) Identification. A backing and facing for an artificial tooth is
a device intended for use in fabrication of a fixed or removable dental
appliance, such as a crown or bridge. The backing, which is made of
gold, is attached to the dental appliance and supports the tooth-colored
facing, which is made of porcelain or plastic.
(b) Classification. Class I.
21 CFR 872.3920 Porcelain tooth.
(a) Identification. A porcelain tooth is a prefabricated device made
of porcelain powder for clinical use ( 872.6660) intended for use in
construction of fixed or removable prostheses, such as crowns and
partial dentures.
(b) Classification. Class II.
21 CFR 872.3930 Tricalcium phosphate granules for dental bone repair.
(a) Identification. Tricalcium phosphate granules for dental bone
repair is a device intended to be implanted into the upper or lower jaw
to provide support for prosthetic devices.
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. As of May
28, 1976, an approval under section 515 of the act is required before
this device may be commercially distributed. See 872.3.
21 CFR 872.3930 Subpart E -- Surgical Devices
21 CFR 872.4120 Bone cutting instrument and accessories.
(a) Identification. A bone cutting instrument and accessories is a
metal device intended for use in reconstructive oral surgery to drill or
cut into the upper or lower jaw and may be used to prepare bone to
insert a wire, pin, or screw. The device includes the manual bone drill
and wire driver, powered bone drill, rotary bone cutting handpiece, and
AC-powered bone saw.
(b) Classification. Class II.
21 CFR 872.4130 Intraoral dental drill.
(a) Identification. An intraoral dental drill is a rotary device
intended to be attached to a dental handpiece to drill holes in teeth to
secure cast or preformed pins to retain operative dental appliances.
(b) Classification. Class I.
21 CFR 872.4200 Dental handpiece and accessories.
(a) Identification. A dental handpiece and accessories is an
AC-powered, water-powered, air-powered, or belt-driven, hand-held device
that may include a foot controller for regulation of speed and direction
of rotation or a contra-angle attachment for difficult to reach areas
intended to prepare dental cavities for restorations, such as fillings,
and for cleaning teeth.
(b) Classification. Class I.
(55 FR 48439, Nov. 20, 1990)
21 CFR 872.4465 Gas-powered jet injector.
(a) Identification. A gas-powered jet injector is a syringe device
intended to administer a local anesthetic. The syringe is powered by a
cartridge containing pressurized carbon dioxide which provides the
pressure to force the anesthetic out of the syringe.
(b) Classification. Class II.
21 CFR 872.4475 Spring-powered jet injector.
(a) Identification. A spring-powered jet injector is a syringe
device intended to administer a local anesthetic. The syringe is
powered by a spring mechanism which provides the pressure to force the
anesthetic out of the syringe.
(b) Classification. Class II.
21 CFR 872.4535 Dental diamond instrument.
(a) Identification. A dental diamond instrument is an abrasive
device intended to smooth tooth surfaces during the fitting of crowns or
bridges. The device consists of a shaft which is inserted into a
handpiece and a head which has diamond chips imbedded into it. Rotation
of the diamond instrument provides an abrasive action when it contacts a
tooth.
(b) Classification. Class I.
21 CFR 872.4565 Dental hand instrument.
(a) Identification. A dental hand instrument is a hand-held device
intended to perform various tasks in general dentistry and oral surgery
procedures. The device includes the operative burnisher, operative
amalgam carrier, operative dental amalgam carver, surgical bone chisel,
operative amalgam and foil condenser, endodontic curette, operative
curette, periodontic curette, surgical curette, dental surgical
elevator, operative dental excavator, operative explorer surgical bone
file, operative margin finishing file, periodontic file, periodontic
probe, surgical rongeur forceps, surgical tooth extractor forceps,
surgical hemostat, periodontic hoe, operative matrix contouring
instrument, operative cutting instrument, operative margin finishing
periodontic knife, periodontic marker, operative pliers, endodontic root
canal plugger, endodontic root canal preparer, surgical biopsy punch,
endodontic pulp canal reamer, crown remover, periodontic scaler, collar
and crown scissors, endodontic pulp canal filling material spreader,
surgical osteotome chisel, endodontic broach, dental wax carver,
endodontic pulp canal file, hand instrument for calculus removal, dental
depth gauge instrument, plastic dental filling instrument, dental
instrument handle, surgical tissue scissors, mouth mirror, orthodontic
band driver, orthodontic band pusher, orthodontic band setter,
orthodontic bracket aligner, orthodontic pliers, orthodontic ligature
tucking instrument, forceps, for articulation paper, forceps for dental
dressing, dental matrix band, matrix retainer, dental retractor, dental
retractor accessories, periodontic or endodontic irrigating syringe, and
restorative or impression material syringe.
(b) Classification. Class I. If the device is made of the same
materials that were used in the device before May 28, 1976, it is exempt
from the premarket notification procedures in Subpart E of Part 807 of
this chapter.
(52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989)
21 CFR 872.4600 Intraoral ligature and wire lock.
(a) Identification. An intraoral ligature and wire lock is a metal
device intended to constrict fractured bone segments in the oral cavity.
The bone segments are stabilized by wrapping the ligature (wire) around
the fractured bone segments and locking the ends together.
(b) Classification. Class II.
21 CFR 872.4620 Fiber optic dental light.
(a) Identification. A fiber optic dental light is a device that is a
light, usually AC-powered, that consists of glass or plastic fibers
which have special optical properties. The device is usually attached
to a dental handpiece and is intended to illuminate a patient's oral
structures.
(b) Classification. Class I.
(55 FR 48439, Nov. 20, 1990)
21 CFR 872.4630 Dental operating light.
(a) Identification. A dental operating light, including the surgical
headlight, is an AC-powered device intended to illuminate oral
structures and operating areas.
(b) Classification. Class II.
21 CFR 872.4730 Dental injecting needle.
(a) Identification. A dental injecting needle is a slender, hollow
metal device with a sharp point intended to be attached to a syringe to
inject local anesthetics and other drugs.
(b) Classification. Class I.
21 CFR 872.4760 Bone plate.
(a) Identification. A bone plate is a metal device intended to
stabilize fractured bone structures in the oral cavity. The bone
segments are attached to the plate with screws to prevent movement of
the segments.
(b) Classification. Class II.
21 CFR 872.4840 Rotary scaler.
(a) Identification. A rotary scaler is an abrasive device intended
to be attached to a powered handpiece to remove calculus deposits from
teeth during dental cleaning and periodontal (gum) therapy.
(b) Classification. Class II.
21 CFR 872.4850 Ultrasonic scaler.
(a) Identification. An ultrasonic scaler is a device intended for
use during dental cleaning and periodontal (gum) therapy to remove
calculus deposits from teeth by application of an ultrasonic vibrating
scaler tip to the teeth.
(b) Classification. Class II.
21 CFR 872.4880 Intraosseous fixation screw or wire.
(a) Identification. An intraosseous fixation screw or wire is a
metal device intended to be inserted into fractured jaw bone segments to
prevent their movement.
(b) Classification. Class II.
21 CFR 872.4920 Dental electrosurgical unit and accessories.
(a) Identification. A dental electrosurgical unit and accessories is
an AC-powered device consisting of a controlled power source and a set
of cutting and coagulating electrodes. This device is intended to cut
or remove soft tissue or to control bleeding during surgical procedures
in the oral cavity. An electrical current passes through the tip of the
electrode into the tissue and, depending upon the operating mode
selected, cuts through soft tissue or coagulates the tissue.
(b) Classification. Class II.
21 CFR 872.5410 Orthodontic appliance and accessories.
(a) Identification. An orthodontic appliance and accessories is a
device intended for use in orthodontic treatment. The device is affixed
to a tooth so that pressure can be exerted on the teeth. This device
includes the preformed orthodontic band, orthodontic band material,
orthodontic elastic band, orthodontic metal bracket, orthodontic wire
clamp, preformed orthodontic space maintainer, orthodontic expansion
screw retainer, orthodontic spring, orthodontic tube, and orthodontic
wire.
(b) Classification. Class I.
21 CFR 872.5470 Orthodontic plastic bracket.
(a) Identification. An orthodontic plastic bracket is a plastic
device intended to be bonded to a tooth to apply pressure to a tooth
from a flexible orthodontic wire to alter its position.
(b) Classification. Class II.
21 CFR 872.5500 Extraoral orthodontic headgear.
(a) Identification. An extraoral orthodontic headgear is a device
intended for use with an orthodontic appliance to exert pressure on the
teeth from outside the mouth. The headgear has a strap intended to wrap
around the patient's neck or head and an inner bow portion intended to
be fastened to the orthodontic appliance in the patient's mouth.
(b) Classification. Class II.
21 CFR 872.5525 Preformed tooth positioner.
(a) Identification. A preformed tooth positioner is a plastic device
that is an impression of a perfected bite intended to prevent a
patient's teeth from shifting position or to move teeth to a final
position after orthodontic appliances (braces) have been removed. The
patient bites down on the device for several hours a day to force the
teeth into a final position or to maintain the teeth in their corrected
position.
(b) Classification. Class I.
21 CFR 872.5550 Teething ring.
(a) Identification. A teething ring is a divice intended for use by
infants for medical purposes to soothe gums during the teething process.
(b) Classification. (1) Class I if the teething ring does not
contain a fluid, such as water.
(2) Class II if the teething ring contains a fluid, such as water.
21 CFR 872.5550 Subpart G -- Miscellaneous Devices
21 CFR 872.6010 Abrasive device and accessories.
(a) Identification. An abrasive device and accessories is a device
constructed of various abrasives, such as diamond chips, that are glued
to shellac-based paper. The device is intended to remove excessive
restorative materials, such as gold, and to smooth rough surfaces from
oral restorations, such as crowns. The device is attached to a shank
that is held by a handpiece. The device includes the abrasive disk,
guard for an abrasive disk, abrasive point, polishing agent strip, and
polishing wheel.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter. If the device is not labeled or otherwise represented as
sterile, it is also exempt from the current good manufacturing practice
regulations in Part 820 of this chapter, with the exceptions of
820.180, with respect to general requirements concerning records, and
820.198, with respect to complaint files.
(52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989)
21 CFR 872.6030 Oral cavity abrasive polishing agent.
(a) Identification. An oral cavity abrasive polishing agent is a
device in paste or powder form that contains an abrasive material, such
as silica pumice, intended to remove debris from the teeth. The
abrasive polish is applied to the teeth by a handpiece attachment
(prophylaxis cup).
(b) Classification. Class I.
21 CFR 872.6050 Saliva absorber.
(a) Identification. A saliva absorber is a device made of paper or
cotton intended to absorb moisture from the oral cavity during dental
procedures.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter. If the device is not labeled or otherwise represented as
sterile, it is also exempt from the current good manufacturing practice
regulations in Part 820 of this chapter, with the exceptions of
820.180, with respect to general requirements concerning records, and
820.198, with respect to complaint files.
(52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989)
21 CFR 872.6070 Ultraviolet activator for polymerization.
(a) Identification. An ultraviolet activator for polymerization is a
device that produces ultraviolet radiation intended to polymerize (set)
resinous dental pit and fissure sealants or restorative materials by
transmission of light through a rod.
(b) Classification. Class II.
21 CFR 872.6080 Airbrush.
(a) Identification. An airbrush is an AC-powered device intended for
use in conjunction with articulation paper. The device uses air-driven
particles to roughen the surfaces of dental restorations. Uneven areas
of the restorations are then identified by use of articulation paper.
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 872.3.
(52 FR 30097, Aug. 12, 1987; 52 FR 49250, Dec. 30, 1987)
21 CFR 872.6100 Anesthetic warmer.
(a) Identification. An anesthetic warmer is an AC-powered device
into which tubes containing anesthetic solution are intended to be
placed to warm them prior to administration of the anesthetic.
(b) Classification. Class I.
21 CFR 872.6140 Articulation paper.
(a) Identification. Articulation paper is a device composed of paper
coated with an ink dye intended to be placed between the patient's upper
and lower teeth when the teeth are in the bite position to locate uneven
or high areas.
(b) Classification. Class I. If the device is not labeled or
otherwise represented as sterile, it is exempt from the current good
manufacturing practice regulations in Part 820, with the exception of
820.180, with respect to general requirements concerning records, and
820.198, with respect to complaint files.
21 CFR 872.6200 Base plate shellac.
(a) Identification. Base plant shellac is a device composed of
shellac intended to rebuild the occlusal rim of full or partial
dentures.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter. If the device is not labeled or otherwise represented as
sterile, it is also exempt from the current good manufacturing practice
regulations in Part 820 of this chapter, with the exceptions of
820.180, with respect to general requirements concerning records, and
820.198, with respect to complaint files.
(52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989)
21 CFR 872.6250 Dental chair and accessories.
(a) Identification. A dental chair and accessories is a device,
usually AC-powered, in which a patient sits. The device is intended to
properly position a patient to perform dental procedures. A dental
operative unit may be attached.
(b) Classification. Class I.
(55 FR 48439, Nov. 20, 1990)
21 CFR 872.6290 Prophylaxis cup.
(a) Identification. A prophylaxis cup is a device made of rubber
intended to be held by a dental handpiece and used to apply polishing
agents during prophylaxis (cleaning). The dental handpiece spins the
rubber cup holding the polishing agent and the user applies it to the
teeth to remove debris.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter. If the device is not labeled or otherwise respresented as
sterile, it is also exempt from the current good manufacturing practice
regulations in Part 820 of this chapter, with the exceptions of
820.180, with respect to general requirements concerning records, and
820.198, with respect to complaint files.
(52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13831, Apr. 5, 1989)
21 CFR 872.6300 Rubber dam and accessories.
(a) Identification. A rubber dam and accessories is a device
composed of a thin sheet of latex with a hole in the center intended to
isolate a tooth from fluids in the mouth duing dental procedures, such
as filling a cavity preparation. The device is stretched around a tooth
by inserting the tooth through the hole in the center. The device
includes the rubber dam, rubber dam clamp, rubber dam frame, and forceps
for a rubber dam clamp.
(b) Classification. Class I. If the device is not labeled or
otherwise represented as sterile, it is exempt from the current good
manufacturing practice regulations in Part 820, with the exception of
820.180, with respect to general requirements concerning records, and
820.198, with respect to complaint files.
21 CFR 872.6350 Ultraviolet detector.
(a) Identification. An ultraviolet detector is a device intended to
provide a source of ultraviolet light which is used to identify
otherwise invisible material, such as dental plaque, present in or on
teeth.
(b) Classification. Class II.
21 CFR 872.6390 Dental floss.
(a) Identification. Dental floss is a string-like device made of
cotton or other fibers intended to remove plaque and food particles from
between the teeth to reduce tooth decay. The fibers of the device may
be coated with wax for easier use.
(b) Classification. Class I. If the device is made of the same
materials that were used in the device before May 28, 1976, it is exempt
from the premarket notification procedures in Subpart E of Part 807 of
this chapter.
(52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13831, Apr. 5, 1989)
21 CFR 872.6475 Heat source for bleaching teeth.
(a) Identification. A heat source for bleaching teeth is an
AC-powered device that consists of a light or an electric heater
intended to apply heat to a tooth after it is treated with a bleaching
agent.
(b) Classification. Class I.
(55 FR 48439, Nov. 20, 1990)
21 CFR 872.6510 Oral irrigation unit.
(a) Identification. An oral irrigation unit is an AC-powered device
intended to provide a pressurized stream of water to remove food
particles from between the teeth and promote good periodontal (gum)
condition.
(b) Classification. Class I.
(55 FR 48439, Nov. 20, 1990)
21 CFR 872.6570 Impression tube.
(a) Identification. An impression tube is a device consisting of a
hollow copper tube intended to take an impression of a single tooth.
The hollow tube is filled with impression material. One end of the tube
is sealed with a softened material, such as wax, the remaining end is
slipped over the tooth to make the impression.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter. If the device is not labeled or otherwise represented as
sterile, it is also exempt from the current good manufacturing practice
regulations in Part 820 of this chapter, with the exceptions of
820.180, with respect to general requirements concerning records, and
820.198, with respect to complaint files.
(52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13831, Apr. 5, 1989)
21 CFR 872.6640 Dental operative unit and accessories.
(a) Identification. A dental operative unit and accessories is an
AC-powered device that is intended to supply power to and serve as a
base for other dental devices, such as a dental handpiece, a dental
operating light, an air or water syringe unit, and oral cavity
evacuator, a suction operative unit, and other dental devices and
accessories. The device may be attached to a dental chair.
(b) Classification. Class I.
(55 FR 48439, Nov. 20, 1990)
21 CFR 872.6650 Massaging pick or tip for oral hygiene.
(a) Identification. A massaging pick or tip for oral hygiene is a
rigid, pointed device intended to be used manually to stimulate and
massage the gums to promote good periodontal (gum) condition.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter. If the device is not labeled or otherwise represented as
sterile, it is also exempt from the current good manufacturing practice
regulations in Part 820 of this chapter, with the exceptions of
820.180, with respect to general requirements concerning records, and
820.198, with respect to complaint files.
(52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13831, Apr. 5, 1989)
21 CFR 872.6660 Porcelain powder for clinical use.
(a) Identification. Porcelain powder for clinical use is a device
consisting of a mixture of kaolin, felspar, quartz, or other substances
intended for use in the production of artificial teeth in fixed or
removable dentures, of jacket crowns, facings, and veneers. The device
is used in prosthetic dentistry by heating the powder mixture to a high
temperature in an oven to produce a hard prosthesis with a glass-like
finish.
(b) Classification. Class II.
21 CFR 872.6670 Silicate protector.
(a) Identification. A silicate protector is a device made of
silicone intended to be applied with an absorbent tipped applicator to
the surface of a new restoration to exclude temporarily fluids from its
surface.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter. If the device is not labeled or otherwise represented as
sterile, it is also exempt from the current good manufacturing practice
regulations in Part 820 of this chapter, with the exceptions of
820.180, with respect to general requirements concerning records, and
820.198, with respect to complaint files.
(52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13831, Apr. 5, 1989)
21 CFR 872.6710 Boiling water sterilizer.
(a) Identification. A boiling water sterilizer is an AC-powered
device that consists of a container for boiling water. The device is
intended to sterilize dental and surgical instruments by submersion in
the boiling water in the container.
(b) Classification. Class I.
(55 FR 48439, Nov. 20, 1990)
21 CFR 872.6730 Endodontic dry heat sterilizer.
(a) Identification. An endodontic dry heat sterilizer is a device
intended to sterilize endodontic and other dental instruments by the
application of dry heat. The heat is supplied through glass beads which
have been heated by electricity.
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 872.3.
21 CFR 872.6770 Cartridge syringe.
(a) Identification. A cartridge syringe is a device intended to
inject anesthetic agents subcutaneously or intramuscularly. The device
consists of a metal syringe body into which a disposable, previously
filled, glass carpule (a cylindrical cartridge) containing anesthetic is
placed. After attaching a needle to the syringe body and activating the
carpule by partially inserting the plunger on the syringe, the device is
used to administer an injection to the patient.
(b) Classification. Class II.
21 CFR 872.6855 Manual toothbrush.
(a) Identification. A manual toothbrush is a device composed of a
shaft with either natural or synthetic bristles at one end intended to
remove adherent plaque and food debris from the teeth to reduce tooth
decay.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter. If the device is not labeled or otherwise represented as
sterile, it is also exempt from the current good manufacturing practice
regulations in Part 820 of this chapter, with the exceptions of
820.180, with respect to general requirements concerning records, and
820.198, with respect to complaint files.
(52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13831, Apr. 5, 1989)
21 CFR 872.6865 Powered toothbrush.
(a) Identification. A powered toothbrush is an AC-powered or
battery-powered device that consists of a handle containing a motor that
provides mechanical movement to a brush intended to be applied to the
teeth. The device is intended to remove adherent plaque and food debris
from the teeth to reduce tooth decay.
(b) Classification. Class I.
(55 FR 48440, Nov. 20, 1990)
21 CFR 872.6870 Disposable flouride tray.
(a) Identification. A disposable fluoride tray is a device made of
styrofoam intended to apply fluoride topically to the teeth. To use the
tray, the patient bites down on the tray which has been filled with a
fluoride solution.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter. If the device is not labeled or otherwise represented as
sterile, it is also exempt from the current good manufacturing practice
regulations in Part 820 of this chapter, with the exceptions of
820.180, with respect to general requirements concerning records, and
820.198, with respect to complaint files.
(52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13831, Apr. 5, 1989)
21 CFR 872.6880 Preformed impression tray.
(a) Identification. A preformed impression tray is a metal or
plastic device intended to hold impression material, such as alginate,
to make an impression of a patient's teeth or alveolar process (bony
tooth sockets) to reproduce the structure of a patient's teeth and gums.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter. If the device is not labeled or otherwise represented as
sterile, it is also exempt from the current good manufacturing practice
regulations in Part 820 of this chapter, with the exceptions of
820.180, with respect to general requirements concerning records, and
820.198, with respect to complaint files.
(52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13832, Apr. 5, 1989)
21 CFR 872.6890 Intraoral dental wax.
(a) Identification. Intraoral dental wax is a device made of wax
intended to construct patterns from which custom made metal dental
prostheses, such as crowns and bridges, are cast. In orthodontic
dentistry, the device is intended to make a pattern of a patient's bite
to make study models of the teeth.
(b) Classification. Class I. If the device is not labeled or
otherwise represented as sterile, it is exempt from the current good
manufacturing practice regulations in Part 820, with the exception of
820.180, with respect to general requirements concerning records, and
820.198, with respect to complaint files.
21 CFR 872.6890 Pt. 874
21 CFR 872.6890 PART 874 -- EAR, NOSE, AND THROAT DEVICES
21 CFR 872.6890 Subpart A -- General Provisions
Sec.
874.1 Scope.
874.3 Effective dates of requirement for premarket approval.
874.9 Limitations of exemptions from section 510(k) of the act.
21 CFR 872.6890 Subpart B -- Diagnostic Devices
874.1050 Audiometer.
874.1060 Acoustic chamber for audiometric testing.
874.1070 Short increment sensitivity index (SISI) adapter.
874.1080 Audiometer calibration set.
874.1090 Auditory impedance tester.
874.1100 Earphone cushion for audiometric testing.
874.1120 Electronic noise generator for audiometric testing.
874.1325 Electroglottograph.
874.1500 Gustometer.
874.1800 Air or water caloric stimulator.
874.1820 Surgical nerve stimulator/locator.
874.1925 Toynbee diagnostic tube.
21 CFR 872.6890 Subpart C -- (Reserved)
21 CFR 872.6890 Subpart D -- Prosthetic Devices
874.3300 Hearing aid.
874.3310 Hearing aid calibrator and analysis system.
874.3320 Group hearing aid or group auditory trainer.
874.3330 Master hearing aid.
874.3375 Battery-powered artificial larynx.
874.3400 Tinnitus masker.
874.3430 Middle ear mold.
874.3450 Partial ossicular replacement prosthesis.
874.3495 Total ossicular replacement prosthesis.
874.3540 Prosthesis modification instrument for ossicular replacement
surgery.
874.3620 Ear, nose, and throat synthetic polymer material.
874.3695 Mandibular implant facial prosthesis.
874.3730 Laryngeal prosthesis (Taub design).
874.3760 Sacculotomy tack (Cody tack).
874.3820 Endolymphatic shunt.
874.3850 Endolymphatic shunt tube with valve.
874.3880 Tympanostomy tube.
874.3930 Tympanostomy tube with semipermeable membrane.
21 CFR 872.6890 Subpart E -- Surgical Devices
874.4100 Epistaxis balloon.
874.4140 Ear, nose, and throat bur.
874.4175 Nasopharyngeal catheter.
874.4250 Ear, nose, and throat electric or pneumatic surgical drill.
874.4350 Ear, nose, and throat fiberoptic light source and carrier.
874.4420 Ear, nose, and throat manual surgical instrument.
874.4490 Microsurgical argon laser.
874.4500 Ear, nose, and throat microsurgical carbon dioxide laser.
874.4680 Bronchoscope (flexible or rigid) and accessories.
874.4710 Esophagoscope (flexible or rigid) and accessories.
874.4720 Mediastinoscope and accessories.
874.4750 Laryngostroboscope.
874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
874.4770 Otoscope.
21 CFR 872.6890 Subpart F -- Therapeutic Devices
874.5220 Ear, nose, and throat drug administration device.
874.5300 Ear, nose, and throat examination and treatment unit.
874.5350 Suction antichoke device.
874.5370 Tongs antichoke device.
874.5550 Powered nasal irrigator.
874.5800 External nasal splint.
874.5840 Antistammering device.
Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j, 371).
Source: 51 FR 40389, Nov. 6, 1986, unless otherwise noted.
21 CFR 872.6890 Subpart A -- General Provisions
21 CFR 874.1 Scope.
(a) This part sets forth the classification of ear, nose, and throat
devices intended for human use that are in commercial distribution.
(b) The identification of a device in a regulation in this part is
not a precise description of every device that is, or will be, subject
to the regulation. A manufacturer who submits a premarket notification
submission for a device under Part 807 cannot show merely that the
device is accurately described by the section title and identification
provision of a regulation in this part, but shall state why the device
is substantially equivalent to other devices, as required by 807.87.
(c) To avoid duplicative listings, an ear, nose, and throat device
that has two or more types of uses (e.g., used both as a diagnostic
device and as a therapeutic device) is listed in one subpart only.
(d) References in this part to regulatory sections of the Code of
Federal Regulations are to Chapter I of Title 21 unless otherwise noted.
21 CFR 874.3 Effective dates of requirement for premarket approval.
A device included in this part that is classified into class III
(premarket approval) shall not be commercially distributed after the
date shown in the regulation classifying the device unless the
manufacturer has an approval under section 515 of the act (unless an
exemption has been granted under section 520(g)(2) of the act). An
approval under section 515 of the act consists of FDA's issuance of an
order approving an application for premarket approval (PMA) for the
device or declaring completed a product development protocol (PDP) for
the device.
(a) Before FDA requires that a device commercially distributed before
the enactment date of the amendments, or a device that has been found
substantially equivalent to such a device, has an approval under section
515 of the act FDA must promulgate a regulation under section 515(b) of
the act requiring such approval, except as provided in paragraph (b) of
this section. Such a regulation under section 515(b) of the act shall
not be effective during the grace period ending on the 90th day after
its promulgation or on the last day of the 30th full calendar month
after the regulation that classifies the device into class III is
effective, whichever is later. See section 501(f)(2)(B) of the act.
Accordingly, unless an effective date of the requirement for premarket
approval is shown in the regulation for a device classified into class
III in this part, the device may be commercially distributed without
FDA's issuance of an order approving a PMA declaring completed a PDP for
the device. If FDA promulgates a regulation under section 515(b) of the
act requiring premarket approval for a device, section 501(f)(1)(A) of
the act applies to the device.
(b) Any new, not substantially equivalent, device introduced into
commercial distribution on or after May 28, 1976, including a device
formerly marketed that has been substantially altered, is classified by
statute (section 513(f) of the act) into class III without any grace
period and FDA must have issued an order approving a PMA or declaring
completed a PDP for the device before the device is commercially
distributed unless it is reclassified. If FDA knows that a device being
commercially distributed may be a ''new'' device as defined in this
section because of any new intended use or other reasons, FDA may codify
the statutory classification of the device into class III for such new
use. Accordingly, the regulation for such a class III device states
that as of the enactment date of the amendments, May 28, 1976, the
device must have an approval under section 515 of the act before
commercial distribution.
21 CFR 874.9 Limitations of exemptions from section 510(k) of the act.
FDA's decision to grant an exemption from the requirement of
premarket notification (section 510(k) of the act) for a generic type of
class I device is based upon the existing and reasonably foreseeable
characteristics of commercially distributed devices within that generic
type. Because FDA cannot anticipate every change in intended use or
characteristic that could significantly affect a device's safety or
effectiveness, manufacturers of any commercially distributed class I
device for which FDA has granted an exemption from the requirement of
premarket notification must still submit a premarket notification to FDA
before introducing or delivering for introduction into interstate
commerce for commercial distribution the device when:
(a) The device is intended for a use different from its intended use
before May 28, 1976, or the device is intended for a use different from
the intended use of a preamendments device to which it had been
determined to be substantially equivalent; e.g., the device is intended
for a different medical purpose, or the device is intended for lay use
where the former intended use was by health care professionals only; or
(b) The modified device operates using a different fundamental
scientific technology than that in use in the device before May 28,
1976; e.g., a surgical instrument cuts tissue with a laser beam rather
than with a sharpened metal blade, or an in vitro diagnostic device
detects or identifies infectious agents by using a deoxyribonucleic acid
(DNA) probe or nucleic acid hybridization technology rather than culture
or immunoassay technology.
(52 FR 32111, Aug. 25, 1987)
21 CFR 874.9 Subpart B -- Diagnostic Devices
21 CFR 874.1050 Audiometer.
(a) Identification. An audiometer or automated audiometer is an
electroacoustic device that produces controlled levels of test tones and
signals intended for use in conducting diagnostic hearing evaluations
and assisting in the diagnosis of possible otologic disorders.
(b) Classification. Class II.
21 CFR 874.1060 Acoustic chamber for audiometric testing.
(a) Identification. An acoustic chamber for audiometric testing is a
room that is intended for use in conducting diagnostic hearing
evaluations and that eliminates sound reflections and provides isolation
from outside sounds.
(b) Classification. Class I.
21 CFR 874.1070 Short increment sensitivity index (SISI) adapter.
(a) Identification. A short increment sensitivity index (SISI)
adapter is a device used with an audiometer in diagnostic hearing
evaluations. A SISI adapter provides short periodic sound pulses in
specific small decibel increments that are intended to be superimposed
on the audiometer's output tone frequency.
(b) Classification. Class I.
(55 FR 48440, Nov. 20, 1990)
21 CFR 874.1080 Audiometer calibration set.
(a) Identification. An audiometer calibration set is an electronic
reference device that is intended to calibrate an audiometer. It
measures the sound frequency and intensity characteristics that emanate
from an audiometer earphone. The device consists of an acoustic cavity
of known volume, a sound level meter, a microphone with calibration
traceable to the National Bureau of Standards, oscillators, frequency
counters, microphone amplifiers, and a recorder. The device can measure
selected audiometer test frequencies at a given intensity level, and
selectable audiometer attenuation settings at a given test frequency.
(b) Classification. Class II.
21 CFR 874.1090 Auditory impedance tester.
(a) Identification. An auditory impedance tester is a device that is
intended to change the air pressure in the external auditory canal and
measure and graph the mobility characteristics of the tympanic membrane
to evaluate the functional condition of the middle ear. The device is
used to determine abnormalities in the mobility of the tympanic membrane
due to stiffness, flaccidity, or the presence of fluid in the middle ear
cavity. The device is also used to measure the acoustic reflex
threshold from contractions of the stapedial muscle, to monitor healing
of tympanic membrane grafts or stapedectomies, or to monitor followup
treatment for inflammation of the middle ear.
(b) Classification. Class II.
21 CFR 874.1100 Earphone cushion for audiometric testing.
(a) Identification. An earphone cushion for audiometric testing is a
device that is used to cover an audiometer earphone during audiometric
testing to provide an acoustic coupling (sound connection path) between
the audiometer earphone and the patient's ear.
(b) Classification. Class I. If the device is made of the same
materials that were used in the device before May 28, 1976, it is exempt
from the premarket notification procedures in Subpart E of Part 807.
(51 FR 40389, Nov. 9, 1986; 52 FR 18495, May 15, 1987, as amended at
52 FR 32111, Aug. 25, 1987)
21 CFR 874.1120 Electronic noise generator for audiometric testing.
(a) Identification. An electronic noise generator for audiometric
testing is a device that consists of a swept frequency generator, an
amplifier, and an earphone. It is intended to introduce a masking noise
into the non-test ear during an audiometric evaluation. The device
minimizes the non-test ear's sensing of test tones and signals being
generated for the ear being tested.
(b) Classification. Class II.
21 CFR 874.1325 Electroglottograph.
(a) Identification. An electroglottograph is an AC-powered device
that employs a pair of electrodes that are placed in contact with the
skin on both sides of the larynx and held in place by a collar. It is
intended to measure the electrical impedance of the larynx to aid in
assessing the degree of closure of the vocal cords, confirm larygeal
diagnosis, aid behavioral treatment of voice disorders, and aid research
concerning the laryngeal mechanism.
(b) Classification. Class II.
21 CFR 874.1500 Gustometer.
(a) Identification. A gustometer is a battery-powered device that
consists of two electrodes that are intended to be placed on both sides
of the tongue at different taste centers and that provides a galvanic
stimulus resulting in taste sensation. It is used for assessing the
sense of taste.
(b) Classification. Class I. If the device is not labeled or
otherwise represented as sterile, it is exempt from the current good
manufacturing practice regulations in Part 820, with the exception of
820.180 with respect to general requirements concerning records, and
820.198 with respect to complaint files.
21 CFR 874.1800 Air or water caloric stimulator.
(a) Identification. An air or water caloric stimulator is a device
that delivers a stream of air or water to the ear canal at controlled
rates of flow and temperature and that is intended for vestibular
function testing of a patient's body balance system. The vestibular
stimulation of the semicircular canals produce involuntary eye movements
that are measured and recorded by a nystagmograph.
(b) Classification. Class I.
(55 FR 48440, Nov. 20, 1990)
21 CFR 874.1820 Surgical nerve stimulator/locator.
(a) Identification. A surgical nerve stimulator/locator is a device
that is intended to provide electrical stimulation to the body to locate
and identify nerves and to test their excitability.
(b) Classification. Class II.
21 CFR 874.1925 Toynbee diagnostic tube.
(a) Identification. The toynbee diagnostic tube is a listening
device intended to determine the degree of openness of the eustachian
tube.
(b) Classification. Class I.
21 CFR 874.1925 Subpart C -- (Reserved)
21 CFR 874.1925 Subpart D -- Prosthetic Devices
21 CFR 874.3300 Hearing Aid.
(a) Identification. A hearing aid is wearable sound-amplifying
device that is intended to compensate for impaired hearing. This
generic type of device includes the air-conduction hearing aid and the
bone-conduction hearing aid, but excludes the group hearing aid or group
auditory trainer ( 874.3320), master hearing aid ( 874.3330), and
tinnitus masker ( 874.3400).
(b) Classification. (1) Class I for the air-conduction hearing aid.
(2) Class II for the bone-conduction hearing aid.
21 CFR 874.3310 Hearing aid calibrator and analysis system.
(a) Identification. A hearing aid calibrator and analysis system is
an electronic reference device intended to calibrate and assess the
electroacoustic frequency and sound intensity characteristics emanating
from a hearing aid, master hearing aid, group hearing aid or group
auditory trainer. The device consists of an acoustic complex of known
cavity volume, a sound level meter, a microphone, oscillators, frequency
counters, microphone amplifiers, a distoration analyzer, a chart
recorder, and a hearing aid test box.
(b) Classification. Class II.
21 CFR 874.3320 Group hearing aid or group auditory trainer.
(a) Identification. A group hearing aid or group auditory trainer is
a hearing aid that is intended for use in communicating simultaneously
with one or more listeners having hearing impairment. The device is
used with an associated transmitter microphone. It may be either
monaural or binaural, and it provides coupling to the ear through either
earphones or earmolds. The generic type of device includes three types
of applications: hardwire systems, inductance loop systems, and
wireless systems.
(b) Classification. Class II.
21 CFR 874.3330 Master hearing aid.
(a) Identification. A master hearing aid is an electronic device
intended to simulate a hearing aid during audiometric testing. It has
adjustable acoustic output levels, such as those for gain, output, and
frequency response. The device is used to select and adjust a person's
wearable hearing aid.
(b) Classification. Class II.
21 CFR 874.3375 Battery-powered artificial larynx.
(a) Identification. A battery-powered artificial larynx is an
externally applied device intended for use in the absence of the larynx
to produce sound. When held against the skin in the area of the
voicebox, the device generates mechanical vibrations which resonate in
the oral and nasal cavities and can be modulated by the tongue and lips
in a normal manner, thereby allowing the production of speech.
(b) Classification. Class I. The device is exempt from the current
good manufacturing practice regulations in Part 820, with the exception
of 820.180 with respect to general requirements concerning records, and
820.198, with respect to complaint files.
21 CFR 874.3400 Tinnitus masker.
(a) Identification. A tinnitus masker is an electronic device
intended to generate noise of sufficient intensity and bandwidth to mask
ringing in the ears or internal head noises. Because the device is able
to mask internal noises, it is also used as an aid in hearing external
noises and speech.
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 874.3.
21 CFR 874.3430 Middle ear mold.
(a) Identification. A middle ear mold is a preformed device that is
intended to be implanted to reconstruct the middle ear cavity during
repair of the tympanic membrane. The device permits an ample air-filled
cavity to be maintained in the middle ear and promotes regeneration of
the mucous membrane lining of the middle ear cavity. A middle ear mold
is made of materials such as polyamide, polytetrafluoroethylene,
silicone elastomer, or polyethylene, but does not contain porous
polyethylene.
(b) Classification. Class II.
21 CFR 874.3450 Partial ossicular replacement prosthesis.
(a) Identification. A partial ossicular replacement prosthesis is a
device intended to be implanted for the functional reconstruction of
segments of the ossicular chain and facilitates the conduction of sound
wave from the tympanic membrane to the inner ear. The device is made of
materials such as stainless steel, tantalum, polytetrafluoroethylene,
polyethylene, polytetrafluoroethylene with carbon fibers composite,
absorbable gelatin material, porous polyethylene, or from a combination
of these materials.
(b) Classification. Class II.
21 CFR 874.3495 Total ossicular replacement prosthesis.
(a) Identification. A total ossicular replacement prosthesis is a
device intended to be implanted for the total functional reconstruction
of the ossicular chain and facilitates the conduction of sound waves
from the tympanic membrance to the inner ear. The device is made of
materials such as polytetrafluoroethylene, polytetrafluoroethylene with
vitreous carbon fibers composite, porous polyethylene, or from a
combination of these materials.
(b) Classification. Class II.
21 CFR 874.3540 Prosthesis modification instrument for ossicular
replacement surgery.
(a) Identification. A prosthesis modification instrument for
ossicular replacement surgery is a device intended for use by a surgeon
to construct ossicular replacements. This generic type of device
includes the ear, nose, and throat cutting block; wire crimper, wire
bending die; wire closure forceps; piston cutting jib; gelfoamTM
punch; wire cutting scissors; and ossicular finger vise.
(b) Classification. Class I. If the device is made of the same
materials that were used in the device before May 28, 1976, it is exempt
from the premarket notification procedures in Subpart E of Part 807. If
the device is not labeled or otherwise represented as sterile, it is
exempt from the current good manufacturing practice regulations in Part
820, with the exception of 820.180, with respect to general
requirements concerning records, and 820.198, with respect to complaint
files.
(51 FR 40389, Nov. 9, 1986, as amended at 52 FR 32111, Aug. 25, 1987)
21 CFR 874.3620 Ear, nose, and throat synthetic polymer material.
(a) Identification. Ear, nose, and throat synthetic polymer material
is a device material that is intended to be implanted for use as a
space-occupying substance in the reconstructive surgery of the head and
neck. The device is used, for example, in augmentation rhinoplasty and
in tissue defect closures in the esophagus. The device is shaped and
formed by the suregon to conform to the patient's needs. This generic
type of device is made of material such as polyamide mesh or foil and
porous polyethylene.
(b) Classification. Class II.
21 CFR 874.3695 Mandibular implant facial prosthesis.
(a) Identification. A mandibular implant facial prosthesis is a
device that is intended to be implanted for use in the functional
reconstruction of mandibular deficits. The device is made of materials
such as stainless steel, tantalum, titanium, cobalt-chromium based
alloy, polytetrafluoroethylene, silicone elastomer, polyethylene,
polyurethane, or polytetrafluoroethylene with carbon fibers composite.
(b) Classification. Class II.
21 CFR 874.3730 Laryngeal prosthesis (Taub design).
(a) Identification. A laryngeal prosthesis (Taub design) is a device
intended to direct pulmonary air flow to the pharynx in the absence of
the larynx, thereby permitting esophageal speech. The device is
interposed between openings in the trachea and the esophagus and may be
removed and replaced each day by the patient. During phonation, air
from the lungs is directed to flow through the device and over the
esophageal mucosa to provide a sound source that is articulated as
speech.
(b) Classification. Class II.
21 CFR 874.3760 Sacculotomy tack (Cody tack)
(a) Identification. A sacculotomy tack (Cody tack) is a device that
consists of a pointed stainless steel tack intended to be implanted to
relieve the symptoms of vertigo. The device repetitively ruptures the
utricular membrane as the membrane expands under increased endolymphatic
pressure.
(b) Classification. Class II.
21 CFR 874.3820 Endolymphatic shunt.
(a) Identification. An endolymphatic shunt is a device that consists
of a tube or sheet intended to be implanted to relieve the symptons of
vertigo. The device permits the unrestricted flow of excess endolymph
from the distended end of the endolymphatic system into the mastoid
cavity where resorption occurs. This device is made of
polytetrafluoroethylene or silicone elastomer.
(b) Classification. Class II.
21 CFR 874.3850 Endolymphatic shunt tube with valve.
(a) Identification. An endolymphatic shunt tube with valve is a
device that consists of a pressure-limiting valve associated with a tube
intended to be implanted in the inner ear to relieve the symptoms of
vertigo. The device directs excess endolymph from the distended end of
the endolymphatic system into the mastoid cavity where resorption
occurs. The function of the pressure-limiting inner ear valve is to
impede the flow of endolymph so that a physiologically normal
endolymphatic pressure is maintained. The device is made of silicone
elastomer and polyamide and contains gold radiopaque markers within the
silicone elastomer sheath.
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 874.3.
21 CFR 874.3880 Tympanostomy tube.
(a) Identification. A tympanostomy tube is a device that is intended
to be implanted for ventilation or drainage of the middle ear. The
device is inserted through the tympanic membrane to permit a free
exchange of air between the outer ear and middle ear. A type of
tympanostomy tube known as the malleous clip tube attaches to the
malleous to provide middle ear ventilation. The device is made of
materials such as polytetrafluoroethylene, polyethylene, silicon
elastomer, or porous polyethylene.
(b) Classification. Class II.
21 CFR 874.3930 Tympanostomy tube with semipermeable membrane.
(a) Identification. A tympanostomy tube with a semipermeable
membrane is a device intended to be implanted for ventilation or
drainage of the middle ear and for preventing fluids from entering the
middle ear cavity. The device is inserted through the tympanic membrane
to permit a free exchange of air between the outer ear and middle ear.
The tube portion of the device is made of silicone elastomer or porous
polyethylene, and the membrane portion is made of
polytetrafluoroethylene.
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 874.3.
21 CFR 874.3930 Subpart E -- Surgical Devices
21 CFR 874.4100 Epistaxis balloon.
(a) Identification. An epistaxis balloon is a device consisting of
an inflatable balloon intended to control internal nasal bleeding by
exerting pressure against the sphenopalatine artery.
(b) Classification. Class I.
21 CFR 874.4140 Ear, nose, and throat bur.
(a) Identification. An ear, nose, and throat bur is a device
consisting of an interchangeable drill bit that is intended for use in
an ear, nose, and throat electric or pneumatic surgical drill (
874.4250) for incising or removing bone in the ear, nose, or throat
area. The bur consists of a carbide cutting tip on a metal shank or a
coating of diamond on a metal shank. The device is used in mastoid
surgery, frontal sinus surgery, and surgery of the facial nerves.
(b) Classification. Class I.
21 CFR 874.4175 Nasopharyngeal catheter.
(a) Identification. A nasopharyngeal catheter is a device consisting
of a bougie or filiform catheter that is intended for use in probing or
dilating the eustachian tube. This generic type of device includes
eustachian catheters.
(b) Classification. Class I.
21 CFR 874.4250 Ear, nose, and throat electric or pneumatic surgical
drill.
(a) Identification. An ear, nose, and throat electric or pneumatic
surgical drill is a rotating drilling device, including the handpiece,
that is intended to drive various accessories, such as an ear, nose, and
throat bur ( 874.4140), for the controlled incision or removal of bone
in the ear, nose, and throat area.
(b) Classification. Class II.
21 CFR 874.4350 Ear, nose, and throat fiberoptic light source and
carrier.
(a) Identification. An ear, nose, and throat fiberoptic light source
and carrier is an AC-powered device that generates and transmits light
through glass of plastic fibers and that is intended to provide
illumination at the tip of an ear, nose, or throat endoscope.
Endoscopic devices which utilize fiberoptic light sources and carriers
include the bronchoscope, esophagoscope, laryngoscope, mediastinoscope,
laryngeal-bronchial telescope, and nasopharyngoscope.
(b) Classification. Class II.
21 CFR 874.4420 Ear, nose, and throat manual surgical instrument.
(a) Identification. An ear, nose, and throat manual surgical
instrument is one of a variety of devices intended for use in surgical
procedures to examine or treat the bronchus, esophagus, trachea, larynx,
pharynx, nasal and paranasal sinus, or ear. This generic type of device
includes the esophageal dilator; tracheal bistour (a long, narrow
surgical knife); tracheal dilator; tracheal hook; laryngeal injection
set; laryngeal knife; laryngeal saw; laryngeal trocar; laryngectomy
tube; adenoid curette; adenotome; metal tongue depressor; mouth gag;
oral screw; salpingeal curette; tonsillectome; tonsil guillotine;
tonsil screw; tonsil snare; tonsil suction tub; tonsil suturing hook;
antom reforator; ethmoid curette; frontal sinus-rasp; nasal curette;
nasal rasp; nasal rongeur; nasal saw; nasal scissors; nasal snare;
sinus irrigator; sinus trephine; ear curette; ear excavator; ear
rasp; ear scissor, ear snare; ear spoon; ear suction tub; malleous
ripper; mastoid gauge; microsurgical ear chisel; myringotomy tube
inserter; ossici holding clamp; sacculotomy tack inserter; vein
press; wire ear loop; microrule; mirror; mobilizer; ear, nose, and
throat punch; ear, nose and throat knife; and ear, nose, and throat
trocar.
(b) Classification. Class I. If the device is made of the same
materials that were used in the device before May 28, 1976, it is exempt
from the premarket notification procedures in Subpart E of Part 807.
(51 FR 40389, Nov. 9, 1986, as amended at 52 FR 32111, Aug. 25, 1987)
21 CFR 874.4490 Microsurgical argon laser.
(a) Microsurgical argon laser for use in otology -- (1)
Identification. A microsurgical argon laser for use in otology is a
device intended to cut, destroy, or alter tissue or bone of the ear
using laser light energy.
(2) Classification. Class II.
(b) Microsurgical argon laser for all other uses -- (1)
Identification. A microsurgical argon laser for all other uses,
including use in laryngology and general use in otolaryngology, is a
device that is intended to cut, destroy, or alter tissue.
(2) Classification. Class III.
(3) Date PMA or notice of completion of a PDP is required. As of May
28, 1976, an approval under section 515 of the act is required before
the device identified in paragraph (b) may be commercially distributed.
See 874.3.
21 CFR 874.4500 Ear, nose, and throat microsurgical carbon dioxide
laser.
(a) Identification. An ear, nose, and throat microsurgical carbon
dioxide laser is a device intended for the surgical excision of tissue
from the ear, nose, and throat area. The device is used, for example,
in microsurgical procedures to excise lesions and tumors of the vocal
cords and adjacent areas.
(b) Classification. Class II.
21 CFR 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a) Identification. A bronchoscope (flexible or rigid) and
accessories is a tubular endoscopic device with any of a group of
accessory devices which attach to the bronchoscope and is intended to
examine or treat the larynx and tracheobronchial tree. It is typically
used with a fiberoptic light source and carrier to provide illumination.
The device is made of materials such as stainless steel or flexible
plastic. This generic type of device includes the rigid ventilating
bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope,
laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope
tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy
brush, rigid biopsy forceps, flexible biopsy curette, and rigid
bronchoscope aspirating tube, but excludes the fiberoptic light source
and carrier.
(b) Classification. Class II.
21 CFR 874.4710 Esophagoscope (flexible or rigid) and accessories.
(a) Identification. An esophagoscope (flexible or rigid) and
accessories is a tubular endoscopic device with any of a group of
accessory devices which attach to the esophagoscope and is intended to
examine or treat esophageal malfunction symptoms, esophageal or
mediastinal disease, or to remove foreign bodies from the esophagus.
When inserted, the device extends from the area of the hypopharynx to
the stomach. It is typically used with a fiberoptic light source and
carrier to provide illumination. The device is made of materials such
as stainless steel or flexible plastic. This generic type of device
includes the flexible foreign body claw, flexible biopsy forceps, rigid
biopsy curette, flexible biopsy brush, rigid biopsy forceps and flexible
biopsy curette, but excludes the fiberoptic light source and carrier.
(b) Classification. Class II.
21 CFR 874.4720 Mediastinoscope and accessories.
(a) Identification. A mediastinoscope and accessories is a tubular
tapered electrical endoscopic device with any of a group of accessory
devices which attach to the mediastinoscope and is intended to examine
or treat tissue in the area separating the lungs. The device is
inserted transthoracicly and is used in diagnosis of tumors and lesions
and to determine whether excision of certain organs or tissues is
indicated. It is typically used with a fiberoptic light source and
carrier to provide illumination. The device is made of materials such
as stainless steel. This generic type of device includes the flexible
foreign body claw, flexible biopsy forceps, rigid biopsy curette,
flexible biopsy brush, rigid biopsy forceps, and flexible biopsy
curette, but excludes the fiberoptic light source and carrier.
(b) Classification. Class II.
21 CFR 874.4750 Laryngostroboscope.
(a) Identification. A laryngostroboscope is a device that is
intended to allow observation of glottic action during phonation. The
device operates by focusing a stroboscopic light through a lens for
direct or mirror reflected viewing of glottic action. The light and
microphone that amplifies acoustic signals from the glottic area may or
may not contact the patient.
(b) Classification. Class I.
(55 FR 48440, Nov. 20, 1990)
21 CFR 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
(a) Identification. A nasopharyngoscope (flexible or rigid) and
accessories is a tubular endoscopic device with any of a group of
accessory devices which attach to the nasopharyngoscope and is intended
to examine or treat the nasal cavity and nasal pharynx. It is typically
used with a fiberoptic light source and carrier to provide illumination.
The device is made of materials such as stainless steel and flexible
plastic. This generic type of device includes the antroscope,
nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope,
rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy
forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy
forceps and flexible biopsy curette, but excludes the fiberoptic light
source and carrier.
(b) Classification. Class II.
21 CFR 874.4770 Otoscope.
(a) Identification. An otoscope is a device intended to allow
inspection of the external ear canal and tympanic membrane under
magnification. The device provides illumination of the ear canal for
observation by using an AC- or battery-powered light source and an
optical magnifying system.
(b) Classification. Class I.
(55 FR 48440, Nov. 20, 1990)
21 CFR 874.4770 Subpart F -- Therapeutic Devices
21 CFR 874.5220 Ear, nose, and throat drug administration device.
(a) Identification. An ear, nose, and throat drug administration
device is one of a group of ear, nose, and throat devices intended
specifically to administer medicinal substances to treat ear, nose, and
throat disorders. These instruments include the powder blower, dropper,
ear wick, manual nebulizer pump, and nasal inhaler.
(b) Classification. Class I. If the device is not labeled or
otherwise represented as sterile, it is exempt from the current good
manufacturing practice regulations in Part 820, with the exception of
820.180, with respect to general requirements concerning records, and
820.198, with respect to complaint files.
21 CFR 874.5300 Ear, nose, and throat examination and treatment unit.
(a) Identification. An ear, nose, and throat examination and
treatment unit is an AC-powered device intended to support a patient
during an otologic examination while providing specialized features for
examination and treatment. The unit consists of a patient chair and
table, drawers for equipment, suction and blowing apparatus, and
receptacles for connection of specialized lights and examining
instruments.
(b) Classification. Class I.
(55 FR 48440, Nov. 20, 1990)
21 CFR 874.5350 Suction antichoke device.
(a) Identification. A suction antichoke device is a device intended
to be used in an emergency situation to remove, by the application of
suction, foreign objects that obstruct a patient's airway to prevent
asphyxiation to the patient.
(b) Classification. Class III.
(c) Date PMA or notice or completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 874.3.
21 CFR 874.5370 Tongs antichoke device.
(a) Identification. A tongs antichoke device is a device that is
intended to be used in an emergency situation to grasp and remove
foreign objects that obstruct a patient's airway to prevent asphyxiation
of the patient. This generic type of device includes a plastic
instrument with serrated ends that is inserted into the airway in a
blind manner to grasp and extract foreign objects, and a stainless steel
forceps with spoon ends that is inserted under tactile guidance to grasp
and extract foreign objects from the airway.
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. A No
effective date has been established of the requirement for premarket
approval. See 874.3.
21 CFR 874.5550 Powered nasal irrigator.
(a) Identification. A powered nasal irrigator is an AC-powered
device intended to wash the nasal cavity by means of a
pressure-controlled pulsating stream of water. The device consists of a
control unit and pump connected to a spray tube and nozzle.
(b) Classification. Class I.
(55 FR 48440, Nov. 20, 1990)
21 CFR 874.5800 External nasal splint.
(a) Identification. An external nasal splint is a rigid or partially
rigid device intended for use externally for immobilization of parts of
the nose.
(b) Classification. Class I. If the device is made of the same
materials that were used in the device before May 28, 1976, it is exempt
from the premarket notification procedures in Subpart E of Part 807.
(51 FR 40389, Nov. 9, 1986, as amended at 52 FR 32111, Aug. 25, 1987)
21 CFR 874.5840 Antistammering device.
(a) Identification. An antistammering device is a device that
electronically generates a noise when activated or when it senses the
user's speech and that is intended to prevent the user from hearing the
sounds of his or her own voice. The device is used to minimize a user's
involuntary hesitative or repetitive speech.
(b) Classification. Class I.
21 CFR 874.5840 Pt. 876
21 CFR 874.5840 PART 876 -- GASTROENTEROLOGY-UROLOGY DEVICES
21 CFR 874.5840 Subpart A -- General Provisions
Sec.
876.1 Scope.
876.3 Effective dates of requirement for premarket approval.
876.9 Limitations of exemptions from section 510(k) of the Federal
Food, Drug, and Cosmetic Act (the act).
21 CFR 874.5840 Subpart B -- Diagnostic Devices
876.1075 Gastroenterology-urology biopsy instrument.
876.1400 Stomach pH electrode.
876.1500 Endoscope and accessories.
876.1620 Urodynamics measurement system.
876.1725 Gastrointestinal motility monitoring system.
876.1800 Urine flow or volume measuring system.
21 CFR 874.5840 Subpart C -- Monitoring Devices
876.2040 Enuresis alarm.
21 CFR 874.5840 Subpart D -- Prosthetic Devices
876.3350 Penile inflatable implant.
876.3630 Penile rigidity implant.
876.3750 Testicular prosthesis.
21 CFR 874.5840 Subpart E -- Surgical Devices
876.4020 Fiberoptic light ureteral catheter.
876.4270 Colostomy rod.
876.4300 Endoscopic electrosurgical unit and accessories.
876.4370 Gastroenterology-urology evacuator.
876.4400 Hemorrhoidal ligator.
876.4480 Electrohydraulic lithotriptor.
876.4500 Mechanical lithotriptor.
876.4530 Gastroenterology-urology fiberoptic retractor.
876.4560 Ribdam.
876.4590 Interlocking urethral sound.
876.4620 Ureteral stent.
876.4650 Water jet renal stone dislodger system.
876.4680 Ureteral stone dislodger.
876.4730 Manual gastroenterology-urology surgical instrument and
accessories.
876.4770 Urethrotome.
876.4890 Urological table and accessories.
21 CFR 874.5840 Subpart F -- Therapeutic Devices
876.5010 Biliary catheter and accessories.
876.5030 Continent ileostomy catheter.
876.5090 Suprapubic urological catheter and accessories.
876.5130 Urological catheter and accessories.
876.5160 Urological clamp for males.
876.5210 Enema kit.
876.5220 Colonic irrigation system.
876.5250 Urine collector and accessories.
876.5270 Implanted electrical urinary continence device.
876.5280 Implanted mechanical/hydraulic urinary continence device.
876.5320 Nonimplanted electrical continence device.
876.5365 Esophageal dilator.
876.5450 Rectal dilator.
876.5470 Ureteral dilator.
876.5520 Urethral dilator.
876.5540 Blood access device and accessories.
876.5600 Sorbent regenarated dialysate delivery system for
hemodialysis.
876.5630 Peritoneal dialysis system and accessories.
876.5665 Water purification system for hemodialysis.
876.5820 Hemodialysis system and accessories.
876.5830 Hemodialyzer with disposable insert (Kiil type).
876.5860 High permeability hemodialysis system.
876.5870 Sorbent hemoperfusion system.
876.5880 Isolated kidney perfusion and transport system and
accessories.
876.5895 Ostomy irrigator.
876.5900 Ostomy pouch and accessories.
876.5920 Protective garment for incontinence.
876.5955 Peritoneo-venous shunt.
876.5970 Hernia support.
876.5980 Gastrointestinal tube and accessories.
Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j, 371).
Source: 48 FR 53023, Nov. 23, 1983, unless otherwise noted.
21 CFR 874.5840 Subpart A -- General Provisions
21 CFR 876.1 Scope.
(a) This part sets forth the classification of
gastroenterology-urology devices intended for human use that are in
commercial distribution.
(b) The identification of a device in a regulation in this part is
not a precise description of every device that is, or will be, subject
to the regulation. A manufacturer who submits a premarket notification
submission for a device under Part 807 may not show merely that the
device is accurately described by the section title and identification
provisions of a regulation in this part, but shall state why the device
is substantially equivalent to other devices, as required by 807.87.
(c) To avoid duplicative listings, a gastroenterology-urology device
that has two or more types of uses (e.g., used both as a diagnostic
device and as a therapeutic device) is listed only in one subpart.
(d) References in this part to regulatory sections of the Code of
Federal Regulations are to Chapter I of Title 21, unless otherwise
noted.
(52 FR 17737, May 11, 1987; 52 FR 22577, June 12, 1987)
21 CFR 876.3 Effective dates of requirement for premarket approval.
A device included in this part that is classified into class III
(premarket approval) shall not be commercially distributed after the
date shown in the regulation classifying the device unless the
manufacturer has an approval under section 515 of the act (unless an
exemption has been granted under section 520(g)(2) of the act). An
approval under section 515 of the act consists of FDA's issuance of an
order approving an application for premarket approval (PMA) for the
device or declaring completed a product development protocol (PDP) for
the device.
(a) Before FDA requires that a device commercially distributed before
the enactment date of the amendments, or a device that has been found
substantially equivalent to such a device, has an approval under section
515 of the act FDA must promulgate a regulation under section 515(b) of
the act requiring such approval, except as provided in paragraph (b) of
this section. Such a regulation under section 515(b) of the act shall
not be effective during the grace period ending on the 90th day after
its promulgation or on the last day of the 30th full calendar month
after the regulation that classifies the device into class III is
effective, whichever is later. See section 501(f)2)(B) of the act.
Accordingly, unless an effective date of the requirement for premarket
approval is shown in the regulation for a device classified into class
III in this part, the device may be commerically distributed without
FDA's issuance of an order approving a PMA or declaring completed a PDP
for the device. If FDA promulgates a regulation under section 515(b) of
the act requiring premarket approval for a device, section 501(f)(1)(A)
of the act applies to the device.
(b) Any new, not substantially equivalent, device introduced into
commercial distribution on or after May 28, 1976, including a device
formerly marketed that has been substantially altered, is classified by
statute (section 513(f) of the act) into class III without any grace
period and FDA must have issued an order approving a PMA or declaring
completed a PDP for the device before the device is commercially
distributed unless it is reclassified. If FDA knows that a device being
commercially distributed may be a ''new'' device as defined in this
section because of any new intended use or other reasons, FDA may codify
the statutory classification of the device into class III for such new
use. Accordingly, the regulation for such a class III device states
that as of the enactment date of the amendments, May 28, 1976, the
device must have an approval under section 515 of the act before
commercial distribution.
(52 FR 17737, May 11, 1987)
21 CFR 876.9 Limitations of exemptions from section 510(k) of the
Federal Food, Drug, and Cosmetic Act (the act).
The Food and Drug Administration (FDA's) decision to grant an
exemption from the requirement of premarket notification (section 510(k)
of the act) for a generic type of class I device is based upon the
existing and reasonably foreseeable characteristics of commercially
distributed devices within that generic type. Because FDA cannot
anticipate every change in intended use or characteristic that could
significantly affect a device's safety or effectiveness, manufacturers
of any commercially distributed class I device for which FDA has granted
an exemption from the requirement of premarket notification must still
submit a premarket notification to FDA before introducing or delivering
for introduction into interstate commerce for commercial distribution
the device when:
(a) The device is intended for a use different from its intended use
before May 28, 1976, or the device is intended for a use different from
the intended use of a preamendments device to which it had been
determined to be substantially equivalent; e.g., the device is intended
for a different medical purpose, or the device is intended for lay use
where the former intended use was by health care professionals only; or
(b) The modified device operates using a different fundamental
scientific technology than that in use in the device before May 28,
1976; e.g., a surgical instrument cuts tissue with a laser beam rather
than with a sharpened metal blade, or an in vitro diagnostic device
detects or identifies infectious agents by using a deoxyribonucleic acid
(DNA) probe or nucleic acid hybridization technology rather than culture
or immunoassay technology.
(54 FR 25049, June 12, 1989)
21 CFR 876.9 Subpart B -- Diagnostic Devices
21 CFR 876.1075 Gastroenterology-urology biopsy instrument.
(a) Identification. A gastroenterology-urology biopsy instrument is
a device used to remove, by cutting or aspiration, a specimen of tissue
for microscopic examination. This generic type of device includes the
biopsy punch, gastrointestinal mechanical biopsy instrument, suction
biopsy instrument, gastro-urology biopsy needle and needle set, and
nonelectric biopsy forceps. This section does not apply to biopsy
instruments that have specialized uses in other medical specialty areas
and that are covered by classification regulations in other parts of the
device classification regulations.
(b) Classification. Class II (performance standards).
21 CFR 876.1400 Stomach pH electrode.
(a) Identification. A stomach pH electrode is a device used to
measure intragastric and intraesophageal pH (hydrogen ion
concentration). The pH electrode is at the end of a flexible lead which
may be inserted into the esophagus or stomach through the patient's
mouth. The device may include an integral gastrointestinal tube.
(b) Classification. Class II (performance standards).
21 CFR 876.1500 Endoscope and accessories.
(a) Identification. An endoscope and accessories is a device used to
provide access, illumination, and allow observation or manipulation of
body cavities, hollow organs, and canals. The device consists of
various rigid or flexible instruments that are inserted into body spaces
and may include an optical system for conveying an image to the user's
eye and their accessories may assist in gaining access or increase the
versatility and augment the capabilities of the devices. Examples of
devices that are within this generic type of device include cleaning
accessories for endoscopes, photographic accessories for endoscopes,
nonpowered anoscopes, binolcular attachments for endoscopes, pocket
battery boxes, flexible or rigid choledochoscopes, colonoscopes,
diagnostic cystoscopes, cystourethroscopes, enteroscopes,
esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic
illuminators for endoscopes, incandescent endoscope lamps, biliary
pancreatoscopes, proctoscopes, resectoscopes, nephroscopes,
sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers,
cytology brushes for endoscopes, and lubricating jelly for transurethral
surgical instruments. This section does not apply to endoscopes that
have specialized uses in other medical specialty areas and that are
covered by classification regulations in other parts of the device
classification regulations.
(b) Classification. Class II (performance standards).
21 CFR 876.1620 Urodynamics measurement system.
(a) Identification. A urodynamics measurement system is a device
used to measure volume and pressure in the urinary bladder when it is
filled through a catheter with carbon dioxide or water. The device
controls the supply of carbon dioxide or water and may also record the
electrical activity of the muscles associated with urination. The
device system may include transducers, electronic signal conditioning
and display equipment, a catheter withdrawal device to enable a urethral
pressure profile to be obtained, and special catheters for urethral
profilometry and electrodes for electromyography. This generic type of
device includes the cystometric gas (carbon dioxide) device, the
cystometric hydrualic device, and the electrical recording cystometer,
but excludes any device that uses air to fill the bladder.
(b) Classification. Class II (performance standards).
21 CFR 876.1725 Gastrointestinal motility monitoring system.
(a) Identification. A gastrointestinal motility monitoring system is
a device used to measure peristalic activity or pressure in the stomach
or esophagus by means of a probe with transducers that is introduced
through the mouth into the gastrointestinal tract. The device may
include signal conditioning, amplifying, and recording equipment. This
generic type of device includes the esophageal motility monitor and
tube, the gastrointestinal motility (electrical) system, and certain
accessories, such as a pressure transducer, amplifier, and external
recorder.
(b) Classification. Class II (performance standards).
21 CFR 876.1800 Urine flow or volume measuring system.
(a) Identification. A urine flow or volume measuring system is a
device that measures directly or indirectly the volume or flow of urine
from a patient, either during the course of normal urination or while
the patient is catheterized. The device may include a drip chamber to
reduce the risk of retrograde bacterial contamination of the bladder and
a transducer and electrical signal conditioning and display equipment.
This generic type of device includes the electrical urinometer,
mechanical urinometer, nonelectric urinometer, disposable nonelectric
urine flow rate measuring device, and uroflowmeter.
(b) Classification. Class II (performance standards).
21 CFR 876.1800 Subpart C -- Monitoring Devices
21 CFR 876.2040 Enuresis alarm.
(a) Identification. An enuresis alarm is a device intended for use
in treatment of bedwetting. Through an electrical trigger mechanism,
the device sounds an alarm when a small quantity of urine is detected on
a sensing pad. This generic type of device includes conditioned
response enuresis alarms.
(b) Classification. Class II (performance standards).
21 CFR 876.2040 Subpart D -- Prosthetic Devices
21 CFR 876.3350 Penile inflatable implant.
(a) Identification. A penile inflatable implant is a device that
consists of two inflatable cylinders implanted in the penis, connected
to a reservoir filled with radiopaque fluid implanted in the abdomen,
and a subcutaneous manual pump implanted in the scrotum. When the
cylinders are inflated, they provide rigidity to the penis. This device
is used in the treatment of erectile impotence.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 876.3.
(48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987)
21 CFR 876.3630 Penile rigidity implant.
(a) Identification. A penile rigidity implant is a device that
consists of a single semi-rigid rod or a pair of semi-rigid rods
implanted in the penis to provide rigidity. It is used in the treatment
of erectile impotence.
(b) Classification. Class III (permarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 876.3.
(48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987)
21 CFR 876.3750 Testicular prosthesis.
(a) Identification. A testicular prosthesis is an implanted device
that consists of a solid or gel-filled silicone rubber prosthesis that
is implanted surgically to resemble a testicle.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 876.3.
(48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987)
21 CFR 876.3750 Subpart E -- Surgical Devices
21 CFR 876.4020 Fiberoptic light ureteral catheter.
(a) Identification. A fiberoptic light ureteral catheter is a device
that consists of a fiberoptic bundle that emits light throughout its
length and is shaped so that it can be inserted into the ureter to
enable the path of the ureter to be seen during lower abdominal or
pelvic surgery.
(b) Classification. Class II (performance standards).
21 CFR 876.4270 Colostomy rod.
(a) Identification. A colostomy rod is a device used during the loop
colostomy procedure. A loop of colon is surgically brought out through
the abdominal wall and the stiff colostomy rod is placed through the
loop temporarily to keep the colon from slipping back through the
surgical opening.
(b) Classification. Class II (performance standards).
21 CFR 876.4300 Endoscopic electrosurgical unit and accessories.
(a) Identification. An endoscopic electrosurgical unit and
accessories is a device used to perform electrosurgical procedures
through an endoscope. This generic type of device includes the
electrosurgical generator, patient plate, electric biopsy forceps,
electrode, flexible snare, electrosurgical alarm system, electrosurgical
power supply unit, electrical clamp, self-opening rigid snare, flexible
suction coagulator electrode, patient return wristlet, contact jelly,
adaptor to the cord for transurethral surgical instruments, the electric
cord for transurethral surgical instruments, and the transurethral
desiccator.
(b) Classification. Class II (performance standards).
21 CFR 876.4370 Gastroenterology-urology evacuator.
(a) Identification. A gastroenterology-urology evacuator is a device
used to remove debris and fluids during gastroenterological and
urological procedures by drainage, aspiration, or irrigation. This
generic type of device includes the fluid evacuator system, manually
powered bladder evacuator, and the AC-powered vacuum pump.
(b) Classification. (1) Class II (performance standards) for the
gastroenterology-urology evacuator when other than manually powered.
(2) Class I for the gastroenterology-urology evacuator when manually
powered. The device subject to this paragraph (b)(2) is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(48 FR 53023, Nov. 23, 1983, as amended at 54 FR 25049, June 12,
1989)
21 CFR 876.4400 Hemorrhoidal ligator.
(a) Identification. A hemorrhoidal ligator is a device used to cut
off the blood flow to hemorrhoidal tissue by means of a ligature or band
placed around the hemorrhoid.
(b) Classification. Class II (performance standards).
21 CFR 876.4480 Electrohydraulic lithotriptor.
(a) Identification. An electrohydraulic lithotriptor is an
AC-powered device used to fragment urinary bladder stones. It consists
of a high voltage source connected by a cable to a bipolar electrode
that is introduced into the urinary bladder through a cystoscope. The
electrode is held against the stone in a water-filled bladder and
repeated electrical discharges between the two poles of the electrode
cause electrohydraulic shock waves which disintegrate the stone.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 876.3.
(48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987)
21 CFR 876.4500 Mechanical lithotriptor.
(a) Identification. A mechanical lithotriptor is a device with steel
jaws that is inserted into the urinary bladder through the urethra to
grasp and crush bladder stones.
(b) Classification. Class II (performance standards).
21 CFR 876.4530 Gastroenterology-urology fiberoptic retractor.
(a) Identification. A gastroenterology-urology fiberoptic retractor
is a device that consists of a mechanical retractor with a fiberoptic
light system that is used to illuminate deep surgical sites.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(48 FR 53023, Nov. 23, 1983, as amended at 54 FR 25049, June 12,
1989)
21 CFR 876.4560 Ribdam.
(a) Identification. A ribdam is a device that consists of a broad
strip of latex with supporting ribs used to drain surgical wounds where
copious urine drainage is expected.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(48 FR 53023, Nov. 23, 1983, as amended at 54 FR 25049, June 12,
1989)
21 CFR 876.4590 Interlocking urethal sound.
(a) Identification. An interlocking urethral sound is a device that
consists of two metal sounds (elongated instruments for exploring or
sounding body cavities) with interlocking ends, such as with male and
female threads or a rounded point and mating socket, used in the repair
of a ruptured urethra. The device may include a protective cap to fit
over the metal threads.
(b) Classification. Class II (performance standards).
21 CFR 876.4620 Ureteral stent.
(a) Identification. A ureteral stent is a tube-like implanted device
that is inserted into the ureter to provide ureteral rigidity and allow
the passage of urine. The device may have finger-like protrusions or
hooked ends to keep the tube in place. It is used in the treatment of
ureteral injuries and ureteral obstruction.
(b) Classification. Class II (performance standards).
21 CFR 876.4650 Water jet renal stone dislodger system.
(a) Identification. A water jet renal stone dislodger system is a
device used to dislodge stones from renal calyces (recesses of the
pelvis of the kidney) by means of a pressurized stream of water through
a conduit. The device is used in the surgical removal of kidney stones.
(b) Classification. Class II (performance standards).
21 CFR 876.4680 Ureteral stone dislodger.
(a) Identification. A ureteral stone dislodger is a device that
consists of a bougie or a catheter with an expandable wire basket near
the tip, a special flexible tip, or other special construction. It is
inserted through a cystoscope and used to entrap and remove stones from
the ureter. This generic type of device includes the metal basket and
the flexible ureteral stone dislodger.
(b) Classification. Class II (performance standards).
21 CFR 876.4730 Manual gastroenterology-urology surgical instrument and
accessories.
(a) Identification. A manual gastroenterology-urology surgical
instrument and accessories is a device designed to be used for
gastroenterological and urological surgical procedures. The device may
be nonpowered, hand-held, or hand-manipulated. Manual
gastroenterology-urology surgical instruments include the biopsy forceps
cover, biopsy tray without biopsy instruments, line clamp, nonpowered
rectal probe, nonelectrical clamp, colostomy spur-crushers, locking
device for intestinal clamp, needle holder, gastro-urology hook,
gastro-urology probe and director, nonself-retaining retractor,
laparotomy rings, nonelectrical snare, rectal specula, bladder neck
spreader, self-retaining retractor, and scoop.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(48 FR 53023, Nov. 23, 1983, as amended at 54 FR 25049, June 12,
1989)
21 CFR 876.4770 Urethrotome.
(a) Identification. A urethrotome is a device that is inserted into
the urethra and used to cut urethral strictures and enlarge the urethra.
It is a metal instrument equipped with a dorsal-fin cutting blade which
can be elevated from its sheath. Some urethrotomes incorporate an
optical channel for visual control.
(b) Classification. Class II (performance standards).
21 CFR 876.4890 Urological table and accessories.
(a) Identification. A urological table and accessories is a device
that consists of a table, stirrups, and belts used to support a patient
in a suitable position for endoscopic procedures of the lower urinary
tract. The table can be adjusted into position manually or
electrically.
(b) Classification. (1) Class II (performance standards) for the
electrically powered urological table and accessories.
(2) Class I for the manually powered table and accessories. The
device subject to this paragraph (b)(2) is exempt from the premarket
notification procedures in Subpart E of Part 807 of this chapter.
(48 FR 53023, Nov. 23, 1983, as amended at 54 FR 25050, June 12,
1989)
21 CFR 876.4890 Subpart F -- Therapeutic Devices
21 CFR 876.5010 Biliary catheter and accessories.
(a) Identification. A biliary catheter and accessories is a tubular
flexible device used for temporary or prolonged drainage of the biliary
tract, for splinting of the bile duct during healing, or for preventing
stricture of the bile duct. This generic type of device may include a
bile collecting bag that is attached to the biliary catheter by a
connector and fastened to the patient with a strap.
(b) Classification. Class II (performance standards).
21 CFR 876.5030 Continent ileostomy catheter.
(a) Identification. A continent ileostomy catheter is a flexible
tubular device used as a form during surgery for continent ileostomy and
it provides drainage after surgery. Additionally, the device may be
inserted periodically by the patient for routine care to empty the ileal
pouch. This generic type of device includes the rectal catheter for
continent ileostomy.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(48 FR 53023, Nov. 23, 1983, as amended at 54 FR 25050, June 12,
1989)
21 CFR 876.5090 Suprapubic urological catheter and accessories.
(a) Identification. A suprapubic urological catheter and accessories
is a flexible tubular device that is inserted through the abdominal wall
into the urinary bladder with the aid of a trocar and cannula. The
device is used to pass fluids to and from the urinary tract. This
generic type of device includes the suprapubic catheter and tube,
Malecot catheter, catheter punch instrument, suprapubic drainage tube,
and the suprapubic cannula and trocar.
(b) Classification. Class II (performance standards).
21 CFR 876.5130 Urological catheter and accessories.
(a) Identification. A urological catheter and accessories is a
flexible tubular device that is inserted through the urethra and used to
pass fluids to or from the urinary tract. This generic type of device
includes radiopaque urological catheters, ureteral catheters, urethral
catheters, coude1 catheters, balloon retention type catheters, straight
catheters, upper urinary tract catheters, double lumen female
urethrographic catheters, disposable ureteral catheters, male
urethrographic catheters, and urological catheter accessories including
ureteral catheter stylets, ureteral catheter adapters, ureteral catheter
holders, ureteral catheter stylets, ureteral catheterization trays, and
the gastro-urological irrigation tray (for urological use).
(b) Classification. Class II (performance standards).
21 CFR 876.5160 Urological clamp for males.
(a) Identification. A urological clamp for males is a device used to
close the urethra of a male to control urinary incontinence or to hold
anesthetic or radiography contrast media in the urethra temporarily. It
is an external clamp.
(b) Classification. Class I (general controls).
21 CFR 876.5210 Enema kit.
(a) Identification. An enema kit is a device intended to instill
water or other fluids into the colon through a nozzle inserted into the
rectum to promote evacuation of the contents of the lower colon. The
device consists of a container for fluid connected to the nozzle either
directly or via tubing. This device does not include the colonic
irrigation system ( 876.5220).
(b) Classification. Class I (general controls). The device is
exempt from the current good manufacturing practice regulations in Part
820, with the exception of 820.180, with respect to general
requirements concerning records, and 820.198, with respect to complaint
files.
21 CFR 876.5220 Colonic irrigation system.
(a) Identification. A colonic irrigation system is a device intended
to instill water into the colon through a nozzle inserted into the
rectum to cleanse (evacuate) the contents of the lower colon. The
system is designed to allow evacuation of the contents of the colon
during the administration of the colonic irrigation. The device
consists of a container for fluid connected to the nozzle via tubing and
includes a system which enables the pressure, temperature, or flow of
water through the nozzle to be controlled. The device may include a
console-type toilet and necessary fittings to allow the device to be
connected to water and sewer pipes. The device may use electrical power
to heat the water. The device does not include the enema kit (
876.5210).
(b) Classification. (1) Class II (performance standards) when the
device is intended for colon cleansing when medically indicated, such as
before radiological or endoscopic examinations.
(2) Class III (premarket approval) when the device is intended for
other uses, including colon cleansing routinely for general well being.
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval for the device intended for the uses described in paragraph
(b)(2). See 876.3.
(48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987)
21 CFR 876.5250 Urine collector and accessories.
(a) Identification. A urine collector and accessories is a device
intended to collect urine. The device and accessories consist of
tubing, a suitable receptacle, connectors, mechanical supports, and may
include a means to prevent the backflow of urine or ascent of infection.
The two kinds of urine collectors are: (1) A urine collector and
accessories intended to be connected to an indwelling catheter, which
includes the urinary drainage collection kit and the closed urine
drainage system and drainage bag; and (2) a urine collector and
accessories not intended to be connected to an indwelling catheter,
which includes the corrugated rubber sheath, pediatric urine collector,
leg bag for external use, urosheath type incontinence device, and the
paste-on device for incontinence.
(b) Classification. (1) Class II (performance standards) for a urine
collector and accessories intended to be connected to an indwelling
catheter.
(2) Class I (general controls) for a urine collector and accessories
not intended to be connected to an indwelling catheter. If the device
is not labeled or otherwise represented as sterile, it is exempt from
the current good manufacturing practice regulations in Part 820, with
the exception of 820.180, with respect to general requirements
concerning records, and 820.198, with respect to complaint files.
21 CFR 876.5270 Implanted electrical urinary continence device.
(a) Identification. An implanted electrical urinary device is a
device intended for treatment of urinary incontinence that consists of a
receiver implanted in the abdomen with electrodes for pulsed-stimulation
that are implanted either in the bladder wall or in the pelvic floor,
and a battery-powered transmitter outside the body.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 876.3.
(48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987)
21 CFR 876.5280 Implanted mechanical/hydraulic urinary continence
device.
(a) Identification. An implanted mechanical/hydraulic urinary
continence device is a device used to treat urinary incontinence by the
application of continuous or intermittent pressure to occlude the
urethra. The totally implanted device may consist of a static pressure
pad, or a system with a container of radiopaque fluid in the abdomen and
a manual pump and valve under the skin surface that is connected by
tubing to an adjustable pressure pad or to a cuff around the urethra.
The fluid is pumped as needed from the container to inflate the pad or
cuff to pass on the urethra.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 876.3.
(48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987)
21 CFR 876.5320 Nonimplanted electrical continence device.
(a) Identification. A nonimplanted electrical continence device is a
device that consists of a pair of electrodes on a plug or a pessary that
are connected by an electrical cable to a battery-powered pulse source.
The plug or pessary is inserted into the rectum or into the vagina and
used to stimulate the muscles of the pelvic floor to maintain urinary or
fecal continence. When necessary, the plug or pessary may be removed by
the user. This device excludes an AC-powered nonimplanted electrical
continence device and the powered vaginal muscle stimulator for
therapeutic use ( 884.5940).
(b) Classification. Class II (performance standards).
21 CFR 876.5365 Esophageal dilator.
(a) Identification. An esophageal dilator is a device that consists
of a cylindrical instrument that may be hollow and weighted with mercury
or a metal olive-shaped weight that slides on a guide, such as a string
or wire and is used to dilate a stricture of the esophagus. This
generic type of device includes esophageal or gastrointestinal bougies
and the esophageal dilator (metal olive).
(b) Classification. Class II (performance standards).
21 CFR 876.5450 Rectal dilator.
(a) Identification. A rectal dilator is a device designed to dilate
the anal sphincter and canal when the size of the anal opening may
interfere with its function or the passage of an examining instrument.
(b) Classification. Class II (performance standards).
21 CFR 876.5470 Ureteral dilator.
(a) Identification. A ureteral dilator is a device that consists of
a specially shaped catheter or bougie and is used to dilate the ureter
at the place where a stone has become lodged or to dilate a ureteral
stricture.
(b) Classification. Class II (performance standards).
21 CFR 876.5520 Urethral dilator.
(a) Identification. A urethral dilator is a device that consists of
a slender hollow or solid instrument made of metal, plastic, or other
suitable material in a cylindrical form and in a range of sizes and
flexibilities. The device may include a mechanism to expand the portion
of the device in the urethra and indicate the degree of expansion on a
dial. It is used to dilate the urethra. This generic type of device
includes the mechanical urethral dilator, urological bougies, metal or
plastic urethral sound, urethrometer, filiform, and filiform follower.
(b) Classification. Class II (performance standards).
21 CFR 876.5540 Blood access device and accessories.
(a) Identification. A blood access device and accessories is a
device intended to provide access to a patient's blood for hemodialysis
or other chronic uses. When used in hemodialysis, it is part of an
artificial kidney system for the treatment of patients with renal
failure or toxemic conditions and provides access to a patient's blood
for hemodialysis. The device includes implanted blood access devices,
nonimplanted blood access devices, and accessories for both the
implanted and nonimplanted blood access devices.
(1) The implanted blood access device consists of various flexible or
rigid tubes, which are surgically implanted in appropriate blood
vessels, may come through the skin, and are intended to remain in the
body for 30 days or more. This generic type of device includes various
shunts and connectors specifically designed to provide access to blood,
such as the arteriovenous (A-V) shunt cannula and vessel tip.
(2) The nonimplanted blood access device consists of various flexible
or rigid tubes, such as catheters, cannulae or hollow needles, which are
inserted into appropriate blood vessels or a vascular graft prosthesis (
870.3450 and 870.3460), and are intended to remain in the body for less
than 30 days. This generic type of device includes fistula needles, the
single needle dialysis set (coaxial flow needle), and the single needle
dialysis set (alternating flow needle).
(3) Accessories common to either type include the shunt adaptor,
cannula clamp, shunt connector, shunt stabilizer, vessel dilator,
disconnect forceps, shunt guard, crimp plier, tube plier, crimp ring,
joint ring, fistula adaptor, and declotting tray (including contents).
(b) Classification. (1) Class III (premarket approval) for the
implanted blood access device.
(2) Class II (performance standards) for the nonimplanted blood
access device.
(3) Class II (performance standards) for accessories for both the
implanted and the nonimplanted blood access device.
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval for the device described in paragraph (b)(1). See 876.3.
(48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987)
21 CFR 876.5600 Sorbent regenerated dialysate delivery system for
hemodialysis.
(a) Identification. A sorbent regenerated dialysate delivery system
for hemodialysis is a device that is part of an artificial kidney system
for the treatment of patients with renal failure or toxemic conditions,
and that consists of a sorbent cartridge and the means to circulate
dialysate through this cartridge and the dialysate compartment of the
dialyzer. The device is used with the extracorporeal blood system and
the dialyzer of the hemodialysis system and accessories ( 876.5820). The
device includes the means to maintain the temperature, conductivity,
electrolyte balance, flow rate and pressure of the dialysate, and alarms
to indicate abnormal dialysate conditions. The sorbent cartridge may
include absorbent, ion exchange and catalytic materials.
(b) Classification. Class II (performance standards).
21 CFR 876.5630 Peritoneal dialysis system and accessories.
(a) Identification. (1) A peritoneal dialysis system and accessories
is a device that is used as an artificial kidney system for the
treatment of patients with renal failure or toxemic conditions, and that
consists of a peritoneal access device, an administration set for
peritoneal dialysis, a source of dialysate, and, in some cases, a water
purification mechanism. After the dialysate is instilled into the
patient's peritoneal cavity, it is allowed to dwell there so that
undesirable substances from the patient's blood pass through the lining
membrane of the peritoneal cavity into this dialysate. These substances
are then removed when the dialysate is drained from the patient. The
peritoneal dialysis system may regulate and monitor the dialysate
temperature, volume, and delivery rate together with the time course of
each cycle of filling, dwell time, and draining of the peritoneal cavity
or manual controls may be used. This generic device includes the
semiautomatic and the automatic peritoneal delivery system.
(2) The peritoneal access device is a flexible tube that is implanted
through the abdominal wall into the peritoneal cavity and that may have
attached cuffs to provide anchoring and a skin seal. The device is
either a single use peritioneal catheter, intended to remain in the
peritoneal cavity for less than 30 days, or a long term peritoneal
catheter. Accessories include stylets and trocars to aid in the
insertion of the catheter and an obturator to maintain the patency of
the surgical fistula in the abdominal wall between treatments.
(3) The disposable administration set for peritoneal dialysis
consists of tubing, an optional reservoir bag, and appropriate
connectors. It may include a peritoneal dialysate filter to trap and
remove contaminating particles.
(4) The source of dialysate may be sterile prepackaged dialysate (for
semiautomatic peritoneal dialysate delivery systems or ''cycler
systems'') or dialysate prepared from dialysate concentrate and sterile
purified water (for automatic peritoneal dialysate delivery systems or
''reverse osmosis'' systems). Prepackaged dialysate intended for use
with either of the peritoneal dialysate delivery systems is regulated by
FDA as a drug.
(b) Classification. Class II (performance standards).
21 CFR 876.5665 Water purification system for hemodialysis.
(a) Identification. A water purification system for hemodialysis is
a device that is intended for use with a hemodialysis system and that is
intended to remove organic and inorganic substances and microbial
contaminants from water used to dilute dialysate concentrate to form
dialysate. This generic type of device may include a water softener,
sediment filter, carbon filter, and water distillation system.
(b) Classification. Class II (performance standards).
21 CFR 876.5820 Hemodialysis system and accessories.
(a) Identification. A hemodialysis system and accessories is a
device that is used as an artificial kidney system for the treatment of
patients with renal failure or toxemic conditions and that consists of
an extracorporeal blood system, a conventional dialyzer, a dialysate
delivery system, and accessories. Blood from a patient flows through
the tubing of the extracorporeal blood system and accessories to the
blood compartment of the dialyzer, then returns through further tubing
of the extracorporeal blood system to the patient. The dialyzer has two
compartments that are separated by a semipermeable membrane. While the
blood is in the blood compartment, undesirable substances in the blood
pass through the semipermeable membrane into the dialysate in the
dialysate compartment. The dialysate delivery system controls and
monitors the dialysate circulating through the dialysate compartment of
the dialyzer.
(1) The extracorporeal blood system and accessories consists of
tubing, pumps, pressure monitors, air foam or bubble detectors, and
alarms to keep blood moving safely from the blood access device and
accessories for hemodialysis ( 876.5540) to the blood compartment of the
dialyzer and back to the patient.
(2) The conventional dialyzer allows a transfer of water and solutes
between the blood and the dialysate through the semipermeable membrane.
The semipermeable membrane of the conventional dialyzer has a
sufficiently low permeability to water that an ultrafiltration
controller is not required to prevent excessive loss of water from the
patient's blood. This conventional dialyzer does not include
hemodialyzers with the disposable inserts (Kiil type) ( 876.5830) or
dialyzers of high permeability ( 876.5860).
(3) The dialysate delivery system consists of mechanisms that monitor
and control the temperature, conductivity, flow rate, and pressure of
the dialysate and circulates dialysate through the dialysate compartment
of the dialyzer. The dialysate delivery system includes the dialysate
concentrate for hemodialysis (liquid or powder) and alarms to indicate
abnormal dialysate conditions. This dialysate delivery system does not
include the sorbent regenerated dialysate delivery system for
hemodialysis ( 876.5600), the dialysate delivery system of the
peritoneal dialysis system and accessories ( 876.5630), or the
controlled dialysate delivery system of the high permeability
hemodialysis system 876.5860).
(4) Remote accessories to the hemodialysis system include the
unpowered dialysis chair without a scale, the powered dialysis chair
without a scale, the dialyzer holder set, dialysis tie gun and ties, and
hemodialysis start/stop tray.
(b) Classification. (1) Class II (performance standards) for
hemodialysis systems and all accessories directly associated with the
extracorporeal blood system and the dialysate delivery system.
(2) Class I for other accessories of the hemodialysis system remote
from the extracorporeal blood system and the dialysate delivery system,
such as the unpowered dialysis chair, hemodialysis start/stop tray,
dialyzer holder set, and dialysis tie gun and ties. The devices subject
to this paragraph (b)(2) are exempt from the premarket notification
procedures in Subpart E of Part 807 of this chapter.
(48 FR 53023, Nov. 23, 1983, as amended at 54 FR 25050, June 12,
1989)
21 CFR 876.5830 Hemodialyzer with disposable insert (kiil type).
(a) Identification. A hemodialyzer with disposable inserts (Kiil
type) is a device that is used as a part of an artificial kidney system
for the treatment of patients with renal failure or toxemic conditions
and that includes disposable inserts consisting of layers of
semipermeable membranes which are sandwiched between support plates.
The device is used with the extracorporeal blood system and the
dialysate delivery system of the hemodialysis system and accessories (
876.5820).
(b) Classification. Class II (performance standards).
(48 FR 53023, Nov. 23, 1983, as amended at 53 FR 11253, Apr. 6, 1988)
21 CFR 876.5860 High permeability hemodialysis system.
(a) Identification. A high permeability hemodialysis system is a
device that is used as an artificial kidney system for the treatment of
patients with renal failure or toxemic conditions, and that has a
dialyzer with a semipermeable membrane that is more permeable to water
than the semipermeable membrane of the conventional dialyzer. The
device system consists of an extracorporeal blood system, a high
permeability dialyzer, and a controlled dialysate delivery system that
incorporates an ultrafiltration controller to prevent excessive loss of
water from the patient's blood. This highly permeable, semipermeable
membrane may also permit greater loss of higher molecular weight
substances from the blood, compared with the conventional dialyzer of
the hemodialysis system and accessories ( 876.5820). The extracorporeal
blood system is the same generic type of extracorporeal blood system
that is used in the hemodialysis system and accessories ( 876.5820). The
controlled dialysate delivery system also is similar to the conventional
disalysate delivery system of the hemodialysis system and accessories (
876.5820), with the addition of an ultrafiltration controller to
regulate the rate of the removal of water from the patient's blood and
ensure that the pressure on the dialysate side of the membrane is always
lower than on the blood side. This generic type of device includes the
sealed dialysate delivery system.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 876.3.
(48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987)
21 CFR 876.5870 Sorbent hemoperfusion system.
(a) Identification. A sorbent hemoperfusion system is a device that
consists of an extracorporeal blood system similar to that identified in
the hemodialysis system and accessories ( 876.5820) and a container
filled with adsorbent material that removes a wide range of substances,
both toxic and normal, from blood flowing through it. The adsorbent
materials are usually activated-carbon or resins which may be coated or
immobilized to prevent fine particles entering the patient's blood. The
generic type of device may include lines and filters specifically
designed to connect the device to the extracorporeal blood system. The
device is used in the treatment of poisoning, drug overdose, hepatic
coma, or metabolic disturbances.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 876.3.
(48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987)
21 CFR 876.5880 Isolated kidney perfusion and transport system and
accessories.
(a) Identification. An isolated kidney perfusion and transport
system and accesssories is a device that is used to support a donated or
a cadaver kidney and to maintain the organ in a near-normal physiologic
state until it is transplanted into a recipient patient. This generic
type of device may include tubing, catheters, connectors, an ice storage
or freezing container with or without bag or preservatives, pulsatile or
nonpulsatile hypothermic isolated organ perfusion apparatus with or
without oxygenator, and disposable perfusion set.
(b) Classification. Class II (performance standards).
21 CFR 876.5895 Ostomy irrigator.
(a) Identification. An ostomy irrigator is a device that consists of
a container for fluid, tubing with a cone-shaped tip or a soft and
flexible catheter with a retention shield and that is used to wash out
the colon through a colostomy, a surgically created opening of the colon
on the surface of the body.
(b) Classification. Class II (performance standards).
21 CFR 876.5900 Ostomy pouch and accessories.
(a) Identification. An ostomy pouch and accessories is a device that
consists of a bag that is attached to the patient's skin by an adhesive
material and that is intended for use as a receptacle for collection of
fecal material or urine following an ileostomy, colostomy, or
ureterostomy (a surgically created opening of the small intestine, large
intestine, or the ureter on the surface of the body). This generic type
of device and its accessories includes the ostomy pouch, ostomy
adhesive, the disposable colostomy appliance, ostomy collector,
colostomy pouch, urinary ileostomy bag, urine collecting ureterostomy
bag, ostomy drainage bag with adhesive, stomal bag, ostomy protector,
and the ostomy size selector, but excludes ostomy pouches which
incorporate arsenic-containing compounds.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(48 FR 53023, Nov. 23, 1983, as amended at 54 FR 25050, June 12,
1989)
21 CFR 876.5920 Protective garment for incontinence.
(a) Identification. A protective garment for incontinence is a
device that consists of absorbent padding and a fluid barrier and that
is intended to protect an incontinent patient's garment from the
patient's excreta. This generic type of device does not include diapers
for infants.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter. The device is also exempt from the current good manufacturing
practice regulations in Part 820 of this chapter, with the exception of
820.180, regarding general requirements concerning records, and
820.198, regarding complaint files.
(48 FR 53023, Nov. 23, 1983, as amended at 54 FR 25050, June 12,
1989)
21 CFR 876.5955 Peritoneo-venous shunt.
(a) Identification. A peritoneo-venous shunt is an implanted device
that consists of a catheter and a pressure activated one-way valve. The
catheter is implanted with one end in the peritoneal cavity and the
other in a large vein. This device enables ascitic fluid in the
peritoneal cavity to flow into the venous system for the treatment of
intractable ascites.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 876.3.
(48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987)
21 CFR 876.5970 Hernia support.
(a) Identification. A hernia support is a device, usually made of
elastic, canvas, leather, or metal, that is intended to be placed over a
hernial opening (a weakness in the abdominal wall) to prevent protrusion
of the abdominal contents. This generic type of device includes the
umbilical truss.
(b) Classification. Class I (general controls). The device is
exempt from the currrent good manufacturing practice regulations in Part
820, with the exception of 820.180, regarding general requirements
concerning records, and 820.198, regarding complaint files.
21 CFR 876.5980 Gastrointestinal tube and accessories.
(a) Identification. A gastrointestinal tube and accessories is a
device that consists of flexible or semi-rigid tubing used for
instilling fluids into, withdrawing fluids from, splinting, or
suppressing bleeding of the alimentary tract. This device may
incorporate an integral inflatable balloon for retention or hemostasis.
This generic type of device includes the hemostatic bag, irrigation and
aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile
infant gavage set, gastrointestinal string and tubes to locate internal
bleeding, double lumen tube for intestinal decompression or intubation,
feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube,
single lumen tube with mercury weight balloon for intestinal intubation
or decompression, and gastro-urological irrigation tray (for
gastrological use).
(b) Classification. (1) Class II (performance standards).
(2) Class I (general controls) for the dissolvable nasogastric feed
tube guide for the nasogastric tube.
(49 FR 573, Jan. 5, 1984)
21 CFR 876.5980 Pt. 878
21 CFR 876.5980 PART 878 -- GENERAL AND PLASTIC SURGERY DEVICES
21 CFR 876.5980 Subpart A -- General Provisions
Sec.
878.1 Scope.
878.3 Effective dates of requirement for premarket approval.
878.9 Limitations of exemptions from section 510(k) of the Federal
Food, Drug, and Cosmetic Act (the act).
21 CFR 876.5980 Subpart B -- Diagnostic Devices
878.1800 Speculum and accessories.
21 CFR 876.5980 Subpart C -- Reserved
21 CFR 876.5980 Subpart D -- Prosthetic Devices
878.3250 External facial fracture fixation appliance.
878.3300 Surgical mesh.
878.3500 Polytetrafluoroethylene with carbon fibers composite implant
material.
878.3530 Silicone inflatable breast prosthesis.
878.3540 Silicone gel-filled breast prosthesis.
878.3550 Chin prosthesis.
878.3590 Ear prosthesis.
878.3610 Esophageal prosthesis.
878.3680 Nose prosthesis.
878.3720 Tracheal prosthesls.
878.3750 External prosthesis adhesive.
878.3800 External aesthetic restoration prosthesis.
878.3900 Inflatable extremity splint.
878.3910 Noninflatable extremity splint.
878.3925 Plastic surgery kit and accessories.
21 CFR 876.5980 Subpart E -- Surgical Devices
878.4040 Surgical apparel.
878.4100 Organ bag.
878.4160 Surgical camera and accessories.
878.4200 Introduction/drainage catheter and accessories.
878.4300 Implantable clip.
878.4320 Removable skin clip.
878.4350 Cryosurgical unit and accessories.
878.4370 Surgical drape and drape accessories.
878.4380 Drape adhesive.
878.4400 Electrosurgical cutting and coagulation device and
accessories.
878.4440 Eye pad.
878.4450 Nonabsorbable gauze for internal use.
878.4460 Surgeon's glove.
878.4470 Surgeon's gloving cream.
878.4480 Absorbable powder for lubricating a surgeon's glove.
878.4490 Absorbable hemostatic agent and dressing.
878.4493 Absorbable poly(glycolide/L-lactide) surgical suture.
878.4520 Polytetrafluoroethylene injectable.
878.4580 Surgical lamp.
878.4630 Ultraviolet lamp for dermatologic disorders.
878.4635 Ultraviolet lamp for tanning.
878.4660 Skin marker.
878.4680 Nonpowered, single patient, portable suction apparatus.
878.4700 Surgical microscope and accessories.
878.4730 Surgical skin degreaser or adhesive tape solvent.
878.4750 Implantable staple.
878.4760 Removable skin staple.
878.4780 Powered suction pump.
Sec.
878.4800 Manual surgical instrument for general use.
878.4810 Laser surgical instrument for use in general and plastic
surgery and in dermatology.
878.4820 Surgical instrument motors and accessories/attachments.
878.4830 Absorbable surgical gut suture.
878.4930 Suture retention device.
878.4950 Manual operating table and accessories and manual operating
chair and accessories.
878.4960 Operating tables and accessories and operating chairs and
accessories.
878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
878.5010 Nonabsorbable polypropylene surgical suture.
878.5020 Nonabsorbable polyamide surgical suture.
21 CFR 876.5980 Subpart F -- Therapeutic Devices
878.5070 Air-handling apparatus for a surgical operating room.
878.5350 Needle-type epilator.
878.5360 Tweezer-type epilator.
878.5650 Topical oxygen chamber for extremities.
878.5900 Nonpneumatic tourniquet.
878.5910 Pneumatic tourniquet.
Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j, 371).
Source: 53 FR 23872, June 24, 1988, unless otherwise noted.
21 CFR 876.5980 Subpart A -- General Provisions
21 CFR 878.1 Scope.
(a) This part sets forth the classification of general and plastic
surgery devices intended for human use that are in commercial
distribution.
(b) The identification of a device in a regulation in this part is
not a precise description of every device that is, or will be, subject
to the regulation. A manufacturer who submits a premarket notification
submission for a device under Part 807 cannot show merely that the
device is accurately described by the section title and identification
provision of a regulation in this part, but shall state why the device
is substantially equivalent to other devices, as required by 807.87 of
this chapter.
(c) To avoid duplicative listings, a general and plastic surgery
device that has two or more types of uses (e.g., used both as a
diagnostic device and as a therapeutic device) is listed in one subpart
only.
(d) References in this part to regulatory sections of the Code of
Federal Regulations are to Chapter I of Title 21 unless otherwise noted.
21 CFR 878.3 Effective dates of requirement for premarket approval.
A device included in this part that is classified into class III
(premarket approval) shall not be commercially distributed after the
date shown in the regulation classifying the device unless the
manufacturer has an approval under section 515 of the act (unless an
exemption has been granted under section 520(g)(2) of the act). An
approval under section 515 of the act consists of FDA's issuance of an
order approving an application for premarket approval (PMA) for the
device or declaring completed a product development protocol (PDP) for
the device.
(a) Before FDA requires that a device commercially distributed before
the enactment date of the amendments, or a device that has been found
substantially equivalent to such a device, has an approval under section
515 of the act, FDA must promulgate a regulation under section 515(b) of
the act requiring such approval, except as provided in paragraphs (b)
and (c) of this section. Such a regulation under section 515(b) of the
act shall not be effective during the grace period ending on the 90th
day after its promulgation or on the last day of the 30th full calendar
month after the regulation that classifies the device into class III is
effective, whichever is later. See section 501(f)(2)(B) of the act.
Accordingly, unless an effective date of the requirement for premarket
approval is shown in the regulation for a device classified into class
III in this part, the device may be commercially distributed without
FDA's issuance of an order approving a PMA or declaring completed a PDP
for the device. If FDA promulgates a regulation under section 515(b) of
the act requiring premarket approval for a device, section 501(f)(1)(A)
of the act applies to the device.
(b) Any new, not substantially equivalent, device introduced into
commercial distribution on or after May 28, 1976, including a device
formerly marketed that has been substantially altered, is classified by
statute (section 513(f) of the act) into class III without any grace
period and FDA must have issued an order approving a PMA or declaring
completed a PDP for the device before the device is commercially
distributed unless it is reclassified. If FDA knows that a device being
commercially distributed may be a ''new'' device as defined in this
section because of any new intended use or other reasons, FDA may codify
the statutory classification of the device into class III for such new
use. Accordingly, the regulation for such a class III device states
that as of the enactment date of the amendments, May 28, 1976, the
device must have an approval under section 515 of the act before
commercial distribution.
(c) A device identified in a regulation in this part that is
classified into class III and that is subject to the transitional
provisions of section 520(l) of the act is automatically classified by
statute into class III and must have an approval under section 515 of
the act before being commercially distributed. Accordingly, the
regulation for such a class III transitional device states that as of
the enactment date of the amendments, May 28, 1976, the device must have
an approval under section 515 of the act before commercial distribution.
21 CFR 878.9 Limitations of exemptions from section 510(k) of the
Federal Food, Drug, and Cosmetic Act (the act).
The Food and Drug Administration's (FDA's) decision to grant an
exemption from the requirement of premarket notification (section 510(k)
of the act) for a generic type of class I device is based upon the
existing and reasonably foreseeable characteristics of commercially
distributed devices within that generic type. Because FDA cannot
anticipate every change in intended use or characteristic that could
significantly affect a device's safety or effectiveness, manufacturers
of any commercially distributed class I device for which FDA has granted
an exemption from the requirement of premarket notification must still
submit a premarket notification to FDA before introducing or delivering
for introduction into interstate commerce for commercial distribution
the device when:
(a) The device is intended for a use different from its intended use
before May 28, 1976, or the device is intended for a use different from
the intended use of a preamendments device to which it has been
determined to be substantially equivalent; e.g., the device is intended
for a different medical purpose, or the device is intended for lay use
where the former intended use was by health care professionals only; or
(b) The modified device operates using a different fundamental
scientific technology than that in use in the device before May 28,
1976; e.g., a surgical instrument cuts tissue with a laser beam rather
than with a sharpened metal blade, or an in vitro diagnostic device
detects or identifies infectious agents by using a deoxyribonucleic acid
(DNA) probe or nucleic acid hybridization technology rather than culture
or immunoassay technology.
(54 FR 13827, Apr. 5, 1989; 54 FR 16438-T, Apr. 24, 1989)
21 CFR 878.9 Subpart B -- Diagnostic Devices
21 CFR 878.1800 Speculum and accessories.
(a) Identification. A speculum is a device intended to be inserted
into a body cavity to aid observation. It is either nonilluminated or
illuminated and may have various accessories.
(b) Classification. Class I. If the device is made of the same
materials that were used in the device before May 28, 1976, it is exempt
from the premarket notification procedures in Subpart E of Part 807 of
this chapter.
(53 FR 23872, June 24, 1988, as amended at 54 FR 13827, Apr. 5, 1989)
21 CFR 878.1800 Subpart C -- Reserved
21 CFR 878.1800 Subpart D -- Prosthetic Devices
21 CFR 878.3250 External facial fracture fixation appliance.
(a) Identification. An external facial fracture fixation appliance
is a metal apparatus intended to be used during surgical reconstruction
and repair to immobilize maxillofacial bone fragments in their proper
facial relationship.
(b) Classification. Class I. If the device is made of the same
materials that were used in the device before May 28, 1976, it is exempt
from the premarket notification procedures in Subpart E of Part 807 of
this chapter.
(53 FR 23872, June 24, 1988, as amended at 54 FR 13827, Apr. 5, 1989)
21 CFR 878.3300 Surgical mesh.
(a) Identification. Surgical mesh is a metallic or polymeric screen
intended to be implanted to reinforce soft tissue or bone where weakness
exists. Examples of surgical mesh are metallic and polymeric mesh for
hernia repair, and acetabular and cement restrictor mesh used during
orthopedic surgery.
(b) Classification. Class II.
21 CFR 878.3500 Polytetrafluoroethylene with carbon fibers composite
implant material.
(a) Identification. A polytetrafluoroethylene with carbon fibers
composite implant material is a porous device material intended to be
implanted during surgery of the chin, jaw, nose, or bones or tissue near
the eye or ear. The device material serves as a space-occupying
substance and is shaped and formed by the surgeon to conform to the
patient's need.
(b) Classification. Class II.
21 CFR 878.3530 Silicone inflatable breast prosthesis.
(a) Identification. A silicone inflatable breast prosthesis is a
silicone rubber shell made of polysiloxane(s), such as
polydimethylsiloxane and polydiphenylsiloxane, that is inflated to the
desired size with sterile isotonic saline before or after implantation.
The device is intended to be implanted to augment or reconstruct the
female breast.
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 878.3.
21 CFR 878.3540 Silicone gel-filled breast prosthesis.
(a) Identification -- (1) Single-lumen silicone gel-filled breast
prosthesis. A single-lumen silicone gel-filled breast prosthesis is a
silicone rubber shell made of polysiloxane(s), such as
polydimethylsiloxane and polydiphenylsiloxane. The shell either
contains a fixed amount cross-linked polymerized silicone gel, filler,
and stabilizers or is filled to the desired size with injectable
silicone gel at time of implantation. The device is intended to be
implanted to augment or reconstruct the female breast.
(2) Double-lumen silicone gel-filled breast prosthesis. A double
lumen silicone gel-filled breast prosthesis is a silicone rubber inner
shell and a silicone rubber outer shell, both shells made of
polysiloxane(s), such as polydimethylsiloxane and polydiphenylsiloxane.
The inner shell contains fixed amounts of cross-linked polymerized
silicone gel, fillers, and stabilizers. The outer shell is inflated to
the desired size with sterile isotonic saline before or after
implantation. The device is intended to be implanted to augment or
reconstruct the female breast.
(3) Polyurethane covered silicone gel-filled breast prosthesis. A
polyurethane covered silicone gel-filled breast prosthesis is an inner
silicone rubber shell made of polysiloxane(s), such as
polydimethylsiloxane and polydiphenylsiloxane, with an outer silicone
adhesive layer and an outer covering of polyurethane; contained within
the inner shell is a fixed amount of cross-linked polymerized silicone
gel, fillers, and stabilizers and an inert support structure
compartmentalizing the silicone gel. The device is intended to be
implanted to augment or reconstruct the female breast.
(b) Classification. Class III.
(c) Date premarket approval application (PMA) is required. A PMA is
required to be filed with the Food and Drug Administration on or before
July 9, 1991 for any silicone gel-filled breast prosthesis that was in
commercial distribution before May 28, 1976, or that has on or before
July 9, 1991 been found to be substantially equivalent to a silicone
gel-filled breast prosthesis that was in commercial distribution before
May 28, 1976. Any other silicone gel-filled breast prosthesis shall
have an approved PMA in effect before being placed in commercial
distribution.
( 53 FR 23872, June 24, 1988, as amended at 56 FR 14627, Apr. 10,
1991)
21 CFR 878.3550 Chin prosthesis.
(a) Identification. A chin prosthesis is a silicone rubber solid
device intended to be implanted to augment or reconstruct the chin.
(b) Classification. Class II.
21 CFR 878.3590 Ear prosthesis.
(a) Identification. An ear prosthesis is a silicone rubber solid
device intended to be implanted to reconstruct the external ear.
(b) Classification. Class II.
21 CFR 878.3610 Esophageal prosthesis.
(a) Identification. An esophageal prosthesis is a plastic tube or
tube-like device that may have mesh reinforcement that is intended to be
implanted in, or affixed externally to, the chest and throat to restore
the esophagus or provide pharyngoesophageal continuity.
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 878.3.
21 CFR 878.3680 Nose prosthesis.
(a) Identification. A nose prosthesis is a silicone rubber solid
device intended to be implanted to augment or reconstruct the nasal
dorsum.
(b) Classification. Class II.
21 CFR 878.3720 Tracheal prosthesis.
(a) Identification. A tracheal prosthesis is a tubular device
intended to be implanted to reconstruct the trachea.
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 878.3.
21 CFR 878.3750 External prosthesis adhesive.
(a) Identification. An external prosthesis adhesive is a
silicone-type adhesive intended to be used to fasten to the body an
external aesthetic restoration prosthesis, such as an artificial nose.
(b) Classification. Class I.
21 CFR 878.3800 External aesthetic restoration prosthesis.
(a) Identification. An external aesthetic restoration prosthesis is
a device intended to be used to construct an external artificial body
structure, such as an ear, breast, or nose. Usually the device is made
of silicone rubber and it may be fastened to the body with an external
prosthesis adhesive. The device is not intended to be implanted.
(b) Classification. Class I. If the device is intended for use
without an external prosthesis adhesive to fasten it to the body, the
device is exempt from the current good manufacturing practice
regulations in Part 820, with the exception of 820.180 of this chapter,
with respect to general requirements concerning records, and 820.198 of
this chapter, with respect to complaint files.
21 CFR 878.3900 Inflatable extremity splint.
(a) Identification. An inflatable extremity splint is a device
intended to be inflated to immobilize a limb or an extremity.
(b) Classification. Class I.
21 CFR 878.3910 Noninflatable extremity splint.
(a) Identification. A noninflatable extremity splint is a device
intended to immobilize a limb or an extremity. It is not inflatable.
(b) Classification. Class I. If the device is made of the same
materials that were used in the device before May 28, 1976, it is exempt
from the premarket notification procedures in Subpart E of Part 807 of
this chapter. If the device is not labeled or otherwise represented as
sterile, it is exempt from the current good manufacturing practice
regulations in Part 820 of this chapter, with the exception of 820.180,
with respect to the general requirements concerning records, and
820.198, with respect to complaint files.
(53 FR 23872, June 24, 1988, as amended at 54 FR 13827, Apr. 5, 1989)
21 CFR 878.3925 Plastic surgery kit and accessories.
(a) Identification. A plastic surgery kit and accessories is a
device intended to be used to reconstruct maxillofacial deficiencies.
The kit contains surgical instruments and materials used to make
maxillofacial impressions before molding an external prosthesis.
(b) Classification. Class I. If the device is made of the same
materials that were used in the device before May 28, 1976, it is exempt
from the premarket notification procedures in Subpart E of Part 807 of
this chapter.
(53 FR 23872, June 24, 1988, as amended at 54 FR 13827, Apr. 5, 1989)
21 CFR 878.3925 Subpart E -- Surgical Devices
21 CFR 878.4040 Surgical apparel.
(a) Identification. Surgical apparel are devices that are intended
to be worn by operating room personnel during surgical procedures to
protect both the surgical patient and the operating room personnel from
transfer of microorganisms, body fluids, and particulate material.
Examples include surgical caps, hoods, masks, gowns, operating room
shoes and shoe covers, and isolation masks and gowns. Surgical suits
and dresses, commonly known as scrub suits, are excluded.
(b) Classification. Class II for surgical gowns and surgical masks.
Class I for surgical apparel other than surgical gowns and surgical
masks.
21 CFR 878.4100 Organ bag.
(a) Identification. An organ bag is a device that is a flexible
plastic bag intended to be used as a temporary receptacle for an organ
during surgical procedures to prevent moisture loss.
(b) Classification. Class I.
21 CFR 878.4160 Surgical camera and accessories.
(a) Identification. A surgical camera and accessories is a device
intended to be used to record operative procedures.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(53 FR 23872, June 24, 1988, as amended at 54 FR 13827, Apr. 5, 1989)
21 CFR 878.4200 Introduction/drainage catheter and accessories.
(a) Identification. An introduction/drainage catheter is a device
that is a flexible single or multilumen tube intended to be used to
introduce nondrug fluids into body cavities other than blood vessels,
drain fluids from body cavities, or evaluate certain physiologic
conditions. Examples include irrigation and drainage catheters,
pediatric catheters, peritoneal catheters (including dialysis), and
other general surgical catheters. An introduction/drainage catheter
accessory is intended to aid in the manipulation of or insertion of the
device into the body. Examples of accessories include adaptors,
connectors, and catheter needles.
(b) Classification. Class I.
21 CFR 878.4300 Implantable clip.
(a) Identification. An implantable clip is a clip-like device
intended to connect internal tissues to aid healing. It is not
absorbable.
(b) Classification. Class II.
21 CFR 878.4320 Removable skin clip.
(a) Identification. A removable skin clip is a clip-like device
intended to connect skin tissues temporarily to aid healing. It is not
absorbable.
(b) Classification. Class I.
21 CFR 878.4350 Cryosurgical unit and accessories.
(a) Identification -- (1) Cryosurgical unit with a liquid nitrogen
cooled cryoprobe and accessories. A cryosurgical unit with a liquid
nitrogen cooled cryoprobe and accessories is a device intended to
destroy tissue during surgical procedures by applying extreme cold.
(2) Cryosurgical unit with a nitrous oxide cooled cryoprobe and
accessories. A cryosurgical unit with a nitrous oxide cooled cryoprobe
and accessories is a device intended to destroy tissue during surgical
procedures, including urological applications, by applying extreme cold.
(3) Cryosurgical unit with a carbon dioxide cooled cryoprobe or a
carbon dioxide dry ice applicator and accessories. A cryosurgical unit
with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice
applicator and accessories is a device intended to destroy tissue during
surgical procedures by applying extreme cold. The device is intended to
treat disease conditions such as tumors, skin cancers, acne scars, or
hemangiomas (benign tumors consisting of newly formed blood vessels) and
various benign or malignant gynecological conditions affecting vulvar,
vaginal, or cervical tissue. The device is not intended for urological
applications.
(b) Classification. Class II.
21 CFR 878.4370 Surgical drape and drape accessories.
(a) Identification. A surgical drape and drape accessories is a
device made of natural or synthetic materials intended to be used as a
protective patient covering, such as to isolate a site of surgical
incision from microbial and other contamination. The device includes a
plastic wound protector that may adhere to the skin around a surgical
incision or be placed in a wound to cover its exposed edges, and a latex
drape with a self-retaining finger cot that is intended to allow
repeated insertion of the surgeon's finger into the rectum during
performance of a transurethral prostatectomy.
(b) Classification. Class II.
21 CFR 878.4380 Drape adhesive.
(a) Identification. A drape adhesive is a device intended to be
placed on the skin to attach a surgical drape.
(b) Classification. Class I.
21 CFR 878.4400 Electrosurgical cutting and coagulation device and
accessories.
(a) Identification. An electrosurgical cutting and coagulation
device and accessories is a device intended to remove tissue and control
bleeding by use of high-frequency electrical current.
(b) Classification. Class II.
21 CFR 878.4440 Eye pad.
(a) Identification. An eye pad is a device that consists of a pad
made of various materials, such as gauze and cotton, intended for use as
a bandage over the eye for protection or absorption of secretions.
(b) Classification. Class I.
21 CFR 878.4450 Nonabsorbable gauze for internal use.
(a) Identification. Nonabsorbable gauze for internal use is a device
made of an open mesh fabric intended to be used inside the body or a
surgical incision or applied to internal organs or structures, to
control bleeding, absorb fluid, or protect organs or structures from
abrasion, drying, or contamination. The device is woven from material
made of not less than 50 percent by mass cotton, cellulose, or a simple
chemical derivative of cellulose, and contains x-ray detectable
elements.
(b) Classification. Class II.
21 CFR 878.4460 Surgeon's glove.
(a) Identification. A surgeon's glove is a device made of natural or
synthetic rubber intended to be worn by operating room personnel to
protect a surgical wound from contamination. The lubricating or dusting
powder used in the glove is excluded.
(b) Classification. Class I.
21 CFR 878.4470 Surgeon's gloving cream.
(a) Identification. Surgeon's gloving cream is an ointment intended
to be used to lubricate the user's hand before putting on a surgeon's
glove.
(b) Classification. Class I.
21 CFR 878.4480 Absorbable powder for lubricating a surgeon's glove.
(a) Identification. Absorbable powder for lubricating a surgeon's
glove is a powder made from corn starch that meets the specifications
for absorbable powder in the United States Pharmacopeia (U.S.P.) and
that is intended to be used to lubricate the surgeon's hand before
putting on a surgeon's glove. The device is absorbable through
biological degradation.
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. As of May
28, 1976, an approval under section 515 of the act is required before
this device may be commercially distributed. See 878.3.
21 CFR 878.4490 Absorbable hemostatic agent and dressing.
(a) Identification. An absorbable hemostatic agent or dressing is a
device intended to produce hemostasis by accelerating the clotting
process of blood. It is absorbable.
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. As of May
28, 1976, an approval under section 515 of the act is required before
this device may be commercially distributed. See 878.3.
21 CFR 878.4493 Absorbable poly(glycolide/L-lactide) surgical suture.
(a) Identification. An absorbable poly(glycolide/l-lactide) surgical
suture (PGL suture) is an absorbable sterile, flexible strand as
prepared and synthesized from homopolymers of glycolide and copolymers
made from 90 percent glycolide and 10 percent L-lactide, and is
indicated for use in soft tissue approximation. A PGL suture meets
United States Pharmacopeia (U.S.P.) requirements as described in the
U.S.P. ''Monograph for Absorbable Surgical Sutures;'' it may be
monofilament or multifilament (braided) in form; it may be uncoated or
coated; and it may be undyed or dyed with an FDA-approved color
additive. Also, the suture may be provided with or without a standard
needle attached.
(b) Classification. Class II.
(56 FR 47151, Sept. 18, 1991)
21 CFR 878.4520 Polytetrafluoroethylene injectable.
(a) Identification. Polytetrafluoroethylene injectable is an
injectable paste prosthetic device composed of polytetrafluoroethylene
intended to be used to augment or reconstruct a vocal cord.
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. As of May
28, 1976, an approval under section 515 of the act is required before
this device may be commercially distributed. See 878.3.
21 CFR 878.4580 Surgical lamp.
(a) Identification. A surgical lamp (including a fixture) is a
device intended to be used to provide visible illumination of the
surgical field or the patient.
(b) Classification. Class II.
21 CFR 878.4630 Ultraviolet lamp for dermatologic disorders.
(a) Identification. An ultraviolet lamp for dermatologic disorders
is a device (including a fixture) intended to provide ultraviolet
radiation of the body to photoactivate a drug in the treatment of a
dermatologic disorder if the labeling of the drug intended for use with
the device bears adequate directions for the device's use with that
drug.
(b) Classification. Class II.
21 CFR 878.4635 Ultraviolet lamp for tanning.
(a) Identification. An ultraviolet lamp for tanning is a device that
is a lamp (including a fixture) intended to provide ultraviolet
radiation to tan the skin. See 1040.20 of this chapter.
(b) Classification. Class I.
(55 FR 48440, Nov. 20, 1990)
21 CFR 878.4660 Skin marker.
(a) Identification. A skin marker is a pen-like device intended to
be used to write on the patient's skin, e.g., to outline surgical
incision sites or mark anatomical sites for accurate blood pressure
measurement.
(b) Classification. Class I.
21 CFR 878.4680 Nonpowered, single patient, portable suction apparatus.
(a) Identification. A nonpowered, single patient, portable suction
apparatus is a device that consists of a manually operated plastic,
disposable evacuation system intended to provide a vacuum for suction
drainage of surgical wounds.
(b) Classification. Class I.
21 CFR 878.4700 Surgical microscope and accessories.
(a) Identification. A surgical microscope and accessories is an
AC-powered device intended for use during surgery to provide a magnified
view of the surgical field.
(b) Classification. Class I.
(55 FR 48440, Nov. 20, 1990)
21 CFR 878.4730 Surgical skin degreaser or adhesive tape solvent.
(a) Identification. A surgical skin degreaser or an adhesive tape
solvent is a device that consists of a liquid such as
1,1,2-trichloro-1,2,2-trifluoroethane; 1,1,1-trichloroethane; and
1,1,1-trichloroethane with mineral spirits intended to be used to
dissolve surface skin oil or adhesive tape.
(b) Classification. Class I.
21 CFR 878.4750 Implantable staple.
(a) Identification. An implantable staple is a staple-like device
intended to connect internal tissues to aid healing. It is not
absorbable.
(b) Classification. Class II.
21 CFR 878.4760 Removable skin staple.
(a) Identification. A removable skin staple is a staple-like device
intended to connect external tissues temporarily to aid healing. It is
not absorbable.
(b) Classification. Class I.
21 CFR 878.4780 Powered suction pump.
(a) Identification. A powered suction pump is a portable, AC-powered
or compressed air-powered device intended to be used to remove
infectious materials from wounds or fluids from a patient's airway or
respiratory support system. The device may be used during surgery in
the operating room or at the patient's bedside. The device may include
a microbial filter.
(b) Classification. Class II.
21 CFR 878.4800 Manual surgical instrument for general use.
(a) Identification. A manual surgical instrument for general use is
a nonpowered, hand-held, or hand-manipulated device, either reusable or
disposable, intended to be used in various general surgical procedures.
The device includes the applicator, clip applier, biopsy brush, manual
dermabrasion brush, scrub brush, cannula, ligature carrier, chisel,
clamp, contractor, curette, cutter, dissector, elevator, skin graft
expander, file, forceps, gouge, instrument guide, needle guide, hammer,
hemostat, amputation hook, ligature passing and knot-tying instrument,
knife, blood lancet, mallet, disposable or reusable aspiration and
injection needle, disposable or reusable suturing needle, osteotome,
pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle,
one-piece scalpel, snare, spatula, stapler, disposable or reusable
stripper, stylet, suturing apparatus for the stomach and intestine,
measuring tape, and calipers. A surgical instrument that has
specialized uses in a specific medical specialty is classified in
separate regulations in Parts 868 through 892.
(b) Classification. Class I. If the device is made of the same
materials that were used in the device before May 28, 1976. it is
exempt from the premarket notification procedures in Subpart E of Part
807 of this chapter.
(53 FR 23872, June 24, 1988, as amended at 54 FR 13828, Apr. 5, 1989)
21 CFR 878.4810 Laser surgical instrument for use in general and
plastic surgery and in dermatology.
(a) Identification. (1) A carbon dioxide laser for use in general
surgery and in dermatology is a laser device intended to cut, destroy,
or remove tissue by light energy emitted by carbon dioxide.
(2) An argon laser for use in dermatology is a laser device intended
to destroy or coagulate tissue by light energy emitted by argon.
(b) Classification. Class II.
21 CFR 878.4820 Surgical instrument motors and accessories/attachments.
(a) Identification. Surgical instrument motors and accessories are
AC-powered, battery-powered, or air-powered devices intended for use
during surgical procedures to provide power to operate various
accessories or attachments to cut hard tissue or bone and soft tissue.
Accessories or attachments may include a bur, chisel (osteotome),
dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and
saw blade.
(b) Classification. Class I.
(55 FR 48440, Nov. 20, 1990)
21 CFR 878.4830 Absorbable surgical gut suture.
(a) Identification. An absorbable surgical gut suture, both plain
and chromic, is an absorbable, sterile, flexible thread prepared from
either the serosal connective tissue layer of beef (bovine) or the
submucosal fibrous tissue of sheep (ovine) intestine, and is intended
for use in soft tissue approximation.
(b) Classification. Class II.
(54 FR 50738, Dec. 11, 1989)
21 CFR 878.4930 Suture retention device.
(a) Identification. A suture retention device is a device, such as a
retention bridge, a surgical button, or a suture bolster, intended to
aid wound healing by distributing suture tension over a larger area in
the patient.
(b) Classification. Class I.
21 CFR 878.4950 Manual operating table and accessories and manual
operating chair and accessories.
(a) Identification. A manual operating table and accessories and a
manual operating chair and accessories are nonpowered devices, usually
with movable components, intended to be used to support a patient during
diagnostic examinations or surgical procedures.
(b) Classification. Class I. If the device is made of the same
materials that were used in the device before May 28, 1976, it is exempt
from the premarket notification procedures in Subpart E of Part 807 of
this chapter.
(53 FR 23872, June 24, 1988, as amended at 54 FR 13828, Apr. 5, 1989)
21 CFR 878.4960 Operating tables and accessories and operating chairs
and accessories.
(a) Identification. Operating tables and accessories and operating
chairs and accessories are AC-powered or air-powered devices, usually
with movable components, intended for use during diagnostic examinations
or surgical procedures to support and position a patient.
(b) Classification. Class I.
(55 FR 48440, Nov. 20, 1990)
21 CFR 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical
suture.
(a) Identification. Nonabsorbable poly(ethylene terephthalate)
surgical suture is a multifilament, nonabsorbable, sterile, flexible
thread prepared from fibers of high molecular weight, long-chain, linear
polyesters having recurrent aromatic rings as an integral component and
is indicated for use in soft tissue approximation. The poly(ethylene
terephthalate) surgical suture meets U.S.P. requirements as described in
the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be
provided uncoated or coated; and it may be undyed or dyed with an
appropriate FDA listed color additive. Also, the suture may be provided
with or without a standard needle attached.
(b) Classification. Class II.
(56 FR 24685, May 31, 1991)
21 CFR 878.5010 Nonabsorbable polypropylene surgical suture.
(a) Identification. Nonabsorbable polypropylene surgical suture is a
monofilament, nonabsorbable, sterile, flexible thread prepared from
long-chain polyolefin polymer known as polypropylene and is indicated
for use in soft tissue approximation. The polypropylene surgical suture
meets United States Pharmacopeia (U.S.P.) requirements as described in
the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be
undyed or dyed with an FDA approved color additive; and the suture may
be provided with or without a standard needle attached.
(b) Classification. Class II.
(56 FR 24685, May 31, 1991)
21 CFR 878.5020 Nonabsorbable polyamide surgical suture.
(a) Identification. Nonabsorbable polyamide surgical suture is a
nonabsorbable, sterile, flexible thread prepared from long-chain
aliphatic polymers Nylon 6 and Nylon 6,6 and is indicated for use in
soft tissue approximation. The polyamide surgical suture meets United
States Pharmacopeia (U.S.P.) requirements as described in the U.S.P.
monograph for nonabsorbable surgical sutures; it may be monofilament or
multifilament in form; it may be provided uncoated or coated; and it
may be undyed or dyed with an appropriate FDA listed color additive.
Also, the suture may be provided with or without a standard needle
attached.
(b) Classification. Class II.
(56 FR 24685, May 31, 1991)
21 CFR 878.5020 Subpart F -- Therapeutic Devices
21 CFR 878.5070 Air-handling apparatus for a surgical operating room.
(a) Identification. Air-handling apparatus for a surgical operating
room is a device intended to produce a directed, nonturbulent flow of
air that has been filtered to remove particulate matter and
microorganisms to provide an area free of contaminants to reduce the
possibility of infection in the patient.
(b) Classification. Class II.
21 CFR 878.5350 Needle-type epilator.
(a) Identification. A needle-type epilator is a device intended to
destroy the dermal papilla of a hair by applying electric current at the
tip of a fine needle that has been inserted close to the hair shaft,
under the skin, and into the dermal papilla. The electric current may
be high-frequency AC current, high-frequency AC combined with DC
current, or DC current only.
(b) Classification. Class II.
21 CFR 878.5360 Tweezer-type epilator.
(a) Identification. A tweezer-type epilator is an electrical device
intended for hair removal. The device provides a high-frequency
electric current at the tip of a tweezer used for removing hair.
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 878.3.
21 CFR 878.5650 Topical oxygen chamber for extremities.
(a) Identification. A topical oxygen chamber for extremities is a
device intended to surround hermetically a patient's limb and apply
humidified oxygen topically at a pressure slightly greater than
atmospheric pressure to aid healing of chronic skin ulcers or bed sores.
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 878.3.
21 CFR 878.5900 Nonpneumatic tourniquet.
(a) Identification. A nonpneumatic tourniquet is a device consisting
of a strap or tubing intended to be wrapped around a patient's limb and
tightened to reduce circulation.
(b) Classification. Class I. If the device is made of the same
materials that were used in the device before May 28, 1976, it is exempt
from the premarket notification procedures in Subpart E of Part 807 of
this chapter.
(53 FR 23872, June 24, 1988, as amended at 54 FR 13828, Apr. 5, 1989)
21 CFR 878.5910 Pneumatic tourniquet.
(a) Identification. A pneumatic tourniquet is an air-powered device
consisting of a pressure-regulating unit, connecting tubing, and an
inflatable cuff. The cuff is intended to be wrapped around a patient's
limb and inflated to reduce or totally occlude circulation during
surgery.
(b) Classification. Class II.
21 CFR 878.5910 Pt. 880
21 CFR 878.5910 PART 880 -- GENERAL HOSPITAL AND PERSONAL USE DEVICES
21 CFR 878.5910 Subpart A -- General Provisions
Sec.
880.1 Scope.
880.3 Effective dates of requirement for premarket approval.
880.9 Limitations of exemptions from section 510(k) of the Federal
Food, Drug, and Cosmetic Act (the act).
21 CFR 878.5910 Subpart B -- (Reserved)
21 CFR 878.5910 Subpart C -- General Hospital and Personal Use
Monitoring Devices
880.2200 Liquid crystal forehead temperature strip.
880.2400 Bed-patient monitor.
880.2420 Electronic monitor for gravity flow infusion systems.
880.2460 Electrically powered spinal fluid pressure monitor.
880.2500 Spinal fluid manometer.
880.2700 Stand-on patient scale.
880.2720 Patient scale.
880.2740 Surgical sponge scale.
880.2800 Sterilization process indicator.
880.2900 Clinical color change thermometer.
880.2910 Clinical electronic thermometer.
880.2920 Clinical mercury thermometer.
21 CFR 878.5910 Subparts D-E -- (Reserved)
21 CFR 878.5910 Subpart F -- General Hospital and Personal Use
Therapeutic Devices
880.5025 I.V. container.
880.5045 Medical recirculating air cleaner.
880.5075 Elastic bandage.
880.5090 Liquid bandage.
880.5100 AC-powered adjustable hospital bed.
880.5110 Hydraulic adjustable hospital bed.
880.5120 Manual adjustable hospital bed.
880.5130 Infant radiant warmer.
880.5140 Pediatric hospital bed.
880.5150 Nonpowered flotation therapy mattress.
880.5160 Therapeutic medical binder.
880.5180 Burn sheet.
880.5200 Intravascular catheter.
880.5210 Intravascular catheter securement device.
880.5240 Medical adhesive tape and adhesive bandage.
880.5270 Neonatal eye pad.
880.5300 Medical absorbent fiber.
880.5400 Neonatal incubator.
880.5410 Neonatal transport incubator.
880.5420 Pressure infusor for an I.V. bag.
880.5430 Nonelectrically powered fluid injector.
880.5440 Intravascular administration set.
880.5450 Patient care reverse isolation chamber.
880.5475 Jet lavage.
880.5500 AC-powered patient lift.
880.5510 Non-AC-powered patient lift.
880.5550 Alternating pressure air flotation mattress.
880.5560 Temperature regulated water mattress.
880.5570 Hypodermic single lumen needle.
880.5630 Nipple shield.
880.5640 Lamb feeding nipple.
880.5680 Pediatric position holder.
880.5700 Neonatal phototherapy unit.
880.5725 Infusion pump.
880.5740 Suction snakebite kit.
880.5760 Chemical cold pack snakebite kit.
880.5780 Medical support stocking.
880.5820 Therapeutic scrotal support.
880.5860 Piston syringe.
880.5950 Umbilical occlusion device.
21 CFR 878.5910 Subpart G -- General Hospital and Personal Use
Miscellaneous Devices
880.6025 Absorbent tipped applicator.
880.6050 Ice bag.
880.6060 Medical disposable bedding.
880.6070 Bed board.
880.6080 Cardiopulmonary resuscitation board.
880.6085 Hot/cold water bottle.
880.6100 Ethylene oxide gas aerator cabinet.
880.6140 Medical chair and table.
880.6150 Ultrasonic cleaner for medical instruments.
880.6175 (Reserved)
880.6185 Cast cover.
880.6190 Mattress cover for medical purposes.
880.6200 Ring cutter.
880.6230 Tongue depressor.
880.6250 Patient examination glove.
880.6265 Examination gown.
880.6280 Medical insole.
880.6320 AC-powered medical examination light.
880.6350 Battery-powered medical examination light.
880.6375 Patient lubricant.
880.6430 Liquid medication dispenser.
880.6450 Skin pressure protectors.
880.6500 Medical ultraviolet air purifier.
880.6710 Medical ultraviolet water purifier.
880.6730 Body waste receptacle.
880.6740 Vacuum-powered body fluid suction apparatus.
880.6760 Protective restraint.
880.6775 Powered patient transfer device.
880.6785 Manual patient transfer device.
880.6800 Washer for body waste receptacles.
880.6820 Medical disposable scissors.
880.6850 Sterilization wrap.
880.6860 Ethylene oxide gas sterilizer.
880.6870 Dry-heat sterilizer.
880.6880 Steam sterilizer.
880.6900 Hand-carried stretcher.
880.6910 Wheeled stretcher.
880.6920 Syringe needle introducer.
880.6960 Irrigating syringe.
880.6970 Liquid crystal vein locator.
880.6980 Vein stabilizer.
Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j, 371).
Source: 45 FR 69682-69737, Oct. 21, l980, unless otherwise noted.
21 CFR 878.5910 Subpart A -- General Provisions
21 CFR 880.1 Scope.
(a) This part sets forth the classification of general hospital and
personal use devices intended for human use that are in commercial
distribution.
(b) The identification of a device in a regulation in this part is
not a precise description of every device that is, or will be, subject
to the regulation. A manufacturer who submits a premarket notification
submission for a device under Part 807 may not show merely that the
device is accurately described by the section title and identification
provisions of a regulation in this part, but shall state why the device
is substantially equivalent to other devices, as required by 807.87.
(c) To avoid duplicative listings, a general hospital and personal
use device that has two or more types of uses (e.g., used both as a
diagnostic device and as a therapeutic device) is listed only in one
subpart.
(d) References in this part to regulatory sections of the Code of
Federal Regulations are to Chapter I of Title 21, unless otherwise
noted.
(52 FR 17738, May 11, 1987)
21 CFR 880.3 Effective dates of requirement for premarket approval.
A device included in this part that is classified into class III
(premarket approval) shall not be commercially distributed after the
date shown in the regulation classifying the device unless the
manufacturer has an approval under section 515 of the act (unless an
exemption has been granted under section 520(g)(2) of the act). An
approval under section 515 of the act consists of FDA's issuance of an
order approving an application for premarket approval (PMA) for the
device or declaring completed a product development protocol (PDP) for
the device.
(a) Before FDA requires that a device commercially distributed before
the enactment date of the amendments, or a device that has been found
substantially equivalent to such a device, has an approval under section
515 of the act FDA must promulgate a regulation under section 515(b) of
the act requiring such approval, except as provided in paragraph (b) of
this section. Such a regulation under section 515(b) of the act shall
not be effective during the grace period ending on the 90th day after
its promulgation or on the last day of the 30th full calendar month
after the regulation that classifies the device into class III is
effective, whichever is later. See section 501(f)(2)(B) of the act.
Accordingly, unless an effective date of the requirement for premarket
approval is shown in the regulation for a device classified into class
III in this part, the device may be commercially distributed without
FDA's issuance of an order approving a PMA or declaring completed a PDP
for the device. If FDA promulgates a regulation under section 515(b) of
the act requiring premarket approval for a device, section 501(f)(1)(A)
of the act applies to the device.
(b) Any new, not substantially equivalent, device introduced into
commercial distribution on or after May 28, 1976, including a device
formerly marketed that has been substantially altered, is classified by
statute (section 513(f) of the act) into class III without any grace
period and FDA must have issued an order approving a PMA or declaring
completed a PDP for the device before the device is commercially
distributed unless it is reclassified. If FDA knows that a device being
commercially distributed may be a ''new'' devices defined in this
section because of any new intended use or other reasons, FDA may codify
the statutory classification of the device into class III for such new
use. Accordingly, the regulation for such a class III device states
that as of the enactment date of the amendments, May 28, 1976, the
device must have an approval under section 515 of the act before
commercial distribution.
(52 FR 17738, May 11, 1987)
21 CFR 880.9 Limitations of exemptions from section 510(k) of the
Federal Food, Drug, and Cosmetic Act (the act).
The Food and Drug Administration's (FDA's) decision to grant an
exemption from the requirement of premarket notification (section 510(k)
of the act) for a generic type of class I device is based upon the
existing and reasonably foreseeable characteristics of commercially
distributed devices within that generic type. Because FDA cannot
anticipate every change in intended use or characteristic that could
significantly affect a device's safety or effectiveness, manufacturers
of any commercially distributed class I device for which FDA has granted
an exemption from the requirement of premarket notification must still
submit a premarket notification to FDA before introducing or delivering
for introduction into interstate commerce for commercial distribution
the device when:
(a) The device is intended for a use different from its intended use
before May 28, 1976, or the device is intended for a use different from
the intended use of a preamendments device to which it had been
determined to be substantially equivalent; e.g., the device is intended
for a different medical purpose, or the device is intended for lay use
where the former intended use was by health care professionals only; or
(b) The modified device operates using a different fundamental
scientific technology than that in use in the device before May 28,
1976; e.g., a surgical instrument cuts tissue with a laser beam rather
than with a sharpened metal blade, or an in vitro diagnostic device
detects or identifies infectious agents by using a deoxyribonucleic acid
(DNA) probe or nucleic acid hybridization technology rather than culture
or immunoassay technology.
(54 FR 25050, June 12, 1989)
21 CFR 880.9 Subpart B -- (Reserved)
21 CFR 880.9 Subpart C -- General Hospital and Personal Use Monitoring Devices
21 CFR 880.2200 Liquid crystal forehead temperature strip.
(a) Identification. A liquid crystal forehead temperature strip is a
device applied to the forehead that is used to indicate the presence or
absence of fever, or to monitor body temperature changes. The device
displays the color changes of heat sensitive liquid crystals
corresponding to the variation in the surface temperature of the skin.
The liquid crystals, which are cholesteric esters, are sealed in
plastic.
(b) Classification. Class II (performance standards).
21 CFR 880.2400 Bed-patient monitor.
(a) Identification. A bed-patient monitor is a battery-powered
device placed under a mattress and used to indicate by an alarm or other
signal when a patient attempts to leave the bed.
(b) Classification. Class I (general controls).
21 CFR 880.2420 Electronic monitor for gravity flow infusion systems.
(a) Identification. An electronic monitor for gravity flow infusion
systems is a device used to monitor the amount of fluid being infused
into a patient. The device consists of an electronic transducer and
equipment for signal amplification, conditioning, and display.
(b) Classification. Class II (performance standards).
21 CFR 880.2460 Electrically powered spinal fluid pressure monitor.
(a) Identification. An electrically powered spinal fluid pressure
monitor is an electrically powered device used to measure spinal fluid
pressure by the use of a transducer which converts spinal fluid pressure
into an electrical signal. The device includes signal amplification,
conditioning, and display equipment.
(b) Classification. Class II (performance standards).
21 CFR 880.2500 Spinal fluid manometer.
(a) Identification. A spinal fluid manometer is a device used to
measure spinal fluid pressure. The device uses a hollow needle, which
is inserted into the spinal column fluid space, to connect the spinal
fluid to a graduated column so that the pressure can be measured by
reading the height of the fluid.
(b) Classification. Class II (performance standards).
21 CFR 880.2700 Stand-on patient scale.
(a) Identification. A stand-on patient scale is a device intended
for medical purposes that is used to weigh a patient who is able to
stand on the scale platform.
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in Subpart E of Part
807. The device also is exempt from the good manufacturing practice
regulation in Part 820, with the exception of 820.180, with respect to
general requirements concerning records, and 820.198, with respect to
complaint files.
21 CFR 880.2720 Patient scale.
(a) Identification. A patient scale is a device intended for medical
purposes that is used to measure the weight of a patient who cannot
stand on a scale. This generic device includes devices placed under a
bed or chair to weigh both the support and the patient, devices where
the patient is lifted by a sling from a bed to be weighed, and devices
where the patient is placed on the scale platform to be weighed. The
device may be mechanical, battery powered, or AC-powered and may include
transducers, electronic signal amplification, conditioning and display
equipment.
(b) Classification. (1) Class I (general controls) for a mechanical
or battery powered patient scale.
(2) Class II (performance standards) for an AC-powered patient scale.
21 CFR 880.2740 Surgical sponge scale.
(a) Identification. A surgical sponge scale is a nonelectrically
powered device used to weigh surgical sponges that have been used to
absorb blood during surgery so that, by comparison with the known dry
weight of the sponges, an estimate may be made of the blood lost by the
patient during surgery.
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in Subpart E of Part
807. The device also is exempt from the good manufacturing practice
regulation in Part 820 with the exception of 820.180, with respect to
general requirements concerning records, and 820.198, with respect to
complaint files.
21 CFR 880.2800 Sterilization process indicator.
(a) Biological sterilization process indicator -- (1) Identification.
A biological sterilization process indicator is a device intended for
use by a health care provider to accompany products being sterilized
through a sterilization procedure and to monitor adequacy of
sterilization. The device consists of a known number of microorganisms,
of known resistance to the mode of sterilization, in or on a carrier and
enclosed in a protective package. Subsequent growth or failure of the
microorganisms to grow under suitable conditions indicates the adequacy
of sterilization.
(2) Classification. Class II (performance standards).
(b) Physical/chemical sterilization process indicator -- (1)
Identification. A physical/chemical sterilization process indicator is
a device intended for use by a health care provider to accompany
products being sterilized through a sterilization procedure and to
monitor one or more parameters of the sterilization process. The
adequacy of the sterilization conditions as measured by these parameters
is indicated by a visible change in the device.
(2) Classification. Class II (performance standards).
21 CFR 880.2900 Clinical color change thermometer.
(a) Identification. A clinical color change thermometer is a
disposable device used to measure a patient's oral, rectal, or axillary
(armpit) body temperature. The device records body temperature by use
of heat sensitive chemicals which are sealed at the end of a plastic or
metal strip. Body heat causes a stable color change in the heat
sensitive chemicals.
(b) Classification. Class II (performance standards).
21 CFR 880.2910 Clinical electronic thermometer.
(a) Identification. A clinical electronic thermometer is a device
used to measure the body temperature of a patient by means of a
transducer coupled with an electronic signal amplification,
conditioning, and display unit. The transducer may be in a detachable
probe with or without a disposable cover.
(b) Classification. Class II (performance standards).
21 CFR 880.2920 Clinical mercury thermometer.
(a) Identification. A clinical mercury thermometer is a device used
to measure oral, rectal, or axillary (armpit) body temperature using the
thermal expansion of mercury.
(b) Classification. Class II (performance standards).
21 CFR 880.2920 Subparts D-E -- (Reserved)
21 CFR 880.2920 Subpart F -- General Hospital and Personal Use Therapeutic Devices
21 CFR 880.5025 I.V. container.
(a) Identification. An I.V. container is a container made of plastic
or glass used to hold a fluid mixture to be administered to a patient
through an intravascular administration set.
(b) Classification. Class II (performance standards).
21 CFR 880.5045 Medical recirculating air cleaner.
(a) Identification. A medical recirculating air cleaner is a device
used to remove particles from the air for medical purposes. The device
may function by electrostatic precipitation or filtration.
(b) Classification. Class II (performance standards).
21 CFR 880.5075 Elastic bandage.
(a) Identification. An elastic bandage is a device consisting of
either a long flat strip or a tube of elasticized material that is used
to support and compress a part of a patient's body.
(b) Classification. Class I (general controls). The device is
exempt from premarket notification procedures in Subpart E of Part 807.
If the device is not labeled or otherwise represented as sterile, it
also is exempt from the good manufacturing practice regulation in Part
820, with the exception of 820.180, with respect to general
requirements concerning records, and 820.198, with respect to complaint
files.
21 CFR 880.5090 Liquid bandage.
(a) Identification. A liquid bandage is a sterile device that is a
liquid, semiliquid, or powder and liquid combination used to cover an
opening in the skin or as a dressing for burns. The device is also used
as a topical skin protectant.
(b) Classification. Class I (general controls).
21 CFR 880.5100 AC-powered adjustable hospital bed.
(a) Identification. An AC-powered adjustable hospital bed is a
device intended for medical purposes that consists of a bed with a
built-in electric motor and remote controls that can be operated by the
patient to adjust the height and surface contour of the bed. The device
includes movable and latchable side rails.
(b) Classification. Class II (performance standards).
21 CFR 880.5110 Hydraulic adjustable hospital bed.
(a) Identification. A hydraulic adjustable hospital bed is a device
intended for medical purposes that consists of a bed with a hydraulic
mechanism operated by an attendant to adjust the height and surface
contour of the bed. The device includes movable and latchable side
rails.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
21 CFR 880.5120 Manual adjustable hospital bed.
(a) Identification. A manual adjustable hospital bed is a device
intended for medical purposes that consists of a bed with a manual
mechanism operated by an attendant to adjust the height and surface
contour of the bed. The device includes movable and latchable side
rails.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter. The device is also exempt from the current good manufacturing
practice regulations in Part 820 of this chapter, with the exception of
820.180, regarding general requirements concerning records, and
820.198, regarding complaint files.
(45 FR 69682-69737, Oct. 21, 1980, as amended at 54 FR 25050, June
12, 1989)
21 CFR 880.5130 Infant radiant warmer.
(a) Identification. An infant radiant warmer is a device consisting
of an infrared heating element intended to be placed over an infant to
maintain the infant's body temperature by means of radiant heat. The
device may also contain a temperature monitoring sensor, a heat output
control mechanism and an alarm to alert operators of the device's
failure. The device may be placed over a pediatric hospital bed or it
may be built into the bed as a complete unit.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 880.3.
(45 FR 69682-69737, Oct. 21, 1980, as amended at 52 FR 17739, May 11,
1987)
21 CFR 880.5140 Pediatric hospital bed.
(a) Identification. A pediatric hospital bed is a device intended
for medical purposes that consists of a bed or crib designed for the use
of a pediatric patient, with fixed end rails and movable and latchable
side rails. The contour of the bed surface may be adjustable.
(b) Classification. Class II (performance standards).
21 CFR 880.5150 Nonpowered flotation therapy mattress.
(a) Identification. A nonpowered flotation therapy mattress is a
mattress intended for medical purposes which contains air, fluid, or
other materials that have the functionally equivalent effect of
supporting a patient and avoiding excess pressure on local body areas.
The device is intended to treat or prevent decubitus ulcers (bed sores).
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in Subpart E of Part
807. The device also is exempt from the good manufacturing practice
regulation in Part 820, with the exception of 820.180, with respect to
general requirements concerning records, and 820.198, with respect to
complaint files.
21 CFR 880.5160 Therapeutic medical binder.
(a) Identification. A therapeutic medical binder is a device,
usually made of cloth, that is intended for medical purposes and that
can be secured by ties so that it supports the underlying part of the
body or holds a dressing in place. This generic type of device includes
the abdominal binder, breast binder, and perineal binder.
(b) Classification. Class I (general controls). The device is
exempt from the premarket notifiction procedures in Subpart E of Part
807. If the device is not labeled or otherwise represented as sterile,
it also is exempt from the good manufacturing practice regulation in
Part 820, with the exception of 820.180, with respect to general
requirements concerning records, and 820.198, with respect to complaint
files.
21 CFR 880.5180 Burn sheet.
(a) Identification. A burn sheet is a device made of a porous
material that is wrapped aroung a burn victim to retain body heat, to
absorb wound exudate, and to serve as a barrier against contaminants.
(b) Classification. Class I (general Controls).
21 CFR 880.5200 Intravascular catheter.
(a) Identification. An intravascular catheter is a device that
consists of a slender tube and any necessary connecting fittings and
that is inserted into the patient's vascular system for short term use
(less than 30 days) to sample blood, monitor blood pressure, or
administer fluids intravenously. The device may be constructed of
metal, rubber, plastic, or a combination of these materials.
(b) Classification. Class II (performance standards).
21 CFR 880.5210 Intravascular catheter securement device.
(a) Identification. An intravascular catheter securement device is a
device with an adhesive backing that is placed over a needle or catheter
and is used to keep the hub of the needle or the catheter flat and
securely anchored to the skin.
(b) Classification. Class I (general controls).
21 CFR 880.5240 Medical adhesive tape and adhesive bandage.
(a) Identification. A medical adhesive tape or adhesive bandage is a
device intended for medical purposes that consists of a strip of fabric
material or plastic, coated on one side with an adhesive, and may
include a pad of surgical dressing without a disinfectant. The device
is used to cover and protect wounds, to hold together the skin edges of
a wound, to support an injured part of the body, or to secure objects to
the skin.
(b) Classification. Class I (general controls).
21 CFR 880.5270 Neonatal eye pad.
(a) Identification. A neonatal eye pad is an opaque device used to
cover and protect the eye of an infant during therapeutic procedures,
such as phototherapy.
(b) Classification. Class I (general controls). If the device is
not labeled or otherwise represented as sterile, it is exempt from the
good manufacturing practice regulation Part 820, with the exception of
820.180, with respect to general requirements concerning records, and
820.198, with respect to complaint files.
21 CFR 880.5300 Medical absorbent fiber.
(a) Identification. A medical absorbent fiber is a device intended
for medical purposes that is made from cotton or synthetic fiber in the
shape of a ball or a pad and that is used for applying medication to, or
absorbing small amounts of body fluids from, a patient's body surface.
Absorbent fibers intended solely for cosmetic purposes are not included
in this generic device category.
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in Subpart E of Part
807. If the device is not labeled or otherwise represented as sterile,
it also is exempt from the good manufacturing practice regulation in
Part 820, with the exception of 820.180, with respect to general
requirements concerning records, and 820.198, with respect to complaint
files.
21 CFR 880.5400 Neonatal incubator.
(a) Identification. A neonatal incubator is a device consisting of a
rigid boxlike enclosure in which an infant may be kept in a controlled
environment for medical care. The device may include an AC-powered
heater, a fan to circulate the warmed air, a container for water to add
humidity, a control valve through which oxygen may be added, and access
ports for nursing care.
(b) Classification. Class II (performance standards).
21 CFR 880.5410 Neonatal transport incubator.
(a) Identification. A neonatal transport incubator is a device
consisting of a portable rigid boxlike enclosure with insulated walls in
which an infant may be kept in a controlled environment while being
transported for medical care. The device may include straps to secure
the infant, a battery-operated heater, an AC-powered battery charger, a
fan to circulate the warmed air, a container for water to add humidity,
and provision for a portable oxygen bottle.
(b) Classification. Class II (performance standards).
21 CFR 880.5420 Pressure infusor for an I.V. bag.
(a) Identification. A pressure infusor for an I.V. bag is a device
consisting of an inflatable cuff which is placed around an I.V. bag.
When the device is inflated, it increases the pressure on the I.V. bag
to assist the infusion of the fluid.
(b) Classification. Class I (general controls).
21 CFR 880.5430 Nonelectrically powered fluid injector.
(a) Identification. A nonelectrically powered fluid injector is a
nonelectrically powered device used by a health care provider to give a
hypodermic injection by means of a narrow, high velocity jet of fluid
which can penetrate the surface of the skin and deliver the fluid to the
body. It may be used for mass inoculations.
(b) Classification. Class II (performance standards).
21 CFR 880.5440 Intravascular administration set.
(a) Identification. An intravascular administration set is a device
used to administer fluids from a container to a patient's vascular
system through a needle or catheter inserted into a vein. The device
may include the needle or catheter, tubing, a flow regulator, a drip
chamber, an infusion line filter, an I.V. set stopcock, fluid delivery
tubing, connectors between parts of the set, a side tube with a cap to
serve as an injection site, and a hollow spike to penetrate and connect
the tubing to an I.V. bag or other infusion fluid container.
(b) Classification. Class II (performance standards).
21 CFR 880.5450 Patient care reverse isolation chamber.
(a) Identification. A patient care reverse isolation chamber is a
device consisting of a roomlike enclosure designed to prevent the entry
of harmful airborne material. This device protects a patient who is
undergoing treatment for burns or is lacking a normal immunosuppressive
defense due to therapy or congenital abnormality. The device includes
fans and air filters which maintain an atmosphere of clean air at a
pressure greater than the air pressure outside the enclosure.
(b) Classification. Class II (performance standards).
21 CFR 880.5475 Jet lavage.
(a) Identification. A jet lavage is a device used to clean a wound
by a pulsatile jet of sterile fluid. The device consists of the pulsing
head, tubing to connect to a container of sterile fluid, and a means of
propelling the fluid through the tubing, such as an electric roller
pump.
(b) Classification. Class II (performance standards).
21 CFR 880.5500 AC-powered patient lift.
(a) Identification. An AC-powered lift is an electrically powered
device either fixed or mobile, used to lift and transport patients in
the horizontal or other required position from one place to another, as
from a bed to a bath. The device includes straps and slings to support
the patient.
(b) Classification. Class II (performance standards).
21 CFR 880.5510 Non-AC-powered patient lifts.
(a) Identification. A non-AC-powered patient lift is a hydraulic,
battery, or mechanically powered device, either fixed or mobile, used to
lift and transport a patient in the horizontal or other required
position from one place to another, as from a bed to a bath. The device
includes straps and a sling to support the patient.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(45 FR 69682-69737, Oct. 21, 1980, as amended at 54 FR 25050, June
12, 1989)
21 CFR 880.5550 Alternating pressure air flotation mattress.
(a) Identification. An alternating pressure air flotation mattress
is a device intended for medical purposes that consists of a mattress
with multiple air cells that can be filled and emptied in an alternating
pattern by an associated control unit to provide regular, frequent, and
automatic changes in the distribution of body pressure. The device is
used to prevent and treat decubitus ulcers (bed sores).
(b) Classification. Class II (performance standards).
21 CFR 880.5560 Temperature regulated water mattress.
(a) Identification. A temperature regulated water mattress is a
device intended for medical purposes that consists of a mattress of
suitable size, filled with water which can be heated or in some cases
cooled. The device includes electrical heating and water circulating
components, and an optional cooling component. The temperature control
may be manual or automatic.
(b) Classification. Class II (performance standards).
21 CFR 880.5570 Hypodermic single lumen needle.
(a) Identification. A hypodermic single lumen needle is a device
intended to inject fluids into, or withdraw fluids from, parts of the
body below the surface of the skin. The device consists of a metal tube
that is sharpened at one end and at the other end joined to a female
connector (hub) designed to mate with a male connector (nozzle) of a
piston syringe or an intravascular administration set.
(b) Classification. Class II (performance standards).
21 CFR 880.5630 Nipple shield.
(a) Identification. A nipple shield is a device consisting of a
cover used to protect the nipple of a nursing woman. This generic
device does not include nursing pads intended solely to protect the
clothing of a nursing woman from milk.
(b) Classification. Class I (general controls).
21 CFR 880.5640 Lamb feeding nipple.
(a) Identification. A lamb feeding nipple is a device intended for
use as a feeding nipple for infants with oral or facial abnormalities.
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in Subpart E of Part
807. If the device is not labeled or otherwise represented as sterile,
it also is exempt from the good manufacturing practice regulation in
Part 820, with the exception of 820.180, with respect to general
requirements concerning records, and 820.198, with respect to complaint
files.
21 CFR 880.5680 Pediatric position holder.
(a) Identification. A pediatric position holder is a device used to
hold an infant or a child in a desired position for therapeutic or
diagnostic purposes, e.g., in a crib under a radiant warmer, or to
restrain a child while an intravascular injection is administered.
(b) Classification. Class I (general controls). The device is
exempt from the good manufacturing practice regulation in Part 820, with
the exception of 820.180, with respect to general requirements
concerning records, and 820.198, with respect to complaint files.
21 CFR 880.5700 Neonatal phototherapy unit.
(a) Identification. A neonatal phototherapy unit is a device used to
treat or prevent hyperbilirubinemia (elevated serum bilirubin level).
The device consists of one or more lamps that emit a specific spectral
band of light, under which an infant is placed for therapy. This
generic type of device may include supports for the patient and
equipment and component parts.
(b) Classification. Class II (performance standards).
21 CFR 880.5725 Infusion pump.
(a) Identification. An infusion pump is a device used in a health
care facility to pump fluids into a patient in a controlled manner. The
device may use a piston pump, a roller pump, or a peristaltic pump and
may be powered electrically or mechanically. The device may also
operate using a constant force to propel the fluid through a narrow tube
which determines the flow rate. The device may include means to detect
a fault condition, such as air in, or blockage of, the infusion line and
to activate an alarm.
(b) Classification. Class II (performance standards).
21 CFR 880.5740 Suction snakebite kit.
(a) Identification. A suction snakebite kit is a device consisting
of a knife, suction device, and tourniquet used for first-aid treatment
of snakebites by removing venom from the wound.
(b) Classification. Class I (general controls.).
21 CFR 880.5760 Chemical cold pack snakebite kit.
(a) Identification. A chemical cold pack snakebit kit is a device
consisting of a chemical cold pack and tourniquet used for first-aid
treatment of snakebites.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 880.3.
(45 FR 69682-69737, Oct. 21, 1980, as amended at 52 FR 17739, May 11,
1987)
21 CFR 880.5780 Medical support stocking.
(a) Medical support stocking to prevent the pooling of blood in the
legs -- (1) Identification. A medical support stocking to prevent the
pooling of blood in the legs is a device that is constructed of elastic
material and designed to apply controlled pressure to the leg and that
is intended for use in the prevention of pooling of blood in the leg.
(2) Classification. Class II (performance standards).
(b) Medical support stocking for general medical purposes -- (1)
Identification. A medical support stocking for general medical purposes
is a device that is constructed of elastic material and designed to
apply controlled pressure to the leg and that is intended for medical
purposes other than the prevention of pooling of blood in the leg.
(2) Classification. Class I (general controls). The device is
exempt from the good manufacturing practice regulation in Part 820, with
the exception of 820.180, with respect to general requirements
concerning records, and 820.198, with respect to complaint files.
21 CFR 880.5820 Therapeutic scrotal support.
(a) Identification. A therapeutic scrotal support is a device
intended for medical purposes that consist of a pouch attached to an
elastic waistband and that is used to support the scrotum (the sac that
contains the testicles).
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in Subpart E of Part
807. The device also is exempt from the good manufacturing practice
regulation in Part 820, with the exception of 820.180, with respect to
general requirements concerning records, and 820.198, with respect to
complaint files.
21 CFR 880.5860 Piston syringe.
(a) Identification. A piston syringe is a device intended for
medical purposes that consists of a calibrated hollow barrel and a
movable plunger. At one end of the barrel there is a male connector
(nozzle) for fitting the female connector (hub) of a hypodermic single
lumen needle. The device is used to inject fluids into, or withdraw
fluids from, the body.
(b) Classification. Class II (performance standards).
21 CFR 880.5950 Umbilical occlusion device.
(a) Identification. An umbilical occlusion device is a clip, tie,
tape, or other article used to close the blood vessels in the umbilical
cord of a newborn infant.
(b) Classification. Class I (general controls).
21 CFR 880.5950 Subpart G -- General Hospital and Personal Use Miscellaneous Devices
21 CFR 880.6025 Absorbent tipped applicator.
(a) Identification. An absorbent tipped applicator is a device
intended for medical purposes that consists of an absorbent swab on a
wooden, paper, or plastic stick. The device is used to apply
medications to, or to take specimens from, a patient.
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in Subpart E of Part
807. If the device is not labeled or otherwise represented as sterile,
it also is exempt from the good manufacturing practice regulation in
Part 820, with the exception of 820.180, with respect to general
requirements concerning records, and 820.198, with respect to complaint
files.
21 CFR 880.6050 Ice bag.
(a) Identification. An ice bag is a device intended for medical
purposes that is in the form of a container intended to be filled with
ice that is used to apply dry cold therapy to an area of the body. The
device may include a holder that keeps the bag in place against an
external area of the patient.
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in Subpart E of Part
807. If the device is not labeled or otherwise represented as sterile,
it also is exempt from the good manufacturing practice regulation in
Part 820, with the exception of 820.180, with respect to general
requirements concerning records, and 820.198, with respect to complaint
files.
21 CFR 880.6060 Medical disposable bedding.
(a) Identification. Medical disposable bedding is a device intended
for medical purposes to be used by one patient for a period of time and
then discarded. This generic type of device may include disposable
bedsheets, bedpads, pillows and pillowcases, blankets, emergency rescue
blankets, or waterproof sheets.
(b) Classification. Class I (general controls). If the device is
not labeled or otherwise represented as sterile, it is exempt from the
good manufacturing practice regulation in Part 820, with exception of
820.180, with respect to general requirements concerning records, and
820.198, with respect to complaint files.
21 CFR 880.6070 Bed board.
(a) Identification. A bed board is a device intended for medical
purposes that consists of a stiff board used to increase the firmness of
a bed.
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in Subpart E of Part
807. The device also is exempt from the good manufacturing practice
regulation in Part 820, with the exception of 820.180, with respect to
general requirements concerning records, and 820.198, with respect to
complaint files.
21 CFR 880.6080 Cardiopulmonary resuscitation board.
(a) Identification. A cardiopulmonary resuscitation board is a
device consisting of a rigid board which is placed under a patient to
act as a support during cardiopulmonary resuscitation.
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in Subpart E of Part
807. The device also is exempt from the good manufacturing practice
regulation in Part 820, with the exception of 820.180, with respect to
general requirements concerning records, and 820.198, with respect to
complaint files.
21 CFR 880.6085 Hot/cold water bottle.
(a) Identification. A hot/cold water bottle is a device intended for
medical purposes that is in the form of a container intended to be
filled with hot or cold water to apply heat or cold to an area of the
body.
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in Subpart E of Part
807. The device also is exempt from the good manufacturing practice
regulation in part 820, with the exception of 820.180, with respect to
general requirements concerning records, and 820.198, with respect to
complaint files.
21 CFR 880.6100 Ethylene oxide gas aerator cabinet.
(a) Identification. An ethyene oxide gas aerator cabinet is a device
that is intended for use by a health care provider and consists of a
cabinet with a ventilation system designed to circulate and exchange the
air in the cabinet to shorten the time required to remove residual
ethylene oxide (ETO) from wrapped medical devices that have undergone
ETO sterilization. The device may include a heater to warm the
circulating air.
(b) Classification. Class II (performance standards).
21 CFR 880.6140 Medical chair and table.
(a) Identification. A medical chair or table is a device intended
for medical purposes that consists of a chair or table without wheels
and not electrically powered which, by reason of special shape or
attachments, such as food trays or headrests, or special features such
as a built-in raising and lowering mechanism or removable arms, is
intended for use of blood donors, geriatric patients, or patients
undergoing treatment or examination.
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in Subpart E of Part
807. The device also is exempt from the good manufacturing practice
regulation in Part 820, with the exception of 820.180, with respect to
general requirements concerning records, and 820.198, with respect to
complaint files.
21 CFR 880.6150 Ultrasonic cleaner for medical instruments.
(a) Identification. An ultrasonic cleaner for medical instruments is
a device intended for cleaning medical instruments by the emission of
high frequency soundwaves.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter, except that any solutions intended for use with the device for
cleaning or sanitizing the instruments are not exempt.
(45 FR 69682-69737, Oct. 21, 1980, as amended at 54 FR 25050, June
12, 1989)
21 CFR 880.6175 (Reserved)
21 CFR 880.6185 Cast cover.
(a) Identification. A cast cover is a device intended for medical
purposes that is made of waterproof material and placed over a cast to
protect it from getting wet during a shower or a bath.
(b) Classification. Class I (general controls). The device is
exempt from premarket notification procedures in Subpart 807. If the
device is not labeled or otherwise represented as sterile it is also
exempt from the good manufacturing practice regulation in Part 820, with
the exception of 820.180, with respect to general requirements
concerning records, and 820.198, with respect to complaint files.
21 CFR 880.6190 Mattress cover for medical purposes.
(a) Identification. A mattress cover for medical purposes is a
device intended for medical purposes that is used to protect a mattress.
It may be electrically conductive or contain a germicide.
(b) Classification. Class I (general controls). If the device is
not labeled or otherwise represented as sterile, it is exempt from the
good manufacturing practice regulation in Part 820, with the exception
of 820.180, with respect to general requirements concerning records,
and 820.198, with respect to complaint files.
21 CFR 880.6200 Ring cutter.
(a) Identification. A ring cutter is a device intended for medical
purposes that is used to cut a ring on a patient's finger so that the
ring can be removed. The device incorporates a guard to prevent injury
to the patient's finger.
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in Subpart E of Part
807. The device also is exempt from the good manufacturing practice
regulation in Part 820 with the exception of 820.180, with respect to
general requirements concerning records, and 820.198, with respect to
complaint files.
21 CFR 880.6230 Tongue depressor.
(a) Identification. A tongue depressor is a device intended to
displace the tongue to facilitate examination of the surrounding organs
and tissues.
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in Subpart E of Part
807. If the device is not labeled or otherwise represented as sterile,
it also is exempt from the good manufacturing practice regulation in
Part 820, with the exception of 820.180, with respect to general
requirements concerning records, and 820.198, with respect to complaint
files.
21 CFR 880.6250 Patient examination glove.
(a) Identification. A patient examination glove is a disposable
device intended for medical purposes that is worn on the examiner's hand
or finger to prevent contamination between patient and examiner.
(b) Classification. Class I (general controls).
(45 FR 69682-69737, Oct. 21, 1980, as amended at 53 FR 1604, Jan.
13, 1989)
21 CFR 880.6265 Examination gown.
(a) Identification. An examination gown is a device intended for
medical purposes that is made of cloth, paper, or other material that is
draped over or worn by a patient as a body covering during a medical
examination.
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in Subpart E of Part
807. If the device is not labeled or otherwise represented as sterile,
it also is exempt from the good manufacturing practice regulation in
Part 820, with the exception of 820.180, with respect to general
requirements concerning records, and 820.198, with respect to complaint
files.
21 CFR 880.6280 Medical insole.
(a) Identification. A medical insole is a device intended for
medical purposes that is placed inside a shoe to relieve the symptoms of
athlete's foot infection by absorbing moisture.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(45 FR 69682-69737, Oct. 21, 1980, as amended at 54 FR 25050, June
12, 1989)
21 CFR 880.6320 AC-powered medical examination light.
(a) Identification. An AC-powered medical examination light is an
AC-powered device intended for medical purposes that is used to
illuminate body surfaces and cavities during a medical examination.
(b) Classification. Class II (performance standards).
21 CFR 880.6350 Battery-powered medical examination light.
(a) Identification. A battery-powered medical examination light is a
battery-powered device intended for medical purposes that is used to
illuminate body surfaces and cavities during a medical examination.
(b) Classification. Class I (general controls). The device is
exempt from premarket notification procedures in Subpart E of Part 807.
The device also is exempt from the good manufacturing practice
regulation in Part 820, with the exception of 820.180, with respect to
general requirements concerning records, and 820.198, with respect to
complaint files.
21 CFR 880.6375 Patient lubricant.
(a) Identification. A patient lubricant is a device intended for
medical purposes that is used to lubricate a body orifice to facilitate
entry of a diagnostic or therapeutic device.
(b) Classification. Class I (general controls).
21 CFR 880.6430 Liquid medication dispenser.
(a) Identification. A Liquid medication dispenser is a device
intended for medical purposes that is used to issue a measured amount of
liquid medication.
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in Subpart E of Part
807. The device also is exempt from the good manufacturing practice
regulation in Part 820, with the exception of 820.180, with respect to
general requirements concerning records, and 820.198, with respect to
complaint files.
21 CFR 880.6450 Skin pressure protectors.
(a) Identification. A skin pressure protector is a device intended
for medical purposes that is used to reduce pressure on the skin over a
bony prominence to reduce the likelihood of the patient's developing
decubitus ulcers (bedsores).
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in Subpart E of Part
807. The device also is exempt from the good manufacturing practice
regulation in Part 820, with the exception of 820.180, with respect to
general requirements concerning records, and 820.198, with respect to
complaint files.
21 CFR 880.6500 Medical ultraviolet air purifier.
(a) Identification. A medical ultraviolet air purifier is a device
intended for medical purposes that is used to destroy bacteria in the
air by exposure to ultraviolet radiation.
(b) Classification. Class II (performance standards).
21 CFR 880.6710 Medical ultraviolet water purifier.
(a) Identification. A medical ultraviolet water purifier is a device
intended for medical purposes that is used to destroy bacteria in water
by exposure to ultraviolet radiation.
(b) Classification. Class II (performance standards).
21 CFR 880.6730 Body waste receptacle.
(a) Identification. A body waste receptacle is a device intended for
medical purposes tht is not attached to the body and that is used to
collect the body wastes of a bed patient.
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in Subpart E of Part
807. The device also is exempt from the good manufacturing practice
regulation in Part 820, with the exception of 820.180, with respect to
general requirements concerning records, and 820.198, with respect to
complaint files.
21 CFR 880.6740 Vacuum-powered body fluid suction apparatus.
(a) Identification. A vacuum-powered body fluid suction apparatus is
a device used to aspirate, remove, or sample body fluids. The device is
powered by an external source of vacuum. This generic type of device
includes vacuum regulators, vacuum collection bottles, suction catheters
and tips, connecting flexible aspirating tubes, rigid suction tips,
specimen traps, noninvasive tubing, and suction regulators (with gauge).
(b) Classification. Class II (performance standards).
21 CFR 880.6760 Protective restraint.
(a) Identification. A protective restraint is a device, usually a
wristlet, anklet, or other type of strap, that is intended for medical
purposes and that limits a patient's movements to the extent necessary
for treatment, examination, or protection of the patient.
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in Subpart E of Part
807. The device is also exempt from the good manufacturing practice
regulation in Part 820, with the exception of 820.180, with respect to
general requirements concerning records, and 820.198, with respect to
complaint files.
21 CFR 880.6775 Powered patient transfer device.
(a) Identification. A powered patient transfer device is a device
consisting of a wheeled stretcher and a powered mechanism that has a
broad, flexible band stretched over long rollers that can advance itself
under a patient and transfer the patient with minimal disturbance in a
horizontal position to the stretcher.
(b) Classification. Class II (performance standards).
21 CFR 880.6785 Manual patient transfer device.
(a) Identification. A manual patient transfer device is a device
consisting of a wheeled stretcher and a mechanism on which a patient can
be placed so that the patient can be transferred with minimal
disturbance in a horizontal position to the stretcher.
(b) Classification. Class I (general controls). The device is
exempt from premarket notification procedures in Subpart E of Part 807.
The divice also is exempt from the good manufacturing practice
regulation in Part 820, with the exception of 820.180, with respect to
general requirements concerning records, and 820.198, with respect to
complaint files.
21 CFR 880.6800 Washers for body waste receptacles.
(a) Identification. A washer for body waste receptacles is a device
intended for medical purposes that is used to clean and sanitize a body
waste receptacle, such as a bedpan. The device consists of a
wall-mounted plumbing fixture with a door through which a body waste
receptacle is inserted. When the door is closed the body waste
receptacle is cleaned by hot water, steam, or germicide.
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in Subpart E of Part
807. The device also is exempt from the good manufacturing practice
regulation in Part 820 with the exception of 820.180, with respect to
general requirements concerning records, and 820.198, with respect to
complaint files.
21 CFR 880.6820 Medical disposable scissors.
(a) Identification. Medical disposable scissors are disposable type
general cutting devices intended for medical purposes. This generic
type of device does not include surgical scissors.
(b) Classification. Class I (general controls). The device is
exempt from premarket notification procedures in Subpart E of Part 807.
21 CFR 880.6850 Sterilization wrap.
(a) Identification. A sterilization wrap (pack, sterilization
wrapper, bag, or accessories, is a device intended to be used to enclose
another medical device that is to be sterilized by a health care
provider. It is intended to allow sterilization of the enclosed medical
device and also to maintain sterility of the enclosed device until used.
(b) Classification. Class II (performance standards).
21 CFR 880.6860 Ethylene oxide gas sterilizer.
(a) Identification. An ethylene gas sterilizer is a nonportable
device intended for use by a health care provider that uses ethylene
oxide (ETO) to sterilize medical products.
(b) Classification. Class II (performance standards).
21 CFR 880.6870 Dry-heat sterilizer.
(a) Identification. A dry-heat sterilizer is a device that is
intended for use by a health care provider to sterilize medical products
by means of dry heat.
(b) Classification. Class II (performance standards).
21 CFR 880.6880 Steam sterilizer.
(a) Identification. A steam sterilizer (autoclave) is a device that
is intended for use by a health care provider to sterilize medical
products by means of pressurized steam.
(b) Classification. Class II (performance standards).
21 CFR 880.6900 Hand-carried stretcher.
(a) Identification. A hand-carried stretcher is a device consisting
of a lightweight frame, or of two poles with a cloth or metal platform,
on which a patient can be carried.
(b) Classification. Class I (general controls). The device is
exempt from the good manufacturing practice regulation in Part 820, with
the exception of 820.180, with respect to general requirements
concerning records, and 820.198, with respect to complaint files.
21 CFR 880.6910 Wheeled stretcher.
(a) Identification. A wheeled stretcher is a device consisting of a
platform mounted on a wheeled frame that is designed to transport
patients in a horizontal position. The device may have side rails,
supports for fluid infusion equipment, and patient securement straps.
The frame may be fixed or collapsible for use in an ambulance.
(b) Classification. Class II (performance standards).
21 CFR 880.6920 Syringe needle introducer.
(a) Identification. A syringe needle introducer is a device that
uses a spring-loaded mechanism to drive a hypodermic needle into a
patient to a predetermined depth below the skin surface.
(b) Classification. Class II (performance standards).
21 CFR 880.6960 Irrigating syringe.
(a) Identification. An irrigating syringe is a device intended for
medical purposes that consists of a bulb or a piston syringe with an
integral or a detachable tube. The device is used to irrigate, withdraw
fluid from, or instill fluid into, a body cavity or wound.
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in Subpart E of Part
807. If the device is not labeled or otherwise represented as sterile,
it also is exempt from the good manufacturing practice regulation in
Part 820, with the exception of 820.180, with respect to general
requirements concerning records, and 820.198, with respect to complaint
files.
21 CFR 880.6970 Liquid crystal vein locator.
(a) Identification. A liquid crystal vein locator is a device used
to indicate the location of a vein by revealing variations in the
surface temperature of the skin by displaying the color changes of heat
sensitive liquid crystals (cholesteric esters).
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(45 FR 69682-69737, Oct. 21, 1980, as amended at 54 FR 25050, June
12, 1989)
21 CFR 880.6980 Vein stabilizer.
(a) Identification. A vein stabilizer is a device consisting of a
flat piece of plastic with two noninvasive prongs. The device is placed
on the skin so that the prongs are on either side of a vein and hold it
stable while a hypodermic needle is inserted into the vein.
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in Subpart E of Part
807. If the device is not labeled or otherwise represented as sterile,
it is also exempt from the good manufacturing practice regulation in
Part 820, with the exception of 820.180, general requirements
concerning records, and 820.198, with respect to complaint files.
21 CFR 880.6980 Pt. 882
21 CFR 880.6980 PART 882 -- NEUROLOGICAL DEVICES
21 CFR 880.6980 Subpart A -- General Provisions
Sec.
882.1 Scope.
882.3 Effective dates of requirement for premarket approval.
882.9 Limitations of exemptions from section 510(k) of the Federal
Food, Drug, and Cosmetic Act (the act).
21 CFR 880.6980 Subpart B -- Neurological Diagnostic Devices
882.1020 Rigidity analyzer.
882.1030 Ataxiagraph.
882.1200 Two-point discriminator.
882.1240 Echoencephalograph.
882.1275 Electroconductive media.
882.1310 Cortical electrode.
882.1320 Cutaneous electrode.
882.1330 Depth electrode.
882.1340 Nasopharyngeal electrode.
882.1350 Needle electrode.
882.1400 Electroencephalograph.
882.1410 Electroencephalograph electrode/lead tester.
882.1420 Electroencephalogram (EEG) signal spectrum analyzer.
882.1430 Electroencephalograph test signal generator.
882.1460 Nystagmograph.
882.1480 Neurological endoscope.
882.1500 Esthesiometer.
882.1525 Tuning fork.
882.1540 Galvanic skin response measurement device.
882.1550 Nerve conduction velocity measurement device.
882.1560 Skin potential measurement device.
882.1570 Powered direct-contact temperature measurement device.
882.1610 Alpha monitor.
882.1620 Intracranial pressure monitoring device.
882.1700 Percussor.
882.1750 Pinwheel.
882.1790 Ocular plethysmograph.
882.1825 Rheoencephalograph.
882.1835 Physiological signal amplifier.
882.1845 Physiological signal conditioner.
882.1855 Electroencephalogram (EEG) telemetry system.
882.1870 Evoked response electrical stimulator.
882.1880 Evoked response mechanical stimulator.
882.1890 Evoked response photic stimulator.
882.1900 Evoked response auditory stimulator.
882.1925 Ultrasonic scanner calibration test block.
882.1950 Tremor transducer.
21 CFR 880.6980 Subparts C-D -- (Reserved)
21 CFR 880.6980 Subpart E -- Neurological Surgical Devices
882.4030 Skull plate anvil.
882.4060 Ventricular cannula.
882.4100 Ventricular catheter.
882.4125 Neurosurgical chair.
882.4150 Scalp clip.
882.4175 Aneurysm clip applier.
882.4190 Clip forming/cutting instrument.
882.4200 Clip removal instrument.
882.4215 Clip rack.
882.4250 Cryogenic surgical device.
882.4275 Dowel cutting instrument.
882.4300 Manual cranial drills, burrs, trephines, and their
accessories.
882.4305 Powered compound cranial drills, burrs, trephines, and their
accessories.
882.4310 Powered simple cranial drills, burrs, trephines, and their
accessories.
882.4325 Cranial drill handpiece (brace).
882.4360 Electric cranial drill motor.
882.4370 Pneumatic cranial drill motor.
882.4400 Radiofrequency lesion generator.
882.4440 Neurosurgical headrests.
882.4460 Neurosurgical head holder (skull clamp).
882.4500 Cranioplasty material forming instrument.
882.4525 Microsurgical instrument.
882.4535 Nonpowered neurosurgical instrument.
882.4545 Shunt system implantation instrument.
882.4560 Stereotaxic instrument.
882.4600 Leukotome.
882.4650 Neurosurgical suture needle.
882.4700 Cottonoid paddie.
882.4725 Radiofrequency lesion probe.
882.4750 Skull punch.
882.4800 Self-retaining retractor for neurosurgery.
882.4840 Manual rongeur.
882.4845 Powered rongeur.
882.4900 Skullplate screwdriver.
21 CFR 880.6980 Subpart F -- Neurological Therapeutic Devices
882.5030 Methyl methacrylate for aneurysmorrhaphy.
882.5050 Biofeedback device.
882.5070 Bite block.
882.5150 Intravascular occluding catheter.
882.5175 Carotid artery clamp.
882.5200 Aneurysm clip.
882.5225 Implanted malleable clip.
882.5235 Aversive conditioning device.
882.5250 Burr hole cover.
882.5275 Nerve cuff.
882.5300 Methyl methacrylate for cranioplasty.
882.5320 Preformed alterable cranioplasty plate.
882.5330 Preformed nonalterable cranioplasty plate.
882.5360 Cranioplasty plate fastener.
882.5500 Lesion temperature monitor.
882.5550 Central nervous system fluid shunt and components.
882.5800 Cranial electrotheraphy stimulator.
882.5810 External functional neuromuscular stimulator.
882.5820 Implanted cerebellar stimulator.
882.5830 Implanted diaphragmatic/phrenic nerve stimulator.
882.5840 Implanted intracerebral/subcortical stimulator for pain
relief.
882.5850 Implanted spinal cord stimulator for bladder evacuation.
882.5860 Implanted neuromuscular stimulator.
882.5870 Implanted peripheral nerve stimulator for pain relief.
882.5880 Implanted spinal cord stimulator for pain relief.
882.5890 Transcutaneous electrical nerve stimulator for pain relief.
882.5900 Preformed craniosynostosis strip.
882.5910 Dura substitute.
882.5940 Electroconvulsive therapy device.
882.5950 Artificial embolization device.
882.5960 Skull tongs for traction.
Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j, 371).
Source: 44 FR 51730-51778, Sept. 4, 1979, unless otherwise noted.
21 CFR 880.6980 Subpart A -- General Provisions
21 CFR 882.1 Scope.
(a) This part sets forth the classification of neurological devices
intended for human use that are in commercial distribution.
(b) The identification of a device in a regulation in this part is
not a precise description of every device that is, or will be, subject
to the regulation. A manufacturer who submits a premarket notification
submission for a device under Part 807 may not show merely that the
device is accurately described by the section title and identification
provisions of a regulation in this part, but shall state why the device
is substantially equivalent to other devices, as required by 807.87.
(c) To avoid duplicative listings, a neurological device that has two
or more types of uses (e.g., used both as a diagnostic device and as a
therapeutic device) is listed only in one subpart.
(d) References in this part to regulatory sections of the Code of
Federal Regulations are to Chapter I of Title 21, unless otherwise
noted.
(52 FR 17739, May 11, 1987)
21 CFR 882.3 Effective dates of requirement for premarket approval.
A device included in this part that is classified into class III
(premarket approval) shall not be commercially distributed after the
date shown in the regulation classifying the device unless the
manufacturer has an approval under section 515 of the act (unless an
exemption has been granted under section 520(g)(2) of the act). An
approval under section 515 of the act consists of FDA's issuance of an
order approving an application for premarket approval (PMA) for the
device or declaring completed a product development protocol (PDP) for
the device.
(a) Before FDA requires that a device commercially distributed before
the enactment date of the amendments, or a device that has been found
substantially equivalent to such a device, has an approval under section
515 of the act FDA must promulgate a regulation under section 515(b) of
the act requiring such approval, except as provided in paragraph (b) of
this section. Such a regulation under section 515(b) of the act shall
not be effective during the grace period ending on the 90th day after
its promulgation or on the last day of the 30th full calendar month
after the regulation that classifies the device into class III is
effective, whichever is later. See section 501(f)(2)(B) of the act.
Accordingly, unless an effective date of the requirement for premarket
approval is shown in the regulation for a device classified into class
III in this part, the device may be commercially distributed without
FDA's issuance of an order approving a PMA or declaring completed a PDP
for the device. If FDA promulgates a regulation under section 515(b) of
the act requiring premarket approval for a device, section, 501(f)(1)(A)
of the act applies to the device.
(b) Any new, not substantially equivalent, device introduced into
commercial distribution on or after May 28, 1976, including a device
formerly marketed that has been substantially altered, is classified by
statute (section 513(f) of the act) into class III without any grace
period and FDA must have issued an order approving a PMA or declaring
completed a PDP for the device before the device is commercially
distributed unless it is reclassified. If FDA knows that a device being
commercially distributed may be a ''new'' device as defined in this
section because of any new intended use or other reasons, FDA may codify
the statutory classification of the device into class III for such new
use. Accordingly, the regulation for such a class III device states
that as of the enactment date of the amendments, May 28, 1976, the
device must have an approval under section 515 of the act before
commercial distribution.
(52 FR 17739, May 11, 1987)
21 CFR 882.9 Limitations of exemptions from section 510(k) of the
Federal Food, Drug, and Cosmetic Act (the act).
The Food and Drug Administration's (FDA's) decision to grant an
exemption from the requirement of premarket notification (section 510(k)
of the act) for a generic type of class I device is based upon the
existing and reasonably foreseeable characteristics of commercially
distributed devices within that generic type. Because FDA cannot
anticipate every change in intended use or characteristic that could
significantly affect a device's safety or effectiveness, manufacturers
of any commercially distributed class I device for which FDA has granted
an exemption from the requirement of premarket notification must still
submit a premarket notification to FDA before introducing or delivering
for introduction into interstate commerce for commercial distribution
the device when:
(a) The device is intended for a use different from its intended use
before May 28, 1976, or the device is intended for a use different from
the intended use of a preamendments device to which it had been
determined to be substantially equivalent; e.g., the device is intended
for a different medical purpose, or the device is intended for lay use
where the former intended use was by health care professionals only; or
(b) The modified device operates using a different fundamental
scientific technology than that in use in the device before May 28,
1976; e.g., a surgical instrument cuts tissue with a laser beam rather
than with a sharpened metal blade, or an in vitro diagnostic device
detects or identifies infectious agents by using a deoxyribonucleic acid
(DNA) probe or nucleic acid hybridization technology rather than culture
or immunoassay technology.
(54 FR 25051, June 12, 1989)
21 CFR 882.9 Subpart B -- Neurological Diagnostic Devices
21 CFR 882.1020 Rigidity analyzer.
(a) Identification. A rigidity analyzer is a device for quantifying
the extent of the rigidity of a patient's limb to determine the
effectiveness of drugs or other treatments.
(b) Classification. Class II (performance standards).
21 CFR 882.1030 Ataxiagraph.
(a) Identification. An ataxiagraph is a device used to determine the
extent of ataxia (failure of muscular coordination) by measuring the
amount of swaying of the body when the patient is standing erect and
with eyes closed.
(b) Classification. Class I (general controls).
21 CFR 882.1200 Two-point discriminator.
(a) Identification. A two-point discriminator is a device with
points used for testing a patient's touch discrimination.
(b) Classification. Class I. If the device is made of the same
material (single, surgical-grade, stainless steel alloy) that was used
in the device before May 28, 1976, the device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter. The device is also exempt from the current good manufacturing
practice regulations in Part 820 of this chapter, with the exception of
820.180, with respect to general requirements concerning records, and
820.198, with respect to complaint files.
(44 FR 51730-51778, Sept. 4, 1979, as amended at 54 FR 25051, June
12, 1989)
21 CFR 882.1240 Echoencephalograph.
(a) Identification. An echoencephalograph is an ultrasonic scanning
device (including A-scan, B-scan, and doppler systems) that uses
noninvasive transducers for measuring intracranial interfaces and blood
flow velocity to and in the head.
(b) Classification. Class II (performance standards).
21 CFR 882.1275 Electroconductive media.
(a) Identification. Electroconductive media are the conductive
creams or gels used with external electrodes to reduce the impedance
(resistance to alternating current) of the contact between the electrode
surface and the skin.
(b) Classification. Class II (performance standards).
21 CFR 882.1310 Cortical electrode.
(a) Identification. A cortical electrode is an electrode which is
temporarily placed on the surface of the brain for stimulating the brain
or recording the brain's electrical activity.
(b) Classification. Class II (performance standards).
21 CFR 882.1320 Cutaneous electrode.
(a) Identification. A cutaneous electrode is an electrode that is
applied directly to a patient's skin either to record physiological
signals (e.g., the electroencephalogram) or to apply electrical
stimulation.
(b) Classification. Class II (performance standards).
21 CFR 882.1330 Depth electrode.
(a) Identification. A depth electrode is an electrode used for
temporary stimulation of, or recording electrical signals at, subsurface
levels of the brain.
(b) Classification. Class II (performance standards).
21 CFR 882.1340 Nasopharyngeal electrode.
(a) Identification. A nasopharyngeal electrode is an electrode which
is temporarily placed in the nasopharyngeal region for the purpose of
recording electrical activity.
(b) Classification. Class II (performance standards).
21 CFR 882.1350 Needle electrode.
(a) Identification. A needle electrode is a device which is placed
subcutaneously to stimulate or to record electrical signals.
(b) Classification. Class II (performance standards).
21 CFR 882.1400 Electroencephalograph.
(a) Identification. An electroencephalograph is a device used to
measure and record the electrical activity of the patient's brain
obtained by placing two or more electrodes on the head.
(b) Classification. Class II (performance standards).
21 CFR 882.1410 Electroencephalograph electrode/lead tester.
(a) Identification. An electroencephalograph electrode/lead tester
is a device used for testing the impedance (resistance to alternating
current) of the electrode and lead system of an electroencephalograph to
assure that an adequate contact is made between the electrode and the
skin.
(b) Classification. Class II (performance standards).
21 CFR 882.1420 Electroencephalogram (EEG) signal spectrum analyzer.
(a) Identification. An electroencephalogram (EEG) signal spectrum
analyzer is a device used to display the frequency content or power
spectral density of the electroencephalogram (EEG) signal.
(b) Classification. Class I (general controls).
21 CFR 882.1430 Electroencephalograph test signal generator.
(a) Identification. An electroencephalograph test signal generator
is a device used to test or calibrate an electroencephalograph.
(b) Classification. Class I (general controls).
21 CFR 882.1460 Nystagmograph.
(a) Identification. A nystagmograph is a device used to measure,
record, or visually display the involuntary movements (nystagmus) of the
eyeball.
(b) Classification. Class II (performance standards).
21 CFR 882.1480 Neurological endoscope.
(a) Identification. A neurological endoscope is an instrument with a
light source used to view the inside of the ventricles of the brain.
(b) Classification. Class II (performance standards).
21 CFR 882.1500 Esthesiometer.
(a) Identification. An esthesiometer is a mechanical device which
usually consists of a single rod or fiber which is held in the fingers
of the physician or other examiner and which is used to determine
whether a patient has tactile sensitivity.
(b) Classification. Class I. If the device is composed entirely of
a single material, the device is exempt from the premarket notification
procedures in Subpart E of Part 807 of this chapter. The device is also
exempt from the current good manufacturing practice regulations in Part
820 of this chapter, with the exception of 820.180, with respect to
general requirements concerning records, and 820.198, with respect to
complaint files.
(44 FR 51730-51778, Sept. 4, 1979, as amended at 54 FR 25051, June
12, 1989)
21 CFR 882.1525 Tuning fork.
(a) Identification. A tuning fork is a mechanical device which
resonates at a given frequency and is used to diagnose hearing disorders
and to test for vibratory sense.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter. The device is also exempt from the current good manufacturing
practice regulations in Part 820 of this chapter, with the exception of
820.180, with respect to general requirements concerning records, and
820.198, with respect to complaint files.
(44 FR 51730-51778, Sept. 4, 1979, as amended at 54 FR 25051, June
12, 1989)
21 CFR 882.1540 Galvanic skin response measurement device.
(a) Identification. A galvanic skin response measurement device is a
device used to determine autonomic responses as psychological indicators
by measuring the electrical resistance of the skin and the tissue path
between two electrodes applied to the skin.
(b) Classification. Class II (performance standards).
21 CFR 882.1550 Nerve conduction velocity measurement device.
(a) Identification. A nerve conduction velocity measurement device
is a device which measures nerve conduction time by applying a stimulus,
usually to a patient's peripheral nerve. This device includes the
stimulator and the electronic processing equipment for measuring and
displaying the nerve conduction time.
(b) Classification. Class II (performance standards).
21 CFR 882.1560 Skin potential measurement device.
(a) Identification. A skin potential measurement device is a general
diagnostic device used to measure skin voltage by means of surface skin
electrodes.
(b) Classification. Class II (performance standards).
21 CFR 882.1570 Powered direct-contact temperature measurement device.
(a) Identification. A powered direct-contact temperature measurement
device is a device which contains a power source and is used to measure
differences in temperature between two points on the body.
(b) Classification. Class II (performance standards).
21 CFR 882.1610 Alpha monitor.
(a) Identification. An alpha monitor is a device with electrodes
that are placed on a patient's scalp to monitor that portion of the
electroencephalogram which is referred to as the alpha wave.
(b) Classification. Class II (performance standards).
21 CFR 882.1620 Intracranial pressure monitoring device.
(a) Identification. An intracranial pressure monitoring device is a
device used for short-term monitoring and recording of intracranial
pressures and pressure trends. The device includes the transducer,
monitor, and interconnecting hardware.
(b) Classification. Class II (performance standards).
21 CFR 882.1700 Percussor.
(a) Identification. A percussor is a small hammerlike device used by
a physician to provide light blows to a body part. A percussor is used
as a diagnostic aid during physical examinations.
(b) Classification. Class I. lf the device is a small, hand-held
hammer with a rubber head, the device is exempt from the premarket
notification procedures in Subpart E of Part 807 of this chapter. The
device is also exempt from the current good manufacturing practice
regulations in Part 820 of this chapter, with the exception of 820.180,
with respect to general requirements concerning records, and 820.198,
with respect to complaint files.
(44 FR 51730-51778, Sept. 4, 1979, as amended at 54 FR 25051, June
12, 1989)
21 CFR 882.1750 Pinwheel.
(a) Identification. A pinwheel is a device with sharp points on a
rotating wheel used for testing pain sensation.
(b) Classification. Class I. If the device is made of the same
material (single, surgical-grade, stainless steel alloy) that was used
in the device before May 28, 1976, and it is manually operated, the
device is exempt from the premarket notification procedures in Subpart E
of Part 807 of this chapter.
(44 FR 51730-51778, Sept. 4, 1979, as amended at 54 FR 25051, June
12, 1989)
21 CFR 882.1790 Ocular plethysmograph.
(a) Identification. An ocular plethysmograph is a device used to
measure or detect volume changes in the eye produced by pulsations of
the artery, to diagnose carotid artery occlusive disease (restrictions
on blood flow in the carotid artery).
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 882.3.
(44 FR 51730-51778, Sept. 4, 1979, as amended at 52 FR 17739, May 11,
1987)
21 CFR 882.1825 Rheoencephalograph.
(a) Identification. A rheoencephalograph is a device used to
estimate a patient's cerebral circulation (blood flow in the brain) by
electrical inpedance methods with direct electrical connections to the
scalp or neck area.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 882.3.
(44 FR 51730-51778, Sept. 4, 1979, as amended at 52 FR 17740, May 11,
1987)
21 CFR 882.1835 Physiological signal amplifier.
(a) Identification. A physiological signal amplifier is a general
purpose device used to electrically amplify signals derived from various
physiological sources (e.g., the electroencephalogram).
(b) Classification. Class II (performance standards).
21 CFR 882.1845 Physiological signal conditioner.
(a) Identification. A physiological signal conditioner is a device
such as an integrator or differentiator used to modify physiological
signals for recording and processing.
(b) Classification. Class II (performance standards).
21 CFR 882.1855 Electroencephalogram (EEG) telemetry system.
(a) Identification. An electroencephalogram (EEG) telemetry system
consists of transmitters, receivers, and other components used for
remotely monitoring or measuring EEG signals by means of radio or
telephone transmission systems.
(b) Classification. Class II (performance standards).
21 CFR 882.1870 Evoked response electrical stimulator.
(a) Identification. An evoked response electrical stimulator is a
device used to apply an electrical stimulus to a patient by means of
skin electrodes for the purpose of measuring the evoked response.
(b) Classification. Class II (performance standards).
21 CFR 882.1880 Evoked response mechanical stimulator.
(a) Identification. An evoked response mechanical stimulator is a
device used to produce a mechanical stimulus or a series of mechanical
stimuli for the purpose of measuring a patient's evoked response.
(b) Classification. Class II (performance standards).
21 CFR 882.1890 Evoked response photic stimulator.
(a) Identification. An evoked response photic stimulator is a device
used to generate and display a shifting pattern or to apply a brief
light stimulus to a patient's eye for use in evoked response
measurements or for electroencephalogram (EEG) activation.
(b) Classification. Class II (performance standards).
21 CFR 882.1900 Evoked response auditory stimulator.
(a) Identification. An evoked response auditory stimulator is a
device that produces a sound stimulus for use in evoked response
measurements or electroencephalogram activation.
(b) Classification. Class II (performance standards).
21 CFR 882.1925 Ultrasonic scanner calibration test block.
(a) Identification. An ultrasonic scanner calibration test block is
a block of material with known properties used to calibrate ultrasonic
scanning devices (e.g., the echoencephalograph).
(b) Classification. Class I (general controls).
21 CFR 882.1950 Tremor transducer.
(a) Identification. A tremor transducer is a device used to measure
the degree of tremor caused by certain diseases.
(b) Classification. Class II (performance standards).
21 CFR 882.1950 Subparts C-D -- (Reserved)
21 CFR 882.1950 Subpart E -- Neurological Surgical Devices
21 CFR 882.4030 Skull plate anvil.
(a) Identification. A skull plate anvil is a device used to form
alterable skull plates in the proper shape to fit the curvature of a
patient's skull.
(b) Classification. Class I (general controls).
21 CFR 882.4060 Ventricular cannula.
(a) Identification. A ventricular cannula is a device used to
puncture the ventricles of the brain for aspiration or for injection.
This device is frequently referred to as a ventricular needle.
(b) Classification. Class I (general controls).
21 CFR 882.4100 Ventricular catheter.
(a) Identification. A ventricular catheter is a device used to gain
access to the cavities of the brain for injection of material into, or
removal of material from, the brain.
(b) Classification. Class II (performance standards).
21 CFR 882.4125 Neurosurgical chair.
(a) Identification. A neurosurgical chair is an operating room chair
used to position and support a patient during neurosurgery.
(b) Classification. Class I (general controls).
21 CFR 882.4150 Scalp clip.
(a) Identification. A scalp clip is a plastic or metal clip used to
stop bleeding during surgery on the scalp.
(b) Classification. Class II (performance standards).
21 CFR 882.4175 Aneurysm clip applier.
(a) Identification. An aneurysm clip applier is a device used by the
surgeon for holding and applying intracranial aneurysm clips.
(b) Classification. Class II (performance standards).
21 CFR 882.4190 Clip forming/cutting instrument.
(a) Identification. A clip forming/cutting instrument is a device
used by the physician to make tissue clips from wire stock.
(b) Classification. Class I (general controls).
21 CFR 882.4200 Clip removal instrument.
(a) Identification. A clip removal instrument is a device used to
remove surgical clips from the patient.
(b) Classification. Class I (general controls).
21 CFR 882.4215 Clip rack.
(a) Identification. A clip rack is a device used to hold or store
surgical clips during surgery.
(b) Classification. Class I. If the device is composed entirely of
a single metal alloy having the same composition as the clips it is
intended to hold, the device is exempt from the premarket notification
procedures in Subpart E of Part 807 of this chapter.
(44 FR 51730-51778, Sept. 4, 1979, as amended at 54 FR 25051, June
12, 1989)
21 CFR 882.4250 Cryogenic surgical device.
(a) Identification. A cryogenic surgical device is a device used to
destroy nervous tissue or produce lesions in nervous tissue by the
application of extreme cold to the selected site.
(b) Classification. Class II (performance standards).
21 CFR 882.4275 Dowel cutting instrument.
(a) Identification. A dowel cutting instrument is a device used to
cut dowels of bone for bone grafting.
(b) Classification. Class II (performance standards).
21 CFR 882.4300 Manual cranial drills, burrs, trephines, and their
accessories
(a) Identification. Manual cranial drills, burrs, trephines, and
their accessories are bone cutting and drilling instruments that are
used without a power source on a patient's skull.
(b) Classification. Class II (performance standards).
21 CFR 882.4305 Powered compound cranial drills, burrs, trephines, and
their accessories.
(a) Identification. Powered compound cranial drills, burrs,
trephines, and their accessories are bone cutting and drilling
instruments used on a patient's skull. The instruments employ a clutch
mechanism to disengage the tip of the instrument after penetrating the
skull to prevent plunging of the tip into the brain.
(b) Classification. Class II (performance standards).
21 CFR 882.4310 Powered simple cranial drills, burrs, trephines, and
their accessories.
(a) Identification. Powered simple cranial drills, burrs, trephines,
and their accessories are bone cutting and drilling instruments used on
a patient's skull. The instruments are used with a power source but do
not have a clutch mechanism to disengage the tip after penetrating the
skull.
(b) Classification. Class II (performance standards).
21 CFR 882.4325 Cranial drill handpiece (brace).
(a) Identification. A cranial drill handpiece (brace) is a hand
holder, which is used without a power source, for drills, burrs,
trephines, or other cutting tools that are used on a patient's skull.
(b) Classification. Class II (performance standards).
21 CFR 882.4360 Electric cranial drill motor.
(a) Identification. An electric cranial drill motor is an
electrically operated power source used with removable rotating surgical
cutting tools or drill bits on a patient's skull.
(b) Classification. Class II (performance standards).
21 CFR 882.4370 Pneumatic cranial drill motor.
(a) Identification. A pneumatic cranial drill motor is a
pneumatically operated power source used with removable rotating
surgical cutting tools or drill bits on a patient's skull.
(b) Classification. Class II (performance standards).
21 CFR 882.4400 Radiofrequency lesion generator.
(a) Identification. A radiofrequency lesion generator is a device
used to produce lesions in the nervous system or other tissue by the
direct application of radiofrequency currents to selected sites.
(b) Classification. Class II (performance standards).
21 CFR 882.4440 Neurosurgical headrests.
(a) Identification. A neurosurgical headrest is a device used to
support the patient's head during a surgical procedure.
(b) Classification. Class I (general controls).
21 CFR 882.4460 Neurosurgical head holder (skull clamp).
(a) Identification. A neurosurgical head holder (skull clamp) is a
device used to clamp the patient's skull to hold head and neck in a
particular position during surgical procedures.
(b) Classification. Class II (performance standards).
21 CFR 882.4500 Cranioplasty material forming instrument.
(a) Identification. A cranioplasty material forming instrument is a
roller used in the preparation and forming of cranioplasty (skull
repair) materials.
(b) Classification. Class I (general controls).
21 CFR 882.4525 Microsurgical instrument.
(a) Identification. A microsurgical instrument is a nonpowered
surgical instrument used in neurological microsurgery procedures.
(b) Classification. Class I (general controls).
21 CFR 882.4535 Nonpowered neurosurgical instrument.
(a) Identification. A nonpowered neurosurgical instrument is a hand
instrument or an accessory to a hand instrument used during
neurosurgical procedures to cut, hold, or manipulate tissue. It
includes specialized chisels, osteotomes, curettes, dissectors,
elevators, forceps, gouges, hooks, surgical knives, rasps, scissors,
separators, spatulas, spoons, blades, blade holders, blade breakers,
probes, etc.
(b) Classification. Class I (general controls).
21 CFR 882.4545 Shunt system implantation instrument.
(a) Identification. A shunt system implantation instrument is an
instrument used in the implantation of cerebrospinal fluid shunts, and
includes tunneling instruments for passing shunt components under the
skin.
(b) Classification. Class I (general controls).
21 CFR 882.4560 Stereotaxic instrument.
(a) Identification. A stereotaxic instrument is a device consisting
of a rigid frame with a calibrated guide mechanism for precisely
positioning probes or other devices within a patient's brain, spinal
cord, or other part of the nervous system.
(b) Classification. Class II (performance standards).
21 CFR 882.4600 Leukotome.
(a) Identification. A leukotome is a device used to cut sections out
of the brain.
(b) Classification. Class I (general controls).
21 CFR 882.4650 Neurosurgical suture needle.
(a) Identification. A neurosurgical suture needle is a needle used
in suturing during neurosurgical procedures or in the repair of nervous
tissue.
(b) Classification. Class I. If the device is made of the same
material (single, surgical-grade, stainless steel alloy) that was used
in the device before May 28, 1976, the device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(44 FR 51730-51778, Sept. 4, 1979, as amended at 54 FR 25051, June
12, 1989)
21 CFR 882.4700 Cottonoid paddie.
(a) Identification. A cottonoid paddie is a cotton pad used during
surgery to protect nervous tissue, absorb fluids, or stop bleeding.
(b) Classification. Class II (performance standards).
21 CFR 882.4725 Radiofrequency lesion probe.
(a) Identification. A radiofrequency lesion probe is a device
connected to a radiofrequency (RF) lesion generator to deliver the RF
energy to the site within the nervous system where a lesion is desired.
(b) Classification. Class II (performance standards).
21 CFR 882.4750 Skull punch.
(a) Identification. A skull punch is a device used to punch holes
through a patient's skull to allow fixation of cranioplasty plates or
bone flaps by wire or other means.
(b) Classification. Class I (general controls).
21 CFR 882.4800 Self-retaining retractor for neurosurgery.
(a) Identification. A self-retaining retractor for neurosurgery is a
self-locking device used to hold the edges of a wound open during
neurosurgery.
(b) Classification. Class II (performance standards).
21 CFR 882.4840 Manual rongeur.
(a) Identification. A manual rongeur is a manually operated
instrument used for cutting or biting bone during surgery involving the
skull or spinal column.
(b) Classification. Class II (performance standards).
21 CFR 882.4845 Powered rongeur.
(a) Identification. A powered rongeur is a powered instrument used
for cutting or biting bone during surgery involving the skull or spinal
column.
(b) Classification. Class II (performance standards).
21 CFR 882.4900 Skullplate screwdriver.
(a) Identification. A skullplate screwdriver is a tool used by the
surgeon to fasten cranioplasty plates or skullplates to a patient's
skull by screws.
(b) Classification. Class I (general controls).
21 CFR 882.4900 Subpart F -- Neurological Therapeutic Devices
21 CFR 882.5030 Methyl methacrylate for aneurysmorrhaphy.
(a) Identification. Methyl methacrylate for aneurysmorrhaphy (repair
of aneurysms, which are balloonlike sacs formed on blood vessels) is a
self-curing acrylic used to encase and reinforce intracranial aneurysms
that are not amenable to conservative management, removal, or
obliteration by aneurysm clip.
(b) Classification. Class II (performance standards).
21 CFR 882.5050 Biofeedback device.
(a) Identification. A biofeedback device is an instrument that
provides a visual or auditory signal corresponding to the status of one
or more of a patient's physiological parameters (e.g., brain alpha wave
activity, muscle activity, skin temperature, etc.) so that the patient
can control voluntarily these physiological parameters.
(b) Classification. Class II (performance standards).
21 CFR 882.5070 Bite block.
(a) Identification. A bite block is a device inserted into a
patient's mouth to protect the tongue and teeth while the patient is
having convulsions.
(b) Classification. Class II (performance standards).
21 CFR 882.5150 Intravascular occluding catheter.
(a) Identification. An intravascular occluding catheter is a
catheter with an inflatable or detachable balloon tip that is used to
block a blood vessel to treat malformations, e.g., aneurysms
(balloonlike sacs formed on blood vessels) of intracranial blood
vessels.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 882.3.
(44 FR 51730-51778, Sept. 4, 1979, as amended at 52 FR 17740, May 11,
1987)
21 CFR 882.5175 Carotid artery clamp.
(a) Identification. A carotid artery clamp is a device that is
surgically placed around a patient's carotid artery (the principal
artery in the neck that supplies blood to the brain) and has a removable
adjusting mechanism that protrudes through the skin of the patient's
neck. The clamp is used to occlude the patient's carotid artery to
treat intracranial aneurysms (balloonlike sacs formed on blood vessels)
or other intracranial vascular malformations that are difficult to
attach directly by reducing the blood pressure and blood flow to the
aneurysm or malformation.
(b) Classification. Class II (performance standards).
21 CFR 882.5200 Aneurysm clip.
(a) Identification. An aneurysm clip is a device used to occlude an
intracranial aneurysm (a balloonlike sac formed on a blood vessel) to
prevent it from bleeding or bursting.
(b) Classification. Class II (performance standards).
21 CFR 882.5225 Implanted malleable clip.
(a) Identification. An implanted malleable clip is a bent wire or
staple that is forcibly closed with a special instrument to occlude an
intracranial blood vessel or aneurysm (a balloonlike sac formed on a
blood vessel), stop bleeding, or hold tissue or a mechanical device in
place in a patient.
(b) Classification. Class II (performance standards).
21 CFR 882.5235 Aversive conditioning device.
(a) Identification. An aversive conditioning device is an instrument
used to administer an electrical shock or other noxious stimulus to a
patient to modify undesirable behavioral characteristics.
(b) Classification. Class II (performance standards).
21 CFR 882.5250 Burr hole cover.
(a) Identification. A burr hole cover is a plastic or metal device
used to cover or plug holes drilled into the skull during surgery and to
reattach cranial bone removed during surgery.
(b) Classification. Class II (performance standards).
21 CFR 882.5275 Nerve cuff.
(a) Identification. A nerve cuff is a tubular silicone rubber sheath
used to encase a nerve for aid in repairing the nerve (e.g., to prevent
ingrowth of scar tissue) and for capping the end of the nerve to prevent
the formation of neuroma (tumors).
(b) Classification. Class II (performance standards).
21 CFR 882.5300 Methyl methacrylate for cranioplasty.
(a) Identification. Methyl methacrylate for cranioplasty (skull
repair) is a self-curing acrylic that a surgeon uses to repair a skull
defect in a patient. At the time of surgery, the surgeon initiates
polymerization of the material and forms it into a plate or other
appropriate shape to repair the defect.
(b) Classification. Class II (performance standards).
21 CFR 882.5320 Preformed alterable cranioplasty plate.
(a) Identification. A preformed alterable cranioplasty plate is a
device that is implanted into a patient to repair a skull defect. It is
constructed of a material, e.g., tantalum, that can be altered or
reshaped at the time of surgery without changing the chemical behavior
of the material.
(b) Classification. Class II (performance standards).
21 CFR 882.5330 Preformed nonalterable cranioplasty plate.
(a) Identification. A preformed nonalterable cranioplasty plate is a
device that is implanted in a patient to repair a skull defect and is
constructed of a material, e.g., stainless steel or vitallium, that
cannot be altered or reshaped at the time of surgery without changing
the chemical behavior of the material.
(b) Classification. Class II (performance standards).
21 CFR 882.5360 Cranioplasty plate fastener.
(a) Identification. A cranioplasty plate fastener is a screw, wire,
or other article made of tantalum, vitallium, or stainless steel used to
secure a plate to the patient's skull to repair a skull defect.
(b) Classification. Class II (performance standards).
21 CFR 882.5500 Lesion temperature monitor.
(a) Identification. A lesion temperature monitor is a device used to
monitor the tissue temperature at the site where a lesion (tissue
destruction) is to be made when a surgeon uses a radiofrequency (RF)
lesion generator and probe.
(b) Classification. Class II (performance standards).
21 CFR 882.5550 Central nervous system fluid shunt and components.
(a) Identification. A central nervous system fluid shunt is a device
or combination of devices used to divert fluid from the brain or other
part of the central nervous system to an internal delivery site or an
external receptacle for the purpose of relieving elevated intracranial
pressure or fluid volume (e.g., due to hydrocephalus). Components of a
central nervous system shunt include catheters, valved catheters,
valves, connectors, and other accessory components intended to
facilitate use of the shunt or evaluation of a patient with a shunt.
(b) Classification. Class II (performance standards).
21 CFR 882.5800 Cranial electrotheraphy stimulator.
(a) Identification. A cranial electrotheraphy stimulator is a device
that applies electrical current to a patient's head to treat insomnia,
depression, or anxiety.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 882.3.
(44 FR 51730-51778, Sept. 4, 1979, as amended at 52 FR 17740, May 11,
1987)
21 CFR 882.5810 External functional neuromuscular stimulator.
(a) Identification. An external functional neuromuscular stimulator
is an electrical stimulator that uses external electrodes for
stimulating muscles in the leg and ankle of partially paralyzed patients
(e.g., after stroke) to provide flexion of the foot and thus improve the
patient's gait.
(b) Classification. Class II (performance standards).
21 CFR 882.5820 Implanted cerebellar stimulator.
(a) Identification. An implanted cerebellar stimulator is a device
used to stimulate electrically a patient's cerebellar cortex for the
treatment of intractable epilepsy, spasticity, and some movement
disorders. The stimulator consists of an implanted receiver with
electrodes that are placed on the patient's cerebellum and an external
transmitter for transmitting the stimulating pulses across the patient's
skin to the implanted receiver.
(b) Classification. Class III (premarket approval).
(c) Date premarket approval application (PMA) or notice of completion
of a product development protocol (PDP) is required. A PMA or notice of
completion of a PDP is required to be filed with the Food and Drug
Administration on or before September 26, 1984. Any implanted
cerebellar stimulator that was not in commercial distribution before May
28, 1976, or that has not on or before September 26, 1984 been found by
FDA to be substantially equivalent to an implanted cerebellar stimulator
that was in commercial distribution before May 28, 1976 shall have an
approved PMA or declared completed PDP in effect before beginning
commercial distribution.
(44 FR 51730-51778, Sept. 4, 1979 and 49 FR 26574, June 28, 1984)
21 CFR 882.5830 Implanted diaphragmatic/phrenic nerve stimulator.
(a) Identification. An implanted diaphragmatic/phrenic nerve
stimulator is a device that provides electrical stimulation of a
patient's phrenic nerve to contract the diaphragm rhythmically and
produce breathing in patients who have hypoventilation (a state in which
an abnormally low amount of air enters the lungs) caused by brain stem
disease, high cervical spinal cord injury, or chronic lung disease. The
stimulator consists of an implanted receiver with electrodes that are
placed around the patient's phrenic nerve and an external transmitter
for transmitting the stimulating pulses across the patient's skin to the
implanted receiver.
(b) Classification. Class III (premarket approval).
(c) Date premarket approval application (PMA) or notice of completion
of a product development protocol (PDP) is required. A PMA or a notice
of completion of a PDP is required to be filed with the Food and Drug
Administration on or before July 7, 1986 for any implanted
diaphragmatic/phrenic nerve stimulator that was in commercial
distribution before May 28, 1976, or that has on or before July 7, 1986
been found to be substantially equivalent to an implanted
diaphragmatic/phrenic nerve stimulator that was in commercial
distribution before May 28, 1976. Any other implanted
diaphragmatic/phrenic nerve stimulator shall have an approved PMA or a
declared completed PDP in effect before being placed in commercial
distribution.
(44 FR 51730-51778, Sept. 4, 1979, as amended at 51 FR 12101, Apr.
8, 1986)
21 CFR 882.5840 Implanted intracerebral/subcortical stimulator for pain
relief.
(a) Identification. An implanted intracerebral/subcortical
stimulator for pain relief is a device that applies electrical current
to subsurface areas of a patient's brain to treat severe intractable
pain. The stimulator consists of an implanted receiver with electrodes
that are placed within a patient's brain and an external transmitter for
transmitting the stimulating pulses across the patient's skin to the
implanted receiver.
(b) Classification. Class III (premarket approval).
(c) Date premarket approval application (PMA) or notice of completion
of a product development protocol (PDP) is required. A PMA or a notice
of completion of a PDP is required to be filed with the Food and Drug
Administration on or before March 1, 1989, for any implanted
intracerebral/subcortical stimulator for pain relief that was in
commercial distribution before May 28, 1976, or that has on or before
March 1, 1989, been found to be substantially equivalent to an implanted
intracerebral/subcortical stimulator for pain relief that was in
commercial distribution before May 28, 1976. Any other implanted
intracerebral/subcortical stimulator for pain relief shall have an
approved PMA or a declared completed PDP in effect before being placed
in commercial distribution.
(44 FR 51730-51778, Sept. 4, 1979, as amended at 53 FR 48621, Dec.
1, 1988)
21 CFR 882.5850 Implanted spinal cord stimulator for bladder
evacuation.
(a) Identification. An implanted spinal cord stimulator for bladder
evacuation is an electrical stimulator used to empty the bladder of a
paraplegic patient who has a complete transection of the spinal cord and
who is unable to empty his or her bladder by reflex means or by the
intermittent use of catheters. The stimulator consists of an implanted
receiver with electrodes that are placed on the conus medullaris portion
of the patient's spinal cord and an external transmitter for
transmitting the stimulating pulses across the patient's skin to the
implanted receiver.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 882.3.
(44 FR 51730-51778, Sept. 4, 1979, as amended at 52 FR 17740, May 11,
1987)
21 CFR 882.5860 Implanted neuromuscular stimulator.
(a) Identification. An implanted neuromuscular stimulator is a
device that provides electrical stimulation to a patient's peroneal or
femoral nerve to cause muscles in the leg to contract, thus improving
the gait in a patient with a paralyzed leg. The stimulator consists of
an implanted receiver with electrodes that are placed around a patient's
nerve and an external transmitter for transmitting the stimulating
pulses across the patient's skin to the implanted receiver. The
external transmitter is activated by a switch in the heel in the
patient's shoe.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 882.3.
(44 FR 51730-51778, Sept. 4, 1979, as amended at 52 FR 17740, May 11,
1987)
21 CFR 882.5870 Implanted peripheral nerve stimulator for pain relief.
(a) Identification. An implanted peripheral nerve stimulator for
pain relief is a device that is used to stimulate electrically a
peripheral nerve in a patient to relieve severe intractable pain. The
stimulator consists of an inplanted receiver with electrodes that are
placed around a peripheral nerve and an external transmitter for
transmitting the stimulating pulses across the patient's skin to the
implanted receiver.
(b) Classification. Class II (performance standards).
21 CFR 882.5880 Implanted spinal cord stimulator for pain relief.
(a) Identification. An implanted spinal cord stimulator for pain
relief is a device that is used to stimulate electrically a patient's
spinal cord to relieve severe intractable pain. The stimulator consists
of an implanted receiver with electrodes that are placed on the
patient's spinal cord and an external transmitter for transmitting the
stimulating pulses across the patient's skin to the implanted receiver.
(b) Classification. Class II (performance standards).
21 CFR 882.5890 Transcutaneous electrical nerve stimulator for pain
relief.
(a) Identification. A transcutaneous electrical nerve stimulator for
pain relief is a device used to apply an electrical current to
electrodes on a patient's skin to treat pain.
(b) Classification. Class II (performance standards).
21 CFR 882.5900 Preformed craniosynostosis strip.
(a) Identification. A preformed craniosynostosis strip is a plastic
strip used to cover bone edges of craniectomy sites (sites where the
skull has been cut) to prevent the bone from regrowing in patients whose
skull sutures are abnormally fused together.
(b) Classification. Class II (performance standards).
21 CFR 882.5910 Dura substitute.
(a) Identification. A dura substitute is a sheet or material that is
used to repair the dura mater (the membrane surrounding the brain).
(b) Classification. Class II (performance standards).
21 CFR 882.5940 Electroconvulsive therapy device.
(a) Identification. An electroconvulsive therapy device is a device
used for treating severe psychiatric disturbances (e.g., severe
depression) by inducing in the patient a major motor seizure by applying
a brief intense electrical current to the patient's head.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 882.3.
(44 FR 51730-51778, Sept. 4, 1979, as amended at 52 FR 17740, May 11,
1987)
21 CFR 882.5950 Artificial embolization device.
(a) Identification. An artificial embolization device is an object
that is placed in a blood vessel to permanently obstruct blood flow to
an aneurysm or other vascular malformation.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 882.3.
(44 FR 51730-51778, Sept. 4, 1979, as amended at 52 FR 17740, May 11,
1987)
21 CFR 882.5960 Skull tongs for traction.
(a) Identification. Skull tongs for traction is an instrument used
to immobilize a patient with a cervical spine injury (e.g., fracture or
dislocation). The device is caliper shaped with tips that penetrate the
skin. It is anchored to the skull and has a heavy weight attached to it
that maintains, by traction, the patient's position.
(b) Classification. Class II (performance standards).
21 CFR 882.5960 Pt. 884
21 CFR 882.5960 PART 884 -- OBSTETRICAL AND GYNECOLOGICAL DEVICES
21 CFR 882.5960 Subpart A -- General Provisions
Sec.
884.1 Scope.
884.3 Effective dates of requirement for premarket approval.
884.9 Limitations of exemptions from section 510(k) of the Federal
Food, Drug, and Cosmetic Act (the act).
21 CFR 882.5960 Subpart B -- Obstetrical and Gynecological Diagnostic
Devices
884.1040 Viscometer for cervical mucus.
884.1050 Endocervical aspirator.
884.1060 Endometrial aspirator.
884.1100 Endometrial brush.
884.1175 Endometrial suction curette and accessories.
884.1185 Endometrial washer.
884.1300 Uterotubal carbon dioxide insufflator and accessories.
884.1425 Perineometer.
884.1550 Amniotic fluid sampler (amniocentesis tray).
884.1560 Fetal blood sampler.
884.1600 Transabdominal amnioscope (fetoscope) and accessories.
884.1630 Colposcope.
884.1640 Culdoscope and accessories.
884.1660 Transcervical endoscope (amnioscope) and accessories.
884.1690 Hysteroscope and accessories.
884.1700 Hysteroscopic insufflator.
884.1720 Gynecologic laparoscope and accessories.
884.1730 Laparoscopic insufflator.
21 CFR 882.5960 Subpart C -- Obstetrical and Gynecological Monitoring
Devices
884.2050 Obstetric data analyzer.
884.2225 Obstetric-gynecologic ultrasonic imager.
884.2600 Fetal cardiac monitor.
884.2620 Fetal electroencephalographic monitor.
884.2640 Fetal phonocardiographic monitor and accessories.
884.2660 Fetal ultrasonic monitor and accessories.
884.2675 Fetal scalp circular (spiral) electrode and applicator.
884.2685 Fetal scalp clip electrode and applicator.
884.2700 Intrauterine pressure monitor and accessories.
884.2720 External uterine contraction monitor and accessories.
884.2740 Perinatal monitoring system and accessories.
884.2900 Fetal stethoscope.
884.2960 Obstetric ultrasonic transducer and accessories.
884.2980 Telethermographic system.
884.2982 Liquid crystal thermographic system.
21 CFR 882.5960 Subpart D -- Obstetrical and Gynecological Prosthetic
Devices
884.3200 Cervical drain.
884.3575 Vaginal pessary.
884.3650 Fallopian tube prosthesis.
884.3900 Vaginal stent.
21 CFR 882.5960 Subpart E -- Obstetrical and Gynecological Surgical
Devices
884.4100 Endoscopic electrocautery and accessories.
884.4120 Gynecologic electrocautery and accessories.
884.4150 Bipolar endoscopic coagulator-cutter and accessories.
884.4160 Unipolar endoscopic coagulator-cutter and accessories.
884.4250 Expandable cervical dilator.
884.4260 Hygroscopic Laminaria cervical dilator.
884.4270 Vibratory cervical dilators.
884.4340 Fetal vacuum extractor.
884.4400 Obstetric forceps.
884.4500 Obstetric fetal destructive instrument.
884.4520 Obstetric-gynecologic general manual instrument.
884.4530 Obstetric-gynecologic specialized manual instrument.
884.4550 Gynecologic surgical laser.
884.4900 Obstetric table and accessories.
21 CFR 882.5960 Subpart F -- Obstetrical and Gynecological Therapeutic
Devices
884.5050 Metreurynter-balloon abortion system.
884.5070 Vacuum abortion system.
884.5100 Obstetric anesthesia set.
884.5150 Nonpowered breast pump.
884.5160 Powered breast pump.
884.5225 Abdominal decompression chamber.
884.5250 Cervical cap.
884.5300 Condom.
884.5310 Condom with spermicidal lubricant.
884.5350 Contraceptive diaphragm and accessories.
884.5360 Contraceptive intrauterine device (IUD) and introducer.
884.5380 Contraceptive tubal occlusion device (TOD) and introducer.
884.5390 Perineal heater.
884.5400 Menstrual cup.
884.5425 Scented or scented deodorized menstrual pad.
884.5435 Unscented menstrual pad.
884.5460 Scented or scented deodorized menstrual tampon.
884.5470 Unscented menstrual tampon.
884.5900 Therapeutic vaginal douche apparatus.
884.5920 Vaginal insufflator.
884.5940 Powered vaginal muscle stimulator for therapeutic use.
884.5960 Genital vibrator for therapeutic use.
Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j, 371).
Source: 45 FR 12684-12720, Feb. 26, 1980, unless otherwise noted.
21 CFR 882.5960 Subpart A -- General Provisions
21 CFR 884.1 Scope.
(a) This part sets forth the classification of obstetrical and
gynecological devices intended for human use that are in commercial
distribution.
(b) The identification of a device in a regulation in this part is
not a precise description of every device that is, or will be, subject
to the regulation. A manufacturer who submits a premarket notification
submission for a device under Part 807 may not show merely that the
device is accurately described by the section title and identification
provisions of a regulation in this part, but shall state why the device
is substantially equivalent to other devices, as required by 807.87.
(c) To avoid duplicative listings, a obstetrical and gynecological
device that has two or more types of uses (e.g., used both as a
diagnostic device and as a therapeutic device) is listed only in one
subpart.
(d) References in this part to regulatory sections of the Code of
Federal Regulations are to Chapter I of Title 21, unless otherwise
noted.
(52 FR 17740, May 11, 1987)
21 CFR 884.3 Effective dates of requirement for premarket approval.
A device included in this part that is classified into class III
(premarket approval) shall not be commercially distributed after the
date shown in the regulation classifying the device unless the
manufacturer has an approval under section 515 of the act (unless an
exemption has been granted under section 520(g)(2) of the act). An
approval under section 515 of the act consists of FDA's issuance of an
order approving an application for premarket approval (PMA) for the
device or declaring completed a product development protocol (PDP) for
the device.
(a) Before FDA requires that a device commercially distributed before
the enactment date of the amendments, or a device that has been found
substantially equivalent to such a device, has an approval under section
515 of the act FDA must promulgate a regulation under section 515(b) of
the act requiring such approval, except as provided in paragraph (b) of
this section. Such a regulation under section 515(b) of the act shall
not be effective during the grace period ending on the 90th day after
its promulgation or on the last day of the 30th full calendar month
after the regulation that classifies the device into class III is
effective, whichever is later. See section 501(f)(2)(B) of the act.
Accordingly, unless an effective date of the requirement for premarket
approval is shown in the regulation for a device classified into class
III in this part, the device may be commercially distributed without
FDA's issuance of an order approving a PMA or declaring completed a PDP
for the device. If FDA promulgates a regulation under section 515(b) of
the act requiring premarket approval for a device, section 501(f)(1)(A)
of the act applies to the device.
(b) Any new, not substantially equivalent, device introduced into
commercial distribution on or after May 28, 1976, including a device
formerly marketed that has been substantially altered, is classified by
statute (section 513(f) of the act) into class III without any grace
period and FDA must have issued an order approving a PMA or declaring
completed a PDP for the device before the device is commercially
distributed unless it is reclassified. If FDA knows that a device being
commercially distributed may be a ''new'' device as defined in this
section because of any new intended use or other reasons, FDA may codify
the statutory classification of the device into class III for such new
use. Accordingly, the regulation for such a class III device states
that as of the enactment date of the amendments, May 28, 1976, the
device must have an approval under section 515 of the act before
commercial distribution.
(52 FR 17740, May 11, 1987)
21 CFR 884.9 Limitations of exemptions from section 510(k) of the
Federal Food, Drug, and Cosmetic Act (the act).
The Food and Drug Administration's (FDA's) decision to grant an
exemption from the requirement of premarket notification (section 510(k)
of the act) for a generic type of class I device is based upon the
existing and reasonably foreseeable characteristics of commercially
distributed devices within that generic type. Because FDA cannot
anticipate every change in intended use or characteristic that could
significantly affect a device's safety or effectiveness, manufacturers
of any commercially distributed class I device for which FDA has granted
an exemption from the requirement of premarket notification must still
submit a premarket notification to FDA before introducing or delivering
for introduction into interstate commerce for commercial distribution
the device when:
(a) The device is intended for a use different from its intended use
before May 28, 1976, or the device is intended for a use different from
the intended use of a preamendments device to which it had been
determined to be substantially equivalent; e.g., the device is intended
for a different medical purpose, or the device is intended for lay use
where the former intended use was by health care professionals only; or
(b) The modified device operates using a different fundamental
scientific technology than that in use in the device before May 28,
1976, e.g., a surgical instrument cuts tissue with a laser beam rather
than with a sharpened metal blade, or an in vitro diagnostic device
detects or identifies infectious agents by using a deoxyribonucleic acid
(DNA) probe or nucleic acid hybridization technology rather than culture
or immunoassay technology.
(54 FR 25051, June 12, 1989)
21 CFR 884.9 Subpart B -- Obstetrical and Gynecological Diagnostic Devices
21 CFR 884.1040 Viscometer for cervical mucus.
(a) Identification. A viscometer for cervical mucus is a device that
is intended to measure the relative viscoelasticity of cervical mucus
collected from a female patient. Measurements of relative
viscoelasticity are intended for use as an adjunct in the clinical
evaluation of a female with chronic infertility, to determine the time
of ovulation and the penetrability of cervical mucus to motile sperm.
(b) Classification. Class I (general controls).
(47 FR 14706, Apr. 6, 1982)
21 CFR 884.1050 Endocervical aspirator.
(a) Identification. An endocervical aspirator is a device designed
to remove tissue from the endocervix (mucous membrane lining the canal
of the cervix of the uterus) by suction with a syringe, bulb and
pipette, or catheter. This device is used to evaluate endocervical
tissue to detect malignant and premalignant lesions.
(b) Classification. Class II (performance standards).
21 CFR 884.1060 Endometrial aspirator.
(a) Identification. An endometrial aspirator is a device designed to
remove materials from the endometrium (the mucosal lining of the uterus)
by suction with a syringe, bulb and pipette, or catheter. This device
is used to study endometrial cytology (cells).
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 884.3.
(45 FR 12684-12720, Feb. 26, 1980, as amended at 52 FR 17741, May 11,
1987)
21 CFR 884.1100 Endometrial brush.
(a) Identification. An endometrial brush is a device designed to
remove samples of the endometrium (the mucosal lining of the uterus) by
brushing its surface. This device is used to study endometrial cytology
(cells).
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 884.3.
(45 FR 12684-12720, Feb. 26, 1980, as amended at 52 FR 17741, May 11,
1987)
21 CFR 884.1175 Endometrial suction curette and accessories.
(a) Identification. An endometrial suction curette is a device used
to remove material from the uterus and from the mucosal lining of the
uterus by scraping and vacuum suction. This device is used to obtain
tissue for biopsy or for menstrual extraction. This generic type of
device may include catheters, syringes, and tissue filters or traps.
(b) Classification. Class II (performance standards).
21 CFR 884.1185 Endometrial washer.
(a) Identification. An endometrial washer is a device used to remove
materials from the endometrium (the mucosal lining of the uterus) by
washing with water or saline solution and then aspirating with negative
pressure. This device is used to study endometrial cytology (cells).
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 884.3.
(45 FR 12684-12720, Feb. 26, 1980, as amended at 52 FR 17741, May 11,
1987)
21 CFR 884.1300 Uterotubal carbon dioxide insufflator and accessories.
(a) Identification. A uterotubal carbon dioxide insufflator and
accessories is a device used to test the patency (lack of obstruction)
of the fallopian tubes by pressurizing the uterus and fallopian tubes
and filling them with carbon dioxide gas.
(b) Classification. Class II (performance standards).
21 CFR 884.1425 Perineometer.
(a) Identification. A perineometer is a device consisting of a
fluid-filled sack for intravaginal use that is attached to an external
manometer. The devices measure the strength of the perineal muscles by
offering resistence to a patient's voluntary contractions of these
muscles and is used to diagnose and to correct, through exercise,
uninary incontinence or sexual dysfunction.
(b) Classification. Class II (performance standards).
21 CFR 884.1550 Amniotic fluid sampler (amniocentesis tray).
(a) Identification. An amniotic fluid sampler is a device used for
amniocentesis (transabdominal aspiration of fluid from the amniotic
sac). The sampler consists of disposable instruments, drapes, specimen
containers, and other accessories on a tray.
(b) Classification. Class II (performance standards).
21 CFR 884.1560 Fetal blood sampler.
(a) Identification. A fetal blood sampler is a device used to obtain
fetal blood transcervically through an endoscope by puncturing the fetal
skin with a short blade and drawing blood into a heparinized tube. The
fetal blood pH is determined and used in the diagnosis of fetal distress
and fetal hypoxia.
(b) Classification. Class II (performance standards).
21 CFR 884.1600 Transabdominal amnioscope (fetoscope) and accessories.
(a) Identification. A transabdominal amnioscope is a device designed
to permit direct visual examination of the fetus by a telescopic system
via abdominal entry. The device is used to ascertain fetal
abnormalities, to obtain fetal blood samples, or to obtain fetal tissue.
This generic type of device may include the following accessories:
trocar and cannula, instruments used through an operating channel or
through a separate cannula associated with the amnioscope, light source
and cables, and component parts.
(b) Classification. Class III (premarket approval).
(c) Date premarket approval application (PMA) or notice of completion
of a product development protocol (PDP) is required. A PMA or a notice
of completion of a PDP is required to be filed with the Food and Drug
Administration on or before January 29, 1987 for any transabdominal
amnioscope (fetoscope) and accessories that was in commercial
distribution before May 28, 1976, or that has on or before January 29,
1987 been found to be substantially equivalent to a transabdominal
amnioscope (fetoscope) and accessories that was in commercial
distribution before May 28, 1976. Any other transabdominal amnioscope
(fetoscope) and accessories shall have an approved PMA or a declared
completed PDP in effect before being placed in commercial distribution.
(45 FR 12684 -- 12720, Feb. 26, 1980, as amended at 51 FR 39845, Oct.
31, 1986)
21 CFR 884.1630 Colposcope.
(a) Identification. A colposcope is a device designed to permit
direct viewing of the tissues of the vagina and cervix by a telescopic
system located outside the vagina. It is used to diagnose abnormalities
and select areas for biopsy. This generic type of device may include a
light source, cables, and component parts.
(b) Classification. Class II (performance standards).
21 CFR 884.1640 Culdoscope and accessories.
(a) Identification. A culdoscope is a device designed to permit
direct viewing of the organs within the peritoneum by a telescopic
system introduced into the pelvic cavity through the posterior vaginal
fornix. It is used to perform diagnostic and surgical procedures on the
female genital organs. This generic type of device may include trocar
and cannula, instruments used through an operating channel, scope
preheaters, light source and cables, and component parts.
(b) Classification. Class II (performance standards).
21 CFR 884.1660 Transcervical endoscope (amnioscope) and accessories.
(a) Identification. A transcervical endoscope is a device designed
to permit direct viewing of the fetus and amniotic sac by means of an
open tube introduced into the uterus through the cervix. The device may
be used to visualize the fetus or amniotic fluid and to sample fetal
blood or amniotic fluid. This generic type of device may include
obturators, instruments used through an operating channel, light sources
and cables, and component parts.
(b) Classification. Class II (performance standards).
21 CFR 884.1690 Hysteroscope and accessories.
(a) Identification. A hysteroscope is a device used to permit direct
viewing of the cervical canal and the uterine cavity by a telescopic
system introduced into the uterus through the cervix. It is used to
perform diagnostic and surgical procedures other than sterilization.
This generic type of device may include obturators and sheaths,
instruments used through an operating channel, scope preheaters, light
sources and cables, and component parts.
(b) Classification. Class II (performance standards).
21 CFR 884.1700 Hysteroscopic insufflator.
(a) Identification. A hysteroscopic insufflator is a device designed
to distend the uterus by filling the uterine cavity with a liquid or gas
to facilitate viewing with a hysteroscope.
(b) Classification. Class II (performance standards).
21 CFR 884.1720 Gynecologic laparoscope and accessories.
(a) Identification. A gynecologic laparoscope is a device used to
permit direct viewing of the organs within the peritoneum by a
telescopic system introduced through the abdominal wall. It is used to
perform diagnostic and surgical procedures on the female genital organs.
This generic type of device may include: Trocar and cannula,
instruments used through an operating channel, scope preheater, light
source and cables, and component parts.
(b) Classification. Class II (performance standards).
21 CFR 884.1730 Laparoscopic insufflator.
(a) Identification. A laparoscopic insufflator is a device used to
facilitate the use of the laparoscope by filling the peritoneal cavity
with gas to distend it.
(b) Classification. Class II (performance standards).
21 CFR 884.1730 Subpart C -- Obstetrical and Gynecological Monitoring Devices
21 CFR 884.2050 Obstetric data analyzer.
(a) Identification. An obstetric data analyzer (i.e., fetal status
data analyzer) is a device used during labor to analyze electronic
signal data obtained from fetal and maternal monitors and to indicate
clinical diagnosis of fetal well-being. This generic type of device may
include signal analysis and display equipment, electronic interfaces for
other equipment, and power supplies and component parts.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 884.3.
(45 FR 12684-12720, Feb. 26, 1980, as amended at 52 FR 17741, May 11,
1987)
21 CFR 884.2225 Obstetric-gynecologic ultrasonic imager.
(a) Identification. An obstetric-gynecologic ultrasonic imager is a
device designed to transmit and receive ultrasonic energy into and from
a female patient by pulsed echoscopy. This device is used to provide a
visual representation of some physiological or artificial structure, or
of a fetus, for diagnostic purposes during a limited period of time.
This generic type of device may include the following: signal analysis
and display equipment, electronic interfaces for other equipment,
patient and equipment supports, coupling gel, and component parts. This
generic type of device does not include devices used to monitor the
changes in some physiological condition over long periods of time.
(b) Classification. Class II (performance standards).
21 CFR 884.2600 Fetal cardiac monitor.
(a) Identification. A fetal cardiac monitor is a device used to
ascertain fetal heart activity during pregnancy and labor. The device
is designed to separate fetal heart signals from maternal heart signals
by analyzing electrocardiographic signal (electrical potentials
generated during contraction and relaxation of heart muscle) obtained
from the maternal abdomen with external electrodes. This generic type
of device may include an alarm that signals when the heart rate crosses
a preset threshold. This generic type of device includes the ''fetal
cardiotachometer (with sensors)'' and the ''fetal electrocardiographic
monitor.''
(b) Classification. Class II (performance standards).
21 CFR 884.2620 Fetal electroencephalographic monitor.
(a) Identification. A fetal electroencephalographic monitor is a
device used to detect, measure, and record in graphic form (by means of
one or more electrodes placed transcervically on the fetal scalp during
labor) the rhythmically varying electrical skin potentials produced by
the fetal brain.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 884.3.
(45 FR 12684-12720, Feb. 26, 1980, as amended at 52 FR 17741, May 11,
1987)
21 CFR 884.2640 Fetal phonocardiographic monitor and accessories.
(a) Identification. A fetal phonocardiographic monitor is a device
designed to detect, measure, and record fetal heart sounds
electronically, in graphic form, and noninvasively, to ascertain fetal
condition during labor. This generic type of device includes the
following accessories: signal analysis and display equipment, patient
and equipment supports, and other component parts.
(b) Classification. Class II (performance standards).
21 CFR 884.2660 Fetal ultrasonic monitor and accessories.
(a) Identification. A fetal ultrasonic monitor is a device designed
to transmit and receive ultrasonic energy into and from the pregnant
woman, usually by means of continuous wave (doppler) echoscopy. The
device is used to represent some physiological condition or
characteristic in a measured value over a period of time (e.g.,
perinatal monitoring during labor) or in an immediately perceptible form
(e.g., use of the ultrasonic stethoscope). This generic type of device
may include the following accessories: signal analysis and display
equipment, electronic interfaces for other equipment, patient and
equipment supports, and component parts. This generic type of device
does not include devices used to image some relatively unchanging
physiological structure or interpret a physiological condition, but does
include devices which may be set to alarm automatically at a
predetermined threshold value.
(b) Classification. Class II (performance standards).
21 CFR 884.2675 Fetal scalp circular (spiral) electrode and applicator.
(a) Identification. A fetal scalp circular (spiral) electrode and
applicator is a device used to obtain a fetal electrocardiogram during
labor and delivery. It establishes electrical contact between fetal
skin and an external monitoring device by a shallow subcutaneous
puncture of fetal scalp tissue with a curved needle or needles. This
generic type of device includes nonreusable spiral electrodes and
reusable circular electrodes.
(b) Classification. Class II (performance standards).
21 CFR 884.2685 Fetal scalp clip electrode and applicator.
(a) Identification. A fetal scalp clip electrode and applicator is a
device designed to establish electrical contact between fetal skin and
an external monitoring device by means of pinching skin tissue with a
nonreusable clip. This device is used to obtain a fetal
electrocardiogram. This generic type of device may include a clip
electrode applicator.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 884.3.
(45 FR 12684-12720, Feb. 26, 1980, as amended at 52 FR 17741, May 11,
1987)
21 CFR 884.2700 Intrauterine pressure monitor and accessories.
(a) Identification. An intrauterine pressure monitor is a device
designed to detect and measure intrauterine and amniotic fluid pressure
with a catheter placed transcervically into the uterine cavity. The
device is used to monitor intensity, duration, and frequency of uterine
contractions during labor. This generic type of device may include the
following accessories: signal analysis and display equipment, patient
and equipment supports, and component parts.
(b) Classification. Class II (performance standards).
21 CFR 884.2720 External uterine contraction monitor and accessories.
(a) Identification. An external uterine contraction monitor (i.e.,
the tokodynamometer) is a device used to monitor the progress of labor.
It measures the duration, frequency, and relative pressure of uterine
contractions with a transducer strapped to the maternal abdomen. This
generic type of device may include an external pressure transducer,
support straps, and other patient and equipment supports.
(b) Classification. Class II (performance standards).
21 CFR 884.2740 Perinatal monitoring system and accessories.
(a) Identification. A perinatal monitoring system is a device used
to show graphically the relationship between maternal labor and the
fetal heart rate by means of combining and coordinating uterine
contraction and fetal heart monitors with appropriate displays of the
well-being of the fetus during pregnancy, labor, and delivery. This
generic type of device may include any of the devices subject to
884.2600, 884.2640, 884.2660, 884.2675, 884.2700, and 884.2720. This
generic type of device may include the following accessories: Central
monitoring system and remote repeaters, signal analysis and display
equipment, patient and equipment supports, and component parts.
(b) Classification. Class II (performance standards).
21 CFR 884.2900 Fetal stethoscope.
(a) Identification. A fetal stethoscope is a device used for
listening to fetal heart sounds. It is designed to transmit the fetal
heart sounds not only through sound channels by air conduction, but also
through the user's head by tissue conduction into the user's ears. It
does not use ultrasonic energy. This device is designed to eliminate
noise interference commonly caused by handling conventional
stethoscopes.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
21 CFR 884.2960 Obstetric ultrasonic transducer and accessories.
(a) Identification. An obstetric ultrasonic transducer is a device
used to apply ultrasonic energy to, and to receive ultrasonic energy
from, the body in conjunction with an obstetric monitor or imager. The
device converts electrical signals into ultrasonic energy, and vice
versa, by means of an assembly distinct from an ultrasonic generator.
This generic type of device may include the following accessories:
coupling gel, preamplifiers, amplifiers, signal conditioners with their
power supply, connecting cables, and component parts. This generic type
of device does not include devices used to generate the ultrasonic
frequency electrical signals for application.
(b) Classification. Class II (performance standards).
21 CFR 884.2980 Telethermographic system.
(a) Telethermographic system intended for adjunctive diagnostic
screening for detection of breast cancer or other uses -- (1)
Identification. A telethermographic system for adjunctive diagnostic
screening for detection of breast cancer or other uses is an
electrically powered device with a detector that is intended to measure,
without touching the patient's skin, the self-emanating infrared
radiation that reveals the temperature variations of the surface of the
body. This generic type of device may include signal analysis and
display equipment, patient and equipment supports, component parts, and
accessories.
(2) Classification. Class I.
(b) Telethermographic system intended for use alone in diagnostic
screening for detection of breast cancer or other uses -- (1)
Identification. A telethermographic system for use as the sole
diagnostic screening tool for detection of breast cancer or other uses
is an electrically powered device with a detector that is intended to
measure, without touching the patient's skin, the self-emanating
infrared radiation that reveals the temperature variations of the
surface of the body. This generic type of device may include signal
analysis and display equipment, patient and equipment supports,
component parts, and accessories.
(2) Classification. Class III.
(3) Date PMA or notice of completion of a PDP is required. As of the
enactment date of the amendments, May 28, 1976, an approval under
section 515 of the act is required before the device described in
paragraph (b)(1) may be commercially distributed. See 884.3.
(53 FR 1566, Jan. 20, 1988, as amended at 55 FR 48440, Nov. 20, 1990)
21 CFR 884.2982 Liquid crystal thermographic system.
(a) A nonelectrically powered or an AC-powered liquid crystal
thermographic system intended for adjunctive use in diagnostic screening
for detection of breast cancer or other uses -- (1) Identification. A
nonelectrically powered or an AC-powered liquid crystal thermographic
system intended for use as an adjunct to physical palpation or
mammography in diagnostic screening for detection of breast cancer or
other uses is a nonelectrically powered or an AC-powered device applied
to the skin that displays the color patterns of heat sensitive
cholesteric liquid crystals that respond to temperature variations of
the surface of the body. This generic type of device may include
patient and equipment supports, a means to ensure thermal contact
between the patient's skin and the liquid crystals, component parts, and
accessories.
(2) Classification. Class I.
(b) A nonelectrically powered or an AC-powered liquid crystal
thermographic system intended for use alone in diagnostic screening for
detection of breast cancer or other uses -- (1) Identification. A
nonelectrically powered or an AC-powered liquid crystal thermographic
system intended for use as the sole diagnostic screening tool for
detection of breast cancer or other uses is a nonelectrically powered or
an AC-powered device applied to the skin that displays the color
patterns of heat sensitive cholesteric liquid crystals that respond to
temperature variations of the surface of the body. This generic type of
device may include image display and recording equipment, patient and
equipment supports, a means to ensure thermal contact between the
patient's skin and the liquid crystals, component parts, and
accessories.
(2) Classification. Class III.
(3) Date PMA or notice of completion of a PDP is required. As of the
enactment date of the amendments, May 28, 1976, an approval under
section 515 of the act is required before the device described in
paragraph (b)(1) may be commercially distributed. See 884.3.
(53 FR 1566, Jan. 20, 1988, as amended at 55 FR 48441, Nov. 20, 1990)
21 CFR 884.2982 Subpart D -- Obstetrical and Gynecological Prosthetic Devices
21 CFR 884.3200 Cervical drain.
(a) Identification. A cervical drain is a device designed to provide
an exit channel for draining discharge from the cervix after pelvic
surgery.
(b) Classification. Class II (performance standards).
21 CFR 884.3575 Vaginal pessary.
(a) Identification. A vaginal pessary is a removable structure
placed in the vagina to support the pelvic organs and is used to treat
conditions such as uterine prolapse (falling down of uterus), uterine
retroposition (backward displacement), or gynecologic hernia.
(b) Classification. Class II (performance standards).
21 CFR 884.3650 Fallopian tube prosthesis.
(a) Identification. A fallopian tube prosthesis is a device designed
to maintain the patency (openness) of the fallopian tube and is used
after reconstructive surgery.
(b) Classification. Class II (performance standards).
21 CFR 884.3900 Vaginal stent.
(a) Identification. A vaginal stent is a device used to enlarge the
vagina by stretching, or to support the vagina and to hold a skin graft
after reconstructive surgery.
(b) Classification. Class II (performance standards).
21 CFR 884.3900 Subpart E -- Obstetrical and Gynecological Surgical Devices
21 CFR 884.4100 Endoscopic electrocautery and accessories.
(a) Identification. An endoscopic electrocautery is a device used to
perform female sterilization under endoscopic observation. It is
designed to coagulate fallopian tube tissue with a probe heated by
low-voltage energy. This generic type of device may include the
following accessories: electrical generators, probes, and electrical
cables.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 884.3.
(45 FR 12684-12720, Feb. 26, 1980, as amended at 52 FR 17741, May 11,
1987)
21 CFR 884.4120 Gynecologic electrocautery and accessories.
(a) Identification. A gynecologic electrocautery is a device
designed to destroy tissue with high temperatures by tissue contact with
an electrically heated probe. It is used to excise cervical lesions,
perform biopsies, or treat chronic cervicitis under direct visual
observation. This generic type of device may include the following
accessories: an electrical generator, a probe, and electrical cables.
(b) Classification. Class II (performance standards).
21 CFR 884.4150 Bipolar endoscopic coagulator-cutter and accessories.
(a) Identification. A bipolar endoscopic coagulator-cutter is a
device used to perform female sterilization and other operative
procedures under endoscopic observation. It destroys tissue with high
temperatures by directing a high frequency electrical current through
tissue between two electrical contacts of a probe. This generic type of
device may include the following accessories: an electrical generator,
probes, and electrical cables.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 884.3.
(45 FR 12684-12720, Feb. 26, 1980, as amended at 52 FR 17741, May 11,
1987)
21 CFR 884.4160 Unipolar endoscopic coagulator-cutter and accessories.
(a) Identification. A unipolar endoscopic coagulator-cutter is a
device designed to destroy tissue with high temperatures by directing a
high frequency electrical current through the tissue between an
energized probe and a grounding plate. It is used in female
sterilization and in other operative procedures under endoscopic
observation. This generic type of device may include the following
accessories: an electrical generator, probes and electrical cables, and
a patient grounding plate. This generic type of device does not include
devices used to perform female sterilization under hysteroscopic
observation.
(b) Classification. Class II (performance standards).
21 CFR 884.4250 Expandable cervical dilator.
(a) Identification. An expandable cervical dilator is an instrument
with two handles and two opposing blades used manually to dilate
(stretch open) the cervical os.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 884.3.
(45 FR 12684-12720, Feb. 26, 1980, as amended at 52 FR 17741, May 11,
1987)
21 CFR 884.4260 Hygroscopic Laminaria cervical dilator.
(a) Identification. A hygroscopic Laminaria cervical dilator is a
device designed to dilate (stretch open) the cervical os by cervical
insertion of a conical and expansible material made from the root of a
seaweed (Laminaria digitata or Laminaria japonica). The device is used
to induce abortion.
(b) Classification. Class II (performance standards).
21 CFR 884.4270 Vibratory cervical dilators.
(a) Identification. A vibratory cervical dilator is a device
designed to dilate the cervical os by stretching it with a power-driven
vibrating probe head. The device is used to gain access to the uterus
or to induce abortion, but is not to be used during labor when a viable
fetus is desired or anticipated.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 884.3.
(45 FR 12684-12720, Feb. 26, 1980, as amended at 52 FR 17741, May 11,
1987)
21 CFR 884.4340 Fetal vacuum extractor.
(a) Identification. A fetal vacuum extractor is a device used to
facilitate delivery. The device enables traction to be applied to the
fetal head (in the birth canal) by means of a suction cup attached to
the scalp and is powered by an external vacuum source. This generic
type of device may include the cup, hosing, vacuum source, and vacuum
control.
(b) Classification. Class II (performance standards).
21 CFR 884.4400 Obstetric forceps.
(a) Identification. An obstetric forceps is a device consisting of
two blades, with handles, designed to grasp and apply traction to the
fetal head in the birth passage and facilitate delivery.
(b) Classification. Class II (performance standards).
21 CFR 884.4500 Obstetric fetal destructive instrument.
(a) Identification. An obstetric fetal destructive instrument is a
device designed to crush or pull the fetal body to facilitate the
delivery of a dead or anomalous (abnormal) fetus. This generic type of
device includes the cleidoclast, cranioclast, craniotribe, and
destructive hook.
(b) Classification. Class II (performance standards).
21 CFR 884.4520 Obstetric-gynecologic general manual instrument.
(a) Identification. An obstetric-gynecologic general manual
instrument is one of a group of devices used to perform simple obstetric
and gynecologic manipulative functions. This generic type of device
consists of the following:
(1) An episiotomy scissors is a cutting instrument, with two opposed
shearing blades, used for surgical incision of the vulvar orifice for
obstetrical purposes.
(2) A fiberoptic metal vaginal speculum is a metal instrument, with
fiberoptic light, used to expose and illuminate the interior of the
vagina.
(3) A metal vaginal speculum is a metal instrument used to expose the
interior of the vagina.
(4) An umbilical scissors is a cutting instrument, with two opposed
shearing blades, used to cut the umbilical cord.
(5) A uterine clamp is an instrument used to hold the uterus by
compression.
(6) A uterine packer is an instrument used to introduce dressing into
the uterus or vagina.
(7) A vaginal applicator is an instrument used to insert medication
into the vagina.
(8) A vaginal retractor is an instrument used to maintain vaginal
exposure by separating the edges of the vagina and holding back the
tissue.
(9) A gynecological fibroid hook is an instrument used to exert
traction upon a fibroid.
(10) A pelvimeter (external) is an instrument used to measure the
external diameters of the pelvis.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(45 FR 12684-12720, Feb. 26, 1980, as amended at 54 FR 25052, June
12, 1989)
21 CFR 884.4530 Obstetric-gynecologic specialized manual instrument.
(a) Identification. An obstetric-gynecologic specialized manual
instrument is one of a group of devices used during
obstetric-gynecologic procedures to perform manipulative diagnostic and
surgical functions (e.g., dilating, grasping, measuring, and scraping),
where structural integrity is the chief criterion of device performance.
This type of device consists of the following:
(1) An amniotome is an instrument used to rupture the fetal
membranes.
(2) A circumcision clamp is an instrument used to compress the
foreskin of the penis during circumcision of a male infant.
(3) An umbilical clamp is an instrument used to compress the
umbilical cord.
(4) A uterine curette is an instrument used to scrape and remove
material from the uterus.
(5) A fixed-size cervical dilator is any of a series of bougies of
various sizes used to dilate the cervical os by stretching the cervix.
(6) A uterine elevator is an instrument inserted into the uterus used
to lift and manipulate the uterus.
(7) A gynecological surgical forceps is an instrument with two blades
and handles used to pull, grasp, or compress during gynecological
examination.
(8) A cervical cone knife is a cutting instrument used to excise and
remove tissue from the cervix.
(9) A gynecological cerclage needle is a looplike instrument used to
suture the cervix.
(10) A hook-type contraceptive intrauterine device (IUD) remover is
an instrument used to remove an IUD from the uterus.
(11) A gynecological fibroid screw is an instrument used to hold onto
a fibroid.
(12) A uterine sound is an instrument used to determine the depth of
the uterus by inserting it into the uterine cavity.
(13) A cytological cervical spatula is a blunt instrument used to
scrape and remove cytological material from the surface of the cervix or
vagina.
(14) A gynecological biopsy forceps is an instrument with two blades
and handles used for gynecological biopsy procedures.
(15) A uterine tenaculum is a hooklike instrument used to seize and
hold the cervix or fundus.
(16) An internal pelvimeter is an instrument used within the vagina
to measure the diameter and capacity of the pelvis.
(17) A nonmetal vaginal speculum is a nonmetal instrument used to
expose the interior of the vagina.
(18) A fiberoptic nonmetal vaginal speculum is a nonmetal instrument,
with fiberoptic light, used to expose and illuminate the interior of the
vagina.
(b) Classification. Class II (performance standards).
21 CFR 884.4550 Gynecologic surgical laser.
(a) Identification. A gynecologic surgical laser is a continuous
wave carbon dioxide laser designed to destroy tissue thermally or to
remove tissue by radiant light energy. The device is used only in
conjunction with a colposcope as part of a gynecological surgical
system. A colposcope is a magnifying lens system used to examine the
vagina and cervix.
(b) Classification. Class II (performance standards).
21 CFR 884.4900 Obstetric table and accessories.
(a) Identification. An obstetric table is a device with adjustable
sections designed to support a patient in the various positions required
during obstetric and gynecologic procedures. This generic type of
device may include the following accessories: patient equipment,
support attachments, and cabinets for warming instruments and disposing
of wastes.
(b) Classification. Class II (performance standards).
21 CFR 884.4900 Subpart F -- Obstetrical and Gynecological Therapeutic Devices
21 CFR 884.5050 Metreurynter-balloon abortion system.
(a) Identification. A metreurynter-balloon abortion system is a
device used to induce abortion. The device is inserted into the uterine
cavity, inflated, and slowly extracted. The extraction of the balloon
from the uterus causes dilation of the cervical os. This generic type
of device may include pressure sources and pressure controls.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 884.3.
(45 FR 12684-12720, Feb. 26, 1980, as amended at 52 FR 17741, May 11,
1987)
21 CFR 884.5070 Vacuum abortion system.
(a) Identification. A vacuum abortion system is a device designed to
aspirate transcervically the products of conception or menstruation from
the uterus by using a cannula connected to a suction source. This
device is used for pregnancy termination or menstrual regulation. This
type of device may include aspiration cannula, vacuum source, and vacuum
controller.
(b) Classification. Class II (performance standards).
21 CFR 884.5100 Obstetric anesthesia set.
(a) Identification. An obstetric anesthesia set is an assembly of
antiseptic solution, needles, needle guides, syringes, and other
accessories, intended for use with an anesthetic drug. This device is
used to administer regional blocks (e.g., paracervical, uterosacral, and
pudendal) that may be used during labor, delivery, or both.
(b) Classification. Class II (performance standards).
21 CFR 884.5150 Nonpowered breast pump.
(a) Identification. A nonpowered breast pump is a manual suction
device used to express milk from the breast.
(b) Classification. Class I (general controls).
21 CFR 884.5160 Powered breast pump.
(a) Identification. A powered breast pump in an electrically powered
suction device used to express milk from the breast.
(b) Classification. Class II (performance standards).
21 CFR 884.5225 Abdominal decompression chamber.
(a) Identification. An abdominal decompression chamber is a hoodlike
device used to reduce pressure on the pregnant patient's abdomen for the
relief of abdominal pain during pregnancy or labor.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 884.3.
(45 FR 12684-12720, Feb. 26, 1980, as amended at 52 FR 17741, May 11,
1987)
21 CFR 884.5250 Cervical cap.
(a) Identification. A cervical cap is a flexible cuplike receptacle
that fits over the cervix to collect menstrual flow or to aid artificial
insemination. This generic type of device is not for contraceptive use.
(b) Classification. Class II (performance standards).
21 CFR 884.5300 Condom.
(a) Identification. A condom is a sheath which completely covers the
penis with a closely fitting membrane. The condom is used for
contraceptive and for prophylactic purposes (preventing transmission of
venereal disease). The device may also be used to collect semen to aid
in the diagnosis of infertility.
(b) Classification. Class II (performance standards).
21 CFR 884.5310 Condom with spermicidal lubricant.
(a) Identification. A condom with spermicidal lubricant is a sheath
which completely covers the penis with a closely fitting membrane with a
lubricant that contains a spermicidal agent, nonoxynol-9. This condom
is used for contraceptive and prophylactic purposes (preventing
transmission of venereal disease).
(b) Classification. Class II (performance standards).
(47 FR 49022, Oct. 29, 1982)
21 CFR 884.5350 Contraceptive diaphragm and accessories.
(a) Identification. A contraceptive diaphragm is a closely fitting
membrane placed between the posterior aspect of the pubic bone and the
posterior vaginal fornix. The device covers the cervix completely and
is used with a spermicide to prevent pregnancy. This generic type of
device may include an introducer.
(b) Classification. Class II (performance standards).
21 CFR 884.5360 Contraceptive intrauterine device (IUD) and introducer.
(a) Identification. A contraceptive intrauterine device (IUD) is a
device used to prevent pregnancy. The device is placed high in the
uterine fundus with a string extending from the device through the
cervical os into the vagina. This generic type of device includes the
introducer, but does not include contraceptive IUD's that function by
drug activity, which are subject to the new drug provisions of the
Federal Food, Drug, and Cosmetic Act (see 310.502).
(b) Classification. Class III (premarket approval).
(c) Labeling. Labeling requirements for contraceptive IUD's are set
forth in 801.427.
(d) Date premarket approval application (PMA) or notice of completion
of a product development protocol (PDP) is required. A PMA or a notice
of completion of a PDP is required to be filed with the Food and Drug
Administration on or before August 4, 1986, for any IUD and introducer
that was in commercial distribution before May 28, 1976, or that has on
or before August 4, 1986, been found to be substantially equivalent to
an IUD and introducer that was in commercial distribution before May 28,
1976. Any other IUD and introducer shall have an approved PMA or a
declared completed PDP in effect before being placed in commercial
distribution.
(45 FR 12684 -- 12720, Feb. 26, 1980, as amended at 51 FR 16649, May
5, 1986)
21 CFR 884.5380 Contraceptive tubal occlusion device (TOD) and
introducer.
(a) Identification. A contraceptive tubal occlusion device (TOD) and
introducer is a device designed to close a fallopian tube with a
mechanical structure, e.g., a band or clip on the outside of the
fallopian tube or a plug or valve on the inside. The devices are used
to prevent pregnancy.
(b) Classification. Class III (premarket approval).
(c) Date premarket approval application (PMA) or notice of completion
of a product development protocol (PDP) is required. A PMA or a notice
of completion of a PDP is required to be filed with the Food and Drug
Administration on or before December 30, 1987, for any TOD and
introducer that was in commercial distribution before May 28, 1976, or
that has on or before December 30, 1987, been found to be substantially
equivalent to a TOD and introducer that was in commercial distribution
before May 28, 1976. Any other TOD and introducer shall have an
approved PMA or a declared completed PDP in effect before being placed
in commercial distribution.
(45 FR 12684-12720, Feb. 26, 1980, as amended at 52 FR 36883, Oct.
1, 1987)
21 CFR 884.5390 Perineal heater.
(a) Identification. A perineal heater is a device designed to apply
heat directly by contact, or indirectly from a radiant source, to the
surface of the perineum (the area between the vulva and the anus) and is
used to soothe or to help heal the perineum after an episiotomy
(incision of the vulvar orifice for obstetrical purposes).
(b) Classification. Class II (performance standards).
21 CFR 884.5400 Menstrual cup.
(a) Identification. A menstrual cup is a receptacle placed in the
vagina to collect menstrual flow.
(b) Classification. Class II (performance standards).
21 CFR 884.5425 Scented or scented deodorized menstrual pad.
(a) Identification. A scented or scented deodorized menstrual pad is
a device that is a pad made of cellulosic or synthetic material which is
used to absorb menstrual or other vaginal discharge. It has scent
(i.e., fragrance materials) added for aesthetic purposes (scented
menstrual pad) or for deodorizing purposes (scented deodorized menstrual
pad). This generic type of device includes sterile scented menstrual
pads used for medically indicated conditions, but does not include
menstrual pads treated with added antimicrobial agents or other drugs.
(b) Classification. Class II (performance standards).
(45 FR 12684-12720, Feb. 26, 1980, as amended at 45 FR 51185, Aug.
1, 1980)
21 CFR 884.5435 Unscented menstrual pad.
(a) Identification. An unscented menstrual pad is a device that is a
pad made of cellulosic or synthetic material which is used to absorb
menstrual or other vaginal discharge. This generic type of device
includes sterile unscented menstrual pads used for medically indicated
conditions, but does not include menstrual pads treated with scent
(i.e., fragrance materials) or those with added antimicrobial agents or
other drugs.
(b) Classification. Class I (general controls).
21 CFR 884.5460 Scented or scented deodorized menstrual tampon.
(a) Identification. A scented or scented deodorized menstrual tampon
is a device that is a plug made of cellulosic or synthetic material that
is inserted into the vagina and used to absorb menstrual or other
vaginal discharge. It has scent (i.e., fragrance materials) added for
aesthetic purposes (scented menstrual tampon) or for deodorizing
purposes (scented deodorized menstrual tampon). This generic type of
device does not include menstrual tampons treated with added
antimicrobial agents or other drugs.
(b) Classification. Class II (performance standards).
(45 FR 12684-12720, Feb. 26, 1980, as amended at 45 FR 51186, Aug.
1, 1980)
21 CFR 884.5470 Unscented menstrual tampon.
(a) Identification. An unscented menstrual tampon is a device that
is a plug made of cellulosic or synthetic material that is inserted into
the vagina and used to absorb menstrual or other vaginal discharge.
This generic type of device does not include menstrual tampons treated
with scent (i.e., fragrance materials) or those with added antimicrobial
agents or other drugs.
(b) Classification. Class II (performance standards).
21 CFR 884.5900 Therapeutic vaginal douche apparatus.
(a) Identification. A therapeutic vaginal douche apparatus is a
device that is a bag or bottle with tubing and a nozzle. The apparatus
does not include douche solutions. The apparatus is intended and
labeled for use in the treatment of medical conditions except it is not
for contraceptive use. After filling the therapeutic vaginal douche
apparatus with a solution, the patient uses the device to direct a
stream of solution into the vaginal cavity.
(b) Classification. Class II (performance standards).
21 CFR 884.5920 Vaginal insufflator.
(a) Identification. A vaginal insufflator is a device used to treat
vaginitis by introducing medicated powder from a hand-held bulb into the
vagina through an open speculum.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(45 FR 12684-12720, Feb. 26, 1980, as amended at 54 FR 25052, June
12, 1989)
21 CFR 884.5940 Powered vaginal muscle stimulator for therapeutic use.
(a) Identification. A powered vaginal muscle stimulator is an
electrically powered device designed to stimulate directly the muscles
of the vagina with pulsating electrical current. This device is
intended and labeled for therapeutic use in increasing muscular tone and
strength in the treatment of sexual dysfunction. This generic type of
device does not include devices used to treat urinary incontinence.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 884.3.
(45 FR 12684-12720, Feb. 26, 1980, as amended at 52 FR 17741, May 11,
1987)
21 CFR 884.5960 Genital vibrator for therapeutic use.
(a) Identification. A genital vibrator for therapeutic use is an
electrically operated device intended and labeled for therapeutic use in
the treatment of sexual dysfunction or as an adjunct to Kegel's exercise
(tightening of the muscles of the pelvic floor to increase muscle tone).
(b) Classification. Class II (performance standards).
21 CFR 884.5960 Pt. 886
21 CFR 884.5960 PART 886 -- OPHTHALMIC DEVICES
21 CFR 884.5960 Subpart A -- General Provisions
Sec.
886.1 Scope.
886.3 Effective dates of requirement for premarket approval.
886.9 Limitations of exemptions from section 510(k) of the act.
21 CFR 884.5960 Subpart B -- Diagnostic Devices
886.1040 Ocular esthesiometer.
886.1050 Adaptometer (biophotometer).
886.1070 Anomaloscope.
886.1090 Haidlinger brush.
886.1120 Ophthalmic camera.
886.1140 Ophthalmic chair.
886.1150 Visual acuity chart.
886.1160 Color vision plate illuminator.
886.1170 Color vision tester.
886.1190 Distometer.
886.1200 Optokinetic drum.
886.1220 Corneal electrode.
886.1250 Euthyscope.
886.1270 Exophthalmometer.
886.1290 Fixation device.
886.1300 Afterimage flasher.
886.1320 Fornixscope.
886.1330 Amsler grid.
886.1340 Haploscope.
886.1350 Keratoscope.
886.1360 Visual field laser instrument.
886.1375 Bagolini lens.
886.1380 Diagnostic condensing lens.
886.1385 Polymethylmethacrylate (PMMA) diagnostic contact lens.
886.1390 Flexible diagnostic Fresnel lens.
886.1395 Diagnostic Hruby fundus lens.
886.1400 Maddox lens.
886.1405 Ophthalmic trial lens set.
886.1410 Ophthalmic trial lens clip.
886.1415 Ophthalmic trial lens frame.
886.1420 Ophthalmic lens gauge.
886.1425 Lens measuring instrument.
886.1430 Ophthalmic contact lens radius measuring device.
886.1435 Maxwell spot.
886.1450 Corneal radius measuring device.
886.1460 Stereopsis measuring instrument.
886.1500 Headband mirror.
886.1510 Eye movement monitor.
886.1570 Ophthalmoscope.
886.1605 Perimeter.
886.1630 AC-powered photostimulator.
886.1640 Ophthalmic preamplifier.
886.1650 Ophthalmic bar prism.
886.1655 Ophthalmic Fresnel prism.
886.1660 Gonioscopic prism.
886.1665 Ophthalmic rotary prism.
886.1670 Ophthalmic isotope uptake probe.
886.1680 Ophthalmic projector.
886.1690 Pupillograph.
886.1700 Pupillometer.
886.1750 Skiascopic rack.
886.1760 Ophthalmic refractometer.
886.1770 Manual refractor.
886.1780 Retinoscope.
886.1790 Nearpoint ruler.
886.1800 Schirmer strip.
886.1810 Tangent screen (campimeter).
886.1840 Simulatan (including crossed cylinder).
886.1850 AC-powered slitlamp biomicroscope.
886.1860 Ophthalmic instrument stand.
886.1870 Stereoscope.
886.1880 Fusion and stereoscopic target.
886.1905 Nystagmus tape.
886.1910 Spectacle dissociation test system.
886.1930 Tonometer and accessories.
886.1940 Tonometer sterilizer.
886.1945 Transilluminator.
21 CFR 884.5960 Subpart C -- (Reserved)
21 CFR 884.5960 Subpart D -- Prosthetic Devices
886.3100 Ophthalmic tantalum clip.
886.3130 Ophthalmic conformer.
886.3200 Artificial eye.
886.3300 Absorbable implant (scleral buckling method).
886.3320 Eye sphere implant.
886.3340 Extraocular orbital implant.
886.3400 Keratoprosthesis.
886.3600 Intraocular lens.
886.3800 Scleral shell.
886.3920 Eye valve implant.
21 CFR 884.5960 Subpart E -- Surgical Devices
886.4070 Powered corneal burr.
886.4100 Radiofrequency electrosurgical cautery apparatus.
886.4115 Thermal cautery unit.
886.4150 Vitreous aspiration and cutting instrument.
886.4170 Cryophthalmic unit.
886.4230 Ophthalmic knife test drum.
886.4250 Ophthalmic electrolysis unit.
886.4270 Intraocular gas.
886.4275 Intraocular fluid.
886.4280 Intraocular pressure measuring device.
886.4300 Intraocular lens guide.
886.4335 Operating headlamp.
886.4350 Manual ophthalmic surgical instrument.
886.4360 Ocular surgery irrigation device.
886.4370 Keratome.
886.4390 Ophthalmic laser.
886.4392 Nd:YAG laser for posterior capsulotomy.
886.4400 Electronic metal locator.
886.4440 AC-powered magnet.
886.4445 Permanent magnet.
886.4570 Ophthalmic surgical marker.
886.4610 Ocular pressure applicator.
886.4670 Phacofragmentation system.
886.4690 Ophthalmic photocoagulator.
886.4750 Ophthalmic eye shield.
886.4770 Ophthalmic operating spectacles (loupes).
886.4790 Ophthalmic sponge.
886.4855 Ophthalmic instrument table.
21 CFR 884.5960 Subpart F -- Therapeutic Devices
886.5100 Ophthalmic beta radiation source.
886.5120 Low-power binocular loupe.
886.5420 Contact lens inserter/remover.
886.5540 Low-vision magnifier.
886.5600 Ptosis crutch.
886.5800 Ophthalmic bar reader.
886.5810 Ophthalmic prism reader.
886.5820 Closed-circuit television reading system.
886.5840 Magnifying spectacles.
886.5842 Spectacle frame.
886.5844 Prescription spectacle lens.
886.5850 Sunglasses (nonprescription).
886.5870 Low-vision telescope.
886.5900 Electronic vision aid.
886.5910 Image intensification vision aid.
886.5915 Optical vision aid.
886.5916 Rigid gas permeable contact lens.
886.5918 Rigid gas permeable contact lens solution.
886.5925 Soft (hydrophilic) contact lens.
886.5928 Soft (hydrophilic) contact lens solution.
886.5933 Contact lens heat disinfection unit.
Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j, 371).
Source: 52 FR 33355, Sept. 2, 1987, unless otherwise noted.
21 CFR 884.5960 Subpart A -- General Provisions
21 CFR 886.1 Scope.
(a) This part sets forth the classification of ophthalmic devices
intended for human use that are in commercial distribution.
(b) The identification of a device in a regulation in this part is
not a precise description of every device that is, or will be, subject
to the regulation. A manufacturer who submits a premarket notification
submission for a device under Part 807 cannot show merely that the
device is accurately described by the section title and identification
provision of a regulation in this part but shall state why the device is
substantially equivalent to other devices, as required by 807.87.
(c) To avoid duplicative listings, an ophthalmic device that has two
or more types of uses (e.g., used both as a diagnostic device and as a
therapeutic device) is listed in one subpart only.
(d) References in this part to regulatory sections of the Code of
Federal Regulations are to Chapter I of Title 21 unless otherwise noted.
21 CFR 886.3 Effective dates of requirement for premarket approval.
A device included in this part that is classified into class III
(premarket approval) shall not be commercially distributed after the
date shown in the regulation classifying the device unless the
manufacturer has an approval under section 515 of the act (unless an
exemption has been granted under section 520(g)(2) of the act). An
approval under section 515 of the act consists of FDA's issuance of an
order approving an application for premarket approval (PMA) for the
device or declaring completed a product development protocol (PDP) for
the device.
(a) Before FDA requires that a device commercially distributed before
the enactment date of the amendments, or a device that has been found
substantially equivalent to such a device, has an approval under section
515 of the act, FDA must promulgate a regulation under section 515(b) of
the act requiring such approval, except as provided in paragraphs (b)
and (c) of this section. Such a regulation under section 515(b) of the
act shall not be effective during the grace period ending on the 90th
day after its promulgation or on the last day of the 30th full calendar
month after the regulation that classifies the device into class III is
effective, whichever is later. See section 501(f)(2)(B) of the act.
Accordingly, unless an effective date of the requirement for premarket
approval is shown in the regulation for a device classified into class
III in this part, the device may be commercially distributed without
FDA's issuance of an order approving a PMA or declaring completed a PDP
for the device. If FDA promulgates a regulation under section 515(b) of
the act requiring premarket approval for a device, section 501(f)(1)(A)
of the act applies to the device.
(b) Any new, not substantially equivalent, device introduced into
commercial distribution on or after May 28, 1976, including a device
formerly marketed that has been substantially altered, is classified by
statute (section 513(f) of the act) into class III without any grace
period and FDA must have issued an order approving a PMA or declaring
completed a PDP for the device before the device is commercially
distributed unless it is reclassified. If FDA knows that a device being
commercially distributed may be a ''new'' device as defined in this
section because of any new intended use or other reasons, FDA may codify
the statutory classification of the device into class III for such new
use. Accordingly, the regulation for such a class III device states
that as of the enactment date of the amendments, May 28, 1976, the
device must have an approval under section 515 of the act before
commercial distribution.
(c) A device identified in a regulation in this part that is
classified into class III and that is subject to the transitional
provisions of section 520(1) of the act is automatically classified by
statute into class III and must have an approval under section 515 of
the act before being commercially distributed. Accordingly, the
regulation for such a class III transitional device states that as of
the enactment date of the amendments, May 28, 1976, the device must have
an approval under section 515 of the act before commercial distribution.
21 CFR 886.9 Limitations of exemptions from section 510(k) of the act.
FDA's decision to grant an exemption from the requirement of
premarket notification (section 510(k) of the act) for a generic type of
class I device is based upon the existing and reasonably foreseeable
characteristics of commercially distributed devices within that generic
type. Because FDA cannot anticipate every change in intended use or
characteristic that could significantly affect a device's safety or
effectiveness, manufacturers of any commercially distributed class I
device for which FDA has granted an exemption from the requirement of
premarket notification must still submit a premarket notification to FDA
before introducing or delivering for introduction into interstate
commerce for commercial distribution the device when:
(a) The device is intended for a use different from its intended use
before May 28, 1976, or the device is intended for a use different from
the intended use of a preamendments device to which it had been
determined to be substantially equivalent; e.g., the device is intended
for a different medical purpose, or the device is intended for lay use
where the former intended use was by health care professionals only; or
(b) The modified device operates using a different fundamental
scientific technology than that in use in the device before May 28,
1976; e.g., a surgical instrument cuts tissue with a laser beam rather
than with a sharpened metal blade, or an in vitro diagnostic device
detects or identifies infectious agents by using a deoxyribonucleic acid
(DNA) probe or nucleic acid hybridization technology rather than culture
or immunoassay technology.
(53 FR 35603, Sept. 14, 1988)
21 CFR 886.9 Subpart B -- Diagnostic Devices
21 CFR 886.1040 Ocular esthesiometer.
(a) Identification. An ocular esthesiometer is a device, such as a
single-hair brush, intended to touch the cornea to assess corneal
sensitivity.
(b) Classification. Class I. If the device is made of the same
materials that were used in the device before May 28, 1976, the device
is exempt from the premarket notification procedures in Part 807,
Subpart E of this chapter. The device also is exempt from the current
good manufacturing practice regulations in Part 820 of this chapter,
with the exception of 820.180, with respect to general requirements
concerning records, and 820.198, with respect to complaint files.
(52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35603, Sept. 14,
1988)
21 CFR 886.1050 Adaptometer (biophotometer).
(a) Identification. An adaptometer (biophotometer) is an AC-powered
device that provides a stimulating light source which has various
controlled intensities intended to measure the time required for retinal
adaptation (regeneration of the visual purple) and the minimum light
threshold.
(b) Classification. Class I.
(55 FR 48441, Nov. 20, 1990)
21 CFR 886.1070 Anomaloscope.
(a) Identification. An anomaloscope is an AC-powered device intended
to test for anomalies of color vision by displaying mixed spectral lines
to be matched by the patient.
(b) Classification. Class I.
(55 FR 48441, Nov. 20, 1990)
21 CFR 886.1090 Haidlinger brush.
(a) Identification. A Haidlinger brush is an AC-powered device that
provides two conical brushlike images with apexes touching which are
viewed by the patient through a Nicol prism and intended to evaluate
visual function. It may include a component for measuring macular
integrity.
(b) Classification. Class I.
(55 FR 48441, Nov. 20, 1990)
21 CFR 886.1120 Opthalmic camera.
(a) Identification. An ophthalmic camera is an AC-powered device
intended to take photographs of the eye and the surrounding area.
(b) Classification. Class II.
(55 FR 48441, Nov. 20, 1990)
21 CFR 886.1140 Ophthalmic chair.
(a) Identification. An ophthalmic chair is an AC-powered or manual
device with adjustable positioning in which a patient is to sit or
recline during ophthalmological examination or treatment.
(b) Classification. Class I. The manual device is exempt from the
premarket notification procedures in part 807, subpart E of this chapter
and it is also exempt from the current good manufacturing practice
regulations in part 820 of this chapter, with the exception of 820.180,
with respect to general requirements concerning records, and 820.198,
with respect to complaint files.
(55 FR 48441, Nov. 20, 1990)
21 CFR 886.1150 Visual acuity chart.
(a) Identification. A visual acuity chart is a device that is a
chart, such as a Snellen chart with block letters or other symbols in
graduated sizes, intended to test visual acuity.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Part 807, Subpart E of this
chapter. The device is exempt from the current good manufacturing
practice regulations in Part 820 of this chapter, with the exception of
820.180, with respect to general requirements concerning records, and
820.198, with respect to complaint files.
(52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35603, Sept. 14,
1988; 53 FR 40825, Oct. 18, 1988)
21 CFR 886.1160 Color vision plate illuminator.
(a) Identification. A color vision plate illuminator is an
AC-powered device that is a lamp intended to properly illuminate color
vision testing plates. It may include a filter.
(b) Classification. Class I.
(55 FR 48441, Nov. 20, 1990)
21 CFR 886.1170 Color vision tester.
(a) Identification. A color vision tester is a device that consists
of various colored materials, such as colored yarns or color vision
plates (multicolored plates which patients with color vision deficiency
would perceive as being of one color), intended to evaluate color
vision.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Part 807, Subpart E of this
chapter. The device is exempt from the current good manufacturing
practice regulations in Part 820 of this chapter, with the exception of
820.180, with respect to general requirements concerning records, and
820.198, with respect to complaint files.
(52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35603, Sept. 14,
1988)
21 CFR 886.1190 Distometer.
(a) Identification. A distometer is a device intended to measure the
distance between the cornea and a corrective lens during refraction to
help measure the change of the visual image when a lens is in place.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Part 807, Subpart E of this
chapter. The device is exempt from the current good manufacturing
practice regulations in Part 820 of this chapter, with the exception of
820.180, with respect to general requirements concerning records, and
820.198, with respect to complaint files.
(52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35603, Sept. 14,
1988)
21 CFR 886.1200 Optokinetic drum.
(a) Identification. An optokinetic drum is a drum-like device
covered with alternating white and dark stripes or pictures that can be
rotated on its handle. The device is intended to elicit and evaluate
nystagmus (involuntary rapid movement of the eyeball) in patients.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Part 807, Subpart E of this
chapter. The device is exempt from the current good manufacturing
practice regulations in Part 820 of this chapter, with the exception of
820.180, with respect to general requirements concerning records, and
820.198, with respect to complaint files.
(52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14,
1988)
21 CFR 886.1220 Corneal electrode.
(a) Identification. A corneal electrode is an AC-powered device,
usually part of a special contact lens, intended to be applied directly
to the cornea to provide data showing the changes in electrical
potential in the retina after electroretinography (stimulation by
light).
(b) Classification. Class II.
21 CFR 886.1250 Euthyscope.
(a) Identification. A euthyscope is a device that is a modified
AC-powered or battery-powered ophthalmoscope (a perforated mirror device
intended to inspect the interior of the eye) that projects a bright
light encompassing an arc of about 30 degrees onto the fundus of the
eye. The center of the light bundle is blocked by a black disk covering
the fovea (the central depression of the macular retinae where only
cones are present and blood vessels are lacking). The device is
intended for use in the treatment of amblyopia (dimness of vision
without apparent disease of the eye).
(b) Classification. Class I for the battery-powered device. Class
II for the AC-powered device.
(55 FR 48441, Nov. 20, 1990)
21 CFR 886.1270 Exophthalmometer.
(a) Identification. An exophthalmometer is a device, such as a
ruler, gauge, or caliper, intended to measure the degree of exophthalmos
(abnormal protrusion of the eyeball).
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Part 807, Subpart E of this
chapter.
(52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14,
1988)
21 CFR 886.1290 Fixation device.
(a) Identification. A fixation device is an AC-powered device
intended for use as a fixation target for the patient during
ophthalmological examination. The patient directs his or her gaze so
that the visual image of the object falls on the fovea centralis (the
center of the macular retina of the eye.)
(b) Classification. Class I.
(55 FR 48441, Nov. 20, 1990)
21 CFR 886.1300 Afterimage flasher.
(a) Identification. An afterimage flasher is an AC-powered light
that automatically switches on and off to allow performance of an
afterimage test in which the patient indicates the positions of
afterimages after the light is off. The device is intended to determine
harmonious/anomalous retinal correspondence (the condition in which
corresponding points on the retina have the same directional value).
(b) Classification. Class II.
(55 FR 48441, Nov. 20, 1990)
21 CFR 886.1320 Fornixscope.
(a) Identification. A fornixscope is a device intended to pull back
and hold open the eyelid to aid examination of the conjunctiva.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Part 807, Subpart E of this
chapter. The device is exempt from the current good manufacturing
practice regulations in Part 820 of this chapter, with the exception of
820.180, with respect to general requirements concerning records, and
820.198, with respect to complaint files.
(52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14,
1988)
21 CFR 886.1330 Amsler grid.
(a) Identification. An Amsler grid is a device that is a series of
charts with grids of different sizes that are held at 30 centimeters
distance from the patient and intended to rapidly detect central and
paracentral irregularities in the visual field.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Part 807, Subpart E of this
chapter. The device is exempt from the current good manufacturing
practice regulations in Part 820 of this chapter, with the exception of
820.180, with respect to general requirements concerning records, and
820.198, with respect to complaint files.
(52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14,
1988)
21 CFR 886.1340 Haploscope.
(a) Identification. A haploscope is an AC-powered device that
consists of two movable viewing tubes, each containing a slide carrier,
a low-intensity light source for the illumination of the slides, and a
high-intensity light source for creating afterimages. The device is
intended to measure strabismus (eye muscle imbalance), to assess
binocular vision (use of both eyes to see), and to treat suppression and
amblyopia (dimness of vision without any apparent disease of the eye).
(b) Classification. Class I.
(55 FR 48441, Nov. 20, 1990)
21 CFR 886.1350 Keratoscope.
(a) Identification. A keratoscope is an AC-powered or
battery-powered device intended to measure and evaluate the corneal
curvature of the eye. Lines and circles within the keratoscope are used
to observe the corneal reflex. This generic type of device includes the
photokeratoscope which records corneal curvature by taking photographs
of the cornea.
(b) Classification. Class I. The battery-powered device is exempt
from the current good manufacturing practice regulations in part 820 of
this chapter, with the exception of 820.180, with respect to general
requirements concerning records, and 820.198, with respect to complaint
files.
(55 FR 48441, Nov. 20, 1990)
21 CFR 886.1360 Visual field laser instrument.
(a) Identification. A visual field laser instrument is an AC-powered
device intended to provide visible laser radiation that produces an
interference pattern on the retina to evaluate retinal function.
(b) Classification. Class II.
21 CFR 886.1375 Bagolini lens.
(a) Identification. A Bagolini lens is a device that consists of a
plane lens containing almost imperceptible striations that do not
obscure visualization of objects. The device is placed in a trial frame
and intended to determine harmonious/anomalous retinal correspondence (a
condition in which corresponding points on the retina have the same
directional values).
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Part 807, Subpart E of this
chapter. The device is exempt from the current good manufacturing
practice regulations in Part 820 of this chapter, with the exception of
820.180, with respect to general requirements concerning records, and
820.198, with respect to complaint files.
(52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14,
1988)
21 CFR 886.1380 Diagnostic condensing lens.
(a) Identification. A diagnostic condensing lens is a device used in
binocular indirect ophthalmoscopy (a procedure that produces an inverted
or reversed direct magnified image of the eye) intended to focus
reflected light from the fundus of the eye.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Part 807, Subpart E of this
chapter. The device is exempt from the current good manufacturing
practice regulations in Part 820 of this chapter, with the exception of
820.180, with respect to general requirements concerning records, and
820.198, with respect to complaint files.
(52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14,
1988)
21 CFR 886.1385 Polymethylmethacrylate (PMMA) diagnostic contact lens.
(a) Identification. A polymethylmethacrylate (PMMA) diagnostic
contact lens is a device that is a curved shell of PMMA intended to be
applied for a short period of time directly on the globe or cornea of
the eye for diagnosis or therapy of intraocular abnormalities.
(b) Classification. Class II.
21 CFR 886.1390 Flexible diagnostic Fresnel lens.
(a) Identification. A flexible diagnostic Fresnel lens is a device
that is a very thin lens which has its surface a concentric series of
increasingly refractive zones. The device is intended to be applied to
the back of the spectacle lenses of patients with aphakia (absence of
the lens of the eye).
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Part 807, Subpart E of this
chapter. The device is exempt from the current good manufacturing
practice regulations in Part 820 of this chapter, with the exception of
820.180, with respect to general requirements concerning records, and
820.198, with respect to complaint files.
(52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14,
1988)
21 CFR 886.1395 Diagnostic Hruby fundus lens.
(a) Identification. A diagnostic Hruby fundus lens is a device that
is a 55 diopter lens intended for use in the examination of the vitreous
body and the fundus of the eye under slitlamp illumination and
magnification.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Part 807, Subpart E of this
chapter. The device is exempt from the current good manufacturing
practice regulations in Part 820 of this chapter, with the exception of
820.180, with respect to general requirements concerning records, and
820.198, with respect to complaint files.
(52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14,
1988)
21 CFR 886.1400 Maddox lens.
(a) Identification. A Maddox lens is a device that is a series of
red cylinders that change the size, shape, and color of an image. The
device is intended to be handheld or placed in a trial frame to evaluate
eye muscle dysfunction.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Part 807, Subpart E of this
chapter. The device is exempt from the current good manufacturing
practice regulations in Part 820 of this chapter, with the exception of
820.180, with respect to general requirements concerning records, and
820.198, with respect to complaint files.
(52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14,
1988)
21 CFR 886.1405 Ophthalmic trial lens set.
(a) Identification. An ophthalmic trial lens set is a device that is
a set of lenses of various dioptric powers intended to be handheld or
inserted in a trial frame for vision testing to determine refraction.
(b) Classification. Class II.
21 CFR 886.1410 Ophthalmic trial lens clip.
(a) Identification. An ophthalmic trial lens clip is a device
intended to hold prisms, spheres, cylinders, or occluders on a trial
frame or spectacles for vision testing.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Part 807, Subpart E of this
chapter. The device is exempt from the current good manufacturing
practice regulations in Part 820 of this chapter, with the exception of
820.180, with respect to general requirements concerning records, and
820.198, with respect to complaint files.
(52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14,
1988)
21 CFR 886.1415 Ophthalmic trial lens frame.
(a) Identification. An opthalmic trial lens frame is a mechanical
device intended to hold trial lenses for vision testing.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Part 807, Subpart E of this
chapter. The device is exempt from the current good manufacturing
practice regulations in Part 820 of this chapter, with the exception of
820.180, with respect to general requirements concerning records, and
820.198, with respect to complaint files.
(52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14,
1988)
21 CFR 886.1420 Ophthalmic lens gauge.
(a) Identification. An ophthalmic lens gauge is a calibrated device
intended to manually measure the curvature of a spectacle lens.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Part 807, Subpart E of this
chapter.
(52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14,
1988)
21 CFR 886.1425 Lens measuring instrument.
(a) Identification. A lens measuring instrument is an AC-powered
device intended to measure the power of lenses, prisms, and their
centers (e.g., lensometer).
(b) Classification. Class I.
(55 FR 48442, Nov. 20, 1990)
21 CFR 886.1430 Ophthalmic contact lens radius measuring device.
(a) Identification. An ophthalmic contact lens radius measuring
device is an AC-powered device that is a microscope and dial gauge
intended to measure the radius of a contact lens.
(b) Classification. Class I.
(55 FR 48442, Nov. 20, 1990)
21 CFR 886.1435 Maxwell spot.
(a) Identification. A Maxwell spot is an AC-powered device that is a
light source with a red and blue filter intended to test macular
function.
(b) Classification. Class I.
(55 FR 48442, Nov. 20, 1990)
21 CFR 886.1450 Corneal radius measuring device.
(a) Identification. A corneal radius measuring device is an
AC-powered device intended to measure corneal size by superimposing the
image of the cornea on a scale at the focal length of the lens of a
small, hand held, single tube penscope or eye gauge magnifier.
(b) Classification. Class I.
(55 FR 48442, Nov. 20, 1990)
21 CFR 886.1460 Stereopsis measuring instrument.
(a) Identification. A stereopsis measuring instrument is a device
intended to measure depth perception by illumination of objects placed
on different planes.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Part 807, Subpart E of this
chapter. The device is exempt from the current good manufacturing
practice regulations in Part 820 of this chapter, with the exception of
820.180, with respect to general requirements concerning records, and
820.198, with respect to complaint files.
(52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35605, Sept. 14,
1988)
21 CFR 886.1500 Headband mirror.
(a) Identification. A headband mirror is a device intended to be
strapped to the head of the user to reflect light for use in examination
of the eye.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Part 807, Subpart E of this
chapter. The device is exempt from the current good manufacturing
practice regulations in Part 820 of this chapter, with the exception of
820.180, with respect to general requirements concerning records, and
820.198, with respect to complaint files.
(52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35605, Sept. 14,
1988)
21 CFR 886.1510 Eye movement monitor.
(a) Identification. An eye movement monitor is an AC-powered device
with an electrode intended to measure and record ocular movements.
(b) Classification. Class II.
21 CFR 886.1570 Ophthalmoscope.
(a) Identification. An ophthalmoscope is an AC-powered or
battery-powered device containing illumination and viewing optics
intended to examine the media (cornea, aqueous, lens, and vitreous) and
the retina of the eye.
(b) Classification. Class II.
21 CFR 886.1605 Perimeter.
(a) Identification. A perimeter is an AC-powered or manual device
intended to determine the extent of the peripheral visual field of a
patient. The device projects light on various points of a curved
surface, and the patient indicates whether he or she sees the light.
(b) Classification. Class I. The manual device is exempt from the
premarket notification procedures in part 807, subpart E of this
chapter, and it is also exempt from the current good manufacturing
practice regulations in part 820 of this chapter, with the exception of
820.180, with respect to general requirements concerning records, and
820.198 with respect to the complaint files.
(55 FR 48442, Nov. 20, 1990)
21 CFR 886.1630 AC-powered photostimulator.
(a) Identification. An AC-powered photostimulator is an AC-powered
device intended to provide light stimulus which allows measurement of
retinal or visual function by perceptual or electrical methods (e.g.,
stroboscope).
(b) Classification. Class II.
21 CFR 886.1640 Ophthalmic preamplifier.
(a) Identification. An ophthalmic preamplifier is an AC-powered or
battery-powered device intended to amplify electrical signals from the
eye in electroretinography (recording retinal action currents from the
surface of the eyeball after stimulation by light), electrooculography
(testing for retinal dysfunction by comparing the standing potential in
the front and the back of the eyeball), and electromyography (recording
electrical currents generated in active muscle).
(b) Classification. Class II.
21 CFR 886.1650 Ophthalmic bar prism.
(a) Identification. An ophthalmic bar prism is a device that is a
bar composed of fused prisms of gradually increasing strengths intended
to measure latent and manifest strabismus (eye muscle deviation) or the
power of fusion of a patient's eyes.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Part 807, Subpart E of this
chapter. The device also is exempt from the current good manufacturing
practice regulations in Part 820 of this chapter, with the exception of
820.180, with respect to general requirements concerning records, and
820.198, with respect to complaint files.
(52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35605, Sept. 14,
1988)
21 CFR 886.1655 Ophthalmic Fresnel prism.
(a) Identification. An ophthalmic Fresnel prism is a device that is
a thin plastic sheet with embossed rulings which provides the optical
effect of a prism. The device is intended to be applied to spectacle
lenses to give a prismatic effect.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Part 807, Subpart E of this
chapter. The device also is exempt from the current good manufacturing
practice regulations in Part 820 of this chapter, with the exception of
820.180, with respect to general requirements concerning records, and
820.198, with respect to complaint files.
(52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35605, Sept. 14,
1988)
21 CFR 886.1660 Gonioscopic prism.
(a) Identification. A gonioscopic prism is a device that is a prism
intended to be placed on the eye to study the anterior chamber. The
device may have angled mirrors to facilitate visualization of anatomical
features.
(b) Classification. Class I. If the device is made of the same
materials that were used in the device before May 28, 1976, the device
is exempt from the premarket notification procedures in Part 807,
Subpart E of this chapter.
(52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35605, Sept. 14,
1988)
21 CFR 886.1665 Ophthalmic rotary prism.
(a) Identification. An ophthalmic rotary prism is a device with
various prismatic powers intended to be handheld and used to measure
ocular deviation in patients with latent or manifest strabismus (eye
muscle deviation).
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Part 807, Subpart E of this
chapter. The device also is exempt from the current good manufacturing
practice regulations in Part 820 of this chapter, with the exception of
820.180, with respect to general requirements concerning records, and
820.198, with respect to complaint files.
(52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35605, Sept. 14,
1988)
21 CFR 886.1670 Ophthalmic isotope uptake probe.
(a) Identification. An ophthalmic isotope uptake probe is an
AC-powered device intended to measure, by a probe which is placed in
close proximity to the eye, the uptake of a radioisotope (phosphorus 32)
by tumors to detect tumor masses on, around, or within the eye.
(b) Classification. Class II.
21 CFR 886.1680 Ophthalmic projector.
(a) Identification. An ophthalmic projector is an AC-powered device
intended to project an image on a screen for vision testing.
(b) Classification. Class I.
(55 FR 48442, Nov. 20, 1990)
21 CFR 886.1690 Pupillograph.
(a) Identification. A pupillograph is an AC-powered device intended
to measure the pupil of the eye by reflected light and record the
responses of the pupil.
(b) Classification. Class I.
(55 FR 48442, Nov. 20, 1990)
21 CFR 886.1700 Pupillometer.
(a) Identification. A pupillometer is an AC-powered or manual device
intended to measure by reflected light the width or diameter of the
pupil of the eye.
(b) Classification. Class I. The manual device is exempt from the
premarket notification procedures in part 807, subpart E of this chapter
and it is also exempt from the current good manufacturing practice
regulations in part 820 of this chapter, with the exception of 820.180,
with respect to general requirements concerning records, and 820.198,
with respect to complaint files.
(55 FR 48442, Nov. 20, 1990)
21 CFR 886.1750 Skiascopic rack.
(a) Identification. A skiascopic rack is a device that is a rack and
a set of attached ophthalmic lenses of various dioptric strengths
intended as an aid in refraction.
(b) Classification. Class II.
21 CFR 886.1760 Ophthalmic refractometer.
(a) Identification. An ophthalmic refractometer is an automatic
AC-powered device that consists of a fixation system, a measurement and
recording system, and an alignment system intended to measure the
refractive power of the eye by measuring light reflexes from the retina.
(b) Classification. Class II.
21 CFR 886.1770 Manual refractor.
(a) Identification. A manual refractor is a device that is a set of
lenses of varous dioptric powers intended to measure the refractive
error of the eye.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Part 807, Subpart E of this
chapter. The device also is exempt from the current good manufacturing
practice regulations in Part 820 of this chapter, with the exception of
820.180, with respect to general requirements concerning records, and
820.198, with respect to complaint files.
(52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35605, Sept. 14,
1988)
21 CFR 886.1780 Retinoscope.
(a) Identification. A retinoscope is an AC-powered or
battery-powered device intended to measure the refraction of the eye by
illuminating the retina and noting the direction of movement of the
light on the retinal surface and of the refraction by the eye of the
emergent rays.
(b) Classification. Class I for the battery-powered device. Class
II for the AC-powered device. The battery-powered device is exempt from
the current good manufacturing practice regulations in Part 820 of this
chapter, with the exception of 820.180, with respect to general
requirements concerning records, and 820.198, with respect to complaint
files.
(55 FR 48442, Nov. 20, 1990; 55 FR 51799, Dec. 17, 1990)
21 CFR 886.1790 Nearpoint ruler.
(a) Identification. A nearpoint ruler is a device calibrated in
centimeters intended to measure the nearpoint of convergence (the point
to which the visual lines are directed when convergence is at its
maximum).
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Part 807, Subpart E of this
chapter. The device also is exempt from the current good manufacturing
practice regulations in Part 820 of this chapter, with the exception of
820.180, with respect to general requirements concerning records, and
820.198, with respect to complaint files.
(52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35605, Sept. 14,
1988; 53 FR 40825, Oct. 18, 1988)
21 CFR 886.1800 Schirmer strip.
(a) Identification. A Schirmer strip is a device made of filter
paper or similar material intended to be inserted under a patient's
lower eyelid to stimulate and evaluate formation of tears.
(b) Classification. Class I. If the device is made of the same
materials that were used in the device before May 28, 1976, the device
is exempt from the premarket notification procedures in Part 807,
Subpart E of this chapter.
(52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35605, Sept. 14,
1988)
21 CFR 886.1810 Tangent screen (campimeter).
(a) Identification. A tangent screen (campimeter) is an AC-powered
or battery-powered device that is a large square cloth chart with a
central mark of fixation intended to map on a flat surface the central
30 degrees of a patient's visual field. This generic type of device
includes projection tangent screens, target tangent screens and targets,
felt tangent screens, and stereo campimeters.
(b) Classification. Class I. The battery-powered device is exempt
from the premarket notification procedures in part 807, subpart E of
this chapter and it is also exempt from the current good manufacturing
practice regulations in part 820 of this chapter, with the exception of
820.180, with respect to general requirements concerning records, and
820.198, with respect to complaint files.
(55 FR 48442, Nov. 20, 1990)
21 CFR 886.1840 Simulatan (including crossed cylinder).
(a) Identification. A simulatan (including crossed cylinder) is a
device that is a set of pairs of cylinder lenses that provides various
equal plus and minus refractive strengths. The lenses are arranged so
that the user can exchange the positions of plus and minus cylinder
lenses of equal strengths. The device is intended for subjective
refraction (refraction in which the patient judges whether a given
object is clearly in focus, as the examiner uses different lenses).
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Part 807, Subpart E of this
chapter. The device also is exempt from the current good manufacturing
practice regulations in Part 820 of this chapter, with the exception of
820.180, with respect to general requirements concerning records, and
820.198, with respect to complaint files.
(52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35605, Sept. 14,
1988)
21 CFR 886.1850 AC-powered slitlamp biomicroscope.
(a) Identification. An AC-powered slitlamp biomicroscope is an
AC-powered device that is a microscope intended for use in eye
examination that projects into a patient's eye through a control
diaphragm a thin, intense beam of light.
(b) Classification. Class II.
21 CFR 886.1860 Ophthalmic instrument stand.
(a) Identification. An ophthalmic instrument stand is an AC-powered
or nonpowered device intended to store ophthalmic instruments in a
readily accessible position.
(b) Classification. Class I. The nonpowered device is exempt from
the premarket notification procedures in part 807, subpart E of this
chapter and it is also exempt from the current good manufacturing
practice regulations in part 820 of this chapter, with the exception of
820.180, with respect to general requirements concerning records, and
820.198, with respect to complaint files.
(55 FR 48442, Nov. 20, 1990)
21 CFR 886.1870 Stereoscope.
(a) Identification. A stereoscope is an AC-powered or
battery-powered device that combines the images of two similar objects
to produce a three-dimensional appearance of solidity and relief. It is
intended to measure the angle of strabismus (eye muscle deviation),
evaluate binocular vision (usage of both eyes to see), and guide a
patient's corrective exercises of eye muscles.
(b) Classification. Class I. The battery-powered device is exempt
from the premarket notification procedures in part 807, subpart E of
this chapter and it is also exempt from the current good manufacturing
practice regulations in part 820 of this chapter, with the exception of
820.180, with respect to general requirements concerning records, and
820.198, with respect to complaint files.
(55 FR 48442, Nov. 20, 1990)
21 CFR 886.1880 Fusion and stereoscopic target.
(a) Identification. A fusion and stereoscopic target is a device
intended for use as a viewing object with a stereoscope ( 886.1870).
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Part 807, Subpart E of this
chapter. The device also is exempt from the current good manufacturing
practice regulations in Part 820 of this chapter, with the exception of
820.180, with respect to general requirements concerning records, and
820.198, with respect to complaint files.
(52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35606, Sept. 14,
1988)
21 CFR 886.1905 Nystagmus tape.
(a) Identification. Nystagmus tape is a device that is a long,
narrow strip of fabric or other flexible material on which a series of
objects are printed. The device is intended to be moved across a
patient's field of vision to elicit optokinetic nystagmus (abnormal and
irregular eye movements) and to test for blindness.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Part 807, Subpart E of this
chapter. The device also is exempt from the current good manufacturing
practice regulations in Part 820 of this chapter, with the exception of
820.180, with respect to general requirements concerning records, and
820.198, with respect to complaint files.
(52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35606, Sept. 14,
1988)
21 CFR 886.1910 Spectacle dissociation test system.
(a) Identification. A spectacle dissociation test system is an
AC-powered or battery-powered device, such as a Lancaster test system,
that consists of a light source and various filters, usually red or
green filters, intended to subjectively measure imbalance of ocular
muscles.
(b) Classification. Class I. The battery-powered device is exempt
from the premarket notification procedures in part 807, subpart E of
this chapter and it is also exempt from the current good manufacturing
practice regulations in part 820 of this chapter, with the exception of
820.180, with respect to general requirements concerning records, and
820.198, with respect to complaint files.
(55 FR 48442, Nov. 20, 1990; 55 FR 51799, Dec. 17, 1990)
21 CFR 886.1930 Tonometer and accessories.
(a) Identification. A tonometer and accessories is a manual device
intended to measure intraocular pressure by applying a known force on
the globe of the eye and measuring the amount of indentation produced
(Schiotz type) or to measure intraocular tension by applanation
(applying a small flat disk to the cornea). Accessories for the device
may include a tonometer calibrator or a tonograph recording system. The
device is intended for use in the diagnosis of glaucoma.
(b) Classification. Class II.
21 CFR 886.1940 Tonometer sterilizer.
(a) Identification. A tonometer sterilizer is an AC-powered device
intended to heat sterilize a tonometer (a device used to measure
intraocular pressure).
(b) Classification. Class I.
(55 FR 48443, Nov. 20, 1990)
21 CFR 886.1945 Transilluminator.
(a) Identification. A transilluminator is an AC-powered or
battery-powered device that is a light source intended to transmit light
through tissues to aid examination of patients.
(b) Classification. Class I for the battery-powered device. Class
II for the AC-powered device.
(55 FR 48443, Nov. 20, 1990)
21 CFR 886.1945 Subpart C -- (Reserved)
21 CFR 886.1945 Subpart D -- Prosthetic Devices
21 CFR 886.3100 Ophthalmic tantalum clip.
(a) Identification. An ophthalmic tantalum clip is a malleable
metallic device intended to be implanted permanently or temporarily to
bring together the edges of a wound to aid healing or prevent bleeding
from small blood vessels in the eye.
(b) Classification. Class II.
21 CFR 886.3130 Ophthalmic conformer.
(a) Identification. An ophthalmic conformer is a device usually made
of molded plastic intended to be inserted temporarily between the
eyeball and eyelid to maintain space in the orbital cavity and prevent
closure or adhesions during the healing process following surgery.
(b) Classification. Class II.
21 CFR 886.3200 Artificial eye.
(a) Identification. An artificial eye is a device resembling an
eyeball, usually made of glass or plastic, intended to be inserted in a
patient's eye socket for cosmetic purposes to replace an eye. The
device is not intended to be implanted.
(b) Classification. Class II.
21 CFR 886.3300 Absorbable implant (scleral buckling method).
(a) Identification. An absorbable implant (scleral buckling method)
is a device intended to be implanted on the sclera to aid retinal
reattachment.
(b) Classification. Class II.
21 CFR 886.3320 Eye sphere implant.
(a) Identification. An eye sphere implant is a device intended to be
implanted in the eyeball to occupy space following the removal of the
contents of the eyeball with the sclera left intact.
(b) Classification. Class II.
21 CFR 886.3340 Extraocular orbital implant.
(a) Identification. An extraocular orbital implant is a
nonabsorbable device intended to be implanted during scleral surgery for
buckling or building up the floor of the eye, usually in conjunction
with retinal reattachment. Injectable substances are excluded.
(b) Classification. Class II.
21 CFR 886.3400 Keratoprosthesis.
(a) Identification. A keratoprosthesis is a device made of plastic
intended to be implanted to replace the central area of an opacified
natural cornea of the eye to maintain or restore sight.
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 886.3.
21 CFR 886.3600 Intraocular lens.
(a) Identification. An intraocular lens is a device made of
materials such as glass or plastic intended to be implanted to replace
the natural lens of an eye.
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. As of May
28, 1976, an approval under section 515 of the act is required before
this device may be commercially distributed. See 886.3.
21 CFR 886.3800 Scleral shell.
(a) Identification. A scleral shell is a device made of glass or
plastic that is intended to be inserted for short time periods over the
cornea and proximal-cornea sclera for cosmetic or reconstructive
purposes. An artificial eye is usually painted on the device. The
device is not intended to be implanted.
(b) Classification. Class II.
21 CFR 886.3920 Eye valve implant.
(a) Identification. An eye valve implant is a one-way,
pressure-sensitive, valve-like device intended to be implanted to
normalize intraocular pressure. The device may be used in the treatment
of glaucoma.
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 886.3.
21 CFR 886.3920 Subpart E -- Surgical Devices
21 CFR 886.4070 Powered corneal burr.
(a) Identification. A powered corneal burr is an AC-powered or
battery-powered device that is a motor and drilling tool intended to
remove rust rings from the cornea of the eye.
(b) Classification. Class I.
(55 FR 48443, Nov. 20, 1990; 55 FR 51799, Dec. 17, 1990)
21 CFR 886.4100 Radiofrequency electrosurgical cautery apparatus.
(a) Identification. A radiofrequency electrosurgical cautery
apparatus is an AC-powered or battery-powered device intended for use
during ocular surgery to coagulate tissue or arrest bleeding by a high
frequency electric current.
(b) Classification. Class II.
21 CFR 886.4115 Thermal cautery unit.
(a) Identification. A thermal cautery unit is an AC-powered or
battery-powered device intended for use during ocular surgery to
coagulate tissue or arrest bleeding by heat conducted through a wire
tip.
(b) Classification. Class II.
21 CFR 886.4150 Vitreous aspiration and cutting instrument.
(a) Identification. A vitreous aspiration and cutting instrument is
an electrically powered device, which may use ultrasound, intended to
remove vitreous matter from the vitreous cavity or remove a crystalline
lens.
(b) Classification. Class II.
21 CFR 886.4170 Cryophthalmic unit.
(a) Identification. A cryophthalmic unit is a device that is a probe
with a small tip that becomes extremely cold through the controlled use
of a refrigerant or gas. The device may be AC-powered. The device is
intended to remove cataracts by the formation of an adherent ice ball in
the lens, to freeze the eye and adjunct parts for surgical removal of
scars, and to freeze tumors.
(b) Classification. Class II.
21 CFR 886.4230 Ophthalmic knife test drum.
(a) Identification. An ophthalmic knife test drum is a device
intended to test the keenness of ophthalmic surgical knives to determine
whether resharpening is needed.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Part 807, Subpart E of this
chapter. The device also is exempt from the current good manufacturing
practice regulations in Part 820 of this chapter, with the exception of
820.180, with respect to general requirements concerning records, and
820.198, with respect to complaint files.
(52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35606, Sept. 14,
1988)
21 CFR 886.4250 Ophthalmic electrolysis unit.
(a) Identification. An ophthalmic electrolysis unit is an AC-powered
or battery-powered device intended to destroy ocular hair follicles by
applying a galvanic electrical current.
(b) Classification. Class I for the battery-powered device. Class
II for the AC-powered device.
(55 FR 48443, Nov. 20, 1990)
21 CFR 886.4270 Intraocular gas.
(a) Identification. An intraocular gas is a device consisting of a
gaseous fluid intended to be introduced into the eye to place pressure
on a detached retina.
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. As of May
28, 1976, an approval under section 515 of the act is required before
this device may be commercially distributed. See 886.3.
21 CFR 886.4275 Intraocular fluid.
(a) Identification. An intraocular fluid is a device consisting of a
nongaseous fluid intended to be introduced into the eye to aid
performance of surgery, such as to maintain anterior chamber depth,
preserve tissue integrity, protect tissue from surgical trauma, or
function as a tamponade during retinal reattachment.
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. As of May
28, 1976, an approval under section 515 of the act is required before
this device may be commercially distributed. See 886.3.
21 CFR 886.4280 Intraocular pressure measuring device.
(a) Identification. An intraocular pressure measuring device is a
manual or AC-powered device intended to measure intraocular pressure.
Also included are any devices found by FDA to be substantially
equivalent to such devices. Accessories for the device may include
calibrators or recorders. The device is intended for use in the
diagnosis of glaucoma.
(b) Classification. Class III.
(c) Date PMA or notice of completion of PDP is required. As of May
28, 1976, an approval under section 515 of the act is required before
this device may be commercially distributed. See 886.3.
21 CFR 886.4300 Intraocular lens guide.
(a) Identification. An intraocular lens guide is a device intended
to be inserted into the eye during surgery to direct the insertion of an
intraocular lens and be removed after insertion is completed.
(b) Classification. Class I.
21 CFR 886.4335 Operating headlamp.
(a) Identification. An operating headlamp is an AC-powered or
battery-powered device intended to be worn on the user's head to provide
a light source to aid visualization during surgical, diagnostic, or
therapeutic procedures.
(b) Classification. Class I for the battery-powered device. Class
II for the AC-powered device. The battery powered-device is exempt from
the premarket notification procedures in part 807, subpart E of this
chapter.
(55 FR 48443, Nov. 20, 1990)
21 CFR 886.4350 Manual ophthalmic surgical instrument.
(a) Identification. A manual ophthalmic surgical instrument is a
nonpowered, handheld device intended to aid or perform ophthalmic
surgical procedures. This generic type of device includes the manual
corneal burr, ophthalmic caliper, ophthalmic cannula, eyelid clamp,
ophthalmic muscle clamp, iris retractor clip, orbital compressor,
ophthalmic curette, cystotome, orbital depressor, lachrymal dilator,
erisophake, expressor, ophthalmic forcep, ophthalmic hook, sphere
introducer, ophthalmic knife, ophthalmic suturing needle, lachrymal
probe, trabeculotomy probe, cornea-sclera punch, ophthalmic retractor,
ophthalmic ring (Flieringa), lachrymal sac rongeur, ophthalmic scissors,
enucleating snare, ophthalmic spatula, ophthalmic specula, ophthalmic
spoon, ophthalmic spud, trabeculotome or ophthalmic manual trephine.
(b) Classification. Class I. If the device is made of the same
materials that were used in the device before May 28, 1976, the device
is exempt from the premarket notification procedures in Part 807,
Subpart E of this chapter.
(52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35606, Sept. 14,
1988)
21 CFR 886.4360 Ocular surgery irrigation device.
(a) Identification. An ocular surgery irrigation device is a device
intended to be suspended over the ocular area during ophthalmic surgery
to deliver continuous, controlled irrigation to the surgical field.
(b) Classification. Class I. If the device does not directly
contact the patient's body, the device is exempt from the premarket
notification procedures in Part 807, Subpart E of this chapter.
(52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35606, Sept. 14,
1988)
21 CFR 886.4370 Keratome.
(a) Identification. A keratome is an AC-powered or battery-powered
device intended to shave tissue from sections of the cornea for a
lamellar (partial thickness) transplant.
(b) Classification. Class I.
(55 FR 48443, Nov. 20, 1990)
21 CFR 886.4390 Ophthalmic laser.
(a) Identification. An ophthalmic laser is an AC-powered device
intended to coagulate or cut tissue of the eye, orbit, or surrounding
skin by a laser beam.
(b) Classification. Class II.
21 CFR 886.4392 Nd:YAG laser for posterior capsulotomy.
(a) Identification. The Nd:YAG laser for posterior capsulotomy
consists of a mode-locked or Q-switched solid state Nd:YAG laser
intended for posterior capsulotomy, which generates short pulse, low
energy, high power, coherent optical radiation. When the laser output
is combined with focusing optics, the high irradiance at the target
causes tissue disruption via optical breakdown. A visible aiming system
is utilized to target the invisible Nd:YAG laser radiation on or in
close proximity to the target tissue.
(b) Classification. Class II.
(53 FR 38947, Oct. 4, 1988)
21 CFR 886.4400 Electronic metal locator.
(a) Identification. An electronic metal locator is an AC-powered
device with probes intended to locate metallic foreign bodies in the eye
or eye socket.
(b) Classification. Class II.
21 CFR 886.4440 AC-powered magnet.
(a) Identification. An AC-powered magnet is an AC-powered device
that generates a magnetic field intended to find and remove metallic
foreign bodies from eye tissue.
(b) Classification. Class II.
21 CFR 886.4445 Permanent magnet.
(a) Identification. A permanent magnet is a nonelectric device that
generates a magnetic field intended to find and remove metallic foreign
bodies from eye tissue.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Part 807, Subpart E of this
chapter. The device also is exempt from the current good manufacturing
practice regulations in Part 820 of this chapter, with the exception of
820.180, with respect to general requirements concerning records, and
820.198, with respect to complaint files.
(52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35606, Sept. 14,
1988)
21 CFR 886.4570 Ophthalmic surgical marker.
(a) Identification. An ophthalmic surgical marker is a device
intended to mark by use of ink, dye, or indentation the location of
ocular or scleral surgical manipulation.
(b) Classification. Class I. If the device is made of the same
materials that were used in the device before May 28, 1976, the device
is exempt from the premarket notification procedures in Part 807,
Subpart E of this chapter. The device also is exempt from the current
good manufacturing practice regulations in Part 820 of this chapter,
with the exception of 820.180, with respect to general requirements
concerning records, and 820.198, with respect to complaint files.
(52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35606, Sept. 14,
1988)
21 CFR 886.4610 Ocular pressure applicator.
(a) Identification. An ocular pressure applicator is a manual device
that consists of a sphygmomanometer-type squeeze bulb, a dial indicator,
a band, and bellows, intended to apply pressure on the eye in
preparation for ophthalmic surgery.
(b) Classification. Class II.
21 CFR 886.4670 Phacofragmentation system.
(a) Identification. A phacofragmentation system is an AC-powered
device with a fragmenting needle intended for use in cataract surgery to
disrupt a cataract with ultrasound and extract the cataract.
(b) Classification. Class II.
21 CFR 886.4690 Ophthalmic photocoagulator.
(a) Identification. An ophthalmic photocoagulator is an AC-powered
device intended to use the energy from an extended noncoherent light
source to occlude blood vessels of the retina, choroid, or iris.
(b) Classification. Class II.
21 CFR 886.4750 Ophthalmic eye shield.
(a) Identification. An ophthalmic eye shield is a device that
consists of a plastic or aluminum eye covering intended to protect the
eye or retain dressing materials in place.
(b) Classification. Class I. The device is exempt from the current
good manufacturing practice regulations in Part 820, with the exception
of 820.180, with respect to general requirements concerning records,
and 820.198, with respect to complaint files.
21 CFR 886.4770 Ophthalmic operating spectacles (loupes).
(a) Identification. Ophthalmic operating spectacles (loupes) are
devices that consist of convex lenses or lens systems intended to be
worn by a surgeon to magnify the surgical site during ophthalmic
surgery.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Part 807, Subpart E of this
chapter. The device also is exempt from the current good manufacturing
practice regulations in Part 820 of this chapter, with the exception of
820.180, with respect to general requirements concerning records, and
820.198, with respect to complaint files.
(52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35606, Sept. 14,
1988)
21 CFR 886.4790 Ophthalmic sponge.
(a) Identification. An ophthalmic sponge is a device that is an
absorbant sponge, pad, or spear made of folded gauze, cotton, cellulose,
or other material intended to absorb fluids from the operative field in
ophthalmic surgery.
(b) Classification. Class II.
21 CFR 886.4855 Ophthalmic instrument table.
(a) Identification. An ophthalmic instrument table is an AC-powered
or manual device on which ophthalmic instruments are intended to be
placed.
(b) Classification. Class I. The manual device is exempt from the
premarket notification procedures in part 807, subpart E of this chapter
and it is also exempt from the current good manufacturing practice
regulations in part 820 of this chapter, with the exception of 820.180,
with respect to general requirements concerning records, and 820.198,
with respect to complaint files.
(55 FR 48443, Nov. 20, 1990)
21 CFR 886.4855 Subpart F -- Therapeutic Devices
21 CFR 886.5100 Ophthalmic beta radiation source.
(a) Identification. An ophthalmic beta radiation source is a device
intended to apply superficial radiation to benign and malignant ocular
growths.
(b) Classification. Class II.
21 CFR 886.5120 Low-power binocular loupe.
(a) Identification. A low-power binocular loupe is a device that
consists of two eyepieces, each with a lens or lens system, intended for
medical purposes to magnify the appearance of objects.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Part 807, Subpart E of this
chapter. The device also is exempt from the current good manufacturing
practice regulations in Part 820 of this chapter, with the exception of
820.180, with respect to general requirements concerning records, and
820.198, with respect to complaint files.
(52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14,
1988)
21 CFR 886.5420 Contact lens inserter/remover.
(a) Identification. A contact lens inserter/remover is a handheld
device intended to insert or remove contact lenses by surface adhesion
or suction.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Part 807, Subpart E of this
chapter.
(52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14,
1988)
21 CFR 886.5540 Low-vision magnifier.
(a) Identification. A low-vision magnifier is a device that consists
of a magnifying lens intended for use by a patient who has impaired
vision. The device may be held in the hand or attached to spectacles.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Part 807, Subpart E of this
chapter. The device also is exempt from the current good manufacturing
practice regulations in Part 820 of this chapter, with the exception of
820.180, with respect to general requirements concerning records, and
820.198, with respect to complaint files.
(52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14,
1988)
21 CFR 886.5600 Ptosis crutch.
(a) Identification. A ptosis crutch is a device intended to be
mounted on the spectacles of a patient who has ptosis (drooping of the
upper eyelid as a result of faulty development or paralysis) to hold the
upper eyelid open.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Part 807, Subpart E of this
chapter. The device also is exempt from the current good manufacturing
practice regulations in Part 820 of this chapter, with the exception of
820.180, with respect to general requirements concerning records, and
820.198, with respect to complaint files.
(52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14,
1988)
21 CFR 886.5800 Ophthalmic bar reader.
(a) Identification. An ophthalmic bar reader is a device that
consists of a magnifying lens intended for use by a patient who has
impaired vision. The device is placed directly onto reading material to
magnify print.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Part 807, Subpart E of this
chapter. The device also is exempt from the current good manufacturing
practice regulations in Part 820 of this chapter, with the exception of
820.180, with respect to general requirements concerning records, and
820.198, with respect to complaint files.
(52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14,
1988)
21 CFR 886.5810 Ophthalmic prism reader.
(a) Identification. An ophthalmic prism reader is a device intended
for use by a patient who is in a supine position to change the angle of
print to aid reading.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Part 807, Subpart E of this
chapter. The device also is exempt from the current good manufacturing
practice regulations in Part 820 of this chapter, with the exception of
820.180, with respect to general requirements concerning records, and
820.198, with respect to complaint files.
(52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14,
1988)
21 CFR 886.5820 Closed-circuit television reading system.
(a) Identification. A closed-circuit television reading system is a
device that consists of a lens, video camera, and video monitor that is
intended for use by a patient who has subnormal vision to magnify
reading material.
(b) Classification. Class I.
(55 FR 48443, Nov. 20, 1990)
21 CFR 886.5840 Magnifying spectacles.
(a) Identification. Magnifying spectacles are devices that consist
of spectacle frames with convex lenses intended to be worn by a patient
who has impaired vision to enlarge images.
(b) Classification. Class I. If the device is made of the same
materials that were used in the device before May 28, 1976, the device
is exempt from the premarket notification procedures in Part 807,
Subpart E of this chapter. The device is exempt from the current good
manufacturing practice regulations in Part 820 of this chapter, with the
exception of 820.180, with respect to general requirements.
(52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14,
1988)
21 CFR 886.5842 Spectacle frame.
(a) Identification. A spectacle frame is a device made of metal or
plastic intended to hold prescription spectacle lenses worn by a patient
to correct refractive errors.
(b) Classification. Class I.
21 CFR 886.5844 Prescription spectacle lens.
(a) Identification. A prescription spectacle lens is a glass or
plastic device that is a lens intended to be worn by a patient in a
spectacle frame to provide refractive corrections in accordance with a
prescription for the patient. The device may be modified to protect the
eyes from bright sunlight (i.e., prescription sunglasses). Prescription
sunglass lenses may be reflective, tinted, polarizing, or
photosensitized.
(b) Classification. Class I. If the device is made of the same
materials that were used in the device before May 28, 1976, the device
is exempt from the premarket notification procedures in Part 807,
Subpart E of this chapter.
(52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14,
1988)
21 CFR 886.5850 Sunglasses (nonprescription).
(a) Identification. Sunglasses (nonprescription) are devices that
consist of spectacle frames or clips with absorbing, reflective, tinted,
polarizing, or photosensitized lenses intended to be worn by a person to
protect the eyes from bright sunlight but not to provide refractive
corrections. This device is usually available over-the-counter.
(b) Classification. Class I.
21 CFR 886.5870 Low-vision telescope.
(a) Identification. A low-vision telescope is a device that consists
of an arrangement of lenses or mirrors intended for use by a patient who
has impaired vision to increase the apparent size of objects. This
generic type of device includes handheld or spectacle telescopes.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Part 807, Subpart E of this
chapter. The device also is exempt from the current good manufacturing
practice regulations in Part 820 of this chapter, with the exception of
820.180, with respect to general requirements concerning records, and
820.198, with respect to complaint files.
(52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14,
1988)
21 CFR 886.5900 Electronic vision aid.
(a) Identification. An electronic vision aid is an AC-powered or
battery-powered device that consists of an electronic sensor/transducer
intended for use by a patient who has impaired vision or blindness to
translate visual images of objects into tactile or auditory signals.
(b) Classification. Class I.
(55 FR 48443, Nov. 20, 1990)
21 CFR 886.5910 Image intensification vision aid.
(a) Identification. An image intensification vision aid is a
battery-powered device intended for use by a patient who has limited
dark adaptation or impaired vision to amplify ambient light.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Part 807, Subpart E of this
chapter. The device also is exempt from the current good manufacturing
practice regulations in Part 820 of this chapter, with the exception of
820.180, with respect to general requirements concerning records, and
820.198, with respect to complaint files.
(52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14,
1988)
21 CFR 886.5915 Optical vision aid.
(a) Identification. An optical vision aid is a device that consists
of a magnifying lens with an accompanying AC-powered or battery-powered
light source intended for use by a patient who has impaired vision to
increase the apparent size of object detail.
(b) Classification. Class I. The battery-powered device is exempt
from the premarket notification procedures in part 807, subpart E of
this chapter and it is also exempt from the current good manufacturing
practice regulations in part 820 of this chapter, with the exception of
820.180, with respect to general requirements concerning records, and
820.198, with respect to complaint files.
(55 FR 48443, Nov. 20, 1990)
21 CFR 886.5916 Rigid gas permeable contact lens.
(a) Identification. A rigid gas permeable contact lens is a device
intended to be worn directly against the cornea of the eye to correct
vision conditions. The device is made of various materials, such as
cellulose acetate butyrate, polyacrylate-silicone, or silicone
elastomers, whose main polymer molecules generally do not absorb or
attract water.
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. As of May
28, 1976, an approval under section 515 of the act is required before
this device may be commercially distributed. See 886.3.
21 CFR 886.5918 Rigid gas permeable contact lens solution.
(a) Identification. A rigid gas permeable contact lens solution is a
device intended to clean, disinfect, wet, or store a rigid gas permeable
contact lens ( 886.5916).
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. As of May
28, 1976, an approval under section 515 of the act is required before
this device may be commercially distributed. See 886.3.
21 CFR 886.5925 Soft (hydrophilic) contact lens.
(a) Identification. A soft (hydrophilic) contact lens is a device
intended to be worn directly against the cornea and adjacent limbal and
scleral areas of the eye to correct vision conditions or act as a
therapeutic bandage. The device is made of various polymer materials
the main polymer molecules of which absorb or attract a certain volume
(percentage) of water.
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. As of May
28, 1976, an approval under section 515 of the act is required before
this device may be commercially distributed. See 886.3.
21 CFR 886.5928 Soft (hydrophilic) contact lens solution.
(a) Identification. A soft (hydrophilic) contact lens solution is a
device intended to clean, disinfect, wet, or store a soft (hydrophilic)
contact lens ( 886.5925).
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. As of May
28, 1976, an approval under section 515 of the act is required before
this device may be commercially distributed. See 886.3.
21 CFR 886.5933 Contact lens heat disinfection unit.
(a) Identification. A contact lens heat disinfection unit is a
device intended to disinfect a contact lens by means of heat.
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. As of May
28, 1976, an approval under section 515 of the act is required before
this device may be commercially distributed. See 886.3.
21 CFR 886.5933 Pt. 888
21 CFR 886.5933 PART 888 -- ORTHOPEDIC DEVICES
21 CFR 886.5933 Subpart A -- General Provisions
Sec.
888.1 Scope.
888.3 Effective dates of requirement for premarket approval.
888.5 Resurfacing technique.
888.6 Degree of constraint.
888.9 Limitations of exemptions from section 510(k) of the act.
21 CFR 886.5933 Subpart B -- Diagnostic Devices
888.1100 Arthroscope.
888.1240 AC-powered dynamometer.
888.1250 Nonpowered dynamometer.
888.1500 Goniometer.
888.1520 Nonpowered goniometer.
21 CFR 886.5933 Subpart C -- (Reserved)
21 CFR 886.5933 Subpart D -- Prosthetic Devices
888.3000 Bone cap.
888.3010 Bone fixation cerclage.
888.3015 Bone heterograft.
888.3020 Intramedullary fixation rod.
888.3025 Passive tendon prosthesis.
888.3027 Polymethylmethacrylate (PMMA) bone cement.
888.3030 Single/multiple component metallic bone fixation appliances
and accessories.
888.3040 Smooth or threaded metallic bone fixation fastener.
888.3050 Spinal interlaminal fixation orthosis.
888.3060 Spinal intervertebral body fixation orthosis.
888.3100 Ankle joint metal/composite semi-constrained cemented
prosthesis.
888.3110 Ankle joint metal/polymer semi-constrained cemented
prosthesis.
888.3120 Ankle joint metal/polymer non-constrained cemented
prosthesis.
888.3150 Elbow joint metal/metal or metal/polymer constrained
cemented prosthesis.
888.3160 Elbow joint metal/polymer semi-constrained cemented
prosthesis.
888.3170 Elbow joint radial (hemi-elbow) polymer prosthesis.
888.3180 Elbow joint humeral (hemi-elbow) metallic uncemented
prosthesis.
888.3200 Finger joint metal/metal constrained uncemented prosthesis.
888.3210 Finger joint metal/metal constrained cemented prosthesis.
888.3220 Finger joint metal/polymer constrained cemented prosthesis.
888.3230 Finger joint polymer constrained prosthesis.
888.3300 Hip joint metal constrained cemented or uncemented
prosthesis.
888.3310 Hip joint metal/polymer constrained cemented or uncemented
prosthesis.
888.3320 Hip joint metal/metal semi-constrained, with a cemented
acetabular component, prosthesis.
888.3330 Hip joint metal/metal semi-constrained, with an uncemented
acetabular component, prosthesis.
888.3340 Hip joint metal/composite semi-constrained cemented
prosthesis.
888.3350 Hip joint metal/polymer semi-constrained cemented
prosthesis.
888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or
nonporous uncemented prosthesis.
888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented
prosthesis.
888.3370 Hip joint (hemi-hip) acetabular metal cemented prosthesis.
888.3380 Hip joint femoral (hemi-hip) trunnion-bearing
metal/polyacetal cemented prosthesis.
888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or
uncemented prosthesis.
888.3400 Hip joint femoral (hemi-hip) metallic resurfacing
prosthesis.
888.3410 Hip joint metal/polymer semi-constrained resurfacing
cemented prosthesis.
888.3480 Knee joint femorotibial metallic constrained cemented
prosthesis.
888.3490 Knee joint femorotibial metal/composite non-constrained
cemented prosthesis.
888.3500 Knee joint femorotibial metal/composite semi-constrained
cemented prosthesis.
888.3510 Knee joint femorotibial metal/polymer constrained cemented
prosthesis.
888.3520 Knee joint femorotibial metal/polymer non-constrained
cemented prosthesis.
888.3530 Knee joint femorotibial metal/polymer semi-constrained
cemented prosthesis.
888.3540 Knee joint patellofemoral polymer/metal semi-constrained
cemented prosthesis.
888.3550 Knee joint patellofemorotibial polymer/metal/metal
constrained cemented prosthesis.
888.3560 Knee joint patellofemorotibial polymer/metal/polymer
semi-constrained cemented prosthesis.
888.3570 Knee joint femoral (hemi-knee) metallic uncemented
prosthesis.
888.3580 Knee joint patellar (hemi-knee) metallic resurfacing
uncemented prosthesis.
888.3590 Knee joint tibial (hemi-knee) metallic resurfacing
uncemented prosthesis.
888.3640 Shoulder joint metal/metal or metal/polymer constrained
cemented prosthesis.
888.3650 Shoulder joint metal/polymer non-constrained cemented
prosthesis.
888.3660 Shoulder joint metal/polymer semi-constrained cemented
prosthesis.
888.3680 Shoulder joint glenoid (hemi-shoulder) metallic cemented
prosthesis.
888.3690 Shoulder joint humeral (hemi-shoulder) metallic uncemented
prosthesis.
888.3720 Toe joint polymer constrained prosthesis.
888.3730 Toe joint phalangeal (hemi-toe) polymer prosthesis.
888.3750 Wrist joint carpal lunate polymer prosthesis.
888.3760 Wrist joint carpal scaphoid polymer prosthesis.
888.3770 Wrist joint carpal trapezium polymer prosthesis.
888.3780 Wrist joint polymer constrained prosthesis.
888.3790 Wrist joint metal constrained cemented prosthesis.
888.3800 Wrist joint metal/polymer semi-constrained cemented
prosthesis.
888.3810 Wrist joint ulnar (hemi-wrist) polymer prosthesis.
21 CFR 886.5933 Subpart E -- Surgical Devices
888.4150 Calipers for clinical use.
888.4200 Cement dispenser.
888.4210 Cement mixer for clinical use.
888.4220 Cement monomer vapor evacuator.
888.4230 Cement ventilation tube.
888.4300 Depth gauge for clinical use.
888.4540 Orthopedic manual surgical instrument.
888.4580 Sonic surgical instrument and accessories/attachments.
888.4600 Protractor for clinical use.
888.4800 Template for clinical use.
888.5850 Nonpowered orthopedic traction apparatus and accessories.
888.5890 Noninvasive traction component.
888.5940 Cast component.
888.5960 Cast removal instrument.
888.5980 Manual cast application and removal instrument.
Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j, 371).
Source: 52 FR 33702, Sept. 4, 1987, unless otherwise noted.
21 CFR 886.5933 Subpart A -- General Provisions
21 CFR 888.1 Scope.
(a) This part sets forth the classification of orthopedic devices
intended for human use that are in commercial distribution.
(b) The identification of a device in a regulation in this part is
not a precise description of every device that is, or will be, subject
to the regulation. A manufacturer who submits a premarket notification
submission for a device under Part 807 cannot show merely that the
device is accurately described by the section title and identification
provision of a regulation in this part, but shall state why the device
is substantially equivalent to other devices, as required by 807.87.
(c) To avoid duplicative listings, an orthopedic device that has two
or more types of uses (e.g., used both as a diagnostic device and as a
surgical device) is listed in one subpart only.
(d) References in this part to regulatory sections of the Code of
Federal Regulations are to Chapter I of Title 21 unless otherwise noted.
21 CFR 888.3 Effective dates of requirement for premarket approval.
A device included in this part that is classified into class III
(premarket approval) shall not be commercially distributed after the
date shown in the regulation classifying the device unless the
manufacturer has an approval under section 515 of the act (unless an
exemption has been granted under section 520(g)(2) of the act). An
approval under section 515 of the act consists of FDA's issuance of an
order approving an application for premarket approval (PMA) for the
device or declaring completed a product development protocol (PDP) for
the device.
(a) Before FDA requires that a device commercially distributed before
the enactment date of the amendments, or a device that has been found
substantially equivalent to such a device, has an approval under section
515 of the act, FDA must promulgate a regulation under section 515(b) of
the act requiring such approval, except as provided in paragraphs (b)
and (c) of this section. Such a regulation under section 515(b) of the
act shall not be effective during the grace period ending on the 90th
day after its promulgation or on the last day of the 30th full calendar
month after the regulation that classifies the device into class III is
effective, whichever is later. See section 501(f)(2)(B) of the act.
Accordingly, unless an effective date of the requirement for premarket
approval is shown in the regulation for a device classified into class
III in this part, the device may be commercially distributed without
FDA's issuance of an order approving a PMA or declaring completed a PDP
for the device. If FDA promulgates a regulation under section 515(b) of
the act requiring premarket approval for a device, section 501(f)(1)(A)
of the act applies to the device.
(b) Any new, not substantially equivalent, device introduced into
commercial distribution on or after May 28, 1976, including a device
formerly marketed that has been substantially altered, is classified by
statute (section 513(f) of the act) into class III without any grace
period and FDA must have issued an order approving a PMA or declaring
completed a PDP for the device before the device is commercially
distributed unless it is reclassified. If FDA knows that a device being
commercially distributed may be a ''new'' device as defined in this
section because of any new intended use or other reasons, FDA may codify
the statutory classification of the device into class III for such new
use. Accordingly, the regulation for such a class III device states
that as of the enactment date of the amendments, May 28, 1976, the
device must have an approval under section 515 of the act before
commercial distribution.
(c) A device identified in a regulation in this part that is
classified into class III and that is subject to the transitional
provisions of section 520(1) of the act is automatically classified by
statute into class III and must have an approval under section 515 of
the act before being commercially distributed. Accordingly, the
regulation for such a class III transitional device states that as of
the enactment date of the amendments, May 28, 1976, the device must have
an approval under section 515 of the act before commercial distribution.
21 CFR 888.5 Resurfacing technique.
Because of resurfacing techniques, certain joint prostheses require
far less bone resection than other devices intended to repair or replace
the same joint. The amount of bone resection may or may not affect the
safety and effectiveness of the implantation of the prosthesis. When a
resurfacing technique is used, the name of the prosthesis includes this
information.
21 CFR 888.6 Degree of constraint.
Certain joint prostheses provide more constraint of joint movement
than others. FDA believes that the degree of constraint is an important
factor affecting the safety and effectiveness of orthopedic prostheses.
FDA is defining the following standard terms for categorizing the degree
of constraint.
(a) A ''constrained'' joint prosthesis is used for joint replacement
and prevents dislocation of the prosthesis in more than one anatomic
plane and consists of either a single, flexible, across-the-joint
component or more than one component linked together or affined.
(b) A ''semi-constrained'' joint prosthesis is used for partial or
total joint replacement and limits translation and rotation of the
prosthesis in one or more planes via the geometry of its articulating
surfaces. It has no across-the-joint linkage.
(c) A ''non-constrained'' joint prosthesis is used for partial or
total joint replacement and restricts minimally prosthesis movement in
one or more planes. Its components have no across-the-joint linkage.
21 CFR 888.9 Limitations of exemptions from section 510(k) of the act.
FDA's decision to grant an exemption from the requirement of
premarket notification (section 510(k) of the act) for a generic type of
class I device is based upon the existing and reasonably foreseeable
characteristics of commercially distributed devices within that generic
type. Because FDA cannot anticipate every change in intended use or
characteristic that could significantly affect a device's safety or
effectiveness, manufacturers of any commercially distributed class I
device for which FDA has granted an exemption from the requirement of
premarket notification must still submit a premarket notification to FDA
before introducing or delivering for introduction into interstate
commerce for commercial distribution the device when:
(a) The device is intended for a use different from its intended use
before May 28, 1976, or the device is intended for a use different from
the intended use of a preamendments device to which it had been
determined to be substantially equivalent; e.g., the device is intended
for a different medical purpose, or the device is intended for lay use
where the former intended use was by health care professionals only; or
(b) The modified device operates using a different fundamental
scientific technology than that in use in the device before May 28,
1976; e.g., a surgical instrument cuts tissue with a laser beam rather
than with a sharpened metal blade, or an in vitro diagnostic device
detects or identifies infectious agents by using a deoxyribonucleic acid
(DNA) probe or nucleic acid hybridization technology rather than culture
or immunoassay technology.
(53 FR 52953, Dec. 29, 1988)
21 CFR 888.9 Subpart B -- Diagnostic Devices
21 CFR 888.1100 Arthroscope.
(a) Identification. An arthroscope is an electrically powered
endoscope lntended to make visible the interior of a joint. The
arthroscope and accessories also is intended to perform surgery within a
joint.
(b) Classification. Class II.
21 CFR 888.1240 AC-powered dynamometer.
(a) Identification. An AC-powered dynamometer is an AC-powered
device intended for medical purposes to assess neuromuscular function or
degree of neuromuscular blockage by measuring, with a force transducer
(a device that translates force into electrical impulses), the
grip-strength of a patient's hand.
(b) Classification. Class II.
21 CFR 888.1250 Nonpowered dynamometer.
(a) Identification. A nonpowered dynamometer is a mechanical device
intended for medical purposes to measure the pinch and grip muscle
strength of a patient's hand.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807.
21 CFR 888.1500 Goniometer.
(a) Identification. A goniometer is an AC-powered device intended to
evaluate joint function by measuring and recording ranges of motion,
acceleration, or forces exerted by a joint.
(b) Classification. Class I.
(55 FR 48443, Nov. 20, 1990)
21 CFR 888.1520 Nonpowered goniometer.
(a) Identification. A nonpowered goniometer is a mechanical device
intended for medical purposes to measure the range of motion of joints.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807.
21 CFR 888.1520 Subpart C -- (Reserved)
21 CFR 888.1520 Subpart D -- Prosthetic Devices
21 CFR 888.3000 Bone cap.
(a) Identification. A bone cap is a mushroom-shaped device intended
to be implanted made of either silicone elastomer or ultra-high
molecular weight polyethylene. It is used to cover the severed end of a
long bone, such as the humerus or tibia, to control bone overgrowth in
juvenile amputees.
(b) Classification. Class II.
21 CFR 888.3010 Bone fixation cerclage.
(a) Identification. A bone fixation cerclage is a device intended to
be implanted that is made of alloys, such as cobalt-chromium-molybdenum,
and that consists of a metallic ribbon or flat sheet or a wire. The
device is wrapped around the shaft of a long bone, anchored to the bone
with wire or screws, and used in the fixation of fractures.
(b) Classification. Class II.
21 CFR 888.3015 Bone heterograft.
(a) Identification. Bone heterograft is a device intended to be
implanted that is made from mature (adult) bovine bones and used to
replace human bone following surgery in the cervical region of the
spinal column.
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. As of May
28, 1976, an approval under section 515 of the act is required before
this device may be commercially distributed. See 888.3.
21 CFR 888.3020 Intramedullary fixation rod.
(a) Identification. An intramedullary fixation rod is a device
intended to be implanted that consists of a rod made of alloys such as
cobalt-chromium-molybdenum and stainless steel. It is inserted into the
medullary (bone marrow) canal of long bones for the fixation of
fractures.
(b) Classification. Class II.
21 CFR 888.3025 Passive tendon prosthesis.
(a) Identification. A passive tendon prosthesis is a device intended
to be implanted made of silicon elastomer or a polyester reinforced
medical grade silicone elastomer intended for use in the surgical
reconstruction of a flexor tendon of the hand. The device is implanted
for a period of 2 to 6 months to aid growth of a new tendon sheath. The
device is not intended as a permanent implant nor to function as a
replacement for the ligament or tendon nor to function as a scaffold for
soft tissue ingrowth.
(b) Classification. Class II.
21 CFR 888.3027 Polymethylmethacrylate (PMMA) bone cement.
(a) Identification. Polymethylmethacrylate (PMMA) bone cement
(luting agent) is a device intended to be implanted that is made from
methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid
or copolymers containing polymethylmethyacrylate and polystyrene. The
device is intended for use in arthroplastic procedures of the hip, knee,
and other joints for the fixation of polymer or metallic prosthetic
implants to the living bone.
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. As of May
28, 1976, an approval under section 515 of the act is required before
this device may be commercially distributed. See 888.3.
21 CFR 888.3030 Single/multiple component metallic bone fixation
appliances and accessories.
(a) Identification. Single/multiple component metallic bone fixation
appliances and accessories are devices intended to be implanted
consisting of one or more metallic components and their metallic
fasteners. The devices contain a plate, a nail/plate combination, or a
blade/plate combination that are made of alloys, such as
cobalt-chromium-molybdenum, stainless steel, and titanium, that are
intended to be held in position with fasteners, such as screws and
nails, or bolts, nuts, and washers. These devices are used for fixation
of fractures of the proximal or distal end of long bones, such as
intracapsular, intertrochanteric, intercervical, supracondylar, or
condylar fractures of the femur; for fusion of a joint; or for
surgical procedures that involve cutting a bone. The devices may be
implanted or attached through the skin so that a pulling force
(traction) may be applied to the skeletal system.
(b) Classification. Class II.
21 CFR 888.3040 Smooth or threaded metallic bone fixation fastener.
(a) Identification. A smooth or threaded metallic bone fixation
fastener is a device intended to be implanted that consists of a stiff
wire segment or rod made of alloys, such as cobalt-chromium-molybdenum
and stainless steel, and that may be smooth on the outside, fully or
partially threaded, straight or U-shaped; and may be either blunt
pointed, sharp pointed, or have a formed, slotted head on the end. It
may be used for fixation of bone fractures, for bone reconstructions, as
a guide pin for insertion of other implants, or it may be implanted
through the skin so that a pulling force (traction) may be applied to
the skeletal system.
(b) Classification. Class II.
21 CFR 888.3050 Spinal interlaminal fixation orthosis.
(a) Identification. A spinal interlaminal fixation orthosis is a
device intended to be implanted made of an alloy, such as stainless
steel, that consists of various hooks and a posteriorly placed
compression or distraction rod. The device is implanted, usually across
three adjacent vertebrae, to straighten and immobilize the spine to
allow bone grafts to unite and fuse the vertebrae together. The device
is used primarily in the treatment of scoliosis (a lateral curvature of
the spine), but it also may be used in the treatment of fracture or
dislocation of the spine, grades 3 and 4 of spondylolisthesis (a
dislocation of the spinal column), and lower back syndrome.
(b) Classification. Class II.
21 CFR 888.3060 Spinal intervertebral body fixation orthosis.
(a) Identification. A spinal intervertebral body fixation orthosis
is a device intended to be implanted made of titanium. It consists of
various vertebral plates that are punched into each of a series of
vertebral bodies. An eye-type screw is inserted in a hole in the center
of each of the plates. A braided cable is threaded through each
eye-type screw. The cable is tightened with a tension device and it is
fastened or crimped at each eye-type screw. The device is used to apply
force to a series of vertebrae to correct ''sway back,'' scoliosis
(lateral curvature of the spine), or other conditions.
(b) Classification. Class II.
21 CFR 888.3100 Ankle joint metal/composite semi-constrained cemented
prosthesis.
(a) Identification. An ankle joint metal/composite semi-constrained
cemented prosthesis is a device intended to be implanted to replace an
ankle joint. The device limits translation and rotation: in one or
more planes via the geometry of its articulating surfaces. It has no
linkage across-the-joint. This generic type of device includes
prostheses that consist of a talar resurfacing component made of alloys,
such as cobalt-chromium-molybdenum, and a tibial resurfacing component
fabricated from ultra-high molecular weight polyethylene with carbon
fibers composite, and is limited to those prostheses intended for use
with bone cement ( 888.3027).
(b) Classification. Class II.
21 CFR 888.3110 Ankle joint metal/polymer semi-constrained cemented
prosthesis.
(a) Identification. An ankle joint metal/polymer semi-constrained
cemented prosthesis is a device intended to be implanted to replace an
ankle joint. The device limits translation and rotation in one or more
planes via the geometry of its articulating surfaces and has no linkage
across-the-joint. This generic type of device includes prostheses that
have a talar resurfacing component made of alloys, such as
cobalt-chromium-molybdenum, and a tibial resurfacing component made of
ultra-high molecular weight polyethylene and is limited to those
prostheses intended for use with bone cement ( 888.3027).
(b) Classification. Class II.
21 CFR 888.3120 Ankle joint metal/polymer non-constrained cemented
prosthesis.
(a) Identification. An ankle joint metal/polymer non-constrained
cemented prosthesis is a device intended to be implanted to replace an
ankle joint. The device limits minimally (less than normal anatomic
constraints) translation in one or more planes. It has no linkage
across-the-joint. This generic type of device includes prostheses that
have a tibial component made of alloys, such as
cobalt-chromium-molybdenum, and a talar component made of ultra-high
molecular weight polyethylene, and is limited to those prostheses
intended for use with bone cement ( 888.3027).
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 888.3.
21 CFR 888.3150 Elbow joint metal/metal or metal/polymer constrained
cemented prosthesis.
(a) Identification. An elbow joint metal/metal or metal/polymer
constrained cemented prosthesis is a device intended to be implanted
made exclusively of alloys, such as cobalt-chromium-molybdenum, or made
from these alloys with a ultra-high molecular weight polyethylene
bushing, and used to replace an elbow joint. The device prevents
dislocation in more than one anatomic plane and consists of two
components which are linked together. This generic type of device is
limited to those prostheses intended for use with bone cement (
888.3027).
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 888.3.
21 CFR 888.3160 Elbow joint metal/polymer semi-constrained cemented
prosthesis.
(a) Identification. An elbow joint metal/polymer semi-constrained
cemented prosthesis is a device intended to be implanted to replace an
elbow joint. The device limits translation and rotation in one or more
planes via the geometry of its articulating surfaces. It has no linkage
across-the-joint. This generic type of device includes prostheses that
consist of a humeral resurfacing component made of alloys, such as
cobalt-chromium-molybdenum, and a radial resurfacing component made of
ultra-high molecular weight polyethylene. This generic type of device
is limited to those prostheses intended for use with bone cement (
888.3027).
(b) Classification. Class II.
21 CFR 888.3170 Elbow joint radial (hemi-elbow) polymer prosthesis.
(a) Identification. An elbow joint radial (hemi-elbow) polymer
prosthesis is a device intended to be implanted made of medical grade
silicone elastomer used to replace the proximal end of the radius.
(b) Classification. Class II.
21 CFR 888.3180 Elbow joint humeral (hemi-elbow) metallic uncemented
prosthesis.
(a) Identification. An elbow joint humeral (hemi-elbow) metallic
uncemented prosthesis is a device intended to be implanted made of
alloys, such as cobalt-chromium-molybdenum, that is used to replace the
distal end of the humerus formed by the trochlea humeri and the
capitulum humeri. The generic type of device is limited to prostheses
intended for use without bone cement ( 888.3027).
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 888.3.
21 CFR 888.3200 Finger joint metal/metal constrained uncemented
prosthesis.
(a) Identification. A finger joint metal/metal constrained
uncemented prosthesis is a device intended to be implanted to replace a
metacarpophalangeal or proximal interphalangeal (finger) joint. The
device prevents dislocation in more than one anatomic plane and consists
of two components which are linked together. This generic type of
device includes prostheses made of alloys, such as
cobalt-chromium-molybdenum, or protheses made from alloys and ultra-high
molecular weight polyethylene. This generic type of device is limited
to prostheses intended for use without bone cement ( 888.3027).
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 888.3.
21 CFR 888.3210 Finger joint metal/metal constrained cemented
prosthesis.
(a) Identification. A finger joint metal/metal constrained cemented
prosthesis is a device intended to be implanted to replace a
metacarpophalangeal (finger) joint. This device prevents dislocation in
more than one anatomic plane and has components which are linked
together. This generic type of device includes prostheses that are made
of alloys, such as cobalt-chromium-molybdenum, and is limited to those
prostheses intended for use with bone cement ( 888.3027).
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 888.3.
21 CFR 888.3220 Finger joint metal/polymer constrained cemented
prosthesis.
(a) Identification. A finger joint metal/polymer constrained
cemented prosthesis is a device intended to be implanted to replace a
metacarpophalangeal or proximal interphalangeal (finger) joint. The
device prevents dislocation in more than one anatomic plane, and
consists of two components which are linked together. This generic type
of device includes prostheses that are made of alloys, such as
cobalt-chromium-molybdenum, and ultra-high molecular weight
polyethylene, and is limited to those prostheses intended for use with
bone cement ( 888.3027).
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 888.3.
21 CFR 888.3230 Finger joint polymer constrained prosthesis.
(a) Identification. A finger joint polymer constrained prosthesis is
a device intended to be implanted to replace a metacarpophalangeal or
proximal interphalangeal (finger) joint. This generic type of device
includes prostheses that consist of a single flexible across-the-joint
component made from either a silicone elastomer or a combination pf
polypropylene and polyester material. The flexible across-the-joint
component may be covered with a silicone rubber sleeve.
(b) Classification. Class II.
21 CFR 888.3300 Hip joint metal constrained cemented or uncemented
prosthesis.
(a) Identification. A hip joint metal constrained cemented or
uncemented prosthesis is a device intended to be implanted to replace a
hip joint. The device prevents dislocation in more than one anatomic
plane and has components that are linked together. This generic type of
device includes prostheses that have components made of alloys, such as
cobalt-chromium-molybdenum, and is intended for use with or without bone
cement ( 888.3027). This device is not intended for biological fixation.
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 888.3.
21 CFR 888.3310 Hip joint metal/polymer constrained cemented or
uncemented prosthesis.
(a) Identification. A hip joint metal/polymer constrained cemented
or uncemented prosthesis is a device intended to be implanted to replace
a hip joint. The device prevents dislocation in more than one anatomic
plane and has components that are linked together. This generic type of
device includes prostheses that have a femoral component made of alloys,
such as cobalt-chromium-molybdenum, and an acetabular component made of
ultra-high molecular weight polyethylene. This generic type of device
is intended for use with or without bone cement ( 888.3027). This device
is not intended for biological fixation.
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 888.3.
21 CFR 888.3320 Hip joint metal/metal semi-constrained, with a cemented
acetabular component, prosthesis.
(a) Identification. A hip joint metal/metal semi-constrained, with a
cemented acetabular component, prosthesis is a two-part device intended
to be implanted to replace a hip joint. The device limits translation
and rotation in one or more planes via the geometry of its articulating
surfaces. It has no linkage across-the-joint. This generic type of
device includes prostheses that consist of a femoral and an acetabular
component, both made of alloys, such as cobalt-chromium-molybdenum.
This generic type of device is limited to those prostheses intended for
use with bone cement ( 888.3027).
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 888.3.
21 CFR 888.3330 Hip joint metal/metal semi-constrained, with an
uncemented acetabular component, prosthesis.
(a) Identification. A hip joint metal/metal semi-constrained, with
an uncemented acetabular component, prosthesis is a two-part device
intended to be implanted to replace a hip joint. The device limits
translation and rotation in one or more planes via the geometry of its
articulating surfaces. It has no linkage across-the-joint. This
generic type of device includes prostheses that consist of a femoral and
an acetabular component, both made of alloys, such as
cobalt-chromium-molybdenum. The femoral component is intended to be
fixed with bone cement. The acetabular component is intended for use
without bone cement ( 888.3027).
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 888.3.
21 CFR 888.3340 Hip joint metal/composite semi-constrained cemented
prosthesis.
(a) Identification. A hip joint metal/composite semi-constrained
cemented prosthesis is a two-part device intended to be implanted to
replace a hip joint. The device limits translation and rotation in one
or more planes via the geometry of its articulating surfaces. It has no
linkage across-the-joint. This generic type of device includes
prostheses that consist of a femoral component made of alloys, such as
cobalt-chromium-molybdenum, and an acetabular component made of
ultra-high molecular weight polyethylene with carbon fibers composite.
Both components are intended for use with bone cement ( 888.3027).
(b) Classification. Class II.
21 CFR 888.3350 Hip joint metal/polymer semi-constrained cemented
prosthesis.
(a) Identification. A hip joint metal/polymer semi-constrained
cemented prosthesis is a device intended to be implanted to replace a
hip joint. The device limits translation and rotation in one or more
planes via the geometry of its articulating surfaces. It has no linkage
across-the-joint. This generic type of device includes prostheses that
have a femoral component made of alloys, such as
cobalt-chromium-molybdenum, and an acetabular resurfacing component made
of ultra-high molecular weight polyethylene and is limited to those
prostheses intended for use with bone cement ( 888.3027).
(b) Classification. Class II.
21 CFR 888.3353 Hip joint metal/ceramic/polymer semi-constrained
cemented or nonporous uncemented prosthesis.
(a) Identification. A hip joint metal/ceramic/polymer
semi-constrained cemented or nonporous uncemented prosthesis is a device
intended to be implanted to replace a hip joint. This device limits
translation and rotation in one or more planes via the geometry of its
articulating surfaces. It has no linkage across-the-joint. The
two-part femoral component consists of a femoral stem made of alloys to
be fixed in the intramedullary canal of the femur by impaction with or
without use of bone cement. The proximal end of the femoral stem is
tapered with a surface that ensures positive locking with the spherical
ceramic (aluminium oxide, A1203) head of the femoral component. The
acetabular component is made of ultra-high molecular weight polyethylene
or ultra-high molecular weight polyethylene reinforced with nonporous
metal alloys, and used with or without bone cement.
(b) Classification. Class II.
(54 FR 48239, Nov. 22, 1989; 54 FR 51342, Dec. 14, 1989)
21 CFR 888.3360 Hip joint femoral (hemi-hip) metallic cemented or
uncemented prosthesis.
(a) Identification. A hip joint femoral (hemi-hip) metallic cemented
or uncemented prosthesis is a device intended to be implanted to replace
a portion of the hip joint. This generic type of device includes
prostheses that have a femoral component made of alloys, such as
cobalt-chromium-molybdenum. This generic type of device includes
designs which are intended to be fixed to the bone with bone cement (
888.3027) as well as designs which have large window-like holes in the
stem of the device and which are intended for use without bone cement.
However, in these latter designs, fixation of the device is not achieved
by means of bone ingrowth.
(b) Classification. Class II.
21 CFR 888.3370 Hip joint (hemi-hip) acetabular metal cemented
prosthesis.
(a) Identification. A hip joint (hemi-hip) acetabular metal cemented
prosthesis is a device intended to be implanted to replace a portion of
the hip joint. This generic type of device includes prostheses that
have an acetabular component made of alloys, such as
cobalt-chromium-molybdenum. This generic type of device is limited to
those prostheses intended for use with bone cement ( 888.3027).
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 888.3.
21 CFR 888.3380 Hip joint femoral (hemi-hip) trunnion-bearing
metal/polyacetal cemented prosthesis.
(a) Identification. A hip joint femoral (hemi-hip) trunnion-bearing
metal/polyacetal cemented prosthesis is a two-part device intended to be
implanted to replace the head and neck of the femur. This generic type
of device includes prostheses that consist of a metallic stem made of
alloys, such as cobalt-chromium-molybdenum, with an integrated
cylindrical trunnion bearing at the upper end of the stem that fits into
a recess in the head of the device. The head of the device is made of
polyacetal (polyoxymethylene) and it is covered by a metallic alloy,
such as cobalt-chromium-molybdenum. The trunnion bearing allows the
head of the device to rotate on its stem. The prosthesis is intended
for use with bone cement ( 888.3027).
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 888.3.
21 CFR 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or
uncemented prosthesis.
(a) Identification. A hip joint femoral (hemi-hip) metal/polymer
cemented or uncemented prosthesis is a two-part device intended to be
implanted to replace the head and neck of the femur. This generic type
of device includes prostheses that have a femoral component made of
alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular
component made of an alloy, such as cobalt-chromium-molybdenum, and
ultra-high molecular weight polyethylene. This generic type of device
may be fixed to the bone with bone cement ( 888.3027) or implanted by
impaction.
(b) Classification. Class II.
21 CFR 888.3400 Hip joint femoral (hemi-hip) metallic resurfacing
prosthesis.
(a) Identification. A hip joint femoral (hemi-hip) metallic
resurfacing prosthesis is a device intended to be implanted to replace a
portion of the hip joint. This generic type of device includes
prostheses that have a femoral resurfacing component made of alloys,
such as cobalt-chromium-molybdenum.
(b) Classification. Class II.
21 CFR 888.3410 Hip joint metal/polymer semi-constrained resurfacing
cemented prosthesis.
(a) Identification. A hip joint metal/polymer semi-constrained
resurfacing cemented prosthesis is a two-part device intended to be
implanted to replace the articulating surfaces of the hip while
preserving the femoral head and neck. The device limits translation and
rotation in one or more planes via the geometry of its articulating
surfaces. It has no linkage across-the-joint. This generic type of
device includes prostheses that consist of a femoral cap component made
of alloy, such as cobalt-chromium-molybdenum, that is placed over a
surgically prepared femoral head, and an acetabular resurfacing polymer
component. Both components are intended for use with bone cement (
888.3027).
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 888.3.
21 CFR 888.3480 Knee joint femorotibial metallic constrained cemented
prosthesis.
(a) Identification. A knee joint femorotibial metallic constrained
cemented prosthesis is a device intended to be implanted to replace part
of a knee joint. The device prevents dislocation in more than one
anatomic plane and has components that are linked together. The only
knee joint movement allowed by the device is in the sagittal plane.
This generic type of device includes prostheses that have an
intramedullary stem at both the proximal and distal locations. The
upper and lower components may be joined either by a solid bolt or pin,
an internally threaded bolt with locking screw, or a bolt retained by
circlip. The components of the device are made of alloys, such as
cobalt-chromium-molybdenum. The stems of the device may be perforated,
but are intended for use with bone cement ( 888.3027).
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 888.3.
21 CFR 888.3490 Knee joint femorotibial metal/composite non-constrained
cemented prosthesis.
(a) Identification. A knee joint femorotibial metal/composite
non-constrained cemented prosthesis is a device intended to be implanted
to replace part of a knee joint. The device limits minimally (less than
normal anatomic constraints) translation in one or more planes. It has
no linkage across-the-joint. This generic type of device includes
prostheses that have a femoral condylar resurfacing component or
components made of alloys, such as cobalt-chromium-molybdenum, and a
tibial condylar component or components made of ultra-high molecular
weight polyethylene with carbon fibers composite and are intended for
use with bone cement ( 888.3027).
(b) Classification. Class II.
21 CFR 888.3500 Knee joint femorotibial metal/composite
semi-constrained cemented prosthesis.
(a) Identification. A knee joint femorotibial metal/composite
semi-constrained cemented prosthesis is a two-part device intended to be
implanted to replace part of a knee joint. The device limits
translation and rotation in one or more planes via the geometry of its
articulating surfaces. It has no linkage across-the-joint. This
generic type of device includes prostheses that have a femoral component
made of alloys, such as cobalt-chromium-molybdenum, and a tibial
component with the articulating surfaces made of ultra-high molecular
weight polyethylene with carbon-fibers composite and is limited to those
prostheses intended for use with bone cement ( 888.3027).
(b) Classification. Class II.
21 CFR 888.3510 Knee joint femorotibial metal/polymer constrained
cemented prosthesis.
(a) Identification. A knee joint femorotibial metal/polymer
constrained cemented prosthesis is a device intended to be implanted to
replace part of a knee joint. The device limits translation or rotation
in one or more planes and has components that are linked together or
affined. This generic type of device includes prostheses composed of a
ball-and-socket joint located between a stemmed femoral and a stemmed
tibial component and a runner and track joint between each pair of
femoral and tibial condyles. The ball-and-socket joint is composed of a
ball at the head of a column rising from the stemmed tibial component.
The ball, the column, the tibial plateau, and the stem for fixation of
the tibial component are made of an alloy, such as
cobalt-chromium-molybdenum. The ball of the tibial component is held
within the socket of the femoral component by the femoral component's
flat outer surface. The flat outer surface of the tibial component
abuts both a reciprocal flat surface within the cavity of the femoral
component and flanges on the femoral component designed to prevent
distal displacement. The stem of the femoral component is made of an
alloy, such as cobalt-chromium-molybdenum, but the socket of the
component is made of ultra-high molecular weight polyethylene. The
femoral component has metallic runners which align with the ultra-high
molecular weight polyethylene tracks that press-fit into the metallic
tibial component. The generic class also includes devices whose upper
and lower components are linked with a solid bolt passing through a
journal bearing of greater radius, permitting some rotation in the
transverse plane, a minimal arc of abduction/adduction. This generic
type of device is limited to those prostheses intended for use with bone
cement ( 888.3027).
(b) Classification. Class II.
21 CFR 888.3520 Knee joint femorotibial metal/polymer non-constrained
cemented prosthesis.
(a) Identification. A knee joint femorotibial metal/polymer
non-constrained cemented prosthesis is a device intended to be implanted
to replace part of a knee joint. The device limits minimally (less than
normal anatomic constraints) translation in one or more planes. It has
no linkage across-the-joint. This generic type of device includes
prostheses that have a femoral condylar resurfacing component or
components made of alloys, such as cobalt-chromium-molybdenum, and a
tibial component or components made of ultra-high molecular weight
polyethylene and are intended for use with bone cement ( 888.3027).
(b) Classification. Class II.
21 CFR 888.3530 Knee joint femorotibial metal/polymer semi-constrained
cemented prosthesis.
(a) Identification. A knee joint femorotibial metal/polymer
semi-constrained cemented prosthesis is a device intended to be
implanted to replace part of a knee joint. The device limits
translation and rotation in one or more planes via the geometry of its
articulating surfaces. It has no linkage across-the-joint. This
generic type of device includes prostheses that consist of a femoral
component made of alloys, such as cobalt-chromium-molybdenum, and a
tibial component made of ultra-high molecular weight polyethylene and is
limited to those prostheses intended for use with bone cement (
888.3027).
(b) Classification. Class II.
21 CFR 888.3540 Knee joint patellofemoral polymer/metal
semi-constrained cemented prosthesis.
(a) Identification. A knee joint patellofemoral polymer/metal
semi-constrained cemented prosthesis is a two-part device intended to be
implanted to replace part of a knee joint in the treatment of primary
patellofemoral arthritis or chondromalacia. The device limits
translation and rotation in one or more planes via the geometry of its
articulating surfaces. It has no linkage across-the-joint. This
generic type of device includes a component made of alloys, such as
cobalt-chromium-molybdenum or austenitic steel, for resurfacing the
intercondylar groove (femoral sulcus) on the anterior aspect of the
distal femur, and a patellar component made of ultra-high molecular
weight polyethylene. This generic type of device is limited to those
devices intended for use with bone cement ( 888.3027). The patellar
component is designed to be implanted only with its femoral component.
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 888.3.
21 CFR 888.3550 Knee joint patellofemorotibial polymer/metal/metal
constrained cemented prosthesis.
(a) Identification. A knee joint patellofemorotibial
polymer/metal/metal constrained cemented prosthesis is a device intended
to be implanted to replace a knee joint. The device prevents
dislocation in more than one anatomic plane and has components that are
linked together. This generic type of device includes prostheses that
have a femoral component, a tibial component, a cylindrical bolt and
accompanying locking hardware that are all made of alloys, such as
cobalt-chromium-molybdenum, and a retropatellar resurfacing component
made of ultra-high molecular weight polyethylene. The retropatellar
surfacing component may be attached to the resected patella either with
a metallic screw or bone cement. All stemmed metallic components within
this generic type are intended for use with bone cement ( 888.3027).
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 888.3.
21 CFR 888.3560 Knee joint patellofemorotibial polymer/metal/polymer
semi-constrained cemented prosthesis.
(a) Identification. A knee joint patellofemorotibial
polymer/metal/polymer semi-constrained cemented prosthesis is a device
intended to be implanted to replace a knee joint. The device limits
translation and rotation in one or more planes via the geometry of its
articulating surfaces. It has no linkage across-the-joint. This
generic type of device includes prostheses that have a femoral component
made of alloys, such as cobalt-chromium-molybdenum, and a tibial
component or components and a retropatellar resurfacing component made
of ultra-high molecular weight polyethylene. This generic type of
device is limited to those prostheses intended for use with bone cement
( 888.3027).
(b) Classification. Class II.
21 CFR 888.3570 Knee joint femoral (hemi-knee) metallic uncemented
prosthesis.
(a) Identification. A knee joint femoral (hemi-knee) metallic
uncemented prosthesis is a device made of alloys, such as
cobalt-chromium-molybdenum, intended to be implanted to replace part of
a knee joint. The device limits translation and rotation in one or more
planes via the geometry of its articulating surfaces. It has no linkage
across-the-joint. This generic type of device includes prostheses that
consist of a femoral component with or without protuberance(s) for the
enhancement of fixation and is limited to those prostheses intended for
use without bone cement ( 888.3027).
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 888.3.
21 CFR 888.3580 Knee joint patellar (hemi-knee) metallic resurfacing
uncemented prosthesis.
(a) Identification. A knee joint patellar (hemi-knee) metallic
resurfacing uncemented prosthesis is a device made of alloys, such as
cobalt-chromium-molybdenum, intended to be implanted to replace the
retropatellar articular surface of the patellofemoral joint. The device
limits minimally (less than normal anatomic constraints) translation in
one or more planes. It has no linkage across-the-joint. This generic
type of device includes prostheses that have a retropatellar resurfacing
component and an orthopedic screw to transfix the patellar remnant.
This generic type of device is limited to those prostheses intended for
use without bone cement ( 888.3027).
(b) Classification. (1) Class II when intended for treatment of
degenerative and posttraumatic patellar arthritis.
(2) Class III when intended for uses other than treatment of
degenerative and posttraumatic patellar arthritis.
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval for the device intended for uses described in paragraph (b)(2).
See 888.3.
21 CFR 888.3590 Knee joint tibial (hemi-knee) metallic resurfacing
uncemented prosthesis.
(a) Identification. A knee joint tibial (hemi-knee) metallic
resurfacing uncemented prosthesis is a device intended to be implanted
to replace part of a knee joint. The device limits minimally (less than
normal anatomic constraints) translation in one or more planes. It has
no linkage across-the-joint. This prosthesis is made of alloys, such as
cobalt-chromium-molybdenum, and is intended to resurface one tibial
condyle. The generic type of device is limited to those prostheses
intended for use without bone cement ( 888.3027).
(b) Classification. Class II.
21 CFR 888.3640 Shoulder joint metal/metal or metal/polymer constrained
cemented prosthesis.
(a) Identification. A shoulder joint metal/metal or metal/polymer
constrained cemented prosthesis is a device intended to be implanted to
replace a shoulder joint. The device prevents dislocation in more than
one anatomic plane and has components that are linked together. This
generic type of device includes prostheses that have a humeral component
made of alloys, such as cobalt-chromium-molybdenum, and a glenoid
component made of this alloy or a combination of this alloy and
ultra-high molecular weight polyethylene. This generic type of device
is limited to those prostheses intended for use with bone cement (
888.3027).
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 888.3.
21 CFR 888.3650 Shoulder joint metal/polymer non-constrained cemented
prosthesis.
(a) Identification. A shoulder joint metal/polymer non-constrained
cemented prosthesis is a device intended to be implanted to replace a
shoulder joint. The device limits minimally (less than normal anatomic
constraints) translation in one or more planes. It has no linkage
across-the-joint. This generic type of device includes prostheses that
have a humeral component made of alloys, such as
cobalt-chromium-molybdenum, and a glenoid resurfacing component made of
ultra-high molecular weight polyethylene, and is limited to those
prostheses intended for use with bone cement ( 888.3027).
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 888.3.
21 CFR 888.3660 Shoulder joint metal/polymer semi-constrained cemented
prosthesis.
(a) Identification. A shoulder joint metal/polymer semi-constrained
cemented prosthesis is a device intended to be implanted to replace a
shoulder joint. The device limits translation and rotation in one or
more planes via the geometry of its articulating surfaces. It has no
linkage across-the-joint. This generic type of device includes
prostheses that have a humeral resurfacing component made of alloys,
such as cobalt-chromium-molybdenum, and a glenoid resurfacing component
made of ultra-high molecular weight polyethylene, and is limited to
those prostheses intended for use with bone cement ( 888.3027).
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 888.3.
21 CFR 888.3680 Shoulder joint glenoid (hemi-shoulder) metallic
cemented prosthesis.
(a) Identification. A shoulder joint glenoid (hemi-shoulder)
metallic cemented prosthesis is a device that has a glenoid (socket)
component made of alloys, such as cobalt-chromium-molybdenum, or alloys
with ultra-high molecular weight polyethylene and intended to be
implanted to replace part of a shoulder joint. This generic type of
device is limited to those prostheses intended for use with bone cement
( 888.3027).
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 888.3.
21 CFR 888.3690 Shoulder joint humeral (hemi-shoulder) metallic
uncemented prosthesis.
(a) Identification. A shoulder joint humeral (hemi-shoulder)
metallic uncemented prosthesis is a device made of alloys, such as
cobalt-chromium-molybdenum. It has an intramedullary stem and is
intended to be implanted to replace the articular surface of the
proximal end of the humerus and to be fixed without bone cement (
888.3027). This device is not intended for biological fixation.
(b) Classification. Class II.
21 CFR 888.3720 Toe joint polymer constrained prosthesis.
(a) Identification. A toe joint polymer constrained prosthesis is a
device made of silicone elastomer or polyester reinforced silicone
elastomer intended to be implanted to replace the first
metatarsophalangeal (big toe) joint. This generic type of device
consists of a single flexible across-the-joint component that prevents
dislocation in more than one anatomic plane.
(b) Classification. Class II.
21 CFR 888.3730 Toe joint phalangeal (hemi-toe) polymer prosthesis.
(a) Identification. A toe joint phalangeal (hemi-toe) polymer
prosthesis is a device made of silicone elastomer intended to be
implanted to replace the base of the proximal phalanx of the toe.
(b) Classification. Class II.
21 CFR 888.3750 Wrist joint carpal lunate polymer prosthesis.
(a) Identification. A wrist joint carpal lunate prosthesis is a
one-piece device made of silicone elastomer intended to be implanted to
replace the carpal lunate bone of the wrist.
(b) Classification. Class II.
21 CFR 888.3760 Wrist joint carpal scaphoid polymer prosthesis.
(a) Identification. A wrist joint carpal scaphoid polymer prosthesis
is a one-piece device made of silicone elastomer intended to be
implanted to replace the carpal scaphoid bone of the wrist.
(b) Classification. Class II.
21 CFR 888.3770 Wrist joint carpal trapezium polymer prosthesis.
(a) Identification. A wrist joint carpal trapezium polymer
prosthesis is a one-piece device made of silicone elastomer or silicone
elastomer/polyester material intended to be implanted to replace the
carpal trapezium bone of the wrist.
(b) Classification. Class II.
21 CFR 888.3780 Wrist joint polymer constrained prosthesis.
(a) Identification. A wrist joint polymer constrained prosthesis is
a device made of polyester-reinforced silicone elastomer intended to be
implanted to replace a wrist joint. This generic type of device
consists of a single flexible across-the-joint component that prevents
dislocation in more than one anatomic plane.
(b) Classification. Class II.
21 CFR 888.3790 Wrist joint metal constrained cemented prosthesis.
(a) Identification. A wrist joint metal constrained cemented
prosthesis is a device intended to be implanted to replace a wrist
joint. The device prevents dislocation in more than one anatomic plane
and consists of either a single flexible across-the-joint component or
two components linked together. This generic type of device is limited
to a device which is made of alloys, such as cobalt-chromium-molybdenum,
and is limited to those prostheses intended for use with bone cement (
888.3027).
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 888.3.
21 CFR 888.3800 Wrist joint metal/polymer semi-constrained cemented
prosthesis.
(a) Identification. A wrist joint metal/polymer semi-constrained
cemented prosthesis is a device intended to be implanted to replace a
wrist joint. The device limits translation and rotation in one or more
planes via the geometry of its articulating surfaces. It has no linkage
across-the-joint. This generic type of device includes prostheses that
have either a one-part radial component made of alloys, such as
cobalt-chromium-molybdenum, with an ultra-high molecular weight
polyethylene bearing surface, or a two-part radial component made of
alloys and an ultra-high molecular weight polyethylene ball that is
mounted on the radial component with a trunnion bearing. The metallic
portion of the two-part radial component is inserted into the radius.
These devices have a metacarpal component(s) made of alloys, such as
cobalt-chromium-molybdenum. This generic type of device is limited to
those prostheses intended for use with bone cement ( 888.3027).
(b) Classification. Class II.
21 CFR 888.3810 Wrist joint ulnar (hemi-wrist) polymer prosthesis.
(a) Identification. A wrist joint ulnar (hemi-wrist) polymer
prosthesis is a mushroom-shaped device made of a medical grade silicone
elastomer or ultra-high molecular weight polyethylene intended to be
implanted into the intramedullary canal of the bone and held in place by
a suture. Its purpose is to cover the resected end of the distal ulna
to control bone overgrowth and to provide an articular surface for the
radius and carpus.
(b) Classification. Class II.
21 CFR 888.3810 Subpart E -- Surgical Devices
21 CFR 888.4150 Calipers for clinical use.
(a) Identification. A caliper for clinical use is a compass-like
device intended for use in measuring the thickness or diameter of a part
of the body or the distance between two body surfaces, such as for
measuring an excised skeletal specimen to determine the proper
replacement size of a prosthesis.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807.
21 CFR 888.4200 Cement dispenser.
(a) Identification. A cement dispenser is a nonpowered syringe-like
device intended for use in placing bone cement ( 888.3027) into surgical
sites.
(b) Classification. Class I. If the device is made of the same
materials that were used in the device before May 28, 1976 (e.g., 316
stainless steel, chrome plated carbon steel, or polyethylene), the
device is exempt from the premarket notification procedures in Subpart E
of Part 807 of this chapter.
(52 FR 33702, Sept. 4, 1987, as amended at 53 FR 52953, Dec. 29,
1988)
21 CFR 888.4210 Cement mixer for clinical use.
(a) Identification. A cement mixer for clinical use is a device
consisting of a container intended for use in mixing bone cement (
888.3027).
(b) Classification. Class I. If the device is made of the same
materials that were used in the device before May 28, 1976 (e.g., 316
stainless steel or polyethylene), the device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(52 FR 33702, Sept. 4, 1987, as amended at 53 FR 52953, Dec. 29,
1988)
21 CFR 888.4220 Cement monomer vapor evacuator.
(a) Identification. A cement monomer vapor evacuator is a device
intended for use during surgery to contain or remove undesirable fumes,
such as monomer vapor from bone cement ( 888.3027).
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(52 FR 33702, Sept. 4, 1987, as amended at 53 FR 52954, Dec. 29,
1988)
21 CFR 888.4230 Cement ventilation tube.
(a) Identification. A cement ventilation tube is a tube-like device
usually made of plastic intended to be inserted into a surgical cavity
to allow the release of air or fluid from the cavity as it is being
filled with bone cement ( 888.3027).
(b) Classification. Class I. If the device is made of the same
materials that were used in the device before May 28, 1976 (e.g.,
polypropylene or polyethylene), the device is exempt from the premarket
notification procedures in Subpart E of Part 807 of this chapter.
(52 FR 33702, Sept. 4, 1987, as amended at 53 FR 52954, Dec. 29,
1988)
21 CFR 888.4300 Depth gauge for clinical use.
(a) Identification. A depth gauge for clinical use is a measuring
device intended for various medical purposes, such as to determine the
proper length of screws for fastening the ends of a fractured bone.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807.
21 CFR 888.4540 Orthopedic manual surgical instrument.
(a) Identification. An orthopedic manual surgical instrument is a
nonpowered hand-held device intended for medical purposes to manipulate
tissue, or for use with other devices in orthopedic surgery. This
generic type of device includes the cerclage applier, awl, bender, drill
brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter,
prosthesis driver, extractor, file, fork, needle holder, impactor,
bending or contouring instrument, compression instrument, passer, socket
positioner, probe, femoral neck punch, socket pusher, reamer, rongeur,
scissors, screwdriver, bone skid, staple driver, bone screw starter,
surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.
(b) Classification. Class I. If the device is made of the same
materials that were used in the device before May 28, 1976, the device
is exempt from the premarket notification procedures in Subpart E of
Part 807.
21 CFR 888.4580 Sonic surgical instrument and accessories/attachments.
(a) Identification. A sonic surgical instrument is a hand-held
device with various accessories or attachments, such as a cutting tip
that vibrates at high frequencies, and is intended for medical purposes
to cut bone or other materials, such as acrylic.
(b) Classification. Class II.
21 CFR 888.4600 Protractor for clinical use.
(a) Identification. A protractor for clinical use is a device
intended for use in measuring the angles of bones, such as on X-rays or
in surgery.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807.
21 CFR 888.4800 Template for clinical use.
(a) Identification. A template for clinical use is a device that
consists of a pattern or guide intended for medical purposes, such as
selecting or positioning orthopedic implants or guiding the marking of
tissue before cutting.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807.
21 CFR 888.5850 Nonpowered orthopedic traction apparatus and
accessories.
(a) Identification. A nonpowered orthopedic traction apparatus is a
device that consists of a rigid frame with nonpowered traction
accessories, such as cords, pulleys, or weights, and that is intended to
apply a therapeutic pulling force to the skeletal system.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807. The device
is exempt from the current good manufacturing practice regulations in
Part 820 with the exception of 820.180, regarding general requirements
concerning records, and 820.198, regarding complaint files.
21 CFR 888.5890 Noninvasive traction component.
(a) Identification. A noninvasive traction component is a device,
such as a head halter, pelvic belt, or a traction splint, that does not
penetrate the skin and is intended to assist in connecting a patient to
a traction apparatus so that a therapeutic pulling force may be applied
to the patient's body.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter. The device is exempt from the current good manufacturing
practice regulations in Part 820 of this chapter, with the exception of
820.180, regarding general requirements concerning records, and
820.198, regarding complaint files.
(52 FR 33702, Sept. 4, 1987, as amended at 53 FR 52954, Dec. 29,
1988)
21 CFR 888.5940 Cast component.
(a) Identification. A cast component is a device intended for
medical purposes to protect or support a cast. This generic type of
device includes the cast heel, toe cap, cast support, and walking iron.
(b) Classification. Class I. If the device is made of the same
materials that were used in the device before May 28, 1976, (e.g., heels
of rubber vinyl; walking irons of plate steel) it is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter. The device is exempt from the current good manufacturing
practice regulations in Part 820 of this chapter, with the exception of
820.180, regarding general requirements concerning records, and
820.198, regarding complaint files.
(52 FR 33702, Sept. 4, 1987, as amended at 53 FR 52954, Dec. 29,
1988)
21 CFR 888.5960 Cast removal instrument.
(a) Identification. A cast removal instrument is an AC-powered,
hand-held device intended to remove a cast from a patient. This generic
type of device includes the electric cast cutter and cast vacuum.
(b) Classification. Class I.
(55 FR 48443, Nov. 20, 1990)
21 CFR 888.5980 Manual cast application and removal instrument.
(a) Identification. A manual cast application and removal instrument
is a nonpowered hand-held device intended to be used in applying or
removing a cast. This generic type of device includes the cast knife,
cast spreader, plaster saw, plaster dispenser, and casting stand.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter. The device is exempt from the current good manufacturing
regulations in Part 820 of this chapter, with the exception of 820.180,
regarding general requirements concerning records, and 820.198,
regarding complaint files.
(52 FR 33702, Sept. 4, 1987, as amended at 53 FR 52954, Dec. 29,
1988)
21 CFR 888.5980 Pt. 890
21 CFR 888.5980 PART 890 -- PHYSICAL MEDICINE DEVICES
21 CFR 888.5980 Subpart A -- General Provisions
Sec.
890.1 Scope.
890.3 Effective dates of requirement for premarket approval.
890.9 Limitations of exemptions from section 510(k) of the Federal
Food, Drug, and Cosmetic Act (the act).
21 CFR 888.5980 Subpart B -- Physical Medicine Diagnostic Devices
890.1175 Electrode cable.
890.1225 Chronaximeter.
890.1375 Diagnostic electromyograph.
890.1385 Diagnostic electromyograph needle electrode.
890.1450 Powered reflex hammer.
890.1575 Force-measuring platform.
890.1600 Intermittent pressure measurement system.
890.1615 Miniature pressure transducer.
890.1850 Diagnostic muscle stimulator.
890.1925 Isokinetic testing and evaluation system.
21 CFR 888.5980 Subpart C -- (Reserved)
21 CFR 888.5980 Subpart D -- Physical Medicine Prosthetic Devices
890.3025 Prosthetic and orthotic accessory.
890.3075 Cane.
890.3100 Mechanical chair.
890.3110 Electric positioning chair.
890.3150 Crutch.
890.3175 Flotation cushion.
890.3410 External limb orthotic component.
890.3420 External limb prosthetic component.
890.3450 Mechanical automobile hand and foot driving control.
890.3475 Limb orthosis.
890.3490 Truncal orthosis.
890.3500 External assembled lower limb prosthesis.
890.3520 Plinth.
890.3610 Rigid pneumatic structure orthosis.
890.3640 Arm sling.
890.3665 Congenital hip dislocation abduction splint.
890.3675 Denis Brown splint.
890.3690 Powered wheeled stretcher.
890.3700 Nonpowered communication system.
890.3710 Powered communication system.
890.3725 Powered environmental control system.
890.3750 Mechanical table.
890.3760 Powered table.
890.3790 Cane, crutch, and walker tips and pads.
890.3800 Motorized three-wheeled vehicle.
890.3825 Mechanical walker.
890.3850 Mechanical wheelchair.
890.3860 Powered wheelchair.
890.3880 Special grade wheelchair.
890.3890 Stair-climbing wheelchair.
890.3900 Standup wheelchair.
890.3910 Wheelchair accessory.
890.3920 Wheelchair component.
890.3930 Wheelchair elevator.
890.3940 Wheelchair platform scale.
21 CFR 888.5980 Subpart E -- (Reserved)
21 CFR 888.5980 Subpart F -- Physical Medicine Therapeutic Devices
890.5050 Daily activity assist device.
890.5100 Immersion hydrobath.
890.5110 Paraffin bath.
890.5125 Nonpowered sitz bath.
890.5150 Powered patient transport.
890.5160 Air-fluidized bed.
890.5170 Powered flotation therapy bed.
890.5180 Manual patient rotation bed.
890.5225 Powered patient rotation bed.
890.5250 Moist steam cabinet.
890.5275 Microwave diathermy.
890.5290 Shortwave diathermy.
890.5300 Ultrasonic diathermy.
890.5350 Exercise component.
890.5360 Measuring exercise equipment.
890.5370 Nonmeasuring exercise equipment.
890.5380 Powered exercise equipment.
890.5410 Powered finger exerciser.
890.5500 Infrared lamp.
890.5525 Iontophoresis device.
890.5575 Powered external limb overload warning device.
890.5650 Powered inflatable tube massager.
890.5660 Therapeutic massager.
890.5700 Cold pack.
890.5710 Hot or cold disposable pack.
890.5720 Water circulating hot or cold pack.
890.5730 Moist heat pack.
890.5740 Powered heating pad.
890.5765 Pressure-applying device.
890.5850 Powered muscle stimulator.
890.5860 Ultrasound and muscle stimulator.
890.5880 Multi-function physical therapy table.
890.5900 Powered traction equipment.
890.5925 Traction accessory.
890.5940 Chilling unit.
890.5950 Powered heating unit.
890.5975 Therapeutic vibrator.
Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j, 371).
Source: 48 FR 53047, Nov. 23, 1983, unless otherwise noted.
21 CFR 888.5980 Subpart A -- General Provisions
21 CFR 890.1 Scope.
(a) This part sets forth the classification of physical medicine
devices intended for human use that are in commercial distribution.
(b) The identification of a device in a regulation in this part is
not a precise description of every device that is, or will be, subject
to the regulation. A manufacturer who submits a premarket notification
submission for a device under Part 807 may not show merely that the
device is accurately described by the section title and identification
provisions of a regulation in this part, but shall state why the device
is substantially equivalent to other devices, as required by 807.87.
(c) To avoid duplicative listings, a physical medicine device that
has two or more types of uses (e.g., used both as a diagnostic device
and as a therapeutic device) is listed only in one subpart.
(d) References in this part to regulatory sections of the Code of
Federal Regulations are the Chapter I of Title 21, unless otherwise
noted.
(52 FR 17741, May 11, 1987)
21 CFR 890.3 Effective dates of requirement for premarket approval.
A device included in this part that is classified into class III
(premarket approval) shall not be commercially distributed after the
date shown in the regulation classifying the device unless the
manufacturer has an approval under section 515 of the act (unless an
exemption has been granted under section 520(g)(2) of the act). An
approval under section 515 of the act consists of FDA's issuance of an
order approving an application of premarket approval (PMA) for the
device or declaring completed a product development protocol (PDP) for
the device.
(a) Before FDA requires that a device commercially distributed before
the enactment date of the amendments, or a device that has been found
substantially equivalent to such a device, has an approval under section
515 of the act FDA must promulgate a regulation under section 515(b) of
the act requiring such approval, except as provided in paragraph (b) of
this section. Such a regulation under section 515(b) of the act shall
not be effective during the grace period ending on the 90th day after
its promulgation or on the last day of the 30th full calendar month
after the regulation that classifies the device into class III is
effective, whichever is later. See section 501(f)(2)(B) of the act.
Accordingly, unless an effective date of the requirement for premarket
approval is shown in the regulation for a device classified into class
III in this part, the device may be commercially distributed without
FDA's issuance of an order approving a PMA or declaring completed a PDP
for the device. If FDA promulgates a regulation under section 515(b) of
the act requiring premarket approval for a device, section 501(f)(1)(A)
of the act applies to the device.
(b) Any new, not substantially equivalent, device introduced into
commercial distribution on or after May 28, 1976, includiing a device
formerly marketed that has been substantially altered, is classified by
statute (section 513(f) of the act) into class III without any grace
period and FDA must have issued an order approving a PMA or declaring
completed a PDP for the device before the device is commercially
distributed unless it is reclassified. If FDA knows that a device being
commerically distributed may be a ''new'' device as defined in this
section because of any new intended use or other reasons, FDA may codify
the statutory classification of the device into class III for such new
use. Accordingly, the regulation for such a class III device states
that as of the enactment date of the amendments, May 28, 1976, the
device must have an approval under section 515 of the act before
commercial distribution.
(52 FR 17741, May 11, 1987)
21 CFR 890.9 Limitations of exemptions from section 510(k) of the
Federal Food, Drug, and Cosmetic Act (the act).
The Food and Drug Administration's (FDA's) decision to grant an
exemption from the requirement of premarket notification (section 510(k)
of the act) for a generic type of class I device is based upon the
existing and reasonably foreseeable characteristics of commercially
distributed devices within that generic type. Because FDA cannot
anticipate every change in intended use or characteristic that could
significantly affect a device's safety or effectiveness, manufacturers
of any commercially distributed class I device for which FDA has granted
an exemption from the requirement of premarket notification must still
submit a premarket notification to FDA before introducing or delivering
for introduction into interstate commerce for commercial distribution
the device when:
(a) The device is intended for a use different from its intended use
before May 28, 1976, or the device is intended for a use different from
the intended use of a preamendments device to which it had been
determined to be substantially equivalent; e.g., the device is intended
for a different medical purpose, or the device is intended for lay use
where the former intended use was by health care professionals only; or
(b) The modified device operates using a different fundamental
scientific technology than that in use in the device before May 28,
1976; e.g., a surgical instrument cuts tissue with a laser beam rather
than with a sharpened metal blade, or an in vitro diagnostic device
detects or identifies infectious agents by using a deoxyribonucleic acid
(DNA) probe or nucleic acid hybridization technology rather than culture
or immunoassay technology.
(54 FR 25052, June 12, 1989)
21 CFR 890.9 Subpart B -- Physical Medicine Diagnostic Devices
21 CFR 890.1175 Electrode cable.
(a) Identification. An electrode cable is a device composed of
strands of insulated electrical conductors laid together around a
central core and intended for medical purposes to connect an electrode
from a patient to a diagnostic machine.
(b) Classification. Class I (general controls). The device is
exempt from the current good manufacturing practice regulations in Part
820, with the exception of 820.180, with respect to general
requirements concerning records, and 820.198, with respect to complaint
files.
21 CFR 890.1225 Chronaximeter.
(a) Identification. A chronaximeter is a device intended for medical
purposes to measure neuromuscular excitability by means of a
strength-duration curve that provides a basis for diagnosis and
prognosis of neurological dysfunction.
(b) Classification. Class II (performance standards).
21 CFR 890.1375 Diagnostic electromyograph.
(a) Identification. A diagnostic electromyograph is a device
intended for medical purposes, such as to monitor and display the
bioelectric signals produced by muscles, to stimulate peripheral nerves,
and to monitor and display the electrical activity produced by nerves,
for the diagnosis and prognosis of neuromuscular disease.
(b) Classification. Class II (performance standards).
21 CFR 890.1385 Diagnostic electromyograph needle electrode.
(a) Identification. A diagnostic electromyograph needle electrode is
a monopolar or bipolar needle intended to be inserted into muscle or
nerve tissue to sense bioelectrical signals. The device is intended for
medial purposes for use in connection with electromyography (recording
the intrinsic electrical properties of skeletal muscle).
(b) Classification. Class II (performance standards).
21 CFR 890.1450 Powered reflex hammer.
(a) Identification. A powered reflex hammer is a motorized device
intended for medical purposes to elicit and determine controlled deep
tendon reflexes.
(b) Classification. Class II (performance standards).
21 CFR 890.1575 Force-measuring platform.
(a) Identification. A force-measuring platform is a device intended
for medical purposes that converts pressure applied upon a planar
surface into analog mechanical or electrical signals. This device is
used to determine ground reaction force, centers of percussion, centers
of torque, and their variations in both magnitude and direction with
time.
(b) Classification. Class II (performance standards).
21 CFR 890.1600 Intermittent pressure measurement system.
(a) Identification. An intermittent pressure measurement system is
an evaluative device intended for medical purposes, such as to measure
the actual pressure between the body surface and the supporting media.
(b) Classification. Class II (performance standards).
21 CFR 890.1615 Miniature pressure transducer.
(a) Identification. A miniature pressure transducer is a device
intended for medical purposes to measure the pressure between a device
and soft tissue by converting mechanical inputs to analog electrical
signals.
(b) Classification. Class II (performance standards).
21 CFR 890.1850 Diagnostic muscle stimulator.
(a) Identification. A diagnostic muscle stimulator is a device used
mainly with an electromyograph machine to initiate muscle activity. It
is intended for medical purposes, such as to diagnose motor nerve or
sensory neuromuscular disorders and neuromuscular function.
(b) Classification. Class II (performance standards).
21 CFR 890.1925 Isokinetic testing and evaluation system.
(a) Identification. An isokinetic testing and evaluation system is a
rehabilitative exercise device intended for medical purposes, such as to
measure, evaluate, and increase the strength of muscles and the range of
motion of joints.
(b) Classification. Class II (performance standards).
21 CFR 890.1925 Subpart C -- (Reserved)
21 CFR 890.1925 Subpart D -- Physical Medicine Prosthetic Devices
21 CFR 890.3025 Prosthetic and orthotic accessory.
(a) Identification. A prosthetic and orthotic accessory is a device
intended for medical purposes to support, protect, or aid in the use of
a cast, orthosis (brace), or prosthesis. Examples of prosthetic and
orthotic accessories include the following: A pelvic support band and
belt, a cast shoe, a cast bandage, a limb cover, a prosthesis alignment
device, a postsurgical pylon, a transverse rotator, and a temporary
training splint.
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in Subpart E of Part
807. The device also is exempt from the current good manufacturing
practice regulations in Part 820, with the exception of 820.180, with
respect to general requirements concerning records, and 820.198, with
respect to complaint files.
21 CFR 890.3075 Cane.
(a) Identification. A cane is a device intended for medical purposes
that is used to provide minimal weight support while walking. Examples
of canes include the following: A standard cane, a forearm cane, and a
cane with a tripod, quad, or retractable stud on the ground end.
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in Subpart E of Part
807. The device also is exempt from the current good manufacturing
practice regulation in Part 820, with the exception of 820.180, with
respect to general requirements concerning records, and 820.198, with
respect to complaint files.
21 CFR 890.3100 Mechanical chair.
(a) Identification. A mechanical chair is a manually operated device
intended for medical purposes that is used to assist a disabled person
in performing an activity that the person would otherwise find difficult
to do or be unable to do. Examples of mechanical chairs include the
following: A chair with an elevating seat used to raise a person from a
sitting position to a standing position and a chair with casters used by
a person to move from one place to another while sitting.
(b) Classification. Class I (general controls).
21 CFR 890.3110 Electric positioning chair.
(a) Identification. An electric positioning chair is a device with a
motorized positioning control that is intended for medical purposes and
that can be adjusted to various positions. The device is used to
provide stability for patients with athetosis (involuntary spasms) and
to alter postural positions.
(b) Classification. Class II (performance standards).
21 CFR 890.3150 Crutch.
(a) Identification. A crutch is a device intended for medical
purposes for use by disabled persons to provide minimal to moderate
weight support while walking.
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in Subpart E of Part
807. The device is also exempt from the current good manufacturing
practice regulations in Part 820, with the exception of 820.180, with
respect to general requirements concerning records, and 820.198, with
respect to complaint files.
21 CFR 890.3175 Flotation cushion.
(a) Identification. A flotation cushion is a device intended for
medical purposes that is made of plastic, rubber, or other type of
covering, that is filled with water, air, gel, mud, or any other
substance allowing a flotation media, used on a seat to lessen the
likelihood of skin ulcers.
(b) Classification. Class I (general controls).
21 CFR 890.3410 External limb orthotic component.
(a) Identification. An external limb orthotic component is a device
intended for medical purposes for use in conjunction with an orthosis
(brace) to increase the function of the orthosis for a patient's
particular needs. Examples of external limb orthotic components include
the following: A brace-setting twister and an external brace stirrup.
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in Subpart E of Part
807. The device also is exempt from the current good manufacturing
practice regulations in Part 820, with the exception of 820.180, with
respect to general requirements concerning records, and 820.198, with
respect to complaint files.
21 CFR 890.3420 External limb prosthetic component.
(a) Identification. An external limb prosthetic component is a
device intended for medical purposes that, when put together with other
appropriate components, constitutes a total prosthesis. Examples of
external limb prosthetic components include the following: Ankle, foot,
hip, knee, and socket components; mechanical or powered hand, hook,
wrist unit, elbow joint, and shoulder joint components; and cable and
prosthesis suction valves.
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in Subpart E of Part
807. The device also is exempt from the current good manufacturing
practice regulations in Part 820, with the exception of 820.180, with
respect to general requirements concerning records, and 820.198, with
respect to complaint files.
21 CFR 890.3450 Mechanical automobile hand and foot driving control.
(a) Identification. A mechanical automobile hand or foot driving
control is a device intended for medical purposes to enable persons who
have limited use of their arms or legs to drive an automobile. The
device allows the hand operation of the gas, brake, and clutch pedals or
foot operation of the steering and gear shift.
(b) Classification. Class II (performance standards).
21 CFR 890.3475 Limb orthosis.
(a) Identification. A limb orthosis (brace) is a device intended for
medical purposes that is worn on the upper or lower extremities to
support, to correct, or to prevent deformities or to align body
structures for functional improvement. Examples of limb orthoses
include the following: A whole limb and joint brace, a hand splint, an
elastic stocking, a knee cage, and a corrective shoe.
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in Subpart E of Part
807. The device also is exempt from the current good manufacturing
practice regulations in Part 820, with the exception of 820.180, with
respect to general requirements concerning records, and 820.198, with
respect to complaint files.
21 CFR 890.3490 Truncal orthosis.
(a) Identification. A truncal orthosis is a device intended for
medical purposes to support or to immobilize fractures, strains, or
sprains of the neck or trunk of the body. Examples of truncal orthoses
are the following: Abdominal, cervical, cervical-thoracic, lumbar,
lumbo-sacral, rib fracture, sacroiliac, and thoracic orthoses and
clavicle splints.
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification precedures in Subpart E of Part
807. The device also is exempt from the current good manufacturing
practice regulations in Part 820, with the exception of 820.180, with
respect to general requirements concerning records, and 820.198, with
respect to complaint files.
21 CFR 890.3500 External assembled lower limb prosthesis.
(a) Identification. An external assembled lower limb prosthesis is a
device that is intended for medical purposes and is a preassembled
external artificial limb for the lower extremity. Examples of external
assembled lower limb prostheses are the following:
Knee/shank/ankle/foot assembly and thigh/knee/shank/ankle/foot assembly.
(b) Classification. Class II (performance standards).
21 CFR 890.3520 Plinth.
(a) Identification. A plinth is a flat, padded board with legs that
is intended for medical purposes. A patient is placed on the device for
treatment or examination.
(b) Classification. Class I (general controls). This device is
exempt from the premarket notification procedure in Subpart E of Part
807. The device is also exempt from the current good manufacturing
practice regulations in Part 820, with the exception of 820.180, with
respect to general requirements concerning records and 820.198 with
respect to complaint files.
21 CFR 890.3610 Rigid pneumatic structure orthosis.
(a) Identification. A rigid pneumatic structure orthosis is a device
intended for medical purposes to provide whole body support by means of
a pressurized suit to help thoracic paraplegics walk.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 890.3.
(48 FR 53047, Nov. 23, 1983, as amended at 52 FR 17742, May 11, 1987)
21 CFR 890.3640 Arm sling.
(a) Identification. An arm sling is a device intended for medical
purposes to immobilize the arm, by means of a fabric band suspended from
around the neck.
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in Subpart E of Part
807. The device also is exempt from the current good manufacturing
practice regulations in Part 820, with the exception of 820.180, with
respect to general requirements concerning records, and 820.198, with
respect to complaint files.
21 CFR 890.3665 Congenital hip dislocation abduction splint.
(a) Identification. A congenital hip dislocation abduction splint is
a device intended for medical purposes to stabilize the hips of a young
child with dislocated hips in an abducted position (away from the
midline).
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in Subpart E of Part
807. The device also is exempt from the current good manufacturing
practice regulations in Part 820, with the exception of 820.180, with
respect to general requirements concerning records, and 820.198, with
respect to complaint files.
21 CFR 890.3675 Denis Brown splint.
(a) Identification. A Denis Brown splint is a device intended for
medical purposes to immobilize the foot. It is used on young children
with tibial torsion (excessive rotation of the lower leg) or club foot.
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in Subpart E of Part
807. The device also is exempt from the current good manufacturing
practice regulations in Part 820, with the exception of 820.180, with
respect to general requirements concerning records, and 820.198, with
respect to complaint files.
21 CFR 890.3690 Powered wheeled stretcher.
(a) Identification. A powered wheeled stretcher is a battery-powered
table with wheels that is intended for medical purposes for use by
patients who are unable to propel themselves independently and who must
maintain a prone or supine position for prolonged periods because of
skin ulcers or contractures (muscle contractions).
(b) Classification. Class II (performance standards).
21 CFR 890.3700 Nonpowered communication system.
(a) Identification. A nonpowered communication system is a
mechanical device intended for medical purposes that is used to assist a
patient in communicating when physical impairment prevents writing,
telephone use, reading, or talking. Examples of nonpowered
communications systems include an alphabet board and a page turner.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter. The device is also exempt from the current good manufacturing
practice regulations in Part 820 of this chapter, with the exception of
820.180, regarding general requirements concerning records, and
820.198, regarding complaint files.
(48 FR 53047, Nov. 23, 1983, as amended at 54 FR 25052, June 12,
1989)
21 CFR 890.3710 Powered communication system.
(a) Identification. A powered communication system is an AC- or
battery-powered device intended for medical purposes that is used to
transmit or receive information. It is used by persons unable to use
normal communication methods because of physical impairment. Examples
of powered communication systems include the following: a specialized
typewriter, a reading machine, and a video picture and word screen.
(b) Classification. Class II (performance standards).
21 CFR 890.3725 Powered environmental control system.
(a) Identification. A powered environmental control system is an AC-
or battery-powered device intended for medical purposes that is used by
a patient to operate an environmental control function. Examples of
environmental control functions include the following: to control room
temperature, to answer a doorbell or telephone, or to sound an alarm for
assistance.
(b) Classification. Class II (performance standards).
21 CFR 890.3750 Mechanical table.
(a) Identification. A mechanical table is a device intended for
medical purposes that has a flat surface that can be inclined or
adjusted to various positions. It is used by patients with circulatory,
neurological, or musculoskeletal conditions to increase tolerance to an
upright or standing position.
(b) Classification. Class I (general controls).
21 CFR 890.3760 Powered table.
(a) Identification. A powered table is a device intended for medical
purposes that is an electrically operated flat surface table that can be
adjusted to various positions. It is used by patients with circulatory,
neurological, or musculoskeletal conditions to increase tolerance to an
upright or standing position.
(b) Classification. Class II (performance standards).
21 CFR 890.3790 Cane, crutch, and walker tips and pads.
(a) Identification. Cane, crutch, and walker tips and pads are
rubber (or rubber substitute) device accessories intended for medical
purposes that are applied to the ground end of mobility aids to prevent
skidding or that are applied to the body contact area of the device for
comfort or as an aid in using an ambulatory assist device.
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in Subpart E of Part
807. The device also is exempt from the current good manufacturing
practice regulations in Part 820, with the exception of 820.180, with
respect to general requirements concerning records, and 820.198, with
respect to complaint files.
21 CFR 890.3800 Motorized three-wheeled vehicle.
(a) Identification. A motorized three-wheeled vehicle is a
gasoline-fueled or battery-powered device intended for medical purposes
that is used for outside transportation by disabled persons.
(b) Classification. Class II (performance standards).
21 CFR 890.3825 Mechanical walker.
(a) Identification. A mechanical walker is a four-legged device with
a metal frame intended for medical purposes to provide moderate weight
support while walking. It is used by disabled persons who lack
strength, good balance, or endurance.
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in Subpart E of Part
807. The device also is exempt from the current good manufacturing
practice regulations in Part 820, with the exception of 820.180, with
respect to general requirements concerning records, and 820.198, with
respect to complaint files.
21 CFR 890.3850 Mechanical wheelchair.
(a) Identification. A mechanical wheelchair is a manually operated
device with wheels that is intended for medical purposes to provide
mobility to persons restricted to a sitting position.
(b) Classification. Class I (general controls).
21 CFR 890.3860 Powered wheelchair.
(a) Identification. A powered wheelchair is a battery-operated
device with wheels that is intended for medical purposes to provide
mobility to persons restricted to a sitting position.
(b) Classification. Class II (performance standards).
21 CFR 890.3880 Special grade wheelchair.
(a) Identification. A special grade wheelchair is a device with
wheels that is intended for medical purposes to provide mobility to
persons restricted to a sitting position. It is intended to be used in
all environments for long-term use, e.g., for paraplegics,
quadraplegics, and amputees.
(b) Classification. Class II (performance standards).
21 CFR 890.3890 Stair-climbing wheelchair.
(a) Identification. A stair-climbing wheelchair is a device with
wheels that is intended for medical purposes to provide mobility to
persons restricted to a sitting position. The device is intended to
climb stairs by means of two endless belt tracks that are lowered from
under the chair and adjusted to the angle of the stairs.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See 890.3.
(48 FR 53047, Nov. 23, 1983, as amended at 52 FR 17742, May 11, 1987;
52 FR 22577, June 12, 1987)
21 CFR 890.3900 Standup wheelchair.
(a) Identification. A standup wheelchair is a device with wheels
that is intended for medical purposes to provide mobility to persons
restricted to a sitting position. The device incorporates an external
manually controlled mechanical system that is intended to raise a
paraplegic to an upright position by means of an elevating seat.
(b) Classification. Class II (performance standards).
21 CFR 890.3910 Wheelchair accessory.
(a) Identification. A wheelchair accessory is a device intended for
medical purposes that is sold separately from a wheelchair and is
intended to meet the specific needs of a patient who uses a wheelchair.
Examples of wheelchair accessories are the following: armboard,
lapboard, pusher cuff, crutch and cane holder, restraint, overhead
suspension sling, head and trunk support, and blanket and leg rest
strap.
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in Subpart E of Part
807. The device also is exempt from the current good manufacturing
practice regulations in Part 820, with the exception of 820.180, with
respect to general requirements concerning records, and 820.198, with
respect to complaint files.
21 CFR 890.3920 Wheelchair component.
(a) Identification. A wheelchair component is a device intended for
medical purposes that is generally sold as an integral part of a
wheelchair, but may also be sold separately as a replacement part.
Examples of wheelchair components are the following: Armrest, narrowing
attachment, belt, extension brake, curb climber, cushion, antitip
device, footrest, handrim, hill holder, leg rest, heel loops, and toe
loops.
(b) Classification. Class I (general controls).
21 CFR 890.3930 Wheelchair elevator.
(a) Identification. A wheelchair elevator is a motorized lift device
intended for medical purposes to provide a means for a disabled person
to move a wheelchair from one level to another.
(b) Classification. Class II (performance standards).
21 CFR 890.3940 Wheelchair Platform scale.
(a) Identification. A wheelchair platform scale is a device with a
base designed to accommodate a wheelchair. It is intended for medical
purposes to weigh a person who is confined to a wheelchair.
(b) Classification. Class I (general controls). The device is
exempt from the current good manufacturing practice regulations in Part
820, with the exception of 820.180, with respect to general
requirements concerning records, and 820.198, with respect to complaint
files.
21 CFR 890.3940 Subpart E -- (Reserved)
21 CFR 890.3940 Subpart F -- Physical Medicine Therapeutic Devices
21 CFR 890.5050 Daily activity assist device.
(a) Identification. A daily activity assist device is a modified
adaptor or utensil (e.g., a dressing, grooming, recreational activity,
transfer, eating, or homemaking aid) that is intended for medical
purposes to assist a patient to perform a specific function.
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in Subpart E of Part
807. If the device is not labeled or otherwise represented as sterile,
it also is exempt from the current good manufacturing practice
regulations in Part 820, with the exception of 820.180, with respect to
general requirements concerning records, and 820.198, with respect to
complaint files.
21 CFR 890.5100 Immersion hydrobath.
(a) Identification. An immersion hydrobath is a device intended for
medical purposes that consists of water agitators and that may include a
tub to be filled with water. The water temperature may be measured by a
gauge. It is used in hydrotherapy to relieve pain and itching and as an
aid in the healing process of inflamed and traumatized tissue, and it
serves as a setting for removal of contaminated tissue.
(b) Classification. Class II (performance standards).
21 CFR 890.5110 Paraffin bath.
(a) Identification. A paraffin bath is a device intended for medical
purposes that consists of a tub to be filled with liquid paraffin (wax)
and maintained at an elevated temperature in which the patient's
appendages (e.g., hands or fingers) are placed to relieve pain and
stiffness.
(b) Classification. Class II (performance standards).
21 CFR 890.5125 Nonpowered sitz bath.
(a) Identification. A nonpowered sitz bath is a device intended for
medical purposes that consists of a tub to be filled with water for use
in external hydrotherapy to relieve pain or pruritis and to accelerate
the healing of inflamed or traumatized tissues of the perianal and
perineal areas.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter. The device is also exempt from the current good manufacturing
practice regulations in Part 820 of this chapter, with the exception of
820.180, regarding general requirements concerning records, and
820.198, regarding complaint files.
(48 FR 53047, Nov. 23, 1983, as amended at 54 FR 25052, June 12,
1989)
21 CFR 890.5150 Powered patient transport.
(a) Identification. A powered patient transport is a motorized
device intended for medical purposes to assist transfers of patients to
and from the bath, beds, chairs, treatment modalities, transport
vehicles, and up and down flights of stairs. This generic type of
device does not include motorized threewheeled vehicles or wheelchairs.
(b) Classification. Class II (performance standards).
21 CFR 890.5160 Air-fluidized bed.
(a) Identification. An air-fluidized bed is a device employing the
circulation of filtered air through ceramic spherules (small, round
ceramic objects) that is intended for medical purposes to treat or
prevent bedsores, to treat severe or extensive burns, or to aid
circulation.
(b) Classification. Class II (performance standards).
21 CFR 890.5170 Powered flotation therapy bed.
(a) Identification. A powered flotation therapy bed is a device that
is equipped with a mattress that contains a large volume of constantly
moving water, air, mud, or sand. It is intended for medical purposes to
treat or prevent a patient's bedsores, to treat severe or extensive
burns, or to aid circulation. The mattress may be electrically heated.
(b) Classification. Class II (performance standards).
21 CFR 890.5180 Manual patient rotation bed.
(a) Identification. A manual patient rotation bed is a device that
turns a patient who is restricted to a reclining position. It is
intended for medical purposes to treat or prevent bedsores, to treat
severe and extensive burns, or to aid circulation.
(b) Classification. Class I (general controls).
21 CFR 890.5225 Powered patient rotation bed.
(a) Identification. A powered patient rotation bed is a device that
turns a patient who is restricted to a reclining position. It is
intended for medical purposes to treat or prevent bedsores, to treat
severe and extensive burns, urinary tract blockage, and to aid
circulation.
(b) Classification. Class II (performance standards).
21 CFR 890.5250 Moist steam cabinet.
(a) Identification. A moist steam cabinet is a device intended for
medical purposes that delivers a flow of heated, moisturized air to a
patient in an enclosed unit. It is used to treat arthritis and fibrosis
(a formation of fibrosis tissue) and to increase local blood flow.
(b) Classification. Class II (performance standards).
21 CFR 890.5275 Microwave diathermy.
(a) Microwave diathermy for use in applying therapeutic deep heat for
selected medical conditions -- (1) Identification. A microwave
diathermy for use in applying therapeutic deep heat for selected medical
conditions is a device that applies to specific areas of the body
electromagnetic energy in the microwave frequency bands of 915 megahertz
to 2,450 megahertz and that is intended to generate deep heat within
body tissues for the treatment of selected medical conditions such as
relief of pain, muscle spasms, and joint contractures, but not for the
treatment of malignancies.
(2) Classification. Class II (performance standards).
(b) Microwave diathermy for all other uses -- (1) Identification. A
microwave diathermy for all other uses except for the treatment of
malignancies is a device that applies to the body electromagnetic energy
in the microwave frequency bands of 915 megahertz to 2,450 megahertz and
that is intended for the treatment of medical conditions by means other
than the generation of deep heat within body tissues as described in
paragraph (a) of this section.
(2) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval for the device described in paragraph (b)(1). See 890.3.
(48 FR 53047, Nov. 23, 1983, as amended at 52 FR 17742, May 11, 1987)
21 CFR 890.5290 Shortwave diathermy.
(a) Shortwave diathermy for use in applying therapeutic deep heat for
selected medical conditions -- (1) Identification. A shortwave
diathermy for use in applying therapeutic deep heat for selected medical
conditions is a device that applies to specific areas of the body
electromagnetic energy in the radio frequency bands of 13 megahertz to
27.12 megahertz and that is intended to generate deep heat within body
tissues for the treatment of selected medical conditions such as relief
of pain, muscle spasms, and joint contractures, but not for the
treatment of malignancies.
(2) Classification. Class II (performance standards).
(b) Shortwave diathermy for all other uses -- (1) Identification. A
shortwave diathermy for all other uses except for the treatment of
malignancies is a device that applies to the body electromagnetic energy
in the radio frequency bands of 13 megahertz to 27.12 megahertz and that
is intended for the treatment of medical conditions by means other than
the generation of deep heat within body tissues as described in
paragraph (a) of this section.
(2) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval for the device described in paragraph (b)(1). See 890.3.
(48 FR 53047, Nov. 23, 1983, as amended at 52 FR 17742, May 11, 1987)
21 CFR 890.5300 Ultrasonic diathermy.
(a) Ultrasonic diathermy for use in applying therapeutic deep heat
for selected medical conditions -- (1) Identification. An ultrasonic
diathermy for use in applying therapeutic deep heat for selected medical
conditions is a device that applies to specific areas of the body
ultrasonic energy at a frequency beyond 20 kilohertz and that is
intended to generate deep heat within body tissues for the treatment of
selected medical conditions such as relief of pain, muscle spasms, and
joint contractures, but not for the treatment of malignancies.
(2) Classification. Class II (performance standards).
(b) Ultrasonic diathermy for all other uses -- (1) Identification.
An ultrasonic diathermy for all other uses except for the treatment of
malignancies is a device that applies to the body ultrasonic energy at a
frequency beyond 20 kilohertz and that is intended for the treatment of
medical conditions by means other than the generation of deep heat
within body tissues as described in paragraph (a) of this section.
(2) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval for the device described in paragraph (b)(1). See 890.3.
(48 FR 53047, Nov. 23, 1983, as amended at 52 FR 17742, May 11, 1987)
21 CFR 890.5350 Exercise component.
(a) Identification. An exercise component is a device that is used
in conjunction with other forms of exercise and that is intended for
medical purposes, such as to redevelope muscles or restore motion to
joints or for use as an adjunct treatment for obesity. Examples include
weights, dumbbells, straps, and adaptive hand mitts.
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in Subpart E of Part
807. The device also is exempt from the current good manufacturing
practice regulations in Part 820, with the exemption of 820.180, with
respect to general requirements concerning records, and 820.198, with
respect to complaint files.
21 CFR 890.5360 Measuring exercise equipment.
(a) Identification. Measuring exercise equipment consist of manual
devices intended for medical purposes, such as to redevelop muscles or
restore motion to joints or for use as an adjunct treatment for obesity.
These devices also include instrumentation, such as the pulse rate
monitor, that provide information used for physical evaluation and
physical planning purposes., Examples include a therapeutic exercise
bicycle with measuring instrumentation, a manually propelled treadmill
with measuring instrumentation, and a rowing machine with measuring
instrumentation.
(b) Classification. Class II (performance standards).
21 CFR 890.5370 Nonmeasuring exercise equipment.
(a) Identification. Nonmeasuring exercise equipment consist of
devices intended for medical purposes, such as to redevelop muscles or
restore motion to joints or for use as an adjunct treatment for obesity.
Examples include a prone scooter board, parallel bars, a mechanical
treadmill, an exercise table, and a manually propelled exercise bicycle.
(b) Classification. Class I (general controls). The devices are
exempt from the premarket notification procedures in Subpart E of Part
807. The devices also are exempt from the current good manufacturing
practice regulations in Part 820, with the exception of 820.180, with
respect to general requirements concerning records, and 820.198, with
respect to complaint files.
21 CFR 890.5380 Powered exercise equipment.
(a) Identification. Powered exercise equipment consist of powered
devices intended for medical purposes, such as to redevelop muscles or
restore motion to joints or for use as an adjunct treatment for obesity.
Examples include a powered treadmill, a powered bicycle, and powered
parallel bars.
(b) Classification. Class II (performance standards).
21 CFR 890.5410 Powered finger exerciser.
(a) Identification. A powered finger exerciser is a device intended
for medical purposes to increase flexion and the extension range of
motion of the joints of the second to the fifth fingers of the hand.
(b) Classification. Class II (performance standards).
21 CFR 890.5500 Infrared lamp.
(a)Identification. An infrared lamp is a device intended for medical
purposes that emits energy at infrared frequencies (approximately 700
nanometers to 50,000 nanometers) to provide topical heating.
(b) Classification. Class II (performance standards).
21 CFR 890.5525 Iontophoresis device.
(a) Iontophoresis device intended for certain specified uses -- (1)
Identification. An iontophoresis device is a device that is intended to
use a direct current to introduce ions of soluble salts or other drugs
into the body and induce sweating for use in the diagnosis of cystic
fibrosis or for other uses if the labeling of the drug intended for use
with the device bears adequate directions for the device's use with that
drug. When used in the diagnosis of cystic fibrosis, the sweat is
collected and its composition and weight are determined.
(2) Classification. Class II (performance standards).
(b) Iontophoresis device intended for any other purposes -- (1)
Identification. An iontophoresis device is a device that is intended to
use a direct current to introduce ions of soluble salts or other drugs
into the body for medical purposes other than those specified in
paragraph (a) of this section.
(2) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval for the device described in paragraph (b)(1). See 890.3.
(48 FR 53047, Nov. 23, 1983, as amended at 52 FR 17742, May 11, 1987)
21 CFR 890.5575 Powered external limb overload warning device.
(a) Identification. A powered external limb overload warning device
is a device intended for medical purposes to warn a patient of an
overload or an underload in the amount of pressure placed on a leg.
(b) Classification. Class II (performance standards).
21 CFR 890.5650 Powered inflatable tube massager.
(a) Identification. A powered inflatable tube massager is a powered
device intended for medical purposes, such as to relieve minor muscle
aches and pains and to increase circulation. It simulates kneading and
stroking of tissues with the hands by use of an inflatable pressure
cuff.
(b) Classification. Class II (performance standards).
21 CFR 890.5660 Therapeutic massager.
(a) Identification. A therapeutic massager is an electrically
powered device intended for medical purposes, such as to relieve minor
muscle aches and pains.
(b) Classification. Class II (performance standards).
21 CFR 890.5700 Cold pack.
(a) Identification. A cold pack is a device intended for medical
purposes that consists of a compact fabric envelope containing a
specially hydrated pliable silicate gel capable of forming to the
contour of the body and that provides cold therapy for body surfaces.
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in Subpart E of Part
807. The device also is exempt from the current good manufacturing
practice regulations in Part 820, with the exception of 820.180, with
respect to general requirements concerning records, and 820.198, with
respect to complaint files.
21 CFR 890.5710 Hot or cold disposable pack.
(a) Identification. A hot or cold disposable pack is a device
intended for medical purposes that consists of a sealed plastic bag
incorporating chemicals that, upon activation, provides hot or cold
therapy for body surfaces.
(b) Classification. Class I (general controls).
21 CFR 890.5720 Water circulating hot or cold pack.
(a) Identification. A water circulating hot or cold pack is a device
intended for medical purposes that operates by pumping heated or chilled
water through a plastic bag and that provides hot or cold therapy for
body surfaces.
(b) Classification. Class II (performance standards).
21 CFR 890.5730 Moist heat pack.
(a) Identification. A moist heat pack is a device intended for
medical purposes that consists of silica gel in a fabric container used
to retain an elevated temperature and that provides moist heat therapy
for body surfaces.
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in Subpart E of Part
807. The device also is exempt from the current good manufacturing
practice regulations in Part 820, with the exception of 820.180, with
respect to general requirements concerning records, and 820.198, with
respect to complaint files.
21 CFR 890.5740 Powered heating pad.
(a) Identification. A powered heating pad is an electrical device
intended for medical purposes that provides dry heat therapy for body
surfaces. It is capable of maintaining an elevated temperature during
use.
(b) Classification. Class II (performance standards).
21 CFR 890.5765 Presssure-applying device.
(a) Identification. A presssure-applying device is a device intended
for medical purposes to apply continuous pressure to the paravertebral
tissues for muscular relaxation and neuro-inhibition. It consists of a
table with an adjustable overhead weight that, in place of the
therapist's hands, presses on the back of a prone patient.
(b) Classification. Class I (general controls).
21 CFR 890.5850 Powered muscle stimulator.
(a) Identification. A powered muscle stimulator is an electrically
powered device intended for medical purposes that repeatedly contracts
muscles by passing electrical currents through electrodes contacting the
affected body area.
(b) Classification. Class II (performance standards).
21 CFR 890.5860 Ultrasound and muscle stimulator.
(a) Ultrasound and muscle stimulator for use in applying therapeutic
deep heat for selected medical conditions -- (1) Identification. An
ultrasound and muscle stimulator for use in applying therapeutic deep
heat for selected medical conditions is a device that applies to
specific areas of the body ultrasonic energy at a frequency beyond 20
kilohertz and that is intended to generate deep heat within body tissues
for the treatment of selected medical conditions such as relief of pain,
muscle spasms, and joint contractures, but not for the treatment of
malignancies. The device also passes electrical currents through the
body area to stimulate or relax muscles.
(2) Classification. Class II (performance standards).
(b) Ultrasound and muscle stimulator for all other uses -- (1)
Identification. An ultrasound and muscle stimulator for all other uses
except for the treatment of malignancies is a device that applies to the
body ultrasonic energy at a frequency beyond 20 kilohertz and applies to
the body electrical currents and that is intended for the treatment of
medical conditions by means other than the generation of deep heat
within body tissues and the stimulation or relaxation of muscles as
described in paragraph (a) of this section.
(2) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval for the device described in paragraph (b)(1). See 890.3.
(48 FR 53047, Nov. 23, 1983, as amended at 52 FR 17742, May 11, 1987)
21 CFR 890.5880 Multi-function physical therapy table.
(a) Identification. A multi-function physical therapy table is a
device intended for medical purposes that consists of a motorized table
equipped to provide patients with heat, traction, and muscle relaxation
therapy.
(b) Classification. Class II (performance standards).
21 CFR 890.5900 Power traction equipment.
(a) Identification. Powered traction equipment consists of powered
devices intended for medical purposes for use in conjunction with
traction accessories, such as belts and harnesses, to exert therapeutic
pulling forces on the patient's body.
(b) Classification. Class II (performance standards).
21 CFR 890.5925 Traction accessory.
(a) Identification. A traction accessory is a nonpowered accessory
device intended for medical purposes to be used with powered traction
equipment to aid in exerting therapeutic pulling forces on the patient's
body. This generic type of device includes the pulley, strap, head
halter, and pelvic belt.
(b) Classification. Class I (general controls). The device is
exempt from the current good manufacturing practice regulations in Part
820, with the exception of 820.180, with respect to general
requirements concerning records, and 820.198, with respect to complaint
files.
21 CFR 890.5940 Chilling unit.
(a) Identification. A chilling unit is a refrigerative device
intended for medical purposes to chill and maintain cold packs at a
reduced temperature.
(b) Classification. Class II (performance standards).
21 CFR 890.5950 Powered heating unit.
(a) Identification. A powered heating unit is a device intended for
medical purposes that consists of an encased cabinet containing hot
water and that is intended to heat and maintain hot packs at an elevated
temperature.
(b) Classification. Class II (performance standards).
21 CFR 890.5975 Therapeutic vibrator.
(a) Identification. A therapeutic vibrator is an electrically
powered device intended for medical purposes that incorporates various
kinds of pads and that is held in the hand or attached to the hand or to
a table. It is intended for various uses, such as relaxing muscles and
relieving minor aches and pains.
(b) Classification. Class II (performance standards).
21 CFR 890.5975 Pt. 892
21 CFR 890.5975 PART 892 -- RADIOLOGY DEVICES
21 CFR 890.5975 Subpart A -- General Provisions
Sec.
892.1 Scope.
892.3 Effective dates of requirement for premarket approval.
892.9 Limitations of exemptions from section 510(k) of the Federal
Food, Drug, and Cosmetic Act (the act).
21 CFR 890.5975 Subpart B -- Diagnostic Devices
892.1000 Magnetic resonance diagnostic device.
892.1100 Scintillation (gamma) camera.
892.1110 Positron camera.
892.1130 Nuclear whole body counter.
892.1170 Bone densitometer.
892.1200 Emission computed tomography system.
892.1220 Fluorescent scanner.
892.1300 Nuclear rectilinear scanner.
892.1310 Nuclear tomography system.
892.1320 Nuclear uptake probe.
892.1330 Nuclear whole body scanner.
892.1350 Nuclear scanning bed.
892.1360 Radionuclide dose calibrator.
892.1370 Nuclear anthropomorphic phantom.
892.1380 Nuclear flood source phantom.
892.1390 Radionuclide rebreathing system.
892.1400 Nuclear sealed calibration source.
892.1410 Nuclear electrocardiograph synchronizer.
892.1420 Radionuclide test pattern phantom.
892.1540 Nonfetal ultrasonic monitor.
892.1550 Ultrasonic pulsed doppler imaging system.
892.1560 Ultrasonic pulsed echo imaging system.
892.1570 Diagnostic ultrasonic transducer.
892.1600 Angiographic X-ray system.
892.1610 Diagnostic X-ray beam-limiting device.
892.1620 Cine or spot fluorographic X-ray camera.
892.1630 Electrostatic X-ray imaging system.
892.1640 Radiographic film marking system.
892.1650 Image-intensified fluoroscopic X-ray system.
892.1660 Non-image-intensified fluoroscopic X-ray system.
892.1670 Spot-film device.
892.1680 Stationary X-ray system.
892.1700 Diagnostic X-ray high voltage generator.
892.1710 Mammographic X-ray system.
892.1720 Mobile X-ray system.
892.1730 Photofluorographic X-ray system.
892.1740 Tomographic X-ray system.
892.1750 Computed tomography X-ray system.
892.1760 Diagnostic X-ray tube housing assembly.
892.1770 Diagnostic X-ray tube mount.
892.1820 Pneumoencephalographic chair.
892.1830 Radiologic patient cradle.
892.1840 Radiographic film.
892.1850 Radiographic film cassette.
892.1860 Radiographic film/cassette changer.
892.1870 Radiographic film/cassette changer programmer.
892.1880 Wall-mounted radiographic cassette holder.
892.1890 Radiographic film illuminator.
892.1900 Automatic radiographic film processor.
892.1910 Radiographic grid.
892.1920 Radiographic head holder.
892.1940 Radiologic quality assurance instrument.
892.1950 Radiographic anthropomorphic phantom.
892.1960 Radiographic intensifying screen.
892.1970 Radiographic ECG/respirator synchronizer.
892.1980 Radiologic table.
21 CFR 890.5975 Subparts C-E -- (Reserved)
21 CFR 890.5975 Subpart F -- Therapeutic Devices
892.5050 Medical charged-particle radiation therapy system.
892.5300 Medical neutron radiation therapy system.
892.5650 Manual radionuclide applicator system.
892.5700 Remote controlled radionuclide applicator system.
892.5710 Radiation therapy beam-shaping block.
892.5730 Radionuclide brachytherapy source.
892.5740 Radionuclide teletherapy source.
892.5750 Radionuclide radiation therapy system.
892.5770 Powered radiation therapy patient support assembly.
892.5780 Light beam patient position indicator.
892.5840 Radiation therapy simulation system.
892.5900 X-ray radiation therapy system.
892.5930 Therapeutic X-ray tube housing assembly.
21 CFR 890.5975 Subpart G -- Miscellaneous Devices
892.6500 Personnel protective shield.
Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j, 371).
Source: 53 FR 1567, Jan. 20, 1988, unless otherwise noted.
21 CFR 890.5975 Subpart A -- General Provisions
21 CFR 892.1 Scope.
(a) This part sets forth the classification of radiology devices
intended for human use that are in commercial distribution.
(b) The identification of a device in a regulation in this part is
not a precise description of every device that is, or will be, subject
to the regulation. A manufacturer who submits a premarket notification
submission for a device under Part 807 cannot show merely that the
device is accurately described by the section title and identification
provision of a regulation in this part but shall state why the device is
substantially equivalent to other devices, as required by 807.87.
(c) To avoid duplicative listings, a radiology device that has two or
more types of uses (e.g., use both as a diagnostic device and a
therapeutic device) is listed in one subpart only.
(d) References in this part to regulatory sections of the Code of
Federal Regulations are to Chapter I of this Title 21, unless otherwise
noted.
21 CFR 892.3 Effective dates of requirement for premarket approval.
A device included in this part that is classified into class III
(premarket approval) shall not be commercially distributed after the
date shown in the regulation classifying the device unless the
manufacturer has an approval under section 515 of the act (unless an
exemption has been granted under section 520(g)(2) of the act). An
approval under section 515 of the act consists of FDA's issuance of an
order approving an application for premarket approval (PMA) for the
device or declaring completed a product development protocol (PDP) for
the device.
(a) Before FDA requires that a device commercially distributed before
the enactment date of the amendments, or a device that has been found
substantially equivalent to such a device, has an approval under section
515 of the act, FDA must promulgate a regulation under section 515(b) of
the act requiring such approval, except as provided in paragraph (b) of
this section. Such a regulation under section 515(b) of the act shall
not be effective during the grace period ending on the 90th day after
its promulgation or on the last day of the 30th full calendar month
after the regulation that classifies the device into class III is
effective, whichever is later. See section 501(f)(2)(B) of the act.
Accordingly, unless an effective date of the requirement for premarket
approval is shown in the regulation for a device classified into class
III in this part, the device may be commercially distributed without
FDA's issuance of an order approving a PMA or declaring completed a PDP
for the device. If FDA promulgates a regulation under section 515(b) of
the act requiring premarket approval for a device, section 501(f)(1)(A)
of the act applies to the device.
(b) Any new, not substantially equivalent, device introduced into
commercial distribution on or after May 28, 1976, including a device
formerly marketed that has been substantially altered, is classified by
statute (section 513(f) of the act) into class III without any grace
period and FDA must have issued an order approving a PMA or declaring
completed a PDP for the device before the device is commercially
distributed unless it is reclassified. If FDA knows that a device being
commerically distributed may be a ''new'' device as defined in this
section because of any new intended use or other reasons, FDA may codify
the statutory classification of the device into class III for such new
use. Accordingly, the regulation for such a class III device states
that as of the enactment date of the amendments, May 28, 1976, the
device must have an approval under section 515 of the act before
commercial distribution.
21 CFR 892.9 Limitations of exemptions from section 510(k) of the
Federal Food, Drug, and Cosmetic Act (the act).
The Food and Drug Administration's (FDA's) decision to grant an
exemption from the requirement of premarket notification (section 510(k)
of the act) for a generic type of class I device is based upon the
existing and reasonably foreseeable characteristics of commercially
distributed devices within that generic type. Because FDA cannot
anticipate every change in intended use or characteristic that could
significantly affect a device's safety or effectiveness, manufacturers
of any commercially distributed class I device for which FDA has granted
an exemption from the requirement of premarket notification must still
submit a premarket notification to FDA before introducing or delivering
for introduction into interstate commerce for commercial distribution
the device when:
(a) The device is intended for a use different from its intended use
before May 28, 1976, or the device is intended for a use different from
the intended use of a preamendments device to which it had been
determined to be substantially equivalent; e.g., the device is intended
for a different medical purpose, or the device is intended for lay use
where the former intended use was by health care professionals only; or
(b) The modified device operates using a different fundamental
scientific technology than that in use in the device before May 28,
1976; e.g., a surgical instrument cuts tissue with a laser beam rather
than with a sharpened metal blade, or an in vitro diagnostic device
detects or identifies infectious agents by using a deoxyribonucleic acid
(DNA) probe or nucleic acid hybridization technology rather than culture
or immunoassay technology.
(54 FR 13831, Apr. 5, 1989)
21 CFR 892.9 Subpart B -- Diagnostic Devices
21 CFR 892.1000 Magnetic resonance diagnostic device.
(a) Identification. A magnetic resonance diagnostic device is
intended for general diagnostic use to present images which reflect the
spatial distribution and/or magnetic resonance spectra which reflect
frequency and distribution of nuclei exhibiting nuclear magnetic
resonance. Other physical parameters derived from the images and/or
spectra may also be produced. The device includes hydrogen-1 (proton)
imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31
spectroscopy, and chemical shift imaging (preserving simultaneous
frequency and spatial information).
(b) Classification. Class II.
(53 FR 5078, Feb. 1, 1989)
21 CFR 892.1100 Scintillation (gamma) camera.
(a) Identification. A scintillation (gamma) camera is a device
intended to image the distribution of radionuclides in the body by means
of a photon radiation detector. This generic type of device may include
signal analysis and display equipment, patient and equipment supports,
radionuclide anatomical markers, component parts, and accessories.
(b) Classification. Class I.
(55 FR 48443, Nov. 20, 1990)
21 CFR 892.1110 Positron camera.
(a) Identification. A positron camera is a device intended to image
the distribution of positron-emitting radionuclides in the body. This
generic type of device may include signal analysis and display
equipment, patient and equipment supports, radionuclide anatomical
markers, component parts, and accessories.
(b) Classification. Class I.
(55 FR 48444, Nov. 20, 1990)
21 CFR 892.1130 Nuclear whole body counter.
(a) Identification. A nuclear whole body counter is a device
intended to measure the amount of radionuclides in the entire body.
This generic type of device may include signal analysis and display
equipment, patient and equipment supports, component parts, and
accessories.
(b) Classification. Class I.
(55 FR 48444, Nov. 20, 1990)
21 CFR 892.1170 Bone densitometer.
(a) Identification. A bone densitometer is a device intended for
medical purposes to measure bone density and mineral content by X-ray or
gamma ray transmission measurements through the bone and adjacent
tissues. This generic type of device may include signal analysis and
display equipment, patient and equipment supports, component parts, and
accessories.
(b) Classification. Class II.
21 CFR 892.1200 Emission computed tomography system.
(a) Identification. An emission computed tomography system is a
device intended to detect the location and distribution of gamma ray-
and positron-emitting radionuclides in the body and produce
cross-sectional images through computer reconstruction of the data.
This generic type of device may include signal analysis and display
equipment, patient and equipment supports, radionuclide anatomical
markers, component parts, and accessories.
(b) Classification. Class II.
21 CFR 892.1220 Fluorescent scanner.
(a) Identification. A fluorescent scanner is a device intended to
measure the induced fluorescent radiation in the body by exposing the
body to certain X-rays or low-energy gamma rays. This generic type of
device may include signal analysis and display equipment, patient and
equipment supports, component parts and accessories.
(b) Classification. Class II.
21 CFR 892.1300 Nuclear rectilinear scanner.
(a) Identification. A nuclear rectilinear scanner is a device
intended to image the distribution of radionuclides in the body by means
of a detector (or detectors) whose position moves in two directions with
respect to the patient. This generic type of device may include signal
analysis and display equipment, patient and equipment supports,
radionuclide anatomical markers, component parts, and accessories.
(b) Classification. Class I.
(55 FR 48444, Nov. 20, 1990)
21 CFR 892.1310 Nuclear tomography system.
(a) Identification. A nuclear tomography system is a device intended
to detect nuclear radiation in the body and produce images of a specific
cross-sectional plane of the body by blurring or eliminating detail from
other planes. This generic type of devices may include signal analysis
and display equipment, patient and equipment supports, radionuclide
anatomical markers, component parts, and accessories.
(b) Classification. Class II.
21 CFR 892.1320 Nuclear uptake probe.
(a) Identification. A nuclear uptake probe is a device intended to
measure the amount of radionuclide taken up by a particular organ or
body region. This generic type of device may include a single or
multiple detector probe, signal analysis and display equipment, patient
and equipment supports, component parts, and accessories.
(b) Classification. Class I.
(55 FR 48444, Nov. 20, 1990)
21 CFR 892.1330 Nuclear whole body scanner.
(a) Identification. A nuclear whole body scanner is a device
intended to measure and image the distribution of radionuclides in the
body by means of a wide-aperture detector whose position moves in one
direction with respect to the patient. This generic type of device may
include signal analysis and display equipment, patient and equipment
supports, radionuclide anatomical markers, component parts, and
accessories.
(b) Classification. Class I.
(55 FR 48444, Nov. 20, 1990)
21 CFR 892.1350 Nuclear scanning bed.
(a) Identification. A nuclear scanning bed is an adjustable bed
intended to support a patient during a nuclear medicine procedure.
(b) Classification. Class I.
(55 FR 48444, Nov. 20, 1990)
21 CFR 892.1360 Radionuclide dose calibrator.
(a) Identification. A radionuclide dose calibrator is a radiation
detection device intended to assay radionuclides before their
administration to patients.
(b) Classification. Class II.
21 CFR 892.1370 Nuclear anthropomorphic phantom.
(a) Identification. A nuclear anthropomorphic phantom is a human
tissue facsimile that contains a radioactive source or a cavity in which
a radioactive sample can be inserted. It is intended to calibrate
nuclear uptake probes or other medical instruments.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(53 FR 1567, Jan. 20, 1988, as amended at 54 FR 13832, Apr. 5, 1989)
21 CFR 892.1380 Nuclear flood source phantom.
(a) Identification. A nuclear flood source phantom is a device that
consists of a radiolucent container filled with a uniformly distributed
solution of a desired radionuclide. It is intended to calibrate a
medical gamma camera-collimator system for uniformity of response.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(53 FR 1567, Jan. 20, 1988, as amended at 54 FR 13832, Apr. 5, 1989)
21 CFR 892.1390 Radionuclide rebreathing system.
(a) Identification. A radionuclide rebreathing system is a device
intended to be used to contain a gaseous or volatile radionuclide or a
radionuclide-labeled aerosol and permit it to be respired by the patient
during nuclear medicine ventilatory tests (testing process of exchange
between the lungs and the atmosphere). This generic type of device may
include signal analysis and display equipment, patient and equipment
supports, component parts, and accessories.
(b) Classification. Class II.
21 CFR 892.1400 Nuclear sealed calibration source.
(a) Identification. A nuclear sealed calibration source is a device
that consists of an encapsulated reference radionuclide intended for
calibration of medical nuclear radiation detectors.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(53 FR 1567, Jan. 20, 1988, as amended at 54 FR 13832, Apr. 5, 1989)
21 CFR 892.1410 Nuclear electrocardiograph synchronizer.
(a) Identification. A nuclear electrocardiograph synchronizer is a
device intended for use in nuclear radiology to relate the time of image
formation to the cardiac cycle during the production of dynamic cardiac
images.
(b) Classification. Class I.
(55 FR 48444, Nov. 20, 1990)
21 CFR 892.1420 Radionuclide test pattern phantom.
(a) Identification. A radionuclide test pattern phantom is a device
that consists of an arrangement of radiopaque or radioactive material
sealed in a solid pattern intended to serve as a test for a performance
characteristic of a nuclear medicine imaging device.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807 of this
chapter.
(53 FR 1567, Jan. 20, 1988, as amended at 54 FR 13832, Apr. 5, 1989)
21 CFR 892.1540 Nonfetal ultrasonic monitor.
(a) Identification. A nonfetal ultrasonic monitor is a device that
projects a continuous high-frequency sound wave into body tissue other
than a fetus to determine frequency changes (doppler shift) in the
reflected wave and is intended for use in the investigation of nonfetal
blood flow and other nonfetal body tissues in motion. This generic type
of device may include signal analysis and display equipment, patient and
equipment supports, component parts, and accessories.
(b) Classification. Class II.
21 CFR 892.1550 Ultrasonic pulsed doppler imaging system.
(a) Identification. An ultrasonic pulsed doppler imaging system is a
device that combines the features of continuous wave doppler-effect
technology with pulsed-echo effect technology and is intended to
determine stationary body tissue characteristics, such as depth or
location of tissue interfaces or dynamic tissue characteristics such as
velocity of blood or tissue motion. This generic type of device may
include signal analysis and display equipment, patient and equipment
supports, component parts, and accessories.
(b) Classification. Class II.
21 CFR 892.1560 Ultrasonic pulsed echo imaging system.
(a) Identification. An ultrasonic pulsed echo imaging system is a
device intended to project a pulsed sound beam into body tissue to
determine the depth or location of the tissue interfaces and to measure
the duration of an acoustic pulse from the transmitter to the tissue
interface and back to the receiver. This generic type of device may
include signal analysis and display equipment, patient and equipment
supports, component parts, and accessories.
(b) Classification. Class II.
21 CFR 892.1570 Diagnostic ultrasonic transducer.
(a) Identification. A diagnostic ultrasonic transducer is a device
made of a piezoelectric material that converts electrical signals into
acoustic signals and acoustic signals into electrical signals and
intended for use in diagnostic ultrasonic medical devices. Accessories
of this generic type of device may include transmission media for
acoustically coupling the transducer to the body surface, such as
acoustic gel, paste, or a flexible fluid container.
(b) Classification. Class II.
21 CFR 892.1600 Angiographic X-ray system.
(a) Identification. An angiographic X-ray system is a device
intended for radiologic visualization of the heart, blood vessels, or
lymphatic system during or after injection of a contrast medium. This
generic type of device may include signal analysis and display
equipment, patient and equipment supports, component parts, and
accessories.
(b) Classification. Class II.
21 CFR 892.1610 Diagnostic X-ray beam-limiting device.
(a) Identification. A diagnostic X-ray beam-limiting device is a
device such as a collimator, a cone, or an aperture intended to restrict
the dimensions of a diagnostic X-ray field by limiting the size of the
primary X-ray beam.
(b) Classification. Class II.
21 CFR 892.1620 Cine or spot fluorographic X-ray camera.
(a) Identification. A cine or spot fluorographic X-ray camera is a
device intended to photograph diagnostic images produced by X-rays with
an image intensifier.
(b) Classification. Class II.
21 CFR 892.1630 Electrostatic X-ray imaging system.
(a) Identification. An electrostatic X-ray imaging system is a
device intended for medical purposes that uses an electrostatic field
across a semiconductive plate, a gas-filled chamber, or other similar
device to convert a pattern of X-radiation into an electrostatic image
and, subsequently, into a visible image. This generic type of device
may include signal analysis and display equipment, patient and equipment
supports, component parts, and accessories.
(b) Classification. Class II.
21 CFR 892.1640 Radiographic film marking system.
(a) Identification. A radiographic film marking system is a device
intended for medical purposes to add identification and other
information onto radiographic film by means of exposure to visible
light.
(b) Classification. Class I.
(55 FR 48444, Nov. 20, 1990)
21 CFR 892.1650 Image-intensified fluoroscopic X-ray system.
(a) Identification. An image-intensified fluoroscopic X-ray system
is a device intended to visualize anatomical structures by converting a
pattern of X-radiation into a visible image through electronic
amplification. This generic type of device may include signal analysis
and display equipment, patient and equipment supports, component parts,
and accessories.
(b) Classification. Class II.
21 CFR 892.1660 Non-image-intensified fluoroscopic X-ray system.
(a) Identification. A non-image-intensified fluoroscopic X-ray
system is a device intended to be used to visualize anatomical
structures by using a fluorescent screen to convert a pattern of
X-radiation into a visible image. This generic type of device may
include signal analysis and display equipment, patient and equipment
supports, component parts, and accessories.
(b) Classification. Class II.
21 CFR 892.1670 Spot-film device.
(a) Identification. A spot-film device is an electromechanical
component of a fluoroscopic X-ray system that is intended to be used for
medical purposes to position a radiographic film cassette to obtain
radiographs during fluoroscopy.
(b) Classification. Class II.
21 CFR 892.1680 Stationary X-ray system.
(a) Identification. A stationary X-ray system is a permanently
installed diagnostic system intended to generate and control X-rays for
examination of various anatomical regions. This generic type of device
may include signal analysis and display equipment, patient and equipment
supports, component parts, and accessories.
(b) Classification. Class II.
21 CFR 892.1700 Diagnostic X-ray high voltage generator.
(a) Identification. A diagnostic X-ray high voltage generator is a
device that is intended to supply and control the electrical energy
applied to a diagnostic X-ray tube for medical purposes. This generic
type of device may include a converter that changes alternating current
to direct current, filament transformers for the X-ray tube, high
voltage switches, electrical protective devices, or other appropriate
elements.
(b) Classification. Class II.
21 CFR 892.1710 Mammographic X-ray system.
(a) Identification. A mammographic X-ray system is a device intended
to be used to produce radiographs of the breast. This generic type of
device may include signal analysis and display equipment, patient and
equipment supports, component parts, and accessories.
(b) Classification. Class II.
21 CFR 892.1720 Mobile X-ray system.
(a) Identification. A mobile X-ray system is a transportable device
system intended to be used to generate and control X-ray for diagnostic
procedures. This generic type of device may include signal analysis and
display equipment, patient and equipment supports, component parts, and
accessories.
(b) Classification. Class II.
21 CFR 892.1730 Photofluorographic X-ray system.
(a) Identification. A photofluorographic X-ray system is a device
that includes a fluoroscopic X-ray unit and a camera intended to be used
to produce, then photograph, a fluoroscopic image of the body. This
generic type of device may include signal analysis and display
equipment, patient and equipment supports, component parts, and
accessories.
(b) Classification. Class II.
21 CFR 892.1740 Tomographic X-ray system.
(a) Identification. A tomographic X-ray system is an X-ray device
intended to be used to produce radiologic images of a specific
cross-sectional plane of the body by blurring or eliminating detail from
other planes. This generic type of device may include signal analysis
and display equipment, patient and equipment supports, component parts,
and accessories.
(b) Classification. Class II.
21 CFR 892.1750 Computed tomography X-ray system.
(a) Identification. A computed tomography X-ray system is a
diagnostic X-ray system intended to produce cross-sectional images of
the body by computer reconstruction of X-ray transmission data from the
same axial plane taken at different angles. This generic type of device
may include signal analysis and display equipment, patient and equipment
supports, component parts, and accessories.
(b) Classification. Class II.
21 CFR 892.1760 Diagnostic X-ray tube housing assembly.
(a) Identification. A diagnostic X-ray tube housing assembly is an
X-ray generating tube encased in a radiation-shielded housing that is
intended for diagnostic purposes. This generic type of device may
include high voltage and filament transformers or other appropriate
components.
(b) Classification. Class II.
21 CFR 892.1770 Diagnostic X-ray tube mount.
(a) Identification. A diagnostic X-ray tube mount is a device
intended to support and to position the diagnostic X-ray tube housing
assembly for a medical radiographic procedure.
(b) Classification. Class II.
21 CFR 892.1820 Pneumoencephalographic chair.
(a) Identification. A pneumoencephalographic chair is a chair
intended to support and position a patient during pneumoencephalography
(X-ray imaging of the brain).
(b) Classification. Class II.
21 CFR 892.1830 Radiologic patient cradle.
(a) Identification. A radiologic patient cradle is a support device
intended to be used for rotational positioning about the longitudinal
axis of a patient during radiologic procedures.
(b) Classification. Class II.
21 CFR 892.1840 Radiographic film.
(a) Identification. Radiographic film is a device that consists of a
thin sheet of radiotransparent material coated on one or both sides with
a photographic emulsion intended to record images during diagnostic
radiologic procedures.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807.
21 CFR 892.1850 Radiographic film cassette.
(a) Identification. A radiographic film cassette is a device
intended for use during diagnostic X-ray procedures to hold a
radiographic film in close contact with an X-ray intensifying screen and
to provide a light-proof enclosure for direct exposure of radiographic
film.
(b) Classification. Class II.
21 CFR 892.1860 Radiographic film/cassette changer.
(a) Identification. A radiographic film/cassette changer is a device
intended to be used during a radiologic procedure to move a radiographic
film or cassette between X-ray exposures and to position it during the
exposure.
(b) Classification. Class II.
21 CFR 892.1870 Radiographic film/cassette changer programmer.
(a) Identification. A radiographic film/cassette changer programmer
is a device intended to be used to control the operations of a film or
cassette changer during serial medical radiography.
(b) Classification. Class II.
21 CFR 892.1880 Wall-mounted radiographic cassette holder.
(a) Identification. A wall-mounted radiographic cassette holder is a
device that is a support intended to hold and position radiographic
cassettes for a radiographic exposure for medical use.
(b) Classification. Class II.
21 CFR 892.1890 Radiographic film illuminator.
(a) Identification. A radiographic film illuminator is a device
containing a visible light source covered with a translucent front that
is intended to be used to view medical radiographs.
(b) Classification. Class I.
(55 FR 48444, Nov. 20, 1990)
21 CFR 892.1900 Automatic radiographic film processor.
(a) Identification. An automatic radiographic film processor is a
device intended to be used to develop, fix, wash, and dry automatically
and continuously film exposed for medical purposes.
(b) Classification. Class II.
(55 FR 48444, Nov. 20, 1990)
21 CFR 892.1910 Radiographic grid.
(a) Identification. A radiographic grid is a device that consists of
alternating radiolucent and radiopaque strips intended to be placed
between the patient and the image receptor to reduce the amount of
scattered radiation reaching the image receptor.
(b) Classification. Class I.
21 CFR 892.1920 Radiographic head holder.
(a) Identification. A radiographic head holder is a device intended
to position the patient's head during a radiographic procedure.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807. The device
is exempt from the current good manufacturing practice regulations in
Part 820, with the exception of 820.180, with respect to general
requirements concerning records, and 820.198, with respect to complaint
files.
21 CFR 892.1940 Radiologic quality assurance instrument.
(a) Identification. A radiologic quality assurance instrument is a
device intended for medical purposes to measure a physical
characteristic associated with another radiologic device.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807. The device
is exempt from the current good manufacturing practice regulations in
Part 820, with the exception of 820.180, with respect to general
requirements concerning records, and 820.198, with respect to complaint
files.
21 CFR 892.1950 Radiographic anthropomorphic phantom.
(a) Identification. A radiographic anthropomorphic phantom is a
device intended for medical purposes to simulate a human body for
positioning radiographic equipment.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in Subpart E of Part 807. The device
is exempt from the current good manufacturing practice regulations in
Part 820, with the exception of 820.180, with respect to general
requirements concerning records, and 820.198, with respect to complaint
files.
21 CFR 892.1960 Radiographic intensifying screen.
(a) Identification. A radiographic intensifying screen is a device
that is a thin radiolucent sheet coated with a luminescent material that
transforms incident X-ray photons into visible light and intended for
medical purposes to expose radiographic film.
(b) Classification. Class I.
21 CFR 892.1970 Radiographic ECG/respirator synchronizer.
(a) Identification. A radiographic ECG/respirator synchronizer is a
device intended to be used to coordinate an X-ray film exposure with the
signal from an electrocardiograph (ECG) or respirator at a predetermined
phase of the cardiac or respiratory cycle.
(b) Classification. Class I.
(55 FR 48444, Nov. 20, 1990)
21 CFR 892.1980 Radiologic table.
(a) Identification. A radiologic table is a device intended for
medical purposes to support a patient during radiologic procedures. The
table may be fixed or tilting and may be electrically powered.
(b) Classification. Class II.
21 CFR 892.1980 Subparts C-E -- (Reserved)
21 CFR 892.1980 Subpart F -- Therapeutic Devices
21 CFR 892.5050 Medical charged-particle radiation therapy system.
(a) Identification. A medical charged-particle radiation therapy
system is a device that produces by acceleration high energy charged
particles (e.g., electrons and protons) intended for use in radiation
therapy. This generic type of device may include signal analysis and
display equipment, patient and equipment supports, treatment planning
computer programs, component parts, and accessories.
(b) Classification. Class II.
21 CFR 892.5300 Medical neutron radiation therapy system.
(a) Identification. A medical neutron radiation therapy system is a
device intended to generate high-energy neutrons for radiation therapy.
This generic type of device may include signal analysis and display
equipment, patient and equipment support, treatment planning computer
programs, component parts, and accessories.
(b) Classification. Class II.
21 CFR 892.5650 Manual radionuclide applicator system.
(a) Identification. A manual radionuclide applicator system is a
manually operated device intended to apply a radionuclide source into
the body or to the surface of the body for radiation therapy. This
generic type of device may include patient and equipment supports,
component parts, treatment planning computer programs, and accessories.
(b) Classification. Class I.
21 CFR 892.5700 Remote controlled radionuclide applicator system.
(a) Identification. A remote controlled radionuclide applicator
system is an electromechanical or pneumatic device intended to enable an
operator to apply, by remote control, a radionuclide source into the
body or to the surface of the body for radiation therapy. This generic
type of device may include patient and equipment supports, component
parts, treatment planning computer programs, and accessories.
(b) Classification. Class II.
21 CFR 892.5710 Radiation therapy beam-shaping block.
(a) Identification. A radiation therapy beam-shaping block is a
device made of a highly attenuating material (such as lead) intended for
medical purposes to modify the shape of a beam from a radiation therapy
source.
(b) Classification. Class II.
21 CFR 892.5730 Radionuclide brachytherapy source.
(a) Identification. A radionuclide brachytherapy source is a device
that consists of a radionuclide which may be enclosed in a sealed
container made of gold, titanium, stainless steel, or platinum and
intended for medical purposes to be placed onto a body surface or into a
body cavity or tissue as a source of nuclear radiation for therapy.
(b) Classification. Class II.
21 CFR 892.5740 Radionuclide teletherapy source.
(a) Identification. A radionuclide teletherapy source is a device
consisting of a radionuclide enclosed in a sealed container. The device
is intended for radiation therapy, with the radiation source located at
a distance from the patient's body.
(b) Classification. Class I.
21 CFR 892.5750 Radionuclide radiation therapy system.
(a) Identification. A radionuclide radiation therapy system is a
device intended to permit an operator to administer gamma radiation
therapy, with the radiation source located at a distance from the
patient's body. This generic type of device may include signal analysis
and display equipment, patient and equipment supports, treatment
planning computer programs, component parts (including beam-limiting
devices), and accessories.
(b) Classification. Class II.
21 CFR 892.5770 Powered radiation therapy patient support assembly.
(a) Identification. A powered radiation therapy patient support
assembly is an electrically powered adjustable couch intended to support
a patient during radiation therapy.
(b) Classification. Class II.
21 CFR 892.5780 Light beam patient position indicator.
(a) Identification. A light beam patient position indicator is a
device that projects a beam of light (incoherent light or laser) to
determine the alignment of the patient with a radiation beam. The beam
of light is intended to be used during radiologic procedures to ensure
proper positioning of the patient and to monitor alignment of the
radiation beam with the patient's anatomy.
(b) Classification. Class II.
21 CFR 892.5840 Radiation therapy simulation system.
(a) Identification. A radiation therapy simulation system is a
fluoroscopic or radiographic X-ray system intended for use in localizing
the volume to be exposed during radiation therapy and confirming the
position and size of the therapeutic irradiation field produced. This
generic type of device may include signal analysis and display
equipment, patient and equipment supports, treatment planning computer
programs, component parts, and accessories.
(b) Classification. Class II.
21 CFR 892.5900 X-ray radiation therapy system.
(a) Identification. An X-ray radiation therapy system is a device
intended to produce and control X-rays used for radiation therapy. This
generic type of device may include signal analysis and display
equipment, patient and equipment supports, treatment planning computer
programs, component parts, and accessories.
(b) Classification. Class II.
21 CFR 892.5930 Therapeutic X-ray tube housing assembly.
(a) Identification. A therapeutic X-ray tube housing assembly is an
X-ray generating tube encased in a radiation-shielded housing intended
for use in radiation therapy. This generic type of device may include
high-voltage and filament transformers or other appropriate components
when contained in radiation-shielded housing.
(b) Classification. Class II.
21 CFR 892.5930 Subpart G -- Miscellaneous Devices
21 CFR 892.6500 Personnel protective shield.
(a) Identification. A personnel protective shield is a device
intended for medical purposes to protect the patient, the operator, or
other persons from unnecessary exposure to radiation during radiologic
procedures by providing an attenuating barrier to radiation. This
generic type of device may include articles of clothing, furniture, and
movable or stationary structures.
(b) Classification. Class I.
21 CFR 892.6500 PART 895 -- BANNED DEVICES
21 CFR 892.6500 Subpart A -- General Provisions
Sec.
895.1 Scope.
895.20 General.
895.21 Procedures for banning a device.
895.22 Submission of data and information by the manufacturer,
distributor, or importer.
895.25 Labeling.
895.30 Special effective date.
21 CFR 892.6500 Subpart B -- Listing of Banned Devices
895.101 Prosthetic hair fibers.
Authority: Secs. 502, 516, 518, 519, 701 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 352, 360f, 360h, 360i, 371).
Source: 44 FR 29221, May 18, 1979, unless otherwise noted.
21 CFR 892.6500 Subpart A -- General Provisions
21 CFR 895.1 Scope.
(a) This part describes the procedures by which the Commissioner may
institute proceedings to make a device intended for human use that
presents substantial deception or an unreasonable and substantial risk
of illness or injury a banned device.
(b) This part applies to any ''device'', as defined in section 201(h)
of the Federal Food, Drug, and Cosmetic Act (act) that is intended for
human use.
(c) A device that is made a banned device in accordance with this
part is adulterated under section 501(g) of the act. A restricted
device that is banned may also be misbranded under section 502(q) of the
act.
(d) Although this part does not cover devices intended for animal
use, the manufacturer, distributor, importer, or any other person(s)
responsible for the labeling of the device that is banned cannot avoid
the ban by relabeling the device for veterinary use. A device that has
been banned from human use but that also has a valid veterinary use may
be marketed for use as a veterinary device only under the following
conditions: The device shall comply with all requirements applicable to
veterinary devices under the Federal Food, Drug, and Cosmetic Act and
this chapter, and the label for the device shall bear the following
statement: ''For Veterinary Use Only. Caution: Federal law prohibits
the distribution of this device for human use.'' A device so labeled,
however, that is determined by the Food and Drug Administration to be
intended for human use, will be considered to be a banned device. In
determining whether such a device is intended for human use, the Food
and Drug Administration will consider, among other things, the ultimate
destination of the device.
21 CFR 895.20 General.
The Commissioner may initiate a proceeding to make a device a banned
device whenever the Commissioner finds, on the basis of all available
data and information, and after consultation with the appropriate device
panel, that the device presents substantial deception or an unreasonable
and substantial risk of illness or injury that the Commissioner
determines cannot be, or has not been, corrected or eliminated by
labeling or by a change in labeling, or by a change in advertising if
the device is a restricted device.
21 CFR 895.21 Procedures for banning a device.
(a) Before initiating a proceeding to make a device a banned device,
the Commissioner shall find that the continued marketing of the device
presents a substantial deception or an unreasonable and substantial risk
of illness or injury.
(1) In determining whether the deception or risk of illness or injury
is substantial, the Commissioner will consider whether the deception or
risk posed by continued marketing of the device, or continued marketing
of the device as presently labeled, is important, material, or
significant in relation to the benefit to the public health from its
continued marketing.
(2) In determining whether a device is deceptive, the Commissioner
will consider whether users of the device may be deceived or otherwise
harmed by the device. The Commissioner is not required to determine
that there was an intent on the part of the manufacturer, distributor,
importer, or any other responsible person(s) to mislead or otherwise
harm users of the device or that there exists any actual proof of
deception of, or injury to, an individual.
(3) In determining whether a device presents deception or risk of
illness or injury, the Commissioner will consider all available data and
information, including data and information that the Commissioner may
obtain under other provisions of the act, data and information that may
be supplied by the manufacturer, distributor, or importer of the device
under 895.22, and data and information voluntarily submitted by any
other interested persons.
(b) Before initiating a proceeding to make a device a banned device,
the Commissioner will consult with the classification panel established
under section 513 of the act that has expertise with respect to the type
of device under consideration. The consultation with the panel may
occur at a regular or specially scheduled panel meeting or may be
accomplished by correspondence or telephone conversation with panel
members. The Commissioner may request that the panel submit in writing
any advice on the device under consideration. The Commissioner will
record in written memorandums any oral communications with the panel or
its members.
(c) If the Commissioner determines that any substantial deception or
unreasonable and substantial risk of illness or injury or any
unreasonable, direct, and substantial danger to the health of
individuals presented by a device can be corrected or eliminated by
labeling or change in labeling, or change in advertising if the device
is a restricted device, the Commissioner will notify the responsible
person of the required labeling or change in labeling or change in
advertising in accordance with 895.25. If such required relabeling or
change in advertising is not accomplished in accordance with 895.25,
the Commissioner may initiate a proceeding to ban the device in
accordance with 895.21(d) and, when appropriate, may establish a
special effective date in accordance with 895.30.
(d) If the Commissioner decides to initiate a proceeding to make a
device a banned device, a notice of proposed rulemaking will be
published in the Federal Register to this effect. The notice will
briefly summarize --
(1) The Commissioner's finding under paragraph (a) of this section
that the device presents substantial deception or an unreasonable and
substantial risk of illness or injury, and, when appropriate, the
Commissioner's determination under 895.30 that the deception or risk of
illness or injury presents an unreasonable, direct, and substantial
danger to the health of individuals;
(2) The reasons why the Commissioner initiated the proceeding;
(3) The evaluation of data and information obtained under other
provisions of the act, submitted by the manufacturer, distributer, or
importer of the device, or voluntarily submitted by any other interested
persons under paragraph (a)(3) of this section, if any;
(4) The consultation with the classification panel under paragraph
(b) of this section;
(5) The determination as to whether the deception or risk of illness
or injury or the danger to the health of individuals could be corrected
by labeling or change in labeling, or change in advertising if the
device is a restricted device;
(6) The determination of whether the required labeling or change of
labeling, or change in advertising if the device is a restricted device,
if any, has been made in accordance with paragraph (c) of this section;
(7) The determination as to whether, and the reasons why, the banning
should apply to devices already in commercial distribution or those
already sold to the ultimate user, or both; and
(8) Any other data and information that the Commissioner believes are
pertinent to the proceeding.
The notice will afford all interested persons an opportunity to
submit written comments and request an informal hearing, as defined in
section 201(y) of the act, before the Food and Drug Administration
within 30 days after the date of publication of the proposed regulation.
If a request for an informal hearing is granted, the hearing will be
conducted as a regulatory hearing under the applicable provisions of
Part 16 of this chapter. All nonconfidential information upon which the
proposed finding is based, including the recommendations of the panel,
will be available for public review in the office of the Dockets
Management Branch, Food and Drug Administration.
(e)(1) If, after reviewing the administrative record of the
regulatory hearing before the Food and Drug Administration, if any, the
written comments received on the proposed regulation, and any additional
available data and information, the Commissioner determines to ban a
device, a final regulation to this effect will be published in the
Federal Register. The final regulation will amend Subpart B by adding
the name or description of the device, or both, to the list of banned
devices.
(2) If the Commissioner determines not to ban the device, a notice of
withdrawal and termination of rulemaking proceedings and reasons
therefor will be published in the Federal Register.
(f) The effective date of a final regulation to make a device a
banned device, promulgated under paragraph (e) of this section, will be
the date of publication of the final regulation in the Federal Register
unless the Commissioner, for reasons stated, determines that the
effective date should be later than the date of the publication and
specifies that date in the notice. Each such regulation will specify
whether devices already in commercial distribution or sold to the
ultimate user or both are banned.
(g) A regulation promulgated under paragraph (e) of this section is
final agency action, subject to judicial review under section 517 of the
act.
(h) Upon petition of any interested person submitted in accordance
with 10.30 of this chapter, or as a matter of discretion, the
Commissioner may institute proceedings to amend or revoke a regulation
that made a device a banned device if the Commissioner finds that the
conditions that constituted the basis for the regulation banning the
device are no longer applicable. When appropriate, the procedures in
this section will be employed in such proceedings.
(44 FR 29221, May 18, 1979, as amended at 53 FR 11254, Apr. 6, 1988)
21 CFR 895.22 Submission of data and information by the manufacturer,
distributor, or importer.
(a) A manufacturer, distributor, or importer of a device may be
required to submit to the Food and Drug Administration all relevant and
available data and information to enable the Commissioner to determine
whether the device presents substantial deception, unreasonable and
substantial risk of illness or injury, or unreasonable, direct, and
substantial danger to the health of individuals. The data and
information required by the Commissioner may include scientific or test
data, reports, records, or other information, including data and
information on whether the device is safe and effective for its intended
use or when used as directed, whether the device performs according to
the claims made for the device, and information on adulteration or
misbranding. Any relevant information that is voluntarily submitted
will also be reviewed.
(b) A manufacturer, distributor, or importer of a device required to
submit data and information as provided in paragraph (a) of this section
will be notified in writing by the Food and Drug Administration that
such data and information shall be submitted. The written notification
will advise the manufacturer, distributor, or importer of the device
that the purpose for the request is to enable the Commissioner to
determine whether any of the conditions listed in paragraph (a) of this
section or 895.30(a)(1) exists with respect to the device such that a
proceeding should be initiated to make the device a banned device. When
the required data and information can be identified by the Food and Drug
Administration at the time of the notification, the agency will provide
such identification to the manufacturer, distributor, or importer of the
device.
(c) The required data and information shall be submitted to the Food
and Drug Administration no more than 30 days after the date of receipt
of the request, unless the Commissioner determines that the data and
information shall be submitted by some other date and so informs the
manufacturer, distributor, or importer, in which case the data and
information shall be submitted on the date specified by the
Commissioner.
(d) If the data or information submitted to the Food and Drug
Administration is sufficient to persuade the Commissioner that the
deception or risk of illness or injury or the danger to the health of
individuals presented by a device could be corrected or eliminated by
labeling or change in labeling, or change in advertising if the device
is a restricted device, the Commissioner will proceed in accordance with
895.25.
(e) If the data or information submitted to the Food and Drug
Administration is insufficient to show that the device does not present
a substantial deception or an unreasonable and substantial risk of
illness or injury, or an unreasonable, direct, and substantial danger to
the health of individuals, or if the manufacturer, distributor, or
importer fails to submit the required information, the Commissioner may
rely upon this insufficiency or failure to submit the required
information in considering whether to initiate a proceeding to make the
device a banned device under 895.21(d) and, when appropriate, to
establish a special effective date in accordance with 895.30. The
Commissioner may also initiate other regulatory action as provided in
the act or this chapter.
21 CFR 895.25 Labeling.
(a) If the Commissioner determines that the substantial deception or
unreasonable and substantial risk of illness or injury or the
unreasonable, direct, and substantial danger to the health of
individuals presented by a device can be corrected or eliminated by
labeling or a change in labeling, or change in advertising if the device
is a restricted device, the Commissioner will provide written notice to
the manufacturer, distributor, importer, or any other person(s)
responsible for the labeling or advertising of the device specifying:
(1) The deception or risk of illness or injury or the danger to the
health of individuals,
(2) The labeling or change in labeling, or change in advertising if
the device is a restricted device, necessary to correct the deception or
eliminate or reduce such risk or danger, and
(3) The period of time within which the labeling, change in labeling,
or change in advertising must be accomplished.
(b) In specifying the labeling or change in labeling or change in
advertising to correct the deception or to eliminate or reduce the risk
of illness or injury or the danger to the health of individuals, the
Commissioner may require the manufacturer, distributor, importer, or any
other person(s) responsible for the labeling or advertising of the
device to include in labeling for the device, and in advertising if the
device is a restricted device, a statement, notice, or warning. Such
statement, notice, or warning shall be in the manner and form prescribed
by the Commissioner and shall identify the deception or risk of illness
or injury or the unreasonable, direct, and substantial danger to the
health of individuals associated with the device as previously labeled.
Such statement, notice, or warning shall be used in the labeling and
advertising of the device for a time period specified by the
Commissioner on the basis of the degree of deception, risk of illness or
injury, or danger to health; the frequency of sale of the device; the
length of time the device has been on the market; the intended uses of
the device; the method of its use; and any other factors that the
Commissioner considers pertinent.
(c) The Commissioner will allow a manufacturer, distributor,
importer, or any other person(s) responsible for the labeling or
advertising of the device a reasonable time, considering the deception
or risk of illness or injury or the danger to the health of individuals
presented by the device, within which to accomplish the required
labeling, change in labeling, and, if the device is a restricted device,
any change in advertising. The Commissioner may, however, request that
no additional devices be introduced into commerce until the labeling or
change in labeling, or change in advertising is accomplished by the
manufacturer, distributor, importer, or other person(s) responsible for
the labeling or advertising of the device.
(d) If such voluntary action is not taken, the Commissioner may take
action under other sections of the act to prevent the introduction of
the devices into commerce. The Commissioner may consider the failure of
a manufacturer, distributor, importer, or any other person(s)
responsible for the labeling or advertising of the device to accomplish
the required labeling or change in labeling, or change in advertising in
accordance with this section as a basis for initiating a proceeding to
make a device a banned device in accordance with 895.21(d) and when
appropriate to establish a special effective date in accordance with
895.30.
21 CFR 895.30 Special effective date.
(a) The Commissioner may declare a proposed regulation under
895.21(d) to be effective upon its publication in the Federal Register
and until the effective date of any final action taken respecting the
regulation if:
(1) The Commissioner determines, on the basis of all available data
and information, that the deception or risk of illness or injury
associated with use of the device that is subject to the regulation
presents an unreasonable, direct, and substantial danger to the health
of individuals, and
(2) Before the date of the publication of such regulation, the
Commissioner notifies the domestic manufacturer and importer, if any, of
the device that the regulation is to be made so effective. If
necessary, the Commissioner may also notify the distributor or any other
responsible person(s). In addition, the Commissioner will attempt to
notify any foreign manufacturer when the name and address of the foreign
manufacturer are readily available.
(b) This procedure may be used when the Commissioner determines that
the potential or actual injury involved is a serious one that the
Commissioner believes will endanger the health of individuals who have
been, or will be, exposed to the device. In assessing the degree of
danger, the Commissioner need not find that the danger is immediate, and
it shall be sufficient for the Commissioner to determine that the danger
may involve a serious long-term risk.
(c) If the Commissioner makes a proposed regulation effective in
accordance with this section, the Commissioner will, as expeditiously as
possible, give interested persons prompt notice of this action in the
Federal Register and will provide an opportunity for an informal hearing
in accordance with Part 16 of this chapter.
(d) After the hearing, if any, and after considering any written
comments submitted on the proposal and any additional available
information and data, the Commissioner will as expeditiously as possible
either affirm, modify, or revoke the proposed regulation making the
device a banned device. If the Commissioner decides to affirm or modify
the proposed regulation to make a device a banned device, the
Commissioner will amend Subpart B by adding the name or description of
the device, or both, to the list of banned devices. If the Commissioner
decides to revoke a proposed regulation making a device a banned device,
a notice of termination of rulemaking proceedings and reasons therefor
will be published in the Federal Register.
(e) The Commissioner may declare the special effective date provided
by this section to be in effect after the publication of a proposed
regulation under 895.21(d), if, based on new information, or upon
reconsideration of previously available information, the Commissioner
makes the determination and provides the appropriate notices and an
opportunity for a hearing in accordance with paragraphs (a) and (c) of
this section.
(f) Those devices that have been named banned devices under 895.30
and that have already been sold to the public may be subject to
relabeling by the manufacturer, distributor, importer, or any other
person(s) responsible for the labeling of the device or may be subject
to the provisions of section 518(a) or (b) of the act.
21 CFR 895.30 Subpart B -- Listing of Banned Devices
21 CFR 895.101 Prosthetic hair fibers.
Prosthetic hair fibers are devices intended for implantation into the
human scalp to simulate natural hair or conceal baldness. Prosthetic
hair fibers may consist of various materials; for example, synthetic
fibers, such as modacrylic, polyacrylic, and polyester; and natural
fibers, such as processed human hair. Excluded from the banned device
are natural hair transplants, in which a person's hair and its
surrounding tissue are surgically removed from one location on the
person's scalp and then grafted onto another area of the person's scalp.
(48 FR 25136, June 3, 1983)
21 CFR 895.101 SUBCHAPTER I -- (RESERVED)
21 CFR 895.101 SUBCHAPTER J -- RADIOLOGICAL HEALTH
21 CFR 895.101 PART 1000 -- GENERAL
21 CFR 895.101 Subpart A -- General Provisions
Sec.
1000.1 General.
1000.3 Definitions.
21 CFR 895.101 Subpart B -- Statements of Policy and Interpretation
1000.15 Examples of electronic products subject to the Radiation
Control for Health and Safety Act of 1968.
21 CFR 895.101 Subpart C -- Radiation Protection Recommendations
1000.50 Recommendation for the use of specific area gonad shielding
on patients during medical diagnostic x-ray procedures.
1000.55 Recommendation for quality assurance programs in diagnostic
radiology facilities.
1000.60 Recommendation on administratively required dental x-ray
examinations.
Authority: Secs. 354-360F of the Public Health Service Act (42
U.S.C. 263b-263n).
Source: 38 FR 28624, Oct. 15, 1973, unless otherwise noted.
21 CFR 895.101 Subpart A -- General Provisions
21 CFR 1000.1 General.
References in this Subchapter J to regulatory sections of the Code of
Federal Regulations are to Chapter I of Title 21 unless otherwise noted.
(50 FR 33688, Aug. 20, 1985)
21 CFR 1000.3 Definitions.
As used in this Subchapter J:
(a) ''Electronic product radiation'' means --
(1) Any ionizing or nonionizing electromagnetic or particulate
radiation, or
(2) Any sonic, infrasonic, or ultrasonic wave, which is emitted from
an electronic product as the result of the operation of an electronic
circuit in such product.
(b) ''Electromagnetic radiation'' includes the entire electromagnetic
spectrum of radiation of any wavelength. The electromagnetic spectrum
illustrated in Figure 1 includes, but is not limited to, gamma rays,
X-rays, ultraviolet, visible, infrared, microwave, radiowave, and low
frequency radiations.
(c) ''Particulate radiation'' is defined as charged particles such as
protons, electrons, alpha particles, heavy particles, etc., which have
sufficient kinetic energy to produce ionization or atomic or electron
excitation by collision, electrical attractions or electrical repulsion
or uncharged particles such as neutrons, which can initiate a nuclear
transformation or liberate charged particles having sufficient kinetic
energy to produce ionization or atomic or electron excitation by
collision.
(d) ''Infrasonic, sonic (or audible) and ultrasonic waves'' refer to
energy transmitted as an alteration (pressure, particle displacement or
density) in a property of an elastic medium (gas, liquid or solid) that
can be detected by an instrument or listener.
(e) ''Electronic product'' means (1) any manufactured or assembled
product which, when in operation, (i) contains or acts as part of an
electronic circuit and (ii) emits (or in the absence of effective
shielding or other controls would emit) electronic product radiation, or
(2) any manufactured or assembled article which is intended for use as a
component, part, or accessory of a product described in paragraph (e)(1)
and which when in operation emits (or in the absence of effective
shielding or other controls would emit) such radiation.
(f) ''Manufacturer'' means any person engaged in the business of
manufacturing, assembling, or importing of electronic products.
(g) ''Commerce'' means (1) commerce between any place in any State
and any place outside thereof, and (2) commerce wholly within the
District of Columbia.
(h) ''State'' means a State, the District of Columbia, the
Commonwealth of Puerto Rico, the Virgin Islands, Guam, and American
Samoa.
(i) ''Act'' means the Radiation Control for Health and Safety Act of
1968 (Pub. L. 90-602, 42 U.S.C. 263b et seq.).
(j) ''Secretary'' means the Secretary of the Department of Health and
Human Services.
(k) ''Federal standard'' means a performance standard issued pursuant
to section 358 of the Act.
(l) The term ''dealer'' means a person engaged in the business of
offering electronic products for sale to purchasers, without regard to
whether such person is or has been primarily engaged in such business,
and includes persons who offer such products for lease or as prizes or
awards.
(m) The term ''distributor'' means a person engaged in the business
of offering electronic products for sale to dealers without regard to
whether such person is or has been primarily or customarily engaged in
such business.
(n) The term ''purchaser'' means the first person who, for value, or
as an award or prize, acquires an electronic product for purposes other
than resale, and also includes a person who leases an electronic product
for purposes other than subleasing.
(o) The term ''model'' means any identifiable, unique electronic
product design, and refers to products having the same structural and
electrical design characteristics and to which the manufacturer has
assigned a specific designation to differentiate between it and other
products produced by that manufacturer.
21 CFR 1000.3 Subpart B -- Statements of Policy and Interpretation
21 CFR 1000.15 Examples of electronic products subject to the Radiation
Control for Health and Safety Act of 1968.
The following listed electronic products are intended to serve as
illustrative examples of sources of electronic product radiation to
which the regulations of this part apply.
(a) Examples of electronic products which may emit X-rays and other
ionizing electromagnetic radiation, electrons, neutrons, and other
particulate radiation include:
Ionizing electromagnetic radiation:
Television receivers.
Accelerators.
X-ray machines (industrial, medical, research, educational).
Particulate radiation and ionizing electromagnetic radiation:
Electron microscopes.
Neutron generators.
(b) Examples of electronic products which may emit ultraviolet,
visible, infrared, microwaves, radio and low frequency electromagnetic
radiation include:
Ultraviolet:
Biochemical and medical analyzers.
Tanning and therapeutic lamps.
Sanitizing and sterilizing devices.
Black light sources.
Welding equipment.
Visible:
White light devices.
Infrared:
Alarm systems.
Diathermy units.
Dryers, ovens, and heaters.
Microwave:
Alarm systems.
Diathermy units.
Dryers, ovens, and heaters.
Medico-biological heaters.
Microwave power generating devices.
Radar devices.
Remote control devices.
Signal generators.
Radio and low frequency:
Cauterizers.
Diathermy units.
Power generation and transmission equipment.
Signal generators.
Electromedical equipment.
(c) Examples of electronic products which may emit coherent
electromagnetic radiation produced by stimulated emission include:
Laser:
Art-form, experimental and educational devices.
Biomedical analyzers.
Cauterizing, burning and welding devices.
Cutting and drilling devices.
Communications transmitters.
Rangefinding devices.
Maser:
Communications transmitters.
(d) Examples of electronic products which may emit infrasonic, sonic,
and ultrasonic vibrations resulting from operation of an electronic
circuit include:
Infrasonic:
Vibrators.
Sonic:
Electronic oscillators.
Sound amplification equipment.
Ultrasonic:
Cauterizers.
Cell and tissue disintegrators.
Cleaners.
Diagnostic and nondestructive testing equipment.
Ranging and detection equipment.
21 CFR 1000.15 Subpart C -- Radiation Protection Recommendations
21 CFR 1000.50 Recommendation for the use of specific area gonad
shielding on patients during medical diagnostic x-ray procedures.
Specific area gonad shielding covers an area slightly larger than the
region of the gonads. It may therefore be used without interfering with
the objectives of the examination to protect the germinal tissue of
patients from radiation exposure that may cause genetic mutations during
many medical x-ray procedures in which the gonads lie within or are in
close proximity to the x-ray field. Such shielding should be provided
when the following conditions exist:
(a) The gonads will lie within the primary x-ray field, or within
close proximity (about 5 centimeters), despite proper beam limitation.
Except as provided in paragraph (b) or (c) of this section:
(1) Specific area testicular shielding should always be used during
those examinations in which the testes usually are in the primary x-ray
field, such as examinations of the pelvis, hip, and upper femur;
(2) Specific area testicular shielding may also be warranted during
other examinations of the abdominal region in which the testes may lie
within or in close proximity to the primary x-ray field, depending upon
the size of the patient and the examination techniques and equipment
employed. Some examples of these are: Abdominal, lumbar spine and
lumbosacral spine examinations, intravenous pyelograms, and abdominal
scout film for barium enemas and upper GI series. Each x-ray facility
should evaluate its procedures, techniques, and equipment and compile a
list of such examinations for which specific area testicular shielding
should be routinely considered for use. As a basis for judgment,
specific area testicular shielding should be considered for all
examinations of male patients in which the pubic symphysis will be
visualized on the film;
(3) Specific area gonad shielding should never be used as a
substitute for careful patient positioning, the use of correct technique
factors and film processing, or proper beam limitation (confinement of
the x-ray field to the area of diagnostic interest), because this could
result in unnecessary doses to other sensitive tissues and could
adversely affect the quality of the radiograph; and
(4) Specific area gonad shielding should provide attenuation of
x-rays at least equivalent to that afforded by 0.25 millimeter of lead.
(b) The clinical objectives of the examination will not be
compromised.
(1) Specific area testicular shielding usually does not obscure
needed information except in a few cases such as oblique views of the
hip, retrograde urethrograms and voiding cystourethrograms,
visualization of the rectum and, occasionally, the pubic symphysis.
Consequently, specific area testicular shielding should be considered
for use in the majority of x-ray examinations of male patients in which
the testes will lie within the primary beam or within 5 centimeters of
its edge. It is not always possible to position shields on male
patients so that no bone is obscured. Therefore, if all bone structure
of the pelvic area must be visualized for a particular patient, the use
of shielding should be carefully evaluated. The decision concerning the
applicability of shielding for an individual patient is dependent upon
consideration of the patient's0unique anthropometric characteristics and
the diagnostic information needs of the examination.
(2) The use of specific area ovarian shielding is frequently
impractical at present because the exact location of the ovaries is
difficult to estimate, and the shield may obscure visualization of
portions of adjacent structures such as the spine, ureters, and small
and large bowels. However, it may be possible for practitioners to use
specific area ovarian shielding during selected views in some
examinations.
(c) The patient has a reasonable reproductive potential.
(1) Specific area shielding need not be used on patients who cannot
or are not likely to have children in the future.
(2) The following table of statistical data regarding the average
number of children expected by potential parents in various age
categories during their remaining lifetimes is provided for x-ray
facilities that wish to use it as a basis for judging reproductive
potential:
(41 FR 30328, July 23, 1976; 41 FR 31812, July 30, 1976)
21 CFR 1000.55 Recommendation for quality assurance programs in
diagnostic radiology facilities.
(a) Applicability. Quality assurance programs as described in
paragraph (c) of this section are recommended for all diagnostic
radiology facilities.
(b) Definitions. As used in this section, the following definitions
apply:
(1) ''Diagnostic radiology facility'' means any facility in which an
x-ray system(s) is used in any procedure that involves irradiation of
any part of the human body for the purpose of diagnosis or
visualization. Offices of individual physicians, dentists, podiatrists,
and chiropractors, as well as mobile laboratories, clinics, and
hospitals are all examples of diagnostic radiology facilities.
(2) ''Quality assurance'' means the planned and systematic actions
that provide adequate confidence that a diagnostic x-ray facility will
produce consistently high quality images with minimum exposure of the
patients and healing arts personnel. The determination of what
constitutes high quality will be made by the facility producing the
images. Quality assurance actions include both ''quality control''
techniques and ''quality administration'' procedures.
(3) ''Quality assurance program'' means an organized entity designed
to provide ''quality assurance'' for a diagnostic radiology facility.
The nature and extent of this program will vary with the size and type
of the facility, the type of examinations conducted, and other factors.
(4) ''Quality control techniques'' are those techniques used in the
monitoring (or testing) and maintenance of the components of an x-ray
system. The quality control techniques thus are concerned directly with
the equipment.
(5) ''Quality administration procedures'' are those management
actions intended to guarantee that monitoring techniques are properly
performed and evaluated and that necessary corrective measures are taken
in response to monitoring results. These procedures provide the
organizational framework for the quality assurance program.
(6) ''X-ray system'' means an assemblage of components for the
controlled production of diagnostic images with x-rays. It includes
minimally an x-ray high voltage generator, an x-ray control, a
tube-housing assembly, a beam-limiting device, and the necessary
supporting structures. Other components that function with the system,
such as image receptors, image processors, view boxes, and darkrooms,
are also parts of the system.
(c) Elements. A quality assurance program should contain the
elements listed in paragraphs (c)(1) through (10) of this section. The
extent to which each element of the quality assurance program is
implemented should be determined by an analysis of the facility's
objectives and resources conducted by its qualified staff or by
qualified outside consultants. The extent of implementation should be
determined on the basis of whether the expected benefits in radiation
exposure reduction, improved image quality, and/or financial savings
will compensate for the resources required for the program.
(1) Responsibility. (i) Responsibility and authority for the overall
quality assurance program as well as for monitoring, evaluation, and
corrective measures should be specified and recorded in a quality
assurance manual.
(ii) The owner or practitioner in charge of the facility has primary
responsibility for implementing and maintaining the quality assurance
program.
(iii) Staff technologists will generally be delegated a basic quality
assurance role by the practitioner in charge. Responsibility for
specific quality control monitoring and maintenance techniques or
quality administration procedures may be assigned, provided that the
staff technologists are qualified by training or experience for these
duties. The staff technologists should also be responsible for
identifying problems or potential problems requiring actions beyond the
level of their training. They should bring these problems to the
attention of the practitioner in charge, or his or her representative,
so that assistance in solving the problems may be obtained from inside
or outside the facility.
(iv) In facilities where they are available, physicists, supervisory
technologists, or quality control technologists should have a major role
in the quality assurance program. Such specialized personnel may be
assigned responsibility for day-to-day administration of the program,
may carry out monitoring duties beyond the level of training of the
staff technologist or, if desired by the facility, may relieve the staff
technologists of some or all of their basic monitoring duties. Staff
service engineers may also be assigned responsibility for certain
preventive or corrective maintenance actions.
(v) Responsibility for certain quality control techniques and
corrective measures may be assigned to personnel qualified by training
or experience, such as consultants or industrial representatives, from
outside of the facility, provided there is a written agreement clearly
specifying these services.
(vi) In large facilities, responsibility for long-range planning of
quality assurance goals and activities should be assigned to a quality
assurance committee as described in paragraph (c)(9) of this section.
(2) Purchase specifications. Before purchasing new equipment, the
staff of the diagnostic radiology facility should determine the desired
performance specifications for the equipment. Initially, these
specifications may be stated in terms of the desired performance of the
equipment, or prospective vendors may be informed solely of the
functions the equipment should be able to perform and asked to provide
the performance specifications of items from their equipment line that
can perform these functions. In either case, the responses of the
prospective vendors should serve as the basis for negotiations to
establish the final purchase specifications, taking into account the
state of the art and balancing the need for the specified performance
levels with the cost of the equipment to meet them. The final purchase
specifications should be in writing and should include performance
specifications. The availability of experienced service personnel
should also be taken into consideration in making the final purchase
decisions. Any understandings with respect to service personnel should
be incorporated into the purchase specifications. After the equipment
is installed, the facility should conduct a testing program, as defined
in its purchase specifications, to ensure that the equipment meets the
agreed upon specifications, including applicable Federal and State
regulatory requirements. The equipment should not be formally accepted
until any necessary corrections have been made by the vendor. The
purchase specifications and the records of the acceptance testing should
be retained throughout the life of the equipment for comparison with
monitoring results in order to assess continued acceptability of
performance.
(3) Monitoring and maintenance. A routine quality control monitoring
and maintenance system incorporating state-of-the-art procedures should
be established and conducted on a regular schedule. The purpose of
monitoring is to permit evaluation of the performance of the facility's
x-ray system(s) in terms of the standards for image quality established
by the facility (as described in paragraph (c)(4) of this section) and
compliance with applicable Federal and State regulatory requirements.
The maintenance program should include corrective maintenance to
eliminate problems revealed by monitoring or other means before they
have a serious deleterious impact on patient care. To the extent
permitted by the training of the facility staff, the maintenance program
should also include preventive maintenance, which could prevent
unexpected breakdowns of equipment and disruption of departmental
routine.
(i) The parameters to be monitored in a facility should be determined
by that facility on the basis of an analysis of expected benefits and
cost. Such factors as the size and resources of the facility, the type
of examinations conducted, and the quality assurance problems that have
occurred in that or similar facilities should be taken into account in
establishing the monitoring system. The monitoring frequency should
also be based upon need and can be different for different parameters.
(ii) Although the parameters to be monitored will vary somewhat from
facility to facility, every diagnostic radiology facility should
consider monitoring the following five key components of the x-ray
system:
(a) Film processing.
(b) Basic performance characteristics of the x-ray unit.
(c) Cassettes and grids.
(d) View boxes.
(e) Darkroom.
(iii) Examples of parameters of the above-named components and of
more specialized equipment that may be monitored are as follows:
(a) For film processing:
An index of speed.
An index of contrast.
Base plus fog.
Solution temperatures.
Film artifact identification.
(b) For basic performance characteristics of the x-ray unit:
(1) For fluoroscopic x-ray units:
Table-top exposure rates.
Centering alignment.
Collimation.
kVp accuracy and reproducibility.
mA accuracy and reproducibility.
Exposure time accuracy and reproducibility.
Reproducibility of x-ray output.
Focal spot size consistency.
Half-value layer.
Representative entrance skin exposures.
(2) For image-intensified systems:
Resolution.
Focusing.
Distortion.
Glare.
Low contrast performance.
Physical alignment of camera and collimating lens.
(3) For radiographic x-ray units:
Reproducibility of x-ray output.
Linearity and reproducibility of mA stations.
Reproducibility and accuracy of timer stations.
Reproducibility and accuracy of kVp stations.
Accuracy of source-to-film distance indicators.
Light/x-ray field congruence.
Half-value layer.
Focal spot size consistency.
Representative entrance skin exposures.
(4) For automatic exposure control devices:
Reproducibility.
kVp compensation.
Field sensitivity matching.
Minimum response time.
Backup timer verification.
(c) For cassettes and grids:
(1) For cassettes:
Film/screen contact.
Screen condition.
Light leaks.
Artifact identification.
(2) For grids:
Alignment and focal distance.
Artifact identification.
(d) For view boxes:
Consistency of light output with time.
Consistency of light output from one box to another.
View box surface conditions.
(e) For darkrooms:
Darkroom integrity.
Safe light conditions.
(f) For specialized equipment:
(1) For tomographic systems:
Accuracy of depth and cut indicator.
Thickness of cut plane.
Exposure angle.
Completeness of tomographic motion.
Flatness of tomographic field.
Resolution.
Continuity of exposure.
Flatness of cassette.
Representative entrance skin exposures.
(2) For computerized tomography:
Precision (noise).
Contrast scale.
High and low contrast resolution.
Alignment.
Representative entrance skin exposures.
(iv) The maintenance program should include both preventive and
corrective aspects.
(a) Preventive maintenance. Preventive maintenance should be
performed on a regularly scheduled basis with the goal of preventing
breakdowns due to equipment failing without warning signs detectable by
monitoring. Such actions have been found cost effective if
responsibility is assigned to facility staff members. Possible
preventive maintenance procedures are visual inspection of the
mechanical and electrical characteristics of the x-ray system (covering
such things as checking conditions of cables, watching the tomographic
unit for smoothness of motion, assuring cleanliness with respect to
spilling of contaminants in the examination room or the darkroom, and
listening for unusual noises in the moving parts of the system),
following the manufacturer's recommended procedures for cleaning and
maintenance of the equipment, and regular inspection and replacement of
switches and parts that routinely wear out or fail. The procedures
included would depend upon the background of the staff members
available. Obviously, a large facility with its own service engineers
can do more than an individual practitioner's office.
(b) Corrective maintenance. For maximum effectiveness, the quality
assurance program should make provision, as described in paragraph
(c)(5) of this section, for ascertaining whether potential problems are
developing. If potential or actual problems are detected, corrective
maintenance should be carried out to eliminate them before they cause a
major impact on patient care.
(4) Standards for image quality. Standards of acceptable image
quality should be established. Ideally, these should be objective,
e.g., acceptability limits for the variations of parameter values, but
they may be subjective, e.g., the opinions of professional personnel, in
cases where adequate objective standards cannot be defined. These
standards should be routinely reviewed and redefined as needed, as
described in paragraph (c)(10) of this section.
(5) Evaluation. The facility's quality assurance program should
include means for two levels of evaluation.
(i) On the first level, the results of the monitoring procedures
should be used to evaluate the performance of the x-ray system(s) to
determine whether corrective actions are needed to adjust the equipment
so that the image quality consistently meets the standards for image
quality. This evaluation should include analysis of trends in the
monitoring data as well as the use of the data to determine the need for
corrective actions on a day-by-day basis. Comparison of monitoring data
with the purchase specifications and acceptance testing results for the
equipment in question is also useful.
(ii) On the second level, the facility quality assurance program
should also include means for evaluating the effectiveness of the
program itself. Possible means include ongoing studies of the retake
rate and the causes of the repeated radiographs, examination of
equipment repair and replacement costs, subjective evaluation of the
radiographs being produced, occurrence and reasons for complaints by
radiologists, and analysis of trends in the results of monitoring
procedures such as sensitometric studies. Of these, ongoing studies of
the retake rate (reject rate) and its causes are often the most useful
and may also provide information of value in the first level of
evaluation. Such studies can be used to evaluate potential for
improvement, to make corrections, and to determine whether the
corrective actions were effective. The number of rejects should be
recorded daily or weekly, depending on the facility's analysis of its
needs. Ideally, the reasons for the rejection should also be determined
and recorded. Should determining these reasons be impossible on a
regular basis with the available staff, the analysis should be done for
a 2-week period after major changes have occurred in diagnostic
procedures or the x-ray system and at least semi-annually.
(6) Records. The program should include provisions for the keeping
of records on the results of the monitoring techniques, any difficulties
detected, the corrective measures applied to these difficulties, and the
effectiveness of these measures. The extent and form of these records
should be determined by the facility on the basis of its needs. The
facility should view these records as a tool for maintaining an
effective quality assurance program and not view the data in them as an
end in itself but rather as a beginning. For example, the records
should be made available to vendors to help them provide better service.
More importantly, the data should be the basis for the evaluation and
the reviews suggested in paragraphs (c)(5) and (10) of this section.
(7) Manual. A quality assurance manual should be written in a format
permitting convenient revision as needed and should be made readily
available to all personnel. The content of the manual should be
determined by the facility staff, but the following items are suggested
as providing essential information:
(i) A list of the individuals responsible for monitoring and
maintenance techniques.
(ii) A list of the parameters to be monitored and the frequency of
monitoring.
(iii) A description of the standards, criteria of quality, or limits
of acceptability that have been established for each of the parameters
monitored.
(iv) A brief description of the procedures to be used for monitoring
each parameter.
(v) A description of procedures to be followed when difficulties are
detected to call these difficulties to the attention of those
responsible for correcting them.
(vi) A list of the publications in which detailed instructions for
monitoring and maintenance procedures can be found. Copies of these
publications should also be readily available to the entire staff, but
they should be separate from the manual. (Publications providing these
instructions can usually be obtained from FDA or private sources,
although the facility may wish to make some modifications to meet its
needs more effectively.)
(vii) A list of the records, with sample forms, that the facility
staff has decided should be kept. The facility staff should also
determine and note in the manual the length of time each type of record
should be kept before discarding.
(viii) A copy of each set of purchase specifications developed for
new equipment and the results of the acceptance testing for that
equipment.
(8) Training. The program should include provisions for appropriate
training for all personnel with quality assurance responsibilities.
This should include both training provided before the quality assurance
responsibilities are assumed and continuing education to keep the
personnel up-to-date. Practical experience with the techniques
conducted under the supervision of experienced instructors, either in
the facility or in a special program, is the most desirable type of
training. The use of self-teaching materials can be an adequate
substitute for supervised instruction, especially in continuing
education programs, if supervised instruction is not available.
(9) Committee. A facility whose size would make it impractical for
all staff members to meet for planning purposes should consider the
establishment of a quality assurance committee whose primary function
would be to maintain lines of communication among all groups with
quality assurance and/or image production or interpretation
responsibilities. For maximum communication, all departments of the
facility with x-ray equipment should be represented. The committee may
also be assigned policy-making duties such as some or all of the
following:
Assign quality assurance responsibilities; maintain acceptable
standards of quality; periodically review program effectiveness, etc.
Alternatively, the duties of this committee could be assigned to an
already-existing committee such as the Radiation Safety Committee. In
smaller facilities, all staff members should participate in the
committee's tasks. The Quality Assurance Committee should report
directly to the head of the radiology department, or, in facilities
where more than one department operates x-ray equipment, to the chief
medical officer of the facility. The committee should meet on a regular
basis.
(10) Review. The facility's quality assurance program should be
reviewed by the Quality Assurance Committee and/or the practitioner in
charge to determine whether its effectiveness could be improved. Items
suggested for inclusion in the review include:
(i) The reports of the monitoring and maintenance techniques to
ensure that they are being performed on schedule and effectively. These
reports should be reviewed at least quarterly.
(ii) The monitoring and maintenance techniques and their schedules to
ensure that they continue to be appropriate and in step with the latest
developments in quality assurance. They should be made current at least
annually.
(iii) The standards for image quality to ensure that they are
consistent with the state-of-the-art and the needs and resources of the
facility. These standards should be evaluated at least annually.
(iv) The results of the evaluations of the effectiveness of the
quality assurance actions to determine whether changes need to be made.
This determination should be made at least annually.
(v) The quality assurance manual should also be reviewed at least
annually to determine whether revision is needed.
(44 FR 71737, Dec. 11, 1979)
21 CFR 1000.60 Recommendation on administratively required dental x-ray
examinations.
(a) The Food and Drug Administration recommends that dental x-ray
examinations be performed only after careful consideration of the dental
or other health needs of the patient, that is, when the patient's
dentist or physician judges them to be necessary for diagnosis,
treatment, or prevention of disease. Administratively required dental
x-ray examinations are those required by a remote third party for
reasons not related to the patient's immediate dental needs. These
x-ray examinations are usually a source of unnecessary radiation
exposure to the patient. Because any unnecessary radiation exposure
should be avoided, third parties should not require dental x-ray
examinations unless they can demonstrate that such examinations provide
a direct clinical benefit to the patient, and the patient's dentist or
physician agrees with that assessment.
(b) Some examples of administrative x-ray examinations that should
not be required by third parties are those intended solely:
(1) To monitor insurance claims or detect fraud;
(2) To satisfy a prerequisite for reimbursement;
(3) To provide training or experience;
(4) To certify qualifications or competence.
(c) This recommendation is not intended to preclude dental x-ray
examinations ordered by the attending practitioner, based on the
patient's history or physical examination, or those performed on
selected populations shown to have significant yields of previously
undiagnosed disease. This recommendation is also not intended to
preclude the administrative use by third parties of dental radiographs
that are taken on the order of the patient's dentist or physician as a
necessary part of the patient's clinical care.
(45 FR 40978, June 17, 1980)
21 CFR 1000.60 PART 1002 -- RECORDS AND REPORTS
21 CFR 1000.60 Subpart A -- General Provisions
Sec.
1002.1 Applicability.
1002.2 Definitions.
1002.3 Records and reports on components.
1002.4 Confidentiality of information.
1002.7 Submission of data and reports.
21 CFR 1000.60 Subpart B -- Required Manufacturers' Reports for Listed
Electronic Products
1002.10 Initial reports.
1002.11 Annual reports.
1002.12 Reports of model changes.
21 CFR 1000.60 Subpart C -- Manufacturers' Reports on Accidental
Radiation Occurrences
1002.20 Reporting of accidental radiation occurrences.
21 CFR 1000.60 Subpart D -- Manufacturers' Records
1002.30 Records to be maintained by manufacturers.
1002.31 Preservation and inspection of records.
21 CFR 1000.60 Subpart E -- Dealer and Distributor Records
1002.40 Records to be obtained by dealers and distributors.
1002.41 Disposition of records obtained by dealers and distributors.
1002.42 Confidentiality of records furnished by dealers and
distributors.
21 CFR 1000.60 Subpart F -- Exemptions From Records and Reports
Requirements
1002.50 Special exemptions.
1002.51 Exemptions for manufacturers of products intended for the
U.S. Government.
21 CFR 1000.60 Subpart G -- Codes for Reporting Listed Electronic
Products
1002.61 List of specific product groups.
Authority: Secs. 502, 510, 519, 520, 701, 704 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 352, 360, 360i. 360j, 371, 374);
secs. 354-360F of the Public Health Service Act (42 U.S.C. 263b-263n).
Source: 38 FR 28625, Oct. 15, 1973, unless otherwise noted.
21 CFR 1000.60 Subpart A -- General Provisions
21 CFR 1002.1 Applicability.
The provisions of this part are applicable to manufacturers, dealers,
and distributors of electronic products as specified herein, but, except
for 1002.20, are not applicable to:
(a) Manufacturers of electronic products intended solely for export
if such product is labeled or tagged to show that the product is
intended for export, and the product meets all the applicable
requirements of the country to which such product is intended for
export:
(b) Manufacturers of electronic products listed in 1002.61 if sold
exclusively to other manufacturers for use as components of electronic
products to be sold to purchasers, with the exception that the
provisions are applicable to those manufacturers certifying components
of diagnostic x-ray systems pursuant to provisions of 1020.30(c) of
this chapter.
(c) Manufacturers of electronic products which are intended for use
by the U.S. Government and whose function or design cannot be divulged
by the manufacturer for reasons of national security, as evidenced by
government security classification.
(d) Assemblers of diagnostic x-ray equipment subject to the
provisions of 1020.30(d) of this chapter, provided the assembler has
submitted the report required by 1020.30(d) (1) or (2) of this chapter
and retains a copy of such report for a period of five years from its
date.
(38 FR 31828, Nov. 19, 1973)
21 CFR 1002.2 Definitions.
As used in this part:
(a) The term ''dealer'' means a person engaged in the business of
offering electronic products for sale to purchasers, without regard to
whether such person is or has been primarily engaged in such business,
and includes persons who offer such products for lease or as prizes or
awards.
(b) The term ''distributor'' means a person engaged in the business
of offering electronic products for sale to dealers without regard to
whether such person is or has been primarily or customarily engaged in
such business.
(c) The term ''purchaser'' means the first person who, for value, or
as an award or prize, acquires an electronic product for purposes other
than resale, and also includes a person who leases an electronic product
for purposes other than subleasing.
(d) The term ''accidental radiation occurrence'' means a single event
or series of events occurring in the course of the manufacturing,
testing, or use of any electronic product which has resulted in
injurious or potentially injurious exposure of any person to electronic
product radiation as a direct result of the manufacturing, testing, or
use of that product.
(e) The term ''model'' means any identifiable, unique electronic
product design, and refers to products having the same structural and
electrical design characteristics and to which the manufacturer has
assigned a specific designation to differentiate between it and other
products produced by that manufacturer.
21 CFR 1002.3 Records and reports on components.
Records and reports required for products listed in 1002.61 shall
include information on all components which the manufacturer may provide
with the listed product and which affect the quantity, quality, or
direction of the radiation emissions.
21 CFR 1002.4 Confidentiality of information.
The Secretary or his representative shall not disclose any
information reported to or otherwise obtained by him, pursuant to this
part, which concerns or relates to a trade secret or other matter
referred to in section 1905 of title 18 of the United States Code,
except that such information may be disclosed to other officers or
employees of the Department and of the other agencies concerned with
carrying out the requirements of the Act. Nothing in this section shall
authorize the withholding of information by the Secretary, or by any
officers or employees under his control, from the duly authorized
committees of the Congress.
21 CFR 1002.7 Submision of data and reports.
All submissions such as reports, test data, product descriptions, and
other information required by this part, or voluntarily submitted to the
Director, Center for Devices and Radiological Health, shall be filed
with the number of copies as prescribed by the Director, Center for
Devices and Radiological Health, and shall be signed by the person
making the submission.
(a) In addition to the requirements of this part, all material
submitted to the Director, Center for Devices and Radiological Health,
shall be submitted pursuant to the provisions of Part 20 -- Public
Information, of this chapter.
(b) Where guides or instructions have been issued by the Director,
Center for Devices and Radiological Health, for the submission of
material required by this part such as test data, initial and annual
reports, and reports of model changes, the material submitted shall
conform to the applicable reporting guide or instruction to the extent
that it is possible or appropriate to do so. Where it is not feasible
or where it would not be appropriate to conform to any portion of a
prescribed reporting guide or instruction, an alternate format for
providing the information requested by that portion of the guide or
instruction may be used provided the submitter of such information
submits adequate explanation and justification for use of an alternate
format. If the Director, Center for Devices and Radiological Health,
determines that such justification is inadequate and that it is feasible
or appropriate to conform to the prescribed reporting guide or
instruction, he may require resubmission of the information in
conformance with the reporting guide or instruction.
(42 FR 18062, Apr. 5, 1977, as amended at 53 FR 11254, Apr. 6, 1988)
21 CFR 1002.7 Subpart B -- Required Manufacturers' Reports for Listed Electronic Products
21 CFR 1002.10 Initial reports.
Every manufacturer of a product listed under 1002.61, shall submit
an initial report to the Director, Center for Devices and Radiological
Health, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD
20857, in accordance with this section. The report shall be submitted
within 90 days following the effective date of listing such product
under 1002.61 or prior to the introduction of such product into
commerce, whichever is later. The report shall be distinctly marked
''Initial Report of (Name of Manufacturer)'' and shall:
(a) State in the report for each model of a listed product whether
the report is submitted pursuant to paragraph (a), (b), or (c) of
1002.61.
(b) Identify each model of the listed product together with
sufficient information concerning the manufacturer's code or other
system of labeling sufficient to enable the Secretary to determine the
place of manufacture.
(c) Describe the function, operational characteristics affecting
radiation emissions, and intended and known uses of each model of the
listed product.
(d) State the standards or design specifications, if any, for each
model with respect to electronic product radiation safety. Reference
may be made to a Federal standard, if applicable.
(e) For each model, describe the physical or electrical
characteristics such as shielding, or electronic circuitry, etc.,
incorporated into the product in order that the standards or
specifications reported pursuant to paragraph (d) of this section are
met.
(f) Describe the methods and procedures employed, if any, in testing
and measuring each model with respect to electronic product radiation
safety including the control of unnecessary, secondary, or leakage
electronic product radiation, the applicable quality control procedures
used for each model, and the basis for selecting such testing and
quality control procedures.
(g) For those products which may produce increased radiation with
aging, describe the methods and procedures used, and frequency of
testing each model for durability and stability with respect to
electronic product radiation safety. Include the basis for selecting
such methods and procedures, or for determining that such testing and
quality control procedures are not necessary.
(h) Provide sufficient results of the testing and measuring of
electronic product radiation safety and of the quality control
procedures described in accordance with paragraphs (f) and (g) of this
section to enable the Secretary to determine the effectiveness of the
methods and procedures used to accomplish the stated purposes.
(i) Report for each model, all warning signs, labels and
instructions, for installation, operation, and use which relate to
electronic product radiation safety.
(j) Provide upon request such other information as the Secretary may
reasonably require to enable him to determine whether the manufacturer
has acted or is acting in compliance with the Act and any standards
prescribed thereunder, and to enable the Secretary to carry out the
purposes of the Act.
(38 FR 28625, Oct. 15, 1973, as amended at 39 FR 16228, May 8, 1974;
40 FR 10175, Mar. 5, 1975; 53 FR 11254, Apr. 6, 1988)
21 CFR 1002.11 Annual reports.
(a) Every manufacturer of products listed under 1002.61(b) and (c)
shall submit an annual report summarizing the contents of the records
required to be maintained by 1002.30(a).
(b) The first annual report shall be submitted by September 1, 1971,
with subsequent reports due annually thereafter. Such reports shall
cover the 12-month period ending on June 30 preceding the due date of
the report.
21 CFR 1002.12 Reports of model changes.
Prior to the introduction into commerce of a new or modified model of
a product listed in 1002.61 for which an initial report under 1002.10
was required, each manufacturer shall submit a report with respect to
such new or modified model containing any changes in the information
submitted in the initial report.
21 CFR 1002.12 Subpart C -- Manufacturers' Reports on Accidental Radiation Occurrences
21 CFR 1002.20 Reporting of accidental radiation occurrences.
(a) Manufacturers of electronic products shall, where reasonable
grounds for suspecting that such an incident has occurred, immediately
report to the Director, Center for Devices and Radiological Health, all
accidental radiation occurrences reported to or otherwise known to the
manufacturer and arising from the manufacturing, testing, or use of any
product introduced or intended to be introduced into commerce by such
manufacturer. Reasonable grounds include, but are not necessarily
limited to, professional, scientific, or medical facts or opinions
documented or otherwise, that conclude or lead to the conclusion that
such an incident has occurred.
(b) Such reports shall be addressed to the Director, Center for
Devices and Radiological Health, 5600 Fishers Lane, Rockville, MD 20857,
and the reports and their envelopes shall be distinctly marked ''Report
on 1002.20'' and shall contain all of the following information where
known to the manufacturer:
(1) The nature of the accidental radiation occurrence;
(2) The location at which the accidental radiation occurrence
occurred;
(3) The manufacturer, type, and model number of the electronic
product or products involved;
(4) The circumstances surrounding the accidental radiation
occurrence, including causes;
(5) The number of persons involved, adversely affected, or exposed
during the accidental radiation occurrence, the nature and magnitude of
their exposure and/or injuries and, if requested by the Director, Center
for Devices and Radiological Health, the names of the persons involved;
(6) The actions, if any, which may have been taken by the
manufacturer, to control, correct, or eliminate the causes and to
prevent reoccurrence; and
(7) Any other pertinent information with respect to the accidental
radiation occurrence.
(c) If a manufacturer is required to report to the Director under
paragraph (a) of this section and also is required to report under Part
803 of this chapter, the manufacturer shall report in accordance with
Part 803. If a manufacturer is required to report to the Director under
paragraph (a) of this section and is not required to report under Part
803, the manufacturer shall report in accordance with paragraph (a) of
this section.
(38 FR 28625, Oct. 15, 1973, as amended at 49 FR 36351, Sept. 14,
1984; 53 FR 11254, Apr. 6, 1988)
21 CFR 1002.20 Subpart D -- Manufacturers' Records
21 CFR 1002.30 Records to be maintained by manufacturers.
(a) Manufacturers of products listed under paragraphs (b) and (c) of
1002.61 shall establish and maintain the following records with respect
to such products:
(1) Description of the quality control procedures with respect to
electronic product radiation safety.
(2) Records of the results of tests for electronic product radiation
safety, including the control of unnecessary, secondary or leakage
electronic product radiation, the methods, devices, and procedures used
in such tests, and the basis for selecting such methods, devices, and
procedures.
(3) For those products displaying aging effects which may increase
electronic product radiation emission, records of the results of tests
for durability and stability of the product, and the basis for selecting
these tests.
(4) Copies of all written communications between the manufacturer and
dealers, distributors, and purchasers concerning radiation safety
including complaints, investigations, instructions, or explanations
affecting the use, repair, adjustment, maintenance, or testing of the
listed product.
(b) In addition to the records required by paragraph (a) of this
section, manufacturers of products listed in paragraph (c) of 1002.61
shall establish and maintain the following records with respect to such
products:
(1) A record of the manufacturer's distribution of products in a form
which will enable the tracing of specific products or production lots to
distributors or to dealers in those instances in which the manufacturer
distributes directly to dealers.
(2) Records received from dealers or distributors pursuant to
1002.41.
21 CFR 1002.31 Preservation and inspection of records.
(a) Every manufacturer required to maintain records pursuant to this
part, including records received pursuant to 1002.41, shall preserve
such records for a period of 5 years from the date of the record.
(b) Upon reasonable notice by an officer or employee duly designated
by the Department, manufacturers shall permit such officer or employee
to inspect appropriate books, records, papers, and documents as are
relevant to determining whether the manufacturer has acted or is acting
in compliance with Federal standards.
(c) Upon request of the Director, Center for Devices and Radiological
Health, a manufacturer of products listed in paragraph (c) of 1002.61
shall submit to the Director, copies of the records required to be
maintained by paragraph (b) of 1002.30.
(38 FR 28625, Oct. 15, 1973, as amended at 53 FR 11254, Apr. 6, 1988)
21 CFR 1002.31 Subpart E -- Dealer and Distributor Records
21 CFR 1002.40 Records to be obtained by dealers and distributors.
(a) Dealers and distributors of electronic products listed in
1002.61(c), for which there are applicable Federal standards under this
subchapter and for which the retail price is not less than $50, shall
obtain such information as is necessary to permit tracing of specific
products to specific purchasers.
(b) Such information shall include:
(1) The name and mailing address of the distributor, dealer, or
purchaser to whom the product was transferred.
(2) Identification and brand name of the product.
(3) Model number and serial or other identification number of the
product.
(4) Date of sale, award, or lease.
(c) The information obtained pursuant to this section shall be
forwarded immediately to the appropriate manufacturer of the electronic
product, or preserved as prescribed in 1002.41.
(38 FR 28625, Oct. 15, 1973, as amended at 42 FR 18063, Apr. 5, 1977)
21 CFR 1002.41 Disposition of records obtained by dealers and
distributors.
(a) Information obtained by dealers and distributors pursuant to
1002.40 shall immediately be forwarded to the appropriate manufacturer
unless:
(1) The dealer or distributor elects to hold and preserve such
information and to immediately furnish it to the manufacturer when
advised by the manufacturer or the Director, Center for Devices and
Radiological Health, that such information is required for purposes of
section 359 of the Act; and
(2) The dealer or distributor, upon making the election under
paragraph (a)(1) of this section, promptly notifies the manufacturer of
such election; such notification shall be in writing and shall identify
the dealer or distributor and the electronic product or products for
which the information is being accumulated and preserved.
(b) Every dealer or distributor who elects to hold and preserve
information required pursuant to 1002.40 shall preserve the information
for a period of 5 years from the date of the sale, award, or lease of
the product, or until the dealer or distributor discontinues dealing in,
or distributing the product, whichever is sooner. If the dealer or
distributor discontinues dealing in, or distributing the product, such
information as obtained pursuant to 1002.40 shall be furnished at that
time, or before, to the manufacturer of the product.
(38 FR 28625, Oct. 15, 1973, as amended at 42 FR 18063, Apr. 5, 1977;
53 FR 11254, Apr. 6, 1988)
21 CFR 1002.42 Confidentiality of records furnished by dealers and
distributors.
All information furnished to manufacturers by dealers and
distributors pursuant to this part shall be treated by such
manufacturers as confidential information which may be used only as
necessary to notify persons pursuant to section 359 of the Act.
21 CFR 1002.42 Subpart F -- Exemptions from Records and Reports Requirements
21 CFR 1002.50 Special exemptions.
(a) Manufacturers of electronic products listed under paragraphs (b)
and (c) of 1002.61 may submit to the Director, Center for Devices and
Radiological Health, with or subsequent to the submission of the initial
report required by 1002.10, a request, together with accompanying
justification, that a product be exempted from the annual reporting and
recordkeeping requirements. In addition to other information which may
be required, the justification must contain documented evidence showing
that the product or product type for which the exemption is requested:
(1) Cannot emit electronic product radiation in sufficient intensity
or of such quality under any conditions of use or product failure to be
hazardous; or
(2) Is produced in such small numbers as to negate the need for
continuous recordkeeping and reporting, and is to be used by trained
individuals who are knowledgeable of the hazards involved in such use.
(b) The Director, Center for Devices and Radiological Health, may
exempt manufacturers from all or part of the record and reporting
requirements of this part on the basis of information submitted in
accordance with paragraph (a) of this section or such other information
which he may possess or may require of the manufacturer if he determines
that such exemption is in keeping with the purposes of the Act.
(38 FR 28625, Oct. 15, 1973, as amended at 53 FR 11254, Apr. 6, 1988)
21 CFR 1002.51 Exemptions for manufacturers of products intended for
the U.S. Government.
Upon application therefor by the manufacturer, the Director, Center
for Devices and Radiological Health, may exempt from the provisions of
this part a manufacturer of any electronic product intended for use by
departments or agencies of the United States provided such department or
agency has prescribed procurement specifications governing emissions of
electronic product radiation and provided further that such product is
of a type used solely or predominantly by departments or agencies of the
United States.
(38 FR 28625, Oct. 15, 1973, as amended at 53 FR 11254, Apr. 6, 1988)
21 CFR 1002.51 Subpart G -- Codes for Reporting Listed Electronic Products
21 CFR 1002.61 List of specific product groups.
(a) Group A. (1) Ultrasonic products.
(2) Microwave heating equipment not listed in paragraph (c) of this
section.
(3) High voltage vacuum switches, high voltage rectifier tubes, shunt
regulator tubes, and cathode ray tubes which are intended to be operated
at voltages greater than 5,000 volts but less than 15,000 volts.
(4) Ultraviolet lamps and products containing such lamps intended for
irradiation of any part of the living human body by light of wavelength
in air less than 320 nanometers to perform a diagnostic or therapeutic
function.
(b) Group B. (1) Television receivers which, on or after the
effective date of this subpart, meet the Federal standard in effect on
June 1, 1971, provided also that the voltage on the cathode ray tube and
any other vacuum tube component cannot exceed 15,000 volts under the
test conditions required by the Federal standard at that time.
(2) High voltage vacuum switches, high voltage rectifier tubes, shunt
regulator tubes, and cathode ray tubes, which are intended to operate at
voltages of 15,000 volts or greater.
(c) Group C. (1) Products subject to Federal standards prescribed
under this subchapter except for television receivers described in
paragraph (b)(1) of this section.
(2) Products which are intended to produce x-radiation.
(3) Industrial dielectric heaters, including radiofrequency (RF)
sealers, and electromagnetic (EM) induction heating equipment that
operate in the frequency range from 2 megahertz to 500 megahertz.
(4) Microwave diathermy machines.
(38 FR 28625, Oct. 15, 1973, as amended at 40 FR 10175, Mar. 5, 1975;
41 FR 27316, July 2, 1976; 44 FR 65357, Nov. 9, 1979; 45 FR 47615,
July 15, 1980)
21 CFR 1002.61 PART 1003 -- NOTIFICATION OF DEFECTS OR FAILURE TO COMPLY
21 CFR 1002.61 Subpart A -- General Provisions
Sec.
1003.1 Applicability.
1003.2 Defect in an electronic product.
1003.5 Effect of regulations on other laws.
21 CFR 1002.61 Subpart B -- Discovery of Defect or Failure to Comply
1003.10 Discovery of defect or failure of compliance by manufacturer;
notice requirements.
1003.11 Determination by Secretary that product fails to comply or
has a defect.
21 CFR 1002.61 Subpart C -- Notification
1003.20 Notification by the manufacturer to the Secretary.
1003.21 Notification by the manufacturer to affected persons.
1003.22 Copies of communications sent to purchasers, dealers, or
distributors.
21 CFR 1002.61 Subpart D -- Exemptions from Notification Requirements
1003.30 Application for exemption from notification requirements.
1003.31 Granting the exemption.
Authority: Secs. 354-360F of the Public Health Service Act (42
U.S.C. 263b-263n).
Source: 38 FR 28628, Oct. 15, 1973, unless otherwise noted.
21 CFR 1002.61 Subpart A -- General Provisions
21 CFR 1003.1 Applicability.
The provisions of this part are applicable to electronic products
which were manufactured after October 18, 1968.
21 CFR 1003.2 Defect in an electronic product.
For the purpose of this part, an electronic product shall be
considered to have a defect which relates to the safety of use by reason
of the emission of electronic product radiation if:
(a) It is a product which does not utilize the emission of electronic
product radiation in order to accomplish its purpose, and from which
such emissions are unintended, and as a result of its design, production
or assembly;
(1) It emits electronic product radiation which creates a risk of
injury, including genetic injury, to any person, or
(2) It fails to conform to its design specifications relating to
electronic radiation emissions; or
(b) It is a product which utilizes electronic product radiation to
accomplish its primary purpose and from which such emissions are
intended, and as a result of its design, production or assembly it;
(1) Fails to conform to its design specifications relating to the
emission of electronic product radiation; or
(2) Without regard to the design specifications of the product, emits
electronic product radiation unnecessary to the accomplishment of its
primary purpose which creates a risk of injury, including genetic injury
to any person; or
(3) Fails to accomplish the intended purpose.
21 CFR 1003.5 Effect of regulations on other laws.
The remedies provided for in this subchapter shall be in addition to
and not in substitution for any other remedies provided by law and shall
not relieve any person from liability at common law or under statutory
law.
21 CFR 1003.5 Subpart B -- Discovery of Defect or Failure to Comply
21 CFR 1003.10 Discovery of defect or failure of compliance by
manufacturer; notice requirements.
Any manufacturer who discovers that any electronic product produced,
assembled, or imported by him, which product has left its place of
manufacture, has a defect or fails to comply with an applicable Federal
standard shall:
(a) Immediately notify the Secretary in accordance with 1003.20, and
(b) Except as authorized by 1003.30, furnish notification with
reasonable promptness to the following persons:
(1) The dealers or distributors to whom such product was delivered by
the manufacturer; and
(2) The purchaser of such product and any subsequent transferee of
such product (where known to the manufacturer or where the manufacturer
upon reasonable inquiry to dealers, distributors, or purchasers can
identify the present user).
(c) If a manufacturer is required to notify the Secretary under
paragraph (a) of this section and also is required to report to the Food
and Drug Administration under Part 803 of this chapter, the manufacturer
shall report in accordance with Part 803. If a manufacturer is required
to notify the Secretary under paragraph (a) of this section and is not
required to report to the Food and Drug Administration under Part 803,
the manufacturer shall notify the Secretary in accordance with paragraph
(a) of this section.
(38 FR 28628, Oct. 15, 1973 and 49 FR 36351, Sept. 14, 1984)
21 CFR 1003.11 Determination by Secretary that product fails to comply
or has a defect.
(a) If, the Secretary, through testing, inspection, research, or
examination of reports or other data, determines that any electronic
product does not comply with an applicable Federal standard issued
pursuant to the Act or has a defect, he shall immediately notify the
manufacturer of the product in writing specifying:
(1) The defect in the product or the manner in which the product
fails to comply with the applicable Federal standard;
(2) The Secretary's findings, with references to the tests,
inspections, studies, or reports upon which such findings are based;
(3) A reasonable period of time during which the manufacturer may
present his views and evidence to establish that there is no failure of
compliance or that the alleged defect does not exist or does not relate
to safety of use of the product by reason of the emission of electronic
product radiation.
The manufacturer shall have an opportunity for a regulatory hearing
before the Food and Drug Administration pursuant to Part 16 of this
chapter.
(b) Every manufacturer who receives a notice under paragraph (a) of
this section shall immediately advise the Secretary in writing of the
total number of such product units produced and the approximate number
of such product units which have left the place of manufacture.
(c) If, after the expiration of the period of time specified in the
notice, the Secretary determines that the product has a defect or does
not comply with an applicable Federal standard and the manufacturer has
not applied for an exemption, he shall direct the manufacturer to
furnish the notification to the persons specified in 1003.10(b) in the
manner specified in 1003.21. The manufacturer shall within 14 days from
the date of receipt of such directive furnish the required notification.
(38 FR 28628, Oct. 15, 1973, as amended at 41 FR 48269, Nov. 2, 1976;
42 FR 15676, Mar. 22, 1977)
21 CFR 1003.11 Subpart C -- Notification
21 CFR 1003.20 Notification by the manufacturer to the Secretary.
The notification to the Secretary required by 1003.10(a) shall be
confirmed in writing and, in addition to other relevant information
which the Secretary may require, shall include the following:
(a) Identification of the product or products involved;
(b) The total number of such product units so produced, and the
approximate number of such product units which have left the place of
manufacture;
(c) The expected usage for the product if known to the manufacturer;
(d) A description of the defect in the product or the manner in which
the product fails to comply with an applicable Federal standard;
(e) An evaluation of the hazards reasonably related to defect or the
failure to comply with the Federal standard;
(f) A statement of the measures to be taken to repair such defect or
to bring the product into compliance with the Federal standard;
(g) The date and circumstances under which the defect was discovered;
and
(h) The identification of any trade secret information which the
manufacturer desires kept confidential.
21 CFR 1003.21 Notification by the manufacturer to affected persons.
(a) The notification to the persons specified in 1003.10(b) shall be
in writing and, in addition to other relevant information which the
Secretary may require, shall include:
(1) The information prescribed by 1003.20 (a), (d), and instructions
with respect to the use of the product pending the correction of the
defect;
(2) A clear evaluation in nontechnical terms of the hazards
reasonably related to any defect or failure to comply; and
(3) The following statement:
The manufacturer will, without charge, remedy the defect or bring the
product into compliance with each applicable Federal standard in
accordance with a plan to be approved by the Secretary of Health and
Human Services, the details of which will be included in a subsequent
communication to you.
Provided, That if at the time the notification is sent, the Secretary
has approved a plan for the repair, replacement or refund of the
product, the notification may include the details of the approved plan
in lieu of the above statement.
(b) The envelope containing the notice shall not contain advertising
or other extraneous material, and such mailings will be made in
accordance with this section.
(1) No. 10 white envelopes shall be used, and the name and address
of the manufacturer shall appear in the upper left corner of the
envelope.
(2) The following statement is to appear in the far left third of the
envelope in the type and size indicated and in reverse printing,
centered in a red rectangle 3 3/4 inches wide and 2 1/4 inches high:
The statement shall be in three lines, all capitals, and centered.
''Important'' shall be in 36-point Gothic Bold type. ''Electronic
Product'' and ''Radiation Warning'' shall be in 36-point Gothic
Condensed type.
(3) Envelopes with markings similar to those prescribed in this
section shall not be used by manufacturers for mailings other than those
required by this part.
(c) The notification shall be sent:
(1) By certified mail to purchasers of the product and to subsequent
transferees.
(2) By certified mail or other more expeditious means to dealers and
distributors.
(d) Where products were sold under a name other than that of the
manufacturer of the product, the name of the individual or company under
whose name the product was sold may be used in the notification required
by this section.
21 CFR 1003.22 Copies of communications sent to purchasers, dealers or
distributors.
(a) Every manufacturer of electronic products shall furnish to the
Secretary a copy of all notices, bulletins, or other communications sent
to the dealers or distributors of such manufacturers or to purchasers
(or subsequent transferees) of electronic products of such manufacturer
regarding any defect in such product or any failure of such product to
comply with an applicable Federal standard.
(b) In the event the Secretary deems the content of such notices to
be insufficient to protect the public health and safety, the Secretary
may require additional notice to such recipients, or may elect to make
or cause to be made such notification by whatever means he deems
appropriate.
21 CFR 1003.22 Subpart D -- Exemptions From Notification Requirements
21 CFR 1003.30 Application for exemption from notification
requirements.
(a) A manufacturer may at the time of giving the written confirmation
required by 1003.20 or within 15 days of the receipt of any notice from
the Secretary pursuant to 1003.11(a), apply for an exemption from the
requirement of notice to the persons specified in 1003.10(b).
(b) The application for exemption shall contain the information
required by 1003.20 and in addition shall set forth in detail the
grounds upon which the exemption is sought.
21 CFR 1003.31 Granting the exemption.
(a) If, in the judgment of the Secretary, the application filed
pursuant to 1003.30 states reasonable grounds for an exemption from the
requirement of notice, the Secretary shall give the manufacturer written
notice specifying a reasonable period of time during which he may
present his views and evidence in support of the application.
(b) Such views and evidence shall be confined to matters relevant to
whether the defect in the product or its failure to comply with an
applicable Federal standard is such as to create a significant risk of
injury, including genetic injury, to any person and shall be presented
in writing unless the Secretary determines that an oral presentation is
desirable. Where such evidence includes nonclinical laboratory studies,
the data submitted shall include, with respect to each such study,
either a statement that the study was conducted in compliance with the
requirements set forth in Part 58 of this chapter, or, if the study was
not conducted in compliance with such regulations, a brief statement of
the reason for the noncompliance. When such evidence includes clinical
investigations involving human subjects, the data submitted shall
include, with respect to each clinical investigation either a statement
that each investigation was conducted in compliance with the
requirements set forth in Part 56 of this chapter, or a statement that
the investigation is not subject to such requirements in accordance with
56.104 or 56.105, and a statement that each investigation was
conducted in compliance with the requirements set forth in Part 50 of
this chapter.
(c) If, during the period of time afforded the manufacturer to
present his views and evidence, the manufacturer proves to the
Secretary's satisfaction that the defect or failure to comply does not
create a significant risk of injury, including genetic injury, to any
person, the Secretary shall issue an exemption from the requirement of
notification to the manufacturer and shall notify the manufacturer in
writing specifying:
(1) The electronic product or products for which the exemption has
been issued; and
(2) Such conditions as the Secretary deems necessary to protect the
public health and safety.
(d) Any person who contests denial of an exemption shall have an
opportunity for a regulatory hearing before the Food and Drug
Administration pursuant to Part 16 of this chapter.
(38 FR 28628, Oct. 15, 1973, as amended at 41 FR 48269, Nov. 2, 1976;
42 FR 15676, Mar. 22, 1977; 50 FR 7518, Feb. 22, 1985)
21 CFR 1003.31 PART 1004 -- REPURCHASE, REPAIRS, OR REPLACEMENT OF
ELECTRONIC PRODUCTS
Sec.
1004.1 Manufacturer's obligation to repair, replace, or refund cost
of electronic products.
1004.2 Plans for the repair of electronic products.
1004.3 Plans for the replacement of electronic products.
1004.4 Plans for refunding the cost of electronic products.
1004.6 Approval of plans.
Authority: Secs. 354-360F of the Public Health Service Act (42
U.S.C. 263b-263n).
Source: 38 FR 28629, Oct. 15, 1973, unless otherwise noted.
21 CFR 1004.1 Manufacturer's obligation to repair, replace, or refund
cost of electronic products.
(a) If any electronic product fails to comply with an applicable
Federal standard or has a defect and the notification specified in
1003.10(b) of this chapter is required to be furnished, the manufacturer
of such product shall;
(1) Without charge, bring such product into conformity with such
standard or remedy such defect and provide reimbursement for any
expenses for transportation of such product incurred in connection with
having such product brought into conformity or having such defect
remedied; or
(2) Replace such product with a like or equivalent product which
complies with each applicable Federal standard and which has no defect
relating to the safety of its use; or
(3) Make a refund of the cost of the product to the purchaser.
(b) The manufacturer shall take the action required by this section
in accordance with a plan approved by the Secretary pursuant to 1004.6.
21 CFR 1004.2 Plans for the repair of electronic products.
Every plan for bringing an electronic product into conformity with
applicable Federal standards or for remedying any defect in such product
shall be submitted to the Secretary in writing, and in addition to other
relevant information which the Secretary may require, shall include:
(a) Identification of the product involved.
(b) The approximate number of defective product units which have left
the place of manufacture.
(c) The specific modifications, alterations, changes, repairs,
corrections, or adjustments to be made to bring the product into
conformity or remedy any defect.
(d) The manner in which the operations described in paragraph (c)
will be accomplished, including the procedure for obtaining access to,
or possession of, the products and the location where such operations
will be performed.
(e) The technical data, test results or studies demonstrating the
effectiveness of the proposed remedial action.
(f) A time limit, reasonable in light of the circumstances, for
completion of the operations.
(g) The system by which the manufacturer will provide reimbursement
for any transportation expenses incurred in connection with having such
product brought into conformity or having any defect remedied.
(h) The text of the statement which the manufacturer will send to the
persons specified in 1003.10(b) of this chapter informing such persons;
(1) That the manufacturer, at his expense, will repair the electronic
product involved,
(2) Of the method by which the manufacturer will obtain access to or
possession of the product to make such repairs,
(3) That the manufacturer will reimburse such persons for any
transportation expenses incurred in connection with making such repairs,
and
(4) Of the manner in which such reimbursement will be effected.
(i) An assurance that the manufacturer will provide the Secretary
with progress reports on the effectiveness of the plan, including the
number of electronic products repaired.
21 CFR 1004.3 Plans for the replacement of electronic products.
Every plan for replacing an electronic product with a like or
equivalent product shall be submitted to the Secretary in writing, and
in addition to other relevant information which the Secretary may
require, shall include:
(a) Identification of the product to be replaced.
(b) A description of the replacement product in sufficient detail to
support the manufacturer's contention that the replacement product is
like or equivalent to the product being replaced.
(c) The approximate number of defective product units which have left
the place of manufacture.
(d) The manner in which the replacement operation will be effected
including the procedure for obtaining possession of the product to be
replaced.
(e) A time limit, reasonable, in light of the circumstances for
completion of the replacement.
(f) The steps which the manufacturer will take to insure that the
defective product will not be reintroduced into commerce, until it
complies with each applicable Federal standard and has no defect
relating to the safety of its use.
(g) The system by which the manufacturer will provide reimbursement
for any expenses for transportation of such product incurred in
connection with effecting the replacement.
(h) The text of the statement which the manufacturer will send to the
persons specified in 1003.10(b) of this chapter informing such persons;
(1) That the manufacturer, at its expense, will replace the
electronic product involved,
(2) Of the method by which the manufacturer will obtain possession of
the product and effect the replacement,
(3) That the manufacturer will reimburse such persons for any
transportation expenses incurred in connection with effecting such
replacement, and
(4) Of the manner in which such reimbursement will be made.
(i) An assurance that the manufacturer will provide the Secretary
with progress reports on the effectiveness of the plan, including the
number of electronic products replaced.
21 CFR 1004.4 Plans for refunding the cost of electronic products.
Every plan for refunding the cost of an electronic product shall be
submitted to the Secretary in writing, and in addition to other relevant
information which the Secretary may require, shall include:
(a) Identification of the product involved.
(b) The approximate number of defective product units which have left
the place of manufacture.
(c) The manner in which the refund operation will be effected
including the procedure for obtaining possession of the product for
which the refund is to be made.
(d) The steps which the manufacturer will take to insure that the
defective products will not be reintroduced into commerce, until it
complies with each applicable Federal standard and has no defect
relating to the safety of its use.
(e) A time limit, reasonable in light of the circumstances, for
obtaining the product and making the refund.
(f) A statement that the manufacturer will refund the cost of such
product together with the information the manufacturer has used to
determine the amount of the refund.
(g) The text of the statement which the manufacturer will send to the
persons specified in 1003.10(b) of this chapter informing such persons;
(1) That the manufacturer, at his expense, will refund the cost of
the electronic product plus any transportation costs,
(2) Of the amount to be refunded exclusive of transportation costs,
(3) Of the method by which the manufacturer will obtain possession of
the product and make the refund.
(h) An assurance that the manufacturer will provide the Secretary
with progress reports on the effectiveness of the plan, including the
number of refunds made.
21 CFR 1004.6 Approval of plans.
If, after review of any plan submitted pursuant to this subchapter,
the Secretary determines that the action to be taken by the manufacturer
will expeditiously and effectively fulfill the manufacturer's obligation
under 1004.1 in a manner designed to encourage the public to respond to
the proposal, the Secretary will send written notice of his approval of
such plan to the manufacturer. Such approval may be conditioned upon
such additional terms as the Secretary deems necessary to protect the
public health and safety. Any person who contests denial of a plan
shall have an opportunity for a regulatory hearing before the Food and
Drug Administration pursuant to Part 16 of this chapter.
(38 FR 28629, Oct. 15, 1973, as amended at 41 FR 48269, Nov. 2, 1976;
42 FR 15676, Mar. 22, 1977)
21 CFR 1004.6 PART 1005 -- IMPORTATION OF ELECTRONIC PRODUCTS
21 CFR 1004.6 Subpart A -- General Provisions
Sec.
1005.1 Applicability.
1005.2 Definitions.
1005.3 Importation of noncomplying goods prohibited.
21 CFR 1004.6 Subpart B -- Inspection and Testing
1005.10 Notice of sampling.
1005.11 Payment for samples.
21 CFR 1004.6 Subpart C -- Bonding and Compliance Procedures
1005.20 Hearing.
1005.21 Application for permission to bring product into compliance.
1005.22 Granting permission to bring product into compliance.
1005.23 Bonds.
1005.24 Costs of bringing product into compliance.
1005.25 Service of process on manufacturers.
Authority: Secs. 356, 360 of the Public Health Service Act (42
U.S.C. 263d, 263h).
Source: 38 FR 28630, Oct. 15, 1973, unless otherwise noted.
21 CFR 1004.6 Subpart A -- General Provisions
21 CFR 1005.1 Applicability.
(a) The provisions of 1005.1 through 1005.24 are applicable to
electronic products which are subject to the standards prescribed under
this subchapter and are offered for importation into the United States.
(b) Section 1005.25 is applicable to every manufacturer of electronic
products offering an electronic product for importation into the United
States.
(38 FR 28630, Oct. 15, 1973, as amended at 45 FR 81739, Dec. 12,
1980)
21 CFR 1005.2 Definitions.
As used in this part:
The term ''owner'' or ''consignee'' means the person who has the
rights of a consignee under the provisions of sections 483, 484, and 485
of the Tariff Act of 1930, as amended (19 U.S.C. 1483, 1484, 1485).
21 CFR 1005.3 Importation of noncomplying goods prohibited.
The importation of any electronic product for which standards have
been prescribed under section 358 of the Act (42 U.S.C. 263f) shall be
refused admission into the United States unless there is affixed to such
product a certification in the form of a label or tag in conformity with
section 358(h) of the Act (42 U.S.C. 263f(h)). Merchandise refused
admission shall be destroyed or exported under regulations prescribed by
the Secretary of the Treasury unless a timely and adequate petition for
permission to bring the product into compliance is filed and granted
under 1005.21 and 1005.22.
21 CFR 1005.3 Subpart B -- Inspection and Testing
21 CFR 1005.10 Notice of sampling.
When a sample of a product to be offered for importation has been
requested by the Secretary, the District Director of Customs having
jurisdiction over the shipment shall, upon the arrival of the shipment,
procure the sample and shall give to its owner or consignee prompt
notice of the delivery or of the intention to deliver such sample to the
Secretary. If the notice so requires, the owner or consignee will hold
the shipment of which the sample is typical and not release such
shipment until he receives notice of the results of the tests of the
sample from the Secretary, stating that the product is in compliance
with the requirements of the Act. The District Director of Customs will
be given the results of the tests. If the Secretary notifies the
District Director of Customs that the product does not meet the
requirements of the Act, the District Director of Customs shall require
the exportation or destruction of the shipment in accordance with
customs laws.
21 CFR 1005.11 Payment for samples.
The Department of Health and Human Services will pay for all import
samples of electronic products rendered unsalable as a result of
testing, or will pay the reasonable costs of repackaging such samples
for sale, if the samples are found to be in compliance with the
requirements of the Radiation Control for Health and Safety Act of 1968.
Billing for reimbursement shall be made by the owner or consignee to
the Center for Devices and Radiological Health, 5600 Fishers Lane,
Rockville, MD 20857. Payment for samples will not be made if the sample
is found to be in violation of the Act, even though subsequently brought
into compliance pursuant to terms specified in a notice of permission
issued under 1005.22.
(38 FR 28630, Oct. 15, 1973, as amended at 53 FR 11254, Apr. 6, 1988)
21 CFR 1005.11 Subpart C -- Bonding and Compliance Procedures
21 CFR 1005.20 Hearing.
(a) If, from an examination of the sample or otherwise, it appears
that the product may be subject to a refusal of admission, the Secretary
shall give the owner or consignee a written notice to that effect,
stating the reasons therefor. The notice shall specify a place and a
period of time during which the owner or consignee shall have an
opportunity to introduce testimony unless the owner or consignee
indicates his intention to bring the product into compliance. Upon
timely request, such time and place may be changed. Such testimony
shall be confined to matters relevant to the admissibility of the
article and may be introduced orally or in writing.
(b) If the owner or consignee submits or indicates his intention to
submit an application for permission to perform such action as is
necessary to bring the product into compliance with the Act, such
application shall include the information required by 1005.21.
(c) If the application is not submitted at or prior to the hearing,
the Secretary may allow a reasonable time for filing such application.
21 CFR 1005.21 Application for permission to bring product into
compliance.
Application for permission to perform such action as is necessary to
bring the product into compliance with the Act may be filed only by the
owner, consignee, or manufacturer and, in addition to any other
information which the Secretary may reasonably require, shall:
(a) Contain a detailed proposal for bringing the product into
compliance with the Act;
(b) Specify the time and place where such operations will be effected
and the approximate time for their completion; and
(c) Identify the bond required to be filed pursuant to 1005.23.
21 CFR 1005.22 Granting permission to bring product into compliance.
(a) When permission contemplated by 1005.21 is granted, the
Secretary shall notify the applicant in writing, specifying:
(1) The procedure to be followed;
(2) The disposition of the rejected articles or portions thereof;
(3) That the operations are to be carried out under the supervision
of a representative of the Department of Health and Human Services;
(4) A reasonable time limit for completing the operations; and
(5) Such other conditions as he finds necessary to maintain adequate
supervision and control over the product.
(b) Upon receipt of a written request for an extension of time to
complete the operations necessary to bring the product into compliance,
the Secretary may grant such additional time as he deems necessary.
(c) The notice of permission may be amended upon a showing of
reasonable grounds thereof and the filing of an amended application for
permission with the Secretary.
(d) If ownership of a product included in a notice of permission
changes before the operations specified in the notice have been
completed, the original owner will remain responsible under its bond,
unless the new owner has executed a superseding bond on customs Form
7601 and obtained a new notice.
(e) The Secretary will notify the District Director of Customs having
jurisdiction over the shipment involved, of the determination as to
whether or not the product has in fact been brought into compliance with
the Act.
21 CFR 1005.23 Bonds.
The bond required under section 360(b) of the Act shall be executed
by the owner or consignee on the appropriate form of a customs
single-entry bond, customs Form 7551 or term bond, customs Form 7553 or
7595, containing a condition for the redelivery of the shipment or any
part thereof not complying with the laws and regulations governing its
admission into the commerce of the United States upon demand of the
District Director of Customs and containing a provision for the
performance of any action necessary to bring the product into compliance
with all applicable laws and regulations. The bond shall be filed with
the District Director of Customs.
21 CFR 1005.24 Costs of bringing product into compliance.
The costs of supervising the operations necessary to bring a product
into compliance with the Act shall be paid by the owner or consignee who
files an application pursuant to 1005.21 and executes a bond under
section 360(b) of the Act. Such costs shall include:
(a) Travel expenses of the supervising officer;
(b) Per diem in lieu of subsistence of the supervising officer when
away from his home station, as provided by law;
(c) Service fees: (1) The charge for the services of the supervising
officer, which shall include administrative support, shall be computed
at a rate per hour equal to 266 percent of the hourly rate of regular
pay of a grade GS-11/4 employee, except that such services performed by
a customs officer and subject to the provisions of the act of February
13, 1911, as amended (sec. 5, 36 Stat. 901, as amended (19 U.S.C. 267)),
shall be calculated as provided in that act.
(2) The charge for the services of the analyst, which shall include
administrative and laboratory support, shall be computed at a rate per
hour equal to 266 percent of the hourly rate of regular pay of a grade
GS-12/4 employee.
(3) The rate per hour equal to 266 percent of the equivalent hourly
rate of regular pay of the supervising officer (GS-11/4) and the analyst
(GS-12/4) is computed as follows:
Note: Ratio of equivalent gross annual number of working hours
charged to Food and Drug appropriation to net number of annual working
hours (4512/1696)=266 pct.
(d) The minimum charge for services of supervising officers shall be
not less than the charge for 1 hour and time after the first hour shall
be computed in multiples of 1 hour, disregarding fractional parts less
than one-half hour.
(38 FR 28630, Oct. 15, 1973, as amended at 42 FR 55207, Oct. 14,
1977; 42 FR 62130, Dec. 9, 1977)
21 CFR 1005.25 Service of process on manufacturers.
(a) Every manufacturer of electronic products, prior to offering such
product for importation into the United States, shall designate a
permanent resident of the United States as the manufacturer's agent upon
whom service of all processes, notices, orders, decisions, and
requirements may be made for and on behalf of the manufacturer as
provided in section 360(d) of the Radiation Control for Health and
Safety Act of 1968 (42 U.S.C. 263h(d)) and this section. The agent may
be an individual, a firm, or a domestic corporation. For purposes of
this section, any number of manufacturers may designate the same agent.
(b) The designation shall be addressed to the Center for Devices and
Radiological Health, 5600 Fishers Lane, Rockville, MD 20857. It shall
be in writing and dated; all signatures shall be in ink. The
designation shall be made in the legal form required to make it valid
and binding on the manufacturer under the laws, corporate bylaws, or
other requirements governing the making of the designation by the
manufacturer at the place and time where it is made, and the persons or
person signing the designation shall certify that it is so made. The
designation shall disclose the manufacturer's full legal name and the
name(s) under which he conducts his business, if applicable, his
principal place of business, and mailing address. If any of the
products of the manufacturer do not bear his legal name, the designation
shall identify the marks, trade names, or other designations of origin
which these products bear. The designation shall provide that it will
remain in effect until withdrawn or replaced by the manufacturer and
shall bear a declaration of acceptance duly signed by the designated
agent. The full legal name and mailing address of the agent shall be
stated. Until rejected by the Secretary, designations are binding on
the manufacturer even when not in compliance with all the requirements
of this section. The designated agent may not assign performance of his
function under the designation to another.
(c) Service of any process, notice, order, requirement, or decision
specified in section 360(d) of the Radiation Control for Health and
Safety Act of 1968 may be made by registered or certified mail addressed
to the agent with return receipt requested, or in any other manner
authorized by law. In the absence of such a designation or if for any
reason service on the designated agent cannot be effected, service may
be made as provided in section 360(d) by posting such process, notice,
order, requirement, or decision in the Office of the Director, Center
for Devices and Radiological Health and publishing a notice that such
service was made in the Federal Register.
(38 FR 28630, Oct. 15, 1973, as amended at 53 FR 11254, Apr. 6, 1988)
21 CFR 1005.25 PART 1010 -- PERFORMANCE STANDARDS FOR ELECTRONIC PRODUCTS: GENERAL
21 CFR 1005.25 Subpart A -- General Provisions
Sec.
1010.1 Scope.
1010.2 Certification.
1010.3 Identification.
1010.4 Variances.
1010.5 Exemptions for products intended for United States Government
use.
21 CFR 1005.25 Subpart B -- Alternate Test Procedures
1010.13 Special test procedures.
21 CFR 1005.25 Subpart C -- Exportation of Electronic Products
1010.20 Electronic products intended for export.
Authority: Secs. 501, 502, 510, 515-520, 701, 801 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 351, 352, 360, 360e-360j, 371,
381); secs. 354-360F of the Public Health Service Act (42 U.S.C.
263b-263n).
Source: 38 FR 28631, Oct. 15, 1973, unless otherwise noted.
21 CFR 1005.25 Subpart A -- General Provisions
21 CFR 1010.1 Scope.
The standards listed in this subchapter are prescribed pursuant to
section 358 of the Radiation Control for Health and Safety Act of 1968
(42 U.S.C. 263f) and are applicable to electronic products as specified
herein, to control electronic product radiation from such products.
Standards so prescribed are subject to amendment or revocation and
additional standards may be prescribed as are determined necessary for
the protection of the public health and safety.
(40 FR 32257, July 31, 1975)
21 CFR 1010.2 Certification.
(a) Every manufacturer of an electronic product for which an
applicable standard is in effect under this subchapter shall furnish to
the dealer or distributor, at the time of delivery of such product, the
certification that such product conforms to all applicable standards
under this subchapter.
(b) The certification shall be in the form of a label or tag
permanently affixed to or inscribed on such product so as to be legible
and readily accessible to view when the product is fully assembled for
use, unless the applicable standard prescribes some other manner of
certification. All such labels or tags shall be in the English
language.
(c) Such certification shall be based upon a test, in accordance with
the standard, of the individual article to which it is attached or upon
a testing program which is in accordance with good manufacturing
practices. The Director, Center for Devices and Radiological Health may
disapprove such a testing program on the grounds that it does not assure
the adequacy of safeguards against hazardous electronic product
radiation or that it does not assure that electronic products comply
with the standards prescribed under this subchapter.
(d) In the case of products for which it is not feasible to certify
in accordance with paragraph (b) of this section, upon application by
the manufacturer, the Director, Center for Devices and Radiological
Health may approve an alternate means by which such certification may be
provided.
(38 FR 28631, Oct. 15, 1973, as amended at 40 FR 32257, July 31,
1975; 42 FR 18063, Apr. 5, 1977; 53 FR 11254, Apr. 6, 1988)
21 CFR 1010.3 Identification.
(a) Every manufacturer of an electronic product to which a standard
under this subchapter is applicable shall set forth the information
specified in paragraphs (a)(1) and (2) of this section. This
information shall be provided in the form of a tag or label permanently
affixed or inscribed on such product so as to be legible and readily
accessible to view when the product is fully assembled for use or in
such other manner as may be prescribed in the applicable standard.
Except for foreign equivalent abbreviations as authorized in paragraph
(a)(1) of this section all such labels or tags shall be in the English
language.
(1) The full name and address of the manufacturer of the product;
abbreviations such as ''Co.,'' ''Inc.,'' or their foreign equivalents
and the first and middle initials of individuals may be used. Where
products are sold under a name other than that of the manufacturer of
the product, the full name and address of the individual or company
under whose name the product was sold may be set forth, provided such
individual or company has previously suppled the Director, Center for
Devices and Radiological Health with sufficient information to identify
the manufacturer of the product.
(2) The place and month and year of manufacture:
(i) The place of manufacture may be expressed in code provided the
manufacturer has previously supplied the Director, Center for Devices
and Radiological Health with the key to such code.
(ii) The month and year of manufacture shall be provided clearly and
legibly, without abbreviation, and with the year shown as a four-digit
number as follows:
(b) In the case of products for which it is not feasible to affix
identification labeling in accordance with paragraph (a) of this
section, upon application by the manufacturer, the Director, Center for
Devices and Radiological Health may approve an alternate means by which
such identification may be provided.
(c) Every manufacturer of an electronic product to which a standard
under this subchapter is applicable shall provide to the Director,
Center for Devices and Radiological Health a list identifying each brand
name which is applied to the product together with the full name and
address of the individual or company for whom each product so branded is
manufactured.
(40 FR 32257, July 31, 1975, as amended at 42 FR 18063, Apr. 5, 1977;
53 FR 11254, Apr. 6, 1988)
21 CFR 1010.4 Variances.
(a) Criteria for variances. (1) Upon application by a manufacturer
(including an assembler), the Director, Center for Devices and
Radiological Health, Food and Drug Administration, may grant a variance
from one or more provisions of any performance standard under Subchapter
J of this chapter for an electronic product subject to such standard
when the Director determines that granting such a variance is in keeping
with the purposes of the Radiation Control for Health and Safety Act of
1968, and:
(i) The scope of the requested variance is so limited in its
applicability as not to justify an amendment to the standard, or
(ii) There is not sufficient time for the promulgation of an
amendment to the standard.
(2) The issuance of the variance shall be based upon a determination
that:
(i) The product utilizes an alternate means for providing radiation
safety or protection equal to or greater than that provided by products
meeting all requirements of the applicable standard, or
(ii) The product performs a function or is intended for a purpose
which could not be performed or accomplished if required to meet the
applicable standards, and suitable means for assuring radiation safety
or protection are provided, or
(iii) One or more requirements of the applicable standard are not
appropriate, and suitable means for assuring radiation safety or
protection are provided.
(b) Applications for variances. Applications for variances or for
amendments or extensions thereof shall be submitted in an original and
two copies to the Dockets Management Branch (HFA-305), Food and Drug
Administration, Rm 4-62, Parklawn Building, 5600 Fishers Lane,
Rockville, MD 20857.
(1) The application for variance shall include the following
information:
(i) A description of the product and its intended use.
(ii) An explanation of how compliance with the applicable standard
would restrict or be inappropriate for this intended use.
(iii) A description of the manner in which it is proposed to deviate
from the requirements of the applicable standard.
(iv) A description of the advantages to be derived from such
deviation.
(v) An explanation of how alternate or suitable means of radiation
protection will be provided.
(vi) The period of time it is desired that the variance be in effect,
and, if appropriate, the number of units the applicant wishes to
manufacture.
(vii) In the case of prototype or experimental equipment, the
proposed location of each unit.
(viii) Such other information required by regulation or by the
Director, Center for Devices and Radiological Health, to evaluate and
act on the application.
(ix) With respect to each nonclinical laboratory study contained in
the application, either a statement that the study was conducted in
compliance with the good laboratory practice regulations set forth in
Part 58 of this chapter, or, if the study was not conducted in
compliance with such regulations, a brief statement of the reason for
the noncompliance.
(x) (Reserved)
(xi) If the electronic product is used in a clinical investigation
involving human subjects, is subject to the requirements for
institutional review set forth in Part 56 of this chapter, and is
subject to the requirements for informed consent set forth in Part 50 of
this chapter, the investigation shall be conducted in compliance with
such requirements.
(2) The application for amendment or extension of a variance shall
include the following information:
(i) The variance number and expiration date.
(ii) The amendment or extension requested and basis for the amendment
or extension.
(iii) A description of the effect of the amendment or extension on
protection from radiation produced by the product.
(iv) An explanation of how alternate or suitable means of protection
will be provided.
(c) Ruling on applications. (1) The Director, Center for Devices and
Radiological Health, may approve or deny, in whole or in part, a
requested variance or any amendment or extension thereof, and the
director shall inform the applicant in writing of this action on a
requested variance or amendment or extension. The written notice will
state the manner in which the variance differs from the standard, the
effective date and the termination date of the variance, a summary of
the requirements and conditions attached to the variance, any other
information that may be relevant to the application or variance, and, if
appropriate, the number of units or other similar limitations for which
the variance is approved. Each variance will be assigned an identifying
number.
(2) The Director, Center for Devices and Radiological Health, shall
amend or withdraw a variance whenever the Director determines that this
action is necessary to protect the public health or otherwise is
justified by this subchapter. Such action will become effective on the
date specified in the written notice of the action sent to the
applicant, except that it will become effective immediately upon
notification to the applicant when the Director determines that such
action is necessary to prevent an imminent health hazard.
(3) All applications for variances and for amendments and extensions
thereof and all correspondence (including written notices of approval)
on these applications will be available for public disclosure in the
office of the Dockets Management Branch, except for information regarded
as confidential under section 360A(e) of the act.
(d) Certification of equipment covered by variance. The manufacturer
of any product for which a variance is granted shall modify the tag,
label, or other certification required by 1010.2 to state:
(1) That the product is in conformity with the applicable standard,
except with respect to those characteristics covered by the variance;
(2) That the product is in conformity with the provisions of the
variance; and
(3) The assigned number and effective date of the variance.
(39 FR 13879, Apr. 18, 1974, as amended at 44 FR 48191, Aug. 17,
1979; 50 FR 7518, Feb. 22, 1985; 50 FR 13565, Apr. 5, 1985; 53 FR
11254, Apr. 6, 1988; 53 FR 52683, Dec. 29, 1988)
21 CFR 1010.5 Exemptions for products intended for United States
Government use.
(a) Criteria for exemption. Upon application by a manufacturer
(including assembler) or by a U.S. department or agency, the Director,
Center for Devices and Radiological Health, Food and Drug
Administration, may grant an exemption from any performance standard
under Subchapter J of this chapter for an electronic product, or class
of products, otherwise subject to such standard when he determines that
such electronic product or class is intended for use by departments or
agencies of the United States and meets the criteria set forth in
paragraph (a) (1) or (2) of this section.
(1) The procuring agency shall prescribe procurement specifications
for the product or class of products governing emissions of electronic
product radiation, and the product or class shall be of a type used
solely or predominantly by a department or agency of the United States.
(2) The product or class of products is intended for research,
investigations, studies, demonstration, or training, or for reasons of
national security.
(b) Consultation between the procuring agency and the Food and Drug
Administration. The United States department or agency that intends to
procure or manufacture a product or class of products subject to
electronic product radiation safety standards contained in this
subchapter should consult with the Center for Devices and Radiological
Health, Food and Drug Administration, whenever it is anticipated that
the specifications for the product or class must deviate from, or be in
conflict with, such applicable standards. Such consultation should
occur as early as possible during development of such specifications.
The department or agency should include in the specifications all
requirements of such standards that are not in conflict with, or are not
inappropriate for, the special or unique uses for which the product is
intended. The procuring agency should indicate to the Center for
Divices and Radiological Health if it desires to be notified of the
approval, amendment, or withdrawal of the exemption.
(c) Application for exemption. An original and two copies of any
application for exemption, or for amendment or extension thereof, shall
be submitted to the Dockets Management Branch (HFA-305), Food and Drug
Administration, Rm. 4-62, 5600 Fishers Lane, Rockville, MD 20857. For
an exemption pursuant to the criteria prescribed in paragraph (a)(1) of
this section, the application shall include the information prescribed
in paragraphs (c)(1) through (13) of this section. For an exemption
pursuant to the criteria prescribed in paragraph (a)(2) of this section,
the application shall include the information prescribed in paragraphs
(c)(3) through (13) of this section. An application for exemption, or
for amendment or extension thereof, and correspondence relating to such
application shall be made available for public disclosure in the Dockets
Management Branch except for confidential or proprietary information
submitted in accordance with Part 20 of this chapter. Information
classified for reasons of national security shall not be included in the
application. Except as indicated above, the application for exemption
shall include the following:
(1) The procurement specifications for the product or class of
products that govern emissions of electronic product radiation.
(2) Evidence that the product or class of products is of a type used
solely or predominantly by departments or agencies of the United States.
(3) Evidence that such product or class of products is intended for
use by a department or agency of the United States.
(4) A description of the product or class of products and its
intended use.
(5) An explanation of how compliance with the applicable standard
would restrict or be inappropriate for this intended use.
(6) A description of the manner in which it is proposed that the
product or class of products shall deviate from the requirements of the
applicable standard.
(7) An explanation of the advantages to be derived from such
deviation.
(8) An explanation of how means of radiation protection will be
provided where the product or class of products deviates from the
requirements of the applicable standard.
(9) The period of time it is desired that the exemption be in effect,
and, if appropriate, the number of units to be manufactured under the
exemption.
(10) The name, address, and telephone number of the manufacturer or
his agent.
(11) The name, address, and telephone number of the appropriate
office of the United States department or agency purchasing the product
or class of products.
(12) Such other information required by regulation or by the
Director, Center for Devices and Radiological Health, to evaluate and
act on the application. Where such information includes nonclinical
laboratory studies, the information shall include, with respect to each
nonclinical study, either a statement that each study was conducted in
compliance with the requirements set forth in Part 58 of this chapter,
or, if the study was not conducted in compliance with such regulations,
a statement that describes in detail all differences between the
practices used in the study and those required in the regulations. When
such information includes clinical investigations involving human
subjects, the information shall include, with respect to each clinical
investigation, either a statement that each investigation was conducted
in compliance with the requirements set forth in Part 56 of this
chapter, or a statement that the investigation is not subject to such
requirements in accordance with 56.104 or 56.105 and a statement that
each investigation was conducted in compliance with the requirements set
forth in Part 50 of this chapter.
(13) With respect to each nonclinical laboratory study contained in
the application, either a statement that the study was conducted in
compliance with the requirements set forth in Part 58 of this chapter,
or, if the study was not conducted in compliance with such regulations,
a brief statement of the reason for the noncompliance.
(d) Amendment or extension of an exemption. An exemption is granted
on the basis of the information contained in the orginal applicaion.
Therefore, if changes are needed in the radiation safety specifications
for the product, or its use, or related radiation control procedures
such that the information in the original application would no longer be
correct with respect to radiation safety, the applicant shall submit in
advance of such changes a request for an amendment to the exemption. He
also shall submit a request for extension of the exemption, if needed,
at least 60 days before the expiration date. The application for
amendment or extension of an exemption shall include the following
information:
(1) The exemption number and expiration date.
(2) The amendment or extension requested and basis for the amendment
or extension.
(3) If the radiation safety specifications for the product or class
of products or the product's or class of products' use or related
radiation control procedures differ from the description provided in the
original application, a description of such changes.
(e) Ruling on an application. (1) The Director, Center for Devices
and Radiological Health, may grant an exemption including in the written
notice of exemption such conditions or terms as may be necessary to
protect the public health and safety and shall notify the applicant in
writing of his action. The conditions or terms of the exemption may
include specifications concerning the manufacture, use, control, and
disposal of the excess or surplus exempted product of class of products
as provided in the Code of Federal Regulations, Title 41, Subtitle C.
Each exemption will be assigned an identifying number.
(2) The Director, Center for Devices and Radiological Health, shall
amend or withdraw an exemption whenever he determines that such action
is necessary to protect the public health or otherwise is justified by
provisions of the act or this subchapter. Such action shall become
effective on the date specified in the written notice of the action sent
to the applicant, except that it shall become effective immediately when
the Director determines that it is necessary to prevent an imminent
health hazard.
(f) Identification of equipment covered by exemption. The
manufacturer of any product for which an exemption is granted shall
provide the following identification in the form of a tag or label
permanently affixed or inscribed on such product so as to be legible and
readily accessible to view when the product is fully assembled for use
or in such other manner as may be prescribed in the exemption:
This electronic product has been exempted from Food and Drug
Administration radiation safety performance standards prescribed in the
Code of Federal Regulations, Title 21, Chapter I, Subchapter J, pursuant
to Exemption No. ------ , granted on ----------------
(42 FR 44229, Sept. 2, 1977; 42 FR 61257, Dec. 2, 1977, as amended
at 44 FR 17657, Mar. 23, 1979; 46 FR 8460, 8958, Jan. 27, 1981; 50 FR
7518, Feb. 22, 1985; 50 FR 13564, Apr. 5, 1985; 53 FR 11254, Apr. 6,
1988)
21 CFR 1010.5 Subpart B -- Alternate Test Procedures
21 CFR 1010.13 Special test procedures.
The Director, Center for Devices and Radiological Health, may, on the
basis of a written application by a manufacturer, authorize test
programs other than those set forth in the standards under this
subchapter for an electronic product if he determines that such products
are not susceptible to satisfactory testing by the procedures set forth
in the standard and that the alternative test procedures assure
compliance with the standard.
(40 FR 32257, July 31, 1975, as amended at 53 FR 11254, Apr. 6, 1988)
21 CFR 1010.13 Subpart C -- Exportation of Electronic Products
21 CFR 1010.20 Electronic products intended for export.
The performance standards prescribed in this subchapter shall not
apply to any electronic product which is intended solely for export if:
(a) Such product and the outside of any shipping container used in
the export of such product are labeled or tagged to show that such
product is intended for export, and
(b) Such product meets all the applicable requirements of the country
to which such product is intended for export.
(40 FR 32257, July 31, 1975)
21 CFR 1010.20 PART 1020 -- PERFORMANCE STANDARDS FOR IONIZING
RADIATION EMITTING PRODUCTS
Sec.
1020.10 Television receivers.
1020.20 Cold-cathode gas discharge tubes.
1020.30 Diagnostic x-ray systems and their major components.
1020.31 Radiographic equipment.
1020.32 Fluoroscopic equipment.
1020.33 Computed tomography (CT) equipment.
1020.40 Cabinet x-ray systems.
Authority: Secs. 501, 502, 515-520, 530-542, 701, 801 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 351, 352, 360gg-360ss,
360e-360j, 371, 381).
Source: 38 FR 28632, Oct. 15, 1973, unless otherwise noted.
21 CFR 1020.10 Television receivers.
(a) Applicability. The provisions of this section are applicable to
television receivers manufactured subsequent to January 15, 1970.
(b) Definitions. (1) ''External surface'' means the cabinet or
enclosure provided by the manufacturer as part of the receiver. If a
cabinet or enclosure is not provided as part of the receiver, the
external surface shall be considered to be a hypothetical cabinet, the
plane surfaces of which are located at those minimum distances from the
chassis sufficient to enclose all components of the receiver except that
portion of the neck and socket of the cathode-ray tube which normally
extends beyond the plane surfaces of the enclosure.
(2) ''Maximum test voltage'' means 130 root mean square volts if the
receiver is designed to operate from nominal 110 to 120 root mean square
volt power sources. If the receiver is designed to operate from a power
source having some voltage other than from nominal 110 to 120 root mean
square volts, maximum test voltage means 110 percent of the nominal root
mean square voltage specified by the manufacturer for the power source.
(3) ''Service controls'' means all of those controls on a television
receiver provided by the manufacturer for purposes of adjustment which,
under normal usage, are not accessible to the user.
(4) ''Television receiver'' means an electronic product designed to
receive and display a television picture through broadcast, cable, or
closed circuit television.
(5) ''Usable picture'' means a picture in synchronization and
transmitting viewable intelligence.
(6) ''User controls'' means all of those controls on a television
receiver, provided by the manufacturer for purposes of adjustment, which
on a fully assembled receiver under normal usage, are accessible to the
user.
(c) Requirements -- (1)Exposure rate limit. Radiation exposure rates
produced by a television receiver shall not exceed 0.5 milliroentgens
per hour at a distance of five (5) centimeters from any point on the
external surface of the receiver, as measured in accordance with this
section.
(2) Measurements. Compliance with the exposure rate limit defined in
paragraph (c)(1) of this section shall be determined by measurements
made with an instrument, the radiation sensitive volume of which shall
have a cross section parallel to the external surface of the receiver
with an area of ten (10) square centimeters and no dimension larger than
five (5) centimeters. Measurements made with instruments having other
areas must be corrected for spatial nonuniformity of the radiation field
to obtain the exposure rate average over a ten (10) square centimeter
area.
(3) Test conditions. All measurements shall be made with the
receiver displaying a usable picture and with the power source operated
at supply voltages up to the maximum test voltage of the receiver and,
as applicable, under the following specific conditions:
(i) On television receivers manufactured subsequent to January 15,
1970, measurements shall be made with all user controls adjusted so as
to produce maximum x-radiation emissions from the receiver.
(ii) On television receivers manufactured subsequent to June 1, 1970,
measurements shall be made with all user controls and all service
controls adjusted to combinations which result in the production of
maximum x-radiation emissions.
(iii) On television receivers manufactured subsequent to June 1,
1971, measurements shall be made under the conditions described in
paragraph (c)(3) (ii) of this section, together with conditions
identical to those which result from that component or circuit failure
which maximizes x-radiation emissions.
(4) Critical component warning. The manufacturer shall permanently
affix or inscribe a warning label, clearly legible under conditions of
service, on all television receivers which could produce radiation
exposure rates in excess of the requirements of this section as a result
of failure or improper adjustment or improper replacement of a circuit
or shield component. The warning label shall include the specification
of operating high voltage and an instruction for adjusting the high
voltage to the specified value.
21 CFR 1020.20 Cold-cathode gas discharge tubes.
(a) Applicability. The provisions of this section are applicable to
cold-cathode gas discharge tubes designed to demonstrate the effects of
a flow of electrons or the production of x-radiation as specified
herein.
(b) Definitions. ''Beam blocking device'' means a movable or
removable portion of any enclosure around a cold-cathode gas discharge
tube, which may be opened or closed to permit or prevent the emergence
of an exit beam.
''Cold-cathode gas discharge tube'' means an electronic device in
which electron flow is produced and sustained by ionization of contained
gas atoms and ion bombardment of the cathode.
''Exit beam'' means that portion of the radiation which passes
through the aperture resulting from the opening of the beam blocking
device.
''Exposure'' means the sum of the electrical charges on all of the
ions of one sign produced in air when all electrons liberated by photons
in a volume element of air are completely stopped in air divided by the
mass of the air in the volume element. The special unit of exposure is
the roentgen. One (1) roentgen equals 2.58 10^4 coulombs/kilogram.
(c) Requirements -- (1) Exposure rate limit. (i) Radiation exposure
rates produced by cold-cathode gas discharge tubes shall not exceed 10
mR./hr. at a distance of thirty (30) centimeters from any point on the
external surface of the tube, as measured in accordance with this
section.
(ii) The divergence of the exit beam from tubes designed primarily to
demonstrate the effects of x radiation, with the beam blocking device in
the open position, shall not exceed (Pi) steradians.
(2) Measurements. (i) Compliance with the exposure rate limit
defined in paragraph (c)(1)(i) of this section shall be determined by
measurements averaged over an area of one hundred (100) square
centimeters with no linear dimension greater than twenty (20)
centimeters.
(ii) Measurements of exposure rates from tubes in enclosures from
which the tubes cannot be removed without destroying the function of the
tube may be made at a distance of thirty (30) centimeters from any point
on the external surface of the enclosure, provided:
(a) In the case of enclosures containing tubes designed primarily to
demonstrate the production of x radiation, measurements shall be made
with any beam blocking device in the beam blocking position, or
(b) In the case of enclosures containing tubes designed primarily to
demonstrate the effects of a flow of electrons, measurements shall be
made with all movable or removable parts of such enclosure in the
position which would maximize external exposure levels.
(3) Test conditions. (i) Measurements shall be made under the
conditions of use specified in instructions provided by the
manufacturer.
(ii) Measurements shall be made with the tube operated under forward
and reverse polarity.
(4) Instructions, labels, and warnings. (i) Manufacturers shall
provide, or cause to be provided, with each tube to which this section
is applicable, appropriate safety instructions, together with
instructions for the use of such tube, including the specification of a
power source for use with the tube.
(ii) Each enclosure or tube shall have inscribed on or permanently
affixed to it, tags or labels, which identify the intended polarity of
the terminals and:
(a) In the case of tubes designed primarily to demonstrate the heat
effect, fluorescence effect, or magnetic effect, a warning that
application of power in excess of that specified may result in the
production of x-rays in excess of allowable limits; and (b) in the case
of tubes designed primarily to demonstrate the production of
x-radiation, a warning that this device produces x-rays when energized.
(iii) The tag or label required by this paragraph shall be located on
the tube or enclosure so as to be readily visible and legible when the
product is fully assembled for use.
21 CFR 1020.30 Diagnostic x-ray systems and their major components.
(a) Applicability. (1) The provisions of this section are applicable
to:
(i) The following components of diagnostic x-ray systems:
(a) Tube housing assemblies, x-ray controls, x-ray high-voltage
generators, tables, cradles, film changers, vertical cassette holders
mounted in a fixed location and cassette holders with front panels, and
beam-limiting devices manufactured after August 1, 1974.
(b) Fluoroscopic imaging assemblies manufactured after August 1, 1974
and before April 26, 1977.
(c) Spot-film devices and image intensifiers manufactured after April
26, 1977.
(d) Cephalometric devices manufactured after February 25, 1978.
(e) Image receptor support devices for mammographic x-ray systems
manufactured after September 5, 1978.
(ii) Diagnostic x-ray systems, except computed tomography x-ray
systems, incorporating one or more of such components; however, such
x-ray systems shall be required to comply only with those provisions of
this section and 1020.31 and 1020.32 which relate to the components
certified in accordance with paragraph (c) of this section and installed
into the systems.
(iii) Computed tomography x-rays systems manufactured before November
29, 1984.
(2) The following provisions of this section and 1020.33 are
applicable to computed tomography x-ray systems manufactured or
remanufactured on and after November 29, 1984:
(i) Section 1020.30(a);
(ii) Section 1020.30(b)(36) (iii)-(v);
(iii) Section 1020.30(b) (58)-(62);
(iv) Section 1020.30(h)(3) (vi)-(viii);
(v) Section 1020.30(n);
(vi) Section 1020.33 (a) and (b);
(vii) Section 1020.33(c)(1) as it affects 1020.33(c)(2); and
(viii) Section 1020.33(c)(2).
(3) The provisions of this section and 1020.33 in its entirety,
including those provisions in paragraph (a)(2) of this section, are
applicable to computed tomography x-ray systems manufactured or
remanufactured on and after September 3, 1985.
(b) Definitions. As used in this section and 1020.31, 1020.32, and
1020.33, the following definitions apply:
(1) ''Accessible surface'' means the external surface of the
enclosure or housing provided by the manufacturer.
(2) ''Aluminum equivalent'' means the thickness of aluminum (type
1100 alloy)1 affording the same attenuation, under specified conditions,
as the material in question.
(3) ''Assembler'' means any person engaged in the business of
assembling, replacing, or installing one or more components into a
diagnostic x-ray system or subsystem. The term includes the owner of an
x-ray system or his or her employee or agent who assembles components
into an x-ray system that is subsequently used to provide professional
or commercial services.
(4) ''Attenuation block'' means a block or stack, having dimensions
20 centimeters by 20 centimeters by 3.8 centimeters, of type 1100
aluminum alloy or aluminum alloy having equivalent attenuation.
(5) ''Automatic exposure control'' means a device which automatically
controls one or more technique factors in order to obtain at a
preselected location(s) a required quantity of radiation.
(6) ''Beam axis'' means a line from the source through the centers of
the x-ray fields.
(7) ''Beam-limiting device'' means a device which provides a means to
restrict the dimensions of the x-ray field.
(8) ''Coefficient of variation'' means the ratio of the standard
deviation to the mean value of a population of observations. It is
estimated using the following equation:
where
s =Estimated standard deviation of the population.
X=Mean value of observations in sample.
Xi=ith observation sampled.
n=Number of observations sampled.
(9) ''Control panel'' means that part of the x-ray control upon which
are mounted the switches, knobs, pushbuttons, and other hardware
necessary for manually setting the technique factors.
(10) ''Cooling curve'' means the graphical relationship between heat
units stored and cooling time.
(11) ''Diagnostic source assembly'' means the tube housing assembly
with a beam-limiting device attached.
(12) ''Diagnostic x-ray system'' means an x-ray system designed for
irradiation of any part of the human body for the purpose of diagnosis
or visualization.
(13) ''Equipment'' means x-ray equipment.
(14) ''Exposure'' means the quotient of dQ by dm where dQ is the
absolute value of the total charge of the ions of one sign produced in
air when all the electrons (negatrons and positrons) liberated by
photons in a volume element of air having mass dm are completely stopped
in air.
(15) ''Field emission equipment'' means equipment which uses an x-ray
tube in which electron emission from the cathode is due solely to the
action of an electric field.
(16) ''Fluoroscopic imaging assembly'' means a subsystem in which
x-ray photons produce a fluoroscopic image. It includes the image
receptor(s) such as the image intensifier and spot-film device,
electrical interlocks, if any, and structural material providing linkage
between the image receptor and diagnostic source assembly.
(17) ''General purpose radiographic x-ray system'' means any
radiographic x-ray system which, by design, is not limited to
radiographic examination of specific anatomical regions.
(18) ''Half-value layer, HVL'' means the thickness of specified
material which attenuates the beam of radiation to an extent such that
the exposure rate is reduced to one-half of its original value. In this
definition the contribution of all scattered radiation, other than any
which might be present initially in the beam concerned, is deemed to be
excluded.
(19) ''Image receptor'' means any device, such as a fluorescent
screen or radiographic film, which transforms incident x-ray photons
either into a visible image or into another form which can be made into
a visible image by further transformations. In those cases where means
are provided to preselect portions of the image receptor, the term
''image receptor'' shall mean the preselected portion of the device.
(20) ''Leakage radiation'' means radiation emanating from the
diagnostic source assembly except for:
(i) The useful beam; and
(ii) Radiation produced when the exposure switch or timer is not
activated.
(21) ''Leakage technique factors'' means the technique factors
associated with the diagnostic source assembly which are used in
measuring leakage radiation. They are defined as follows:
(i) For diagnostic source assemblies intended for capacitor energy
storage equipment, the maximum-rated peak tube potential and the
maximum-rated number of exposures in an hour for operation at the
maximum-rated peak tube potential with the quantity of charge per
exposure being 10 millicoulombs (mAs) or the minimum obtainable from the
unit, whichever is larger.
(ii) For diagnostic source assemblies intended for field emission
equipment rated for pulsed operation, the maximum-rated peak tube
potential and the maximum-rated number of x-ray pulses in an hour for
operation at the maximum-rated peak tube potential.
(iii) For all other diagnostic source assemblies, the maximum-rated
peak tube potential and the maximum-rated continuous tube current for
the maximum-rated peak tube potential.
(22) ''Light field'' means that area of the intersection of the light
beam from the beam-limiting device and one of the set of planes parallel
to and including the plane of the image receptor, whose perimeter is the
locus of points at which the illumination is one-fourth of the maximum
in the intersection.
(23) ''Line-voltage regulation'' means the difference between the
no-load and the load line potentials expressed as a percent of the load
line potential; that is,
Percent line-voltage regulation
where
Vn=No-load line potential and
Vl=Load line potential.
(24) ''Maximum line current'' means the rms current in the supply
line of an x-ray machine operating at its maximum rating.
(25) ''Peak tube potential'' means the maximum value of the potential
difference across the x-ray tube during an exposure.
(26) ''Primary protective barrier'' means the material, excluding
filters, placed in the useful beam to reduce the radiation exposure for
protection purposes.
(27) ''Rated line voltage'' means the range of potentials, in volts,
of the supply line specified by the manufacturer at which the x-ray
machine is designed to operate.
(28) ''Rated output current'' means the maximum allowable load
current of the x-ray high-voltage generator.
(29) ''Rated output voltage'' means the allowable peak potential, in
volts, at the output terminals of the x-ray high-voltage generator.
(30) ''Rating'' means the operating limits specified by the
manufacturer.
(31) ''Recording'' means producing a permanent form of an image
resulting from x-ray photons (e.g., film, video tape).
(32) ''Response time'' means the time required for an instrument
system to reach 90 percent of its final reading when the
radiation-sensitive volume of the instrument system is exposed to a step
change in radiation flux from zero sufficient to provide a steady state
midscale reading.
(33) ''Source'' means the focal spot of the x-ray tube.
(34) ''Source-image receptor distance (SID)'' means the distance from
the source to the center of the input surface of the image receptor.
(35) ''Stationary equipment'' means equipment which is installed in a
fixed location.
(36) ''Technique factors'' means the following conditions of
operation:
(i) For capacitor energy storage equipment, peak tube potential in kV
and quantity of charge in mAs.
(ii) For field emission equipment rated for pulsed operation, peak
tube potential in kV and number of x-ray pulses.
(iii) For CT equipment designed for pulsed operation, peak tube
potential in kV, scan time in seconds, and either tube current in mA,
x-ray pulse width in seconds, and the number of x-ray pulses per scan,
or the product of tube current, x-ray pulse width, and the number of
x-ray pulses in mAs.
(iv) For CT equipment not designed for pulsed operation, peak tube
potential in kV, and either tube current in mA and scan time in seconds,
or the product of tube current and exposure time in mAs and the scan
time when the scan time and exposure time are equivalent.
(v) For all other equipment, peak tube potential in kV, and either
tube current in mA and exposure time in seconds, or the product of tube
current and exposure time in mAs.
(37) ''Tube'' means an x-ray tube, unless otherwise specified.
(38) ''Tube housing assembly'' means the tube housing with tube
installed. It includes high-voltage and/or filament transformers and
other appropriate elements when they are contained within the tube
housing.
(39) ''Tube rating chart'' means the set of curves which specify the
rated limits of operation of the tube in terms of the technique factors.
(40) ''Useful beam'' means the radiation which passes through the
tube housing port and the aperture of the beam-limiting device when the
exposure switch or timer is activated.
(41) ''Variable-aperture beam-limiting device'' means a beam-limiting
device which has capacity for stepless adjustment of the x-ray field
size at a given SID.
(42) ''Visible area'' means that portion of the input surface of the
image receptor over which incident x-ray photons are producing a visible
image.
(43) ''X-ray control'' means a device which controls input power to
the x-ray high-voltage generator and/or the x-ray tube. It includes
equipment such as timers, phototimers, automatic brightness stabilizers,
and similar devices, which control the technique factors of an x-ray
exposure.
(44) ''X-ray equipment'' means an x-ray system, subsystem, or
component thereof.
(45) ''X-ray field'' means that area of the intersection of the
useful beam and any one of the set of planes parallel to and including
the plane of the image receptor, whose perimeter is the locus of points
at which the exposure rate is one-fourth of the maximum in the
intersection.
(46) ''X-ray high-voltage generator'' means a device which transforms
electrical energy from the potential supplied by the x-ray control to
the tube operating potential. The device may also include means for
transforming alternating current to direct current, filament
transformers for the x-ray tube(s), high-voltage switches, electrical
protective devices, and other appropriate elements.
(47) ''X-ray system'' means an assemblage of components for the
controlled production of x-rays. It includes minimally an x-ray
high-voltage generator, an x-ray control, a tube housing assembly, a
beam-limiting device, and the necessary supporting structures.
Additional components which function with the system are considered
integral parts of the system.
(48) ''X-ray subsystem'' means any combination of two or more
components of an x-ray system for which there are requirements specified
in this section and 1020.31 and 1020.32.
(49) ''X-ray tube'' means any electron tube which is designed for the
conversion of electrical energy into x-ray energy.
(50) ''Radiation therapy simulation system'' means a radiographic or
fluoroscopic x-ray system intended for localizing the volume to be
exposed during radiation therapy and confirming the position and size of
the therapeutic irradiation field.
(51) ''Spot-film device'' means a device intended to transport and/or
position a radiographic image receptor between the x-ray source and
fluoroscopic image receptor. It includes a device intended to hold a
cassette over the input end of an image intensifier for the purpose of
making a radiograph.
(52) ''Image intensifier'' means a device, installed in its housing,
which instantaneously converts an x-ray pattern into a corresponding
light image of higher energy density.
(53) ''Cephalometric device'' means a device intended for the
radiographic visualization and measurement of the dimensions of the
human head.
(54) ''Image receptor support'' means, for mammographic systems, that
part of the system designed to support the image receptor in a
horizontal plane during a mammographic examination.
(55) ''Cassette holder'' means a device, other than a spot-film
device, that supports and/or fixes the position of an x-ray film
cassette during an x-ray exposure.
(56) ''Quick change x-ray tube'' means an x-ray tube designed for use
in its associated tube housing such that:
(i) The tube cannot be inserted in its housing in a manner that would
result in noncompliance of the system with the requirements of
paragraphs (k) and (m) of this section, and
(ii) The focal spot position will not cause noncompliance with the
provisions of this section or 1020.31 or 1020.32, and
(iii) The shielding within the tube housing cannot be displaced, and
(iv) Any removal and subsequent replacement of a beam-limiting device
during reloading of the tube in the tube housing will not result in
noncompliance of the x-ray system with the applicable field limitation
and alignment requirements of 1020.31 and 1020.32.
(57) ''Accessory component'' means:
(i) A component used with diagnostic x-ray systems, such as a cradle
or film changer, that is not necessary for the compliance of the system
with applicable provisions of this subchapter but which requires an
initial determination of compatibility with the system, or
(ii) A component necessary for compliance of the system with
applicable provisions of this subchapter but which may be interchanged
with similar compatible components without affecting the system's
compliance, such as one of a set of interchangeable beam-limiting
devices, or
(iii) A component compatible with all x-ray systems with which it may
be used and that does not require compatibility or installation
instructions, such as a tabletop cassette holder.
(58) ''Computed tomography (CT)'' means the production of a tomogram
by the acquisition and computer processing of x-ray transmission data.
(59) ''Scan'' means the complete process of collecting x-ray
transmission data for the production of a tomogram. Data may be
collected simultaneously during a single scan for the production of one
or more tomograms.
(60) ''Scan time'' means the period of time between the beginning and
end of x-ray transmission data accumulation for a single scan.
(61) ''Tomogram'' means the depiction of the x-ray attenuation
properties of a section through a body.
(62) ''Dose'' means the absorbed dose as defined by the International
Commission on Radiation Units and Measurements. The absorbed dose, D,
is the quotient of de by dm where de is the mean energy imparted by
ionizing radiation to matter of mass dm.
(c) Certification of components. Each component subject to this
section and 1020.31, 1020.32, and 1020.33, shall be certified by the
manufacturer thereof as a product which meets all applicable standards
in accordance with the provisions of 1010.2 of this chapter. Where a
combination of two or more such components is manufactured, marketed,
and delivered as a system or subsystem, its certification may be
applicable to all components contained therein, if authorized in writing
by the Director or Deputy Director of the Center for Devices and
Radiological Health, or the Director, Office of Compliance of that
Center upon application by the manufacturer. Certification that the
product conforms to all applicable standards under this part shall be
construed to mean that the component, system, or subsystem can meet the
applicable provisions of this section and 1020.31, 1020.32, and
1020.33, if installed in a diagnostic x-ray system in accordance with
instructions.
(d) Certification by assembler. An assembler who installs one or
more components certified as required by paragraph (c) of this section
into an x-ray system shall install certified components that are of the
type required by 1020.31, 1020.32 or 1020.33, and, except as provided
for in paragraph (d)(2) of this section, shall assemble, install,
adjust, and test the certified components in accordance with the
instructions of their respective manufacturers. All assemblers who
install certified components shall file a report of such assembly as
specified in paragraphs (d) (1), (2), and (3) of this section. The
report will be construed as the assembler's certification and
identification under 1010.2 and 1010.3 of this chapter. All assembler
reports must be on a form prescribed by and available from the Director,
Center for Devices and Radiological Health, 5600 Fishers Lane,
Rockville, MD 20857. Completed reports must be submitted to the
Director, the purchaser, and, where applicable, to the State agency
responsible for radiation protection within 15 days following completion
of the assembly.
(1) Reporting compliance. An assembler who installs one or more
certified components into an x-ray system or subsystem, having properly
followed the assembly instructions provided him by the component
manufacturer, shall certify to this by filing a report containing the
information prescribed on the form which shall include the following:
(i) The full name and address of the assembler and the date of
assembly or installation.
(ii) The name and address of the purchaser and the location and
specific identification of the x-ray system or subsystem.
(iii) An affirmation that all instruction manuals and other
information as required by paragraph (h) of this section applicable to
the newly installed x-ray equipment have been delivered to the
purchaser.
(iv) A statement of the type and intended use of the x-ray system or
subsystem into which the certified components were assembled or
installed, such as ''radiographic -- stationary general purpose.''
(v) A list of all certified components which were assembled or
installed by him into the x-ray system or subsystem in accordance with
the instructions of the component manufacturers, identifying the
components by type, manufacturer, model number, and serial number.
(vi) An affirmation that the certified components listed pursuant to
paragraph (d)(2)(v) of this section were assembled according to the
instructions provided by the manufacturer(s) of such components.
(vii) An affirmation that all certified components installed in the
x-ray system or subsystem were of the type required by 1020.31,
1020.32, or 1020.33.
(viii) An affirmation that a copy of this report will be transmitted
to the purchaser and, where applicable, to the State agency responsible
for radiation protection, in accordance with the requirements of this
paragraph.
(2) Reporting noncompatibility. An assembler who installs a
certified component into an x-ray system shall file a report indicating
noncompatibility if he is unable to follow the instructions of the
manufacturer of such certified component, provided other component(s) of
the system do not meet the manufacturer's specifications for
compatibility as given by the certified component manufacturer pursuant
to paragraph (g) of this section and provided there is no commercially
available certified component of a similar type which is compatible with
the x-ray system. In addition, the component(s) of the system not
meeting the specification for compatibility must either be of a type
listed in paragraph (a)(1) of this section which does not bear a
certification label due to date of manufacture, or if it is a component
not of the type listed in paragraph (a)(1) of this section, it must have
been purchased as new prior to August 1, 1974. No assembler shall
perform any modification of a certified component which will adversely
affect the performance of the certified component with respect to the
requirements of this section and 1020.31, 1020.32 and 1020.33. The
assembler shall file a report indicating noncompatibility containing
information prescribed on the form which shall include the following:
(i) The full name and address of the assembler and the date of
assembly or installation.
(ii) The name and address of the purchaser and the location and
specific identification of the x-ray system or subsystem.
(iii) An affirmation that all instruction manuals and other
information as required by paragraph (h) of this section applicable to
the newly installed x-ray equipment have been delivered to the
purchaser.
(iv) A statement of the type or intended use of the x-ray system or
subsystem into which the certified components were assembled or
installed, such as ''radiographic -- stationary general purpose.''
(v) A list of all certified component(s) which were assembled or
installed by him into the x-ray system or subsystem and which could not
be assembled, installed, adjusted, and tested in accordance with the
manufacturer's instructions due to reasons specified in this paragraph
(this paragraph (d)(2)), identifying the components by type,
manufacturer, model number, and serial number.
(vi) An affirmation that the certified component(s) listed pursuant
to paragraph (d)(2)(v) of this section could not be assembled,
installed, adjusted, and tested in accordance with the installation
instructions of their respective manufacturers due to reasons specified
in this paragraph (this paragraph (d)(2)), and that no certified
component was modified so as to adversely affect its performance with
respect to the requirements of this section and 1020.31, 1020.32 and
1020.33.
(vii) For each certified component listed pursuant to paragraph
(d)(2)(v) of this section, a full and complete explanation of why the
manufacturer's installation instructions could not be followed in
performing the assembly, including a listing by type, manufacturer, and
model number of the incompatible component(s) already in the system, and
either evidence of its date of purchase as new if it is not a type of
component listed in paragraph (a)(1) of this section, or if it is a type
of component listed in paragraph (a)(1) of this section, a statement
that it did not bear a certification label due to its date of
manufacture.
(viii) An affirmation that all certified components installed in the
x-ray system or subsystem were of the type required by 1020.31,
1020.32 or 1020.33.
(ix) An affirmation that a copy of this report will be transmitted to
the purchaser and, where applicable, to the State agency responsible for
radiation protection, in accordance with the requirements of this
paragraph.
(3) Accessory components. The following requirements apply to the
assembly of accessory certified components and x-ray systems that do not
require assembly by the dealer or purchaser.
(i) The initial installation or assembly of interchangeable and
removable accessory certified components within a diagnostic x-ray
system following delivery at the user's facility shall be reported as
required by paragraphs (d)(1) and (2) of this section. No report of
assembly is required for subsequent use of such components.
(ii) Assembler certification as specified in paragraphs (d)(1) and
(2) of this section is not required for certified components or systems
that have been described by their manufacturer in the information
furnished the user as not requiring assembler certification. Prior to
stating that assembler certification is not required for a component or
system, the manufacturer of the item must have reported to the Center
for Devices and Radiological Health, in the report required by 1002.10
of this chapter, that compliance with this section and 1020.31,
1020.32 and 1020.33 is assured by the existence of the following
conditions:
(a) Certification of compliance by the manufacturer is not contingent
upon acts of assembly or installation by the dealer or purchaser.
(b) Preparation for use by either the dealer or user does not require
adherence to the manufacturer's instructions to ensure compliance.
(c) Interconnection or use, or both, of the component or systems does
not require compatibility specifications.
(e) Identification of x-ray components. In addition to the
identification requirements specified in 1010.3 of this chapter,
manufacturers of components subject to this section and 1020.31,
1020.32 and 1020.33, except high-voltage generators contained within
tube housings and beam-limiting devices which are integral parts of tube
housings, shall permanently inscribe or affix thereon the model number
and serial number of the product, so as to be legible and accessible to
view. Where the certification of a system or subsystem, consisting of
two or more components, has been authorized pursuant to paragraph (c) of
this section, a single inscription, tag, or label bearing such
information may be used to identify the product.
(1) Tube housing assemblies. In a similar manner, manufacturers of
tube housing assemblies shall also inscribe or affix thereon the name of
the manufacturer, model number, and serial number of the x-ray tube
which the tube housing assembly incorporates.
(2) Replacement of tubes. Except as specified in paragraph (e)(3) of
this section, the replacement of an x-ray tube in a previously
manufactured tube-housing assembly certified pursuant to paragraph (c)
of this section constitutes manufacture of a new tube housing assembly,
and the manufacturer is subject to the provisions of paragraph (e)(1) of
this section. The manufacturer shall remove, cover, or deface any
previously affixed inscriptions, tags, or labels that are no longer
applicable.
(3) Quick-change x-ray tubes. The requirements of paragraph (e)(2)
of this section shall not apply to tube-housing assemblies designed and
designated by their original manufacturer to contain quick-change x-ray
tubes. The manufacturer of such x-ray tubes shall include with each
replacement tube a label with the tube manufacturer's name, the model,
and serial number of the x-ray tube. The manufacturer of the tube shall
instruct the assembler who installs the new tube to attach the label to
the tube-housing assembly and to remove the cover or deface the
previously affixed inscriptions, tags, or labels that are described by
the tube manufacturer as no longer applicable.
(f) Limits of responsibility -- (1) Manufacturer. The manufacturer
of a certified component installed or assembled into an x-ray system or
subsystem by another person shall not be liable for the noncompliance of
such component which is attributable solely to the improper installation
or assembly of the component into the system, but shall be held
responsible for noncompliance if improper assembly was a result of
inadequate instructions provided by such component manufacturer.
(2) Assembler. The person who certified as to the assembly of an
x-ray system or subsystem shall not be liable for noncompliance of a
certified component if such assembly is in accordance with the
instructions provided by the manufacturer of the component, but shall be
held responsible for noncompliance of a component which is attributable
solely to improper assembly or installation into the system or
subsystem.
(g) Information to be provided to assemblers. Manufacturers of
components listed in paragraph (a)(1) of this section shall provide to
assemblers subject to paragraph (d) of this section and, upon request,
to others at a cost not to exceed the cost of publication and
distribution, instructions for assembly, installation, adjustment, and
testing of such components adequate to assure that the products will
comply with applicable provisions of this section and 1020.31,
1020.32, and 1020.33, when assembled, installed, adjusted, and tested as
directed. Such instructions shall include specifications of other
components compatible with that to be installed when compliance of the
system or subsystem depends on their compatibility. Such specifications
may describe pertinent physical characteristics of the components and/or
may list by manufacturer model number the components which are
compatible.
(h) Information to be provided for users. Manufacturers of x-ray
equipment shall provide for purchasers and, upon request, to others at a
cost not to exceed the cost of publication and distribution, manuals or
instruction sheets which shall include the following technical and
safety information:
(1) All x-ray equipment. For x-ray equipment to which this section
and 1020.31, 1020.32, and 1020.33 are applicable, there shall be
provided:
(i) Adequate instructions concerning any radiological safety
procedures and precautions which may be necessary because of unique
features of the equipment and
(ii) A schedule of the maintenance necessary to keep the equipment in
compliance with this section and 1020.31, 1020.32, and 1020.33.
(2) Tube housing assemblies. For each tube housing assembly, there
shall be provided:
(i) Statements of the leakage technique factors for all combinations
of tube housing assemblies and beam-limiting devices for which the tube
housing assembly manufacturer states compatibility, the minimum
filtration permanently in the useful beam expressed as millimeters of
aluminum equivalent, and the peak tube potential at which the aluminum
equivalent was obtained;
(ii) Cooling curves for the anode and tube housing; and
(iii) Tube rating charts.
If the tube is designed to operate from different types of x-ray
high-voltage generators (such as single-phase self-rectified,
single-phase half-wave rectified, single-phase full-wave rectified,
three-phase six pulse, three-phase 12 pulse, constant potential,
capacitor energy storage) or under modes of operation such as alternate
focal spot sizes or speeds of anode rotation which affect its rating,
specific identification of the difference in ratings shall be noted.
(3) X-ray controls and generators. For the x-ray control and
associated x-ray high-voltage generator, there shall be provided:
(i) A statement of the rated line voltage and the range of
line-voltage regulation for operation at maximum line current;
(ii) A statement of the maximum line current of the x-ray system
based on the maximum input voltage and current characteristics of the
tube housing assembly compatible with rated output voltage and rated
output current characteristics of the x-ray control and associated
high-voltage generator. If the rated input voltage and current
characteristics of the tube housing assembly are not known by the
manufacturer of the x-ray control and associated high-voltage generator,
he shall provide necessary information to allow the purchaser to
determine the maximum line current for his particular tube housing
assembly(s);
(iii) A statement of the technique factors that constitute the
maximum line current condition described in paragraph (h)(3)(ii) of this
section;
(iv) In the case of battery-powered generators, a specification of
the minimum state of charge necessary for proper operation;
(v) Generator rating and duty cycle;
(vi) A statement of the maximum deviation from the preindication
given by labeled technique factor control settings or indicators during
any radiographic or CT exposure where the equipment is connected to a
power supply as described in accordance with this paragraph. In the
case of fixed technique factors, the maximum deviation from the nominal
fixed value of each factor shall be stated;
(vii) A statement of the maximum deviation from the continuous
indication of x-ray tube potential and current during any fluoroscopic
exposure when the equipment is connected to a power supply as described
in accordance with this paragraph; and
(viii) A statement describing the measurement criteria for all
technique factors used in paragraphs (h)(3) (iii), (vi), and (vii) of
this section; for example, the beginning and end points of exposure
time measured with respect to a certain percentage of the voltage
waveform.
(4) Beam-limiting device. For each variable-aperture beam-limiting
device, there shall be provided:
(i) Leakage technique factors for all combinations of tube housing
assemblies and beam-limiting devices for which the beam-limiting device
manufacturer states compatibility; and
(ii) A statement including the minimum aluminum equivalent of that
part of the device through which the useful beam passes and including
the x-ray tube potential at which the aluminum equivalent was obtained.
When two or more filters are provided as part of the device, the
statement shall include the aluminum equivalent of each filter.
(i) (Reserved)
(j) Warning label. The control panel containing the main power
switch shall bear the warning statement, legible and accessible to view:
''WARNING: This x-ray unit may be dangerous to patient and operator
unless safe exposure factors and operating instructions are observed.''
(k) Leakage radiation from the diagnostic source assembly. The
leakage radiation from the diagnostic source assembly measured at a
distance of 1 meter in any direction from the source shall not exceed
100 milliroentgens in 1 hour when the x-ray tube is operated at the
leakage technique factors. If the maximum rated peak tube potential of
the tube housing assembly is greater than the maximum rated peak tube
potential for the diagnostic source assembly, positive means shall be
provided to limit the maximum x-ray tube potential to that of the
diagnostic source assembly. Compliance shall be determined by
measurements averaged over an area of 100 square centimeters with no
linear dimension greater than 20 centimeters.
(l) Radiation from components other than the diagnostic source
assembly. The radiation emitted by a component other than the
diagnostic source assembly shall not exceed 2 milliroentgens in 1 hour
at 5 centimeters from any accessible surface of the component when it is
operated in an assembled x-ray system under any conditions for which it
was designed. Compliance shall be determined by measurements averaged
over an area of 100 square centimeters with no linear dimension greater
than 20 centimeters.
(m) Beam quality -- (1) Half-value layer. The half-value layer (HVL)
of the useful beam for a given x-ray tube potential shall not be less
than the appropriate value shown in Table I under ''Specified dental
systems,'' for any dental x-ray system designed for use with intraoral
image receptors and manufactured after December 1, 1980; and under
''Other x-ray systems,'' for all other x-ray systems subject to this
section. If it is necessary to determine such half-value layer at an
x-ray tube potential which is not listed in Table I, linear
interpolation or extrapolation may be made. Positive means2 shall be
provided to insure that at least the minimum filtration needed to
achieve the above beam quality requirements is in the useful beam during
each exposure.
(2) Measuring compliance. For capacitor energy storage equipment,
compliance shall be determined with the maximum quantity of charge per
exposure.
(n) Aluminum equivalent of material between patient and image
receptor. Except when used in a CT x-ray system, the aluminum
equivalent of each of the items listed in Table II, which are used
between the patient and image receptor may not exceed the indicated
limits. Compliance shall be determined by x-ray measurements made at a
potential of 100 kilovolts peak and with an x-ray beam that has a
half-value layer of 2.7 millimeters of aluminum. This requirement
applies to front panel(s) of cassette holders and film changers provided
by the manufacturer for patient support or for prevention of foreign
object intrusions. It does not apply to screens and their associated
mechanical support panels or grids.
(o) Battery charge indicator. On battery-powered generators, visual
means shall be provided on the control panel to indicate whether the
battery is in a state of charge adequate for proper operation.
(p) Assembly and reassembly of diagnostic x-ray system. The
following provisions apply to the assembly and reassembly of diagnostic
x-ray components specified in paragraph (a)(1) of this section into
diagnostic x-ray systems.
(1) Assembly after August 1, 1974. Except as provided in paragraph
(p)(2)of this section, specified components which are assembled after
August 1, 1974 into those x-ray systems which contain, or will contain
upon completion of the assembly, one or more components certified
pursuant to paragraph (c) of this section, may only be those which have
themselves been so certified. For example, after August 1, 1974:
(i) An assembler who installs a new, complete diagnostic x-ray system
may not assemble a system consisting of both certified and uncertified
components.
(ii) An assembler who installs components into an existing diagnostic
x-ray system containing one or more certified components prior to such
installation may only install components which have been certified by
the component manufacturer(s), regardless of whether certified
components themselves are replaced.
(iii) An assembler who installs a group of components into an
existing diagnostic x-ray system containing no certified components
prior to the assembly may not install a combination of certified and
uncertified components but must install either all uncertified
components or all certified components into such a system.
(iv) An assembler may reassemble a previously existing (used) system
for resale whether or not the system is composed of all uncertified or a
combination of certified and uncertified components. However, any
components added to or installed in place of original components in an
existing system composed of one or more certified components must be
certified.
(2) Purchase prior to August 1, 1974. The provisions of paragraph
(p)(1) of this section do not apply to the assembly of specified
components, provided:
(i) All of the specified components which are assembled into the
x-ray system after August 1, 1974, were purchased prior to that date and
(ii) The report filed pursuant to paragraph (d) of this section
includes adequate evidence that all the specified components assembled
were purchased prior to August 1, 1974. A copy of a notarized bill of
sale or other notarized contract for purchase clearly establishing the
date of purchase of each of the specified components will be considered
adequate evidence.
(3)-(4) (Reserved)
(5) Repair of x-ray systems. The following requirements govern the
assembly and reassembly of diagnostic x-ray components during repair of
diagnostic x-ray components and systems:
(i) The removal of a component, whether certified or uncertified,
from an x-ray system for the purpose of repair and the subsequent
reinstallation of the component into the system following repair are not
prohibited by this section. Those performing repair of certified
components are not required to recertify the repaired component under
paragraph (c) of this section except for reloaded previously certified
x-ray tube housing assemblies. A report pursuant to paragraph (d) of
this section need not be filed to report the reinstallation of a
certified component into an x-ray system following repair of the
component or system.
(ii) The installation into an x-ray system of components specified in
paragraph (a) of this section on an exchange basis when an identical
model is installed in place of a malfunctioning component shall not be
subject to paragraph (p)(1) of this section or affect the status of the
x-ray system under that paragraph. A report pursuant to paragraph (d)
of this section must be filed to report installation of certified
components.
(iii) Components installed temporarily in an x-ray system in place of
certified components removed temporarily for repair must be certified.
The temporary installation of such certified components is not subject
to the report required in paragraph (d) of this section, provided the
temporarily installed component is identified by a tag or label bearing
the information set forth in paragraph (p)(5)(iii) (a) or (b) of this
section. The replacement of the temporarily installed component by a
permanently installed certified component must be reported in accordance
with paragraph (d) of this section.
(a) Temporarily installed compatible component. A temporarily
installed compatible component must bear the following statement and
information:
This certified component has been assembled, installed, adjusted, and
tested by me according to the instructions provided by the manufacturer.
Signature
Company Name
Street Address, P.O. Box
City, State, Zip Code
Date of Installation
(b) Temporarily installed noncompatible component. A temporarily
installed noncompatible component must bear the following statement and
information:
This certified component has been assembled or installed by me, but
could not be assembled, installed, adjusted, and tested according to the
instructions provided by the manufacturer because other already existing
components of the system do not meet the compatibility specifications of
the certified component being installed, and there are no commercially
available certified components of a similar type that are compatible
with the system.
Signature
Company Name
Street Address, P.O. Box
City, State, Zip Code
Date of Installation
(6) Accessory components. The use with an x-ray system of accessory
components specified in paragraph (a) of this section that are not
permanently installed in the x-ray system, which are not essential to
the performance of the system in compliance with the requirements of
this section and 1020.31 1020.32, and 1020.33, and which are subject
to the assembler reporting exceptions of paragraph (d)(3) of this
section are not subject to paragraph (p)(1) of this section and do not
affect the status of the x-ray system under that paragraph.
(q) Modification of certified diagnostic x-ray components and
systems. (1) Diagnostic x-ray components and systems certified in
accordance with 1010.2 of this chapter shall not be modified such that
the component or system fails to comply with any applicable provision of
this chapter unless a variance in accordance with 1010.4 of this
chapter or an exemption under section 358(a)(5) or 360B(b) of the Public
Health Service Act has been granted.
(2) The owner of a diagnostic x-ray system who uses the system in a
professional or commercial capacity may modify the system, provided the
modification does not result in the failure of the system or component
to comply with the applicable requirements of this section or of
1020.31 or 1020.32, or 1020.33. The owner who causes such modification
need not submit the reports required by Subpart B of Part 1002 of this
chapter, provided the owner records the date and the details of the
modification, and provided the modification of the x-ray system does not
result in a failure to comply with 1020.31, 1020.32, or 1020.33.
(38 FR 28632, Oct. 15, 1973, as amended at 39 FR 13880, Apr. 18,
1974; 42 FR 10985, Feb. 25, 1977; 42 FR 44232, Sept. 2, 1977; 44 FR
29654, May 22, 1979; 44 FR 49671, Aug. 24, 1979; 44 FR 68824, Nov.
30, 1979; 45 FR 27928, Apr. 25, 1980; 47 FR 50215, Nov. 5, 1982; 49
FR 34711, Aug. 31, 1984; 50 FR 15544, Apr. 19, 1985; 53 FR 11254, Apr.
6, 1988)
1The nominal chemical composition of type 1100 aluminum alloy is
99.00 percent minimum aluminum, 0.12 percent copper, as given in
''Aluminum Standards and Data'' (1969). Copies may be otained from:
The Aluminum Association, New York, NY.
2In the case of a system which is to be operated with more than on
thickness of filtration, this requirement can be met by a filter
interlock with the kilovoltage selector which will prevent x-ray
emission if the minimum required filtration is not in place.
21 CFR 1020.31 Radiographic equipment.
The provisions of this section apply to equipment for the recording
of images, except equipment involving use of an image intensifier or
computed tomography x-ray systems manufactured on or after November 29,
1984.
(a) Control and indication of technique factors -- (1) Visual
indication. The technique factors to be used during an exposure shall
be indicated before the exposure begins, except when automatic exposure
controls are used, in which case the technique factors which are set
prior to the exposure shall be indicated. On equipment having fixed
technique factors, this requirement may be met by permanent markings.
Indication of technique factors shall be visible from the operator's
position except in the case of spot films made by the fluoroscopist.
(2) Timers. Means shall be provided to terminate the exposure at a
preset time interval, preset product of current and time, a preset
number of pulses, or a preset radiation exposure to the image receptor.
(i) Except during serial radiography, the operator shall be able to
terminate the exposure at any time during an exposure of greater than
one-half second. Termination of exposure shall cause automatic
resetting of the timer to its initial setting or to zero. It shall not
be possible to make an exposure when the timer is set to a zero or off
position if either position is provided.
(ii) During serial radiography, the operator shall be able to
terminate the x-ray exposure(s) at any time, but means may be provided
to permit completion of any single exposure of the series in process.
(3) Automatic exposure controls. When an automatic exposure control
is provided:
(i) Indication shall be made on the control panel when this mode of
operation is selected;
(ii) When the x-ray tube potential is equal to or greater than 50
kVp, the minimum exposure time for field emission equipment rated for
pulsed operation shall be equal to or less than a time interval
equivalent to two pulses and the minimum exposure time for all other
equipment shall be equal to or less than 1/60 second or a time interval
required to deliver 5 mAs, whichever is greater;
(iii) Either the product of peak x-ray tube potential, current, and
exposure time shall be limited to not more than 60 kWs per exposure or
the product of x-ray tube current and exposure time shall be limited to
not more than 600 mAs per exposure except when the x-ray tube potential
is less than 50 kVp in which case the product of x-ray tube current and
exposure time shall be limited to not more than 2000 mAs per exposure;
and
(iv) A visible signal shall indicate when an exposure has been
terminated at the limits described in paragraph (a)(3)(iii) of this
section, and manual resetting shall be required before further
automatically timed exposures can be made.
(4) Accuracy. Deviation of technique factors from indicated values
shall not exceed the limits given in the information provided in
accordance with 1020.30(h)(3).
(b) Reproducibility. The following requirements shall apply when the
equipment is operated on an adequate power supply as specified by the
manufacturer in accordance with the requirements of 1020.30(h)(3):
(1) Coefficient of variation. For any specific combination of
selected technique factors, the estimated coefficient of variation of
radiation exposures shall be no greater than 0.05.
(2) Measuring compliance. Determination of compliance shall be based
on 10 consecutive measurements taken within a time period of 1 hour.
Equipment manufactured after September 5, 1978 shall be subject to the
additional requirement that all variable controls for technique factors
shall be adjusted to alternate settings and reset to the test setting
after each measurement. The percent line-voltage regulation shall be
determined for each measurement. All values for percent line-voltage
regulation shall be within 1 of the mean value for all measurements.
For equipment having automatic exposure controls, compliance shall be
determined with a sufficient thickness of attenuating material in the
useful beam such that the technique factors can be adjusted to provide
individual exposures of a minimum of 12 pulses on field emission
equipment rated for pulsed operation or no less than one-tenth second
per exposure on all other equipment.
(c) Linearity. The following requirement applies when the equipment
allows a choice of x-ray tube current settings and is operated on a
power supply as specified by the manufacturer in accordance with the
requirements of 1020.30(h)(3) for any fixed x-ray tube potential within
the range of 40 percent to 100 percent of the maximum rated.
(1) Average exposure ratios. The average ratios of exposure to the
indicated milliampere-seconds product (mR/mAs) obtained at any two
consecutive tube current settings shall not differ by more than 0.10
times their sum. This is:
X1^X2 l 0.10 (X1+X2); where X1 and X2 are the average mR/mAs values
obtained at each of two consecutive tube current settings.
(2) Measuring compliance. Determination of compliance will be based
on 10 exposures at each of two consecutive x-ray tube current settings
made within 1 hour. The percent line-voltage regulation shall be
determined for each measurement. All values for percent line-voltage
regulation at any one combination of technique factors shall be within
1 of the mean value for all measurements at these technique factors.
Where tube current selection is continuous, X1 and X2 shall be obtained
at current settings differing by no greater than a factor of 2.
(d) Field limitation and alignment for mobile and stationary general
purpose x-ray systems. Except when spot-film devices or special
attachments for mammography are in service, mobile and stationary
general purpose radiographic x-ray systems shall meet the following
requirements:
(1) Variable x-ray field limitation. There shall be provided a means
for stepless adjustment of the size of the x-ray field. The minimum
field size at an SID of 100 centimeters shall be equal to or less than 5
by 5 centimeters.
(2) Visual definition. (i) Means shall be provided for visually
defining the perimeter of the x-ray field. The total misalignment of
the edges of the visually defined field with the respective edges of the
x-ray field along either the length or width of the visually defined
field shall not exceed 2 percent of the distance from the source to the
center of the visually defined field when the surface upon which it
appears is perpendicular to the axis of the x-ray beam.
(ii) When a light localizer is used to define the x-ray field, it
shall provide an average illumination of not less than 160 lux (15
footcandles) at 100 centimeters or at the maximum SID, whichever is
less. The average illumination shall be based upon measurements made in
the approximate center of each quadrant of the light field. Radiation
therapy simulation systems are exempt from this requirement.
(iii) The edge of the light field at 100 centimeters or at the
maximum SID, whichever is less, shall have a contrast ratio, corrected
for ambient lighting, of not less than 4 in the case of beam-limiting
devices designed for use on stationary equipment, and a contrast ratio
of not less than 3 in the case of beam-limiting devices designed for use
on mobile equipment. The contrast ratio is defined as I1/I2 where I1 is
the illumination 3 millimeters from the edge of the light field toward
the center of the field; and I2 is the illumination 3 millimeters from
the edge of the light field away from the center of the field.
Compliance shall be determined with a measuring aperture of 1
millimeter.
(e) Field limitation and alignment on stationary general purpose
x-ray equipment. Except when spot-film devices or special attachments
for mammography are in service, stationary general purpose x-ray systems
shall meet the following requirements in addition to those prescribed in
paragraph (d) of this section:
(1) Field indication and alignment. (i) Means shall be provided to
indicate when the axis of the x-ray beam is perpendicular to the plane
of the image receptor, to align the center of the x-ray field with
respect to the center of the image receptor to within 2 percent of the
SID, and to indicate the SID to within 2 percent;
(ii) The beam-limiting device shall numerically indicate the field
size in the plane of the image receptor to which it is adjusted;
(iii) Indication of field size dimensions and SID's shall be
specified in inches and/or centimeters, and shall be such that aperture
adjustments result in x-ray field dimensions in the plane of the image
receptor which correspond to those indicated by the beam-limiting device
to within 2 percent of the SID when the beam axis is indicated to be
perpendicular to the plane of the image receptor; and
(iv) Compliance measurements will be made at discrete SID's and image
receptor dimensions in common clinical use (such as SID's of 36, 40, 48,
and 72 inches and nominal image receptor dimensions of 5, 7, 8, 9, 10,
11, 12, 14, and 17 inches) or at any other specific dimensions at which
the beam-limiting device or its associated diagnostic x-ray system is
uniquely designed to operate.
(2) Positive beam limitation (PBL). The requirements of this
paragraph shall apply to stationary, general-purpose radiographic
systems which contain a tube housing assembly, an x-ray control, and,
for those systems so equipped, a table, all certified in accordance with
1020.30(c). Means shall be provided for PBL such that x-ray production
is prevented when:
(i) Either the length or width of the x-ray field in the plane of the
image receptor differs from the corresponding image receptor dimension
by more than 3 percent of the SID; or
(ii) The sum of the length and width differences as stated in
paragraph (e)(2)(i) of this section without regard to sign exceeds 4
percent of the SID.
(3) Conditions for positive beam limitation. PBL shall be provided
whenever all the following conditions are met:
(i) The image receptor is inserted into a permanently mounted
cassette holder;
(ii) The image receptor length and width are each less than 50
centimeters;
(iii) The x-ray beam axis is within 3 degrees of vertical and the
SID is 90 centimeters to 130 centimeters inclusive; or the x-ray beam
axis is within 3 degrees of horizontal and the SID is 90 centimeters to
205 centimeters inclusive;
(iv) The x-ray beam axis is perpendicular to the plane of the image
receptor to within 3 degrees; and
(v) Neither tomographic nor stereoscopic radiography is being
performed.
(4) Measuring compliance. Compliance with the requirements of
paragraph (e)(2) of this section shall be determined when the equipment
indicates that the beam axis is perpendicular to the plane of the image
receptor and the provisions of paragraph (e)(3) of this section are met.
Compliance shall be determined no sooner than 5 seconds after insertion
of the image receptor.
(5) Operator initiated undersizing. The PBL system shall be capable
of operation, at the discretion of the operator, such that the size of
the field may be made smaller than the size of the image receptor
through stepless adjustment of the field size. The minimum field size
at an SID of 100 centimeters shall be equal to or less than 5 by 5
centimeters. Return to PBL function as described in paragraph (e)(2) of
this section shall occur automatically upon any change of image receptor
size or SID.
(6) Override of positive beam limitation. A capability may be
provided for overriding PBL in case of system failure and for servicing
the system. This override may be for all SID's and image receptor
sizes. A key shall be required for any override capability that is
accessible to the operator. It may not be possible to remove the key
while the PBL is overridden. Each such key switch or key shall be
clearly and durably labeled as follows:
The override capability is considered accessible to the operator if
it is referenced in the operator's manual or in other material intended
for the operator or if its location is such that the operator would
consider it part of the operational controls.
(f) Field limitation on radiographic x-ray equipment other than
general purpose radiographic systems -- (1) Equipment for use with
intraoral image receptors. Radiographic equipment designed for use with
an intraoral image receptor shall be provided with means to limit the
x-ray beam such that:
(i) If the minimum source-to-skin distance (SSD) is 18 centimeters or
more, the x-ray field at the minimum SSD shall be containable in a
circle having a diameter of no more than 7 centimeters; and
(ii) If the minimum SSD is less than 18 centimeters, the x-ray field
at the minimum SSD shall be containable in a circle having a diameter of
no more than 6 centimeters.
(2) X-ray systems designed for one image receptor size. Radiographic
equipment designed for only one image receptor size at a fixed SID shall
be provided with means to limit the field at the plane of the image
receptor to dimensions no greater than those of the image receptor, and
to align the center of the x-ray field with the center of the image
receptor to within 2 percent of the SID or shall be provided with means
to both size and align the x-ray field such that the x-ray field at the
plane of the image receptor does not extend beyond any edge of the image
receptor.
(3) Systems designed for or provided with special attachments for
mammography. Radiographic systems designed only for mammography and
general purpose radiographic systems, when special attachments for
mammography are in service, shall be provided with means to limit the
useful beam such that the x-ray field at the plane of the image receptor
does not extend beyond any edge of the image receptor at any designated
SID except the edge of the image receptor designed to be adjacent to the
chest wall where the x-ray field may not extend beyond this edge by more
than 2 percent of the SID. This requirement can be met with a system
which performs as prescribed in paragraphs (f)(4) (i), (ii), and (iii)
of this section. When the beam-limiting device and image receptor
support device are designed to be used to immoblize the breast during a
mammographic procedure and the SID may vary, the SID indication
specified in paragraphs (f)(4) (ii) and (iii) of this section shall be
the maximum SID for which the beam-limiting device or aperture is
designed. In addition, each image receptor support intended for
installation on a system designed only for mammography shall have clear
and permanent markings to indicate the maximum image receptor size for
which it is designed.
(4) Other x-ray systems. Radiographic systems not specifically
covered in paragraphs (d), (e), (f) (2) and (3), and (g) of this section
and systems covered in paragraph (f)(1) of this section, which also are
designed for use with extraoral image receptors and when used with an
extraoral image receptor, shall be provided with means to limit the
x-ray field in the plane of the image receptor so that such field does
not exceed each dimension of the image receptor by more than 2 percent
of the SID, when the axis of the x-ray beam is perpendicular to the
plane of the image receptor. In addition, means shall be provided to
align the center of the x-ray field with the center of the image
receptor to within 2 percent of the SID,or means shall be provided to
both size and align the x-ray field such that the x-ray field at the
plane of the image receptor does not extend beyond any edge of the image
receptor. These requirements may be met with:
(i) A system which performs in accordance with paragraphs (d) and
(e)(1) of this section; or, when alignment means are also provided, may
be met with either:
(ii) An assortment of removable, fixed-aperture, beam-limiting
devices sufficient to meet the requirement for each combination of image
receptor size and SID for which the unit is designed. Each such device
shall have clear and permanent markings to indicate the image receptor
size and SID for which it is designed; or
(iii) A beam-limiting device having multiple fixed apertures
sufficient to meet the requirement for each combination of image
receptor size and SID for which the unit is designed. Permanent,
clearly legible markings shall indicate the image receptor size and SID
for which each aperture is designed and shall indicate which aperture is
in position for use.
(g) Field limitation and alignment for spot-film devices. The
following requirements shall apply to spot-film devices, except when the
spot-film device is provided for use with a radiation therapy simulation
system:
(1) Means shall be provided between the source and the patient for
adjustment of the x-ray field size in the plane of the film to the size
of that portion of the film which has been selected on the spot-film
selector. Such adjustment shall be accomplished automatically when the
x-ray field size in the plane of the film is greater than the selected
portion of the film. If the x-ray field size is less than the size of
the selected portion of the film, the means for adjustment of the field
size shall be only at the operator's option.
(2) The total misalignment of the edges of the x-ray field with the
respective edges of the selected portion of the image receptor along the
length or width dimensions of the x-ray field in the plane of the image
receptor shall not exceed 3 percent of the SID when adjusted for full
coverage of the selected portion of the image receptor. The sum without
regard to sign of the misalignment along any two orthogonal dimensions
shall not exceed 4 percent of the SID. On spot-film devices
manufactured after February 25, 1978, if the angle between the plane of
the image receptor and beam axis is variable, means shall be provided to
indicate when the axis of the x-ray beam is perpendicular to the plane
of the image receptor, and compliance shall be determined with the beam
axis indicated to be perpendicular to the plane of the image receptor.
(3) It shall be possible to adjust the x-ray field size in the plane
of the film to a size smaller than the selected portion of the film.
The minimum field size, at the greatest SID, shall be equal to or less
than 5 by 5 centimeters.
(4) The center of the x-ray field in the plane of the film shall be
aligned with the center of the selected portion of the film to within 2
percent of the SID.
(5) A capability may be provided for overriding the automatic x-ray
field size adjustment in case of system failure. If it is so provided,
a signal visible at the fluoroscopist's position shall indicate whenever
the automatic x-ray field size adjustment override is engaged. Each
such system failure override switch shall be clearly labeled as follows:
(h) Source-skin distance. (1) X-ray systems designed for use with an
intra-oral image receptor shall be provided with means to limit
source-to-skin distance to not less than:
(i) Eighteen centimeters if operable above 50 kilovolts peak, or
(ii) Ten centimeters if not operable above 50 kilovolts peak.
(2) Mobile or portable x-ray systems other than dental shall be
provided with means to limit source-to-skin distance to not less than 30
centimeters.
(i) Beam-on indicators. The x-ray control shall provide visual
indication whenever x-rays are produced. In addition, a signal audible
to the operator shall indicate that the exposure has terminated.
(j) Multiple tubes. Where two or more radiographic tubes are
controlled by one exposure switch, the tube or tubes which have been
selected shall be clearly indicated prior to initiation of the exposure.
This indication shall be both on the x-ray control and at or near the
tube housing assembly which has been selected.
(k) Standby radiation from capacitor energy storage equipment.
Radiation emitted from the x-ray tube when the exposure switch or timer
is not activated shall not exceed a rate of 2 milliroentgens per hour at
5 centimeters from any accessible surface of the diagnostic source
assembly, with the beam-limiting device fully open. Compliance shall be
determined by measurements averaged over an area of 100 square
centimeters with no linear dimension greater than 20 centimeters. The
response time of the (radiation measuring) instrument system shall be no
less than 3 and no greater than 20 seconds.
(l) Transmission limit for image receptor supporting devices used for
mammography. For x-ray systems manufactured after September 5, 1978
which are designed only for mammography, the transmission of the primary
beam through any image receptor support provided with the system shall
be limited such that the exposure 5 centimeters from any accessible
surface beyond the plane of the image receptor supporting device does
not exceed 0.1 milliroentgen for each activation of the tube. Exposure
shall be measured with the system operated at the minimum SID for which
it is designed. Compliance shall be determined at the maximum rated
peak tube potential for the system and at the maximum rated product of
the tube current and exposure time (mAs) for that peak tube potential.
Compliance shall be determined by measurements averaged over an area of
100 square centimeters with no linear dimension greater than 20
centimeters.
(38 FR 28632, Oct. 15, 1973, as amended at 39 FR 36008, Oct. 7, 1974;
42 FR 10986, Feb. 25, 1977; 42 FR 44232, Sept. 2, 1977; 42 FR 58169,
Nov. 8, 1977; 44 FR 29654, May 22, 1979; 45 FR 27928, Apr. 25, 1980;
47 FR 50215, Nov. 5, 1982; 49 FR 34712, Aug. 31, 1984)
21 CFR 1020.32 Fluoroscopic equipment.
The provisions of this section apply to equipment for fluoroscopy and
for the recording of images through an image intensifier except computed
tomography x-ray systems manufactured on or after November 29, 1984.
(a) Primary protective barrier -- (1) Limitation of useful beam. The
fluoroscopic imaging assembly shall be provided with a primary
protective barrier which intercepts the entire cross section of the
useful beam at any SID. The x-ray tube used for fluoroscopy shall not
produce x-rays unless the barrier is in position to intercept the entire
useful beam. The exposure rate due to transmission through the barrier
with the attenuation block in the useful beam combined with radiation
form the image intensifier, if provided, shall not exceed 2
milliroentgens per hour at 10 centimeters from any accessible surface of
the fluoroscopic imaging assembly beyond the plane of the image receptor
for each roentgen per minute of entrance exposure rate. Radiation
therapy simulation systems shall be exempt from this requirement
provided the systems are intended only for remote control operation and
the manufacturer sets forth instructions for assemblers with respect to
control location as part of the information required in 1020.30(g).
Additionally, the manufacturer shall provide to users, pursuant to
1020.30(h)(1)(i), precautions concerning the importance of remote
control operation.
(2) Measuring compliance. The entrance exposure rate shall be
measured in accordance with paragraph (d) of this section. The exposure
rate due to transmission through the primary barrier combined with
radiation from the image intensifier shall be determined by measurements
averaged over an area of 100 square centimeters with no linear dimension
greater than 20 centimeters. If the source is below the tabletop, the
measurement shall be made with the input surface of the fluoroscopic
imaging assembly positioned 30 centimeters above the tabletop. If the
source is above the tabletop and the SID is variable, the measurement
shall be made with the end of the beam-limiting device or spacer as
close to the tabletop as it can be placed, provided that it shall not be
closer than 30 centimeters. Movable grids and compression devices shall
be removed from the useful beam during the measurement. For all
measurements, the attenuation block shall be positioned in the useful
beam 10 centimeters from the point of measurement of entrance exposure
rate and between this point and the input surface of the fluoroscopic
imaging assembly.
(b) Field limitation -- (1) Nonimage-intensified fluoroscopy. (i)
The x-ray field produced by nonimage-intensified fluoroscopic equipment
shall not extend beyond the entire visible area of the image receptor.
Means shall be provided for stepless adjustment of the field size. The
minimum field size at the greatest SID shall be equal to or less than
5-by-5 centimeters.
(ii) For equipment manufactured after February 25, 1978, when the
angle between the image receptor and the beam axis of the x-ray beam is
variable, means shall be provided to indicate when the axis of the x-ray
beam is perpendicular to the plane of the image receptor. Compliance
with 1020.32 (b)(1)(i) shall be determined with the beam axis indicated
to be perpendicular to the plane of the image receptor.
(2) Image-intensified fluoroscopy. (i) For image-intensified
fluoroscopic equipment other than radiation therapy simulation systems,
neither the length nor the width of the x-ray field in the plane of the
image receptor shall exceed that of the visible area of the image
receptor by more than 3 percent of the SID. The sum of the excess
length and the excess width shall be no greater than 4 percent of the
SID.
(ii) For rectangular x-ray fields used with circular image receptors,
the error in alignment shall be determined along the length and width
dimensions of the X-ray field which pass through the center of the
visible area of the image receptor.
(iii) For equipment manufactured after February 25, 1978, when the
angle between the image receptor and beam axis is variable, means shall
be provided to indicate when the axis of the x-ray beam is perpendicular
to the plane of the image receptor. Compliance with 1020.32 (b)(2)(i)
shall be determined with the beam axis indicated to be perpendicular to
the plane of the image receptor.
(iv) Means shall be provided to permit further limitation of the
field. Beam-limiting devices manufactured after May 22, 1979, and
incorporated in equipment with a variable SID and/or a visible area of
greater than 300 square centimeters shall be provided with means for
stepless adjustment of the x-ray field. Equipment with a fixed SID and
a visible area of 300 square centimeters or less shall be provided with
either stepless adjustment of the x-ray field or with means to further
limit the x-ray field size at the plane of the image receptor to 125
square centimeters or less. Stepless adjustment shall, at the greatest
SID, provide continuous field sizes from the maximum obtainable to a
field size of 5-by-5 centimeters or less.
(3) If the fluoroscopic x-ray field size is adjusted automatically as
the SID or image receptor size is changed, a capability may be provided
for overriding the automatic adjustment in case of system failure. If
it is so provided, a signal visible at the fluoroscopist's position
shall indicate whenever the automatic field adjustment is overridden.
Each such system failure override switch shall be clearly labeled as
follows:
(c) Activation of tube. X-ray production in the fluoroscopic mode
shall be controlled by a device which requires continuous pressure by
the operator for the entire time of any exposure. When recording serial
fluoroscopic images, the operator shall be able to terminate the x-ray
exposure(s) at any time, but means may be provided to permit completion
of any single exposure of the series in process.
(d) Entrance exposure rate limits -- (1) Equipment with automatic
exposure rate control. Fluoroscopic equipment which is provided with
automatic exposure rate control shall not be operable at any combination
of tube potential and current which will result in an exposure rate in
excess of 10 roentgens per minute at the point where the center of the
useful beam enters the patient, except:
(i) During recording of fluoroscopic images, or
(ii) When an optional high level control is provided. When so
provided, the equipment shall not be operable at any combination of tube
potential and current which will result in an exposure rate in excess of
5 roentgens per minute at the point where the center of the useful beam
enters the patient unless the high level control is activated. Special
means of activation of high level controls shall be required. The high
level control shall only be operable when continuous manual activation
is provided by the operator. A continuous signal audible to the
fluoroscopist shall indicate that the high level control is being
employed.
(2) Equipment without automatic exposure rate control. Fluoroscopic
equipment which is not provided with automatic exposure rate control
shall not be operable at any combination of tube potential and current
which will result in an exposure rate in excess of 5 roentgens per
minute at the point where the center of the useful beam enters the
patient, except:
(i) During recording of fluoroscopic images, or
(ii) When an optional high level control is activated. Special means
of activation of high level controls shall be required. The high level
control shall only be operable when continuous manual activation is
provided by the operator. A continuous signal audible to the
fluoroscopist shall indicate that the high level control is being
employed.
(3) Measuring compliance. Compliance with this paragraph (d) shall
be determined as follows:
(i) If the source is below the table, exposure rate shall be measured
1 centimeter above the tabletop or cradle.
(ii) If the source is above the table, the exposure rate shall be
measured at 30 centimeters above the tabletop with the end of the
beam-limiting device or spacer positioned as closely as possible to the
point of measurement.
(iii) In a C-arm type of fluoroscope, the exposure rate shall be
measured 30 centimeters from the input surface of the fluoroscopic
imaging assembly.
(4) Exemptions. Fluoroscopic radiation therapy simulation systems
are exempt from this requirement.
(e) Indication of potential and current. During fluoroscopy and
cinefluorography x-ray tube potential and current shall be continuously
indicated. Deviation of x-ray tube potential and current from the
indicated values shall not exceed the maximum deviation as stated by the
manufacturer in accordance with 1020.30(h)(3).
(f) Source-skin distance. Means shall be provided to limit the
source-skin distance to not less than 38 centimeters on stationary
fluoroscopes and to not less than 30 centimeters on mobile fluoroscopes.
In addition, for image-intensified fluoroscopes intended for specific
surgical application that would be prohibited at the source-skin
distances specified in this paragraph, provisions may be made for
operation at shorter source-skin distances but in no case less than 20
centimeters. When provided, the manufacturer must set forth precautions
with respect to the optional means of spacing, in addition to other
information as required in 1020.30(h).
(g) Fluoroscopic timer. Means shall be provided to preset the
cumulative on-time of the fluoroscopic tube. The maximum cumulative
time of the timing device shall not exceed 5 minutes without resetting.
A signal audible to the fluoroscopist shall indicate the completion of
any preset cumulative on-time. Such signal shall continue to sound
while x-rays are produced until the timing device is reset. As an
alternative to the requirements of this paragraph, radiation therapy
simulation systems may be provided with a means to indicate the total
cumulative exposure time during which x-rays were produced, and which is
capable of being reset between x-ray examinations.
(h) Mobile fluoroscopes. In addition to the foregoing requirements
of this section, mobile fluoroscopes shall provide intensified imaging.
(38 FR 28632, Oct. 15, 1973, as amended at 39 FR 36008, Oct. 7, 1974;
42 FR 10986, Feb. 25, 1977; 44 FR 29654, May 22, 1979; 45 FR 27928,
Apr. 25, 1980; 47 FR 50215, Nov. 5, 1982; 49 FR 34712, Aug. 31, 1984;
53 FR 11254, Apr. 6, 1988)
21 CFR 1020.33 Computed tomography (CT) equipment.
(a) Applicability. (1) The provisions of this section, except for
paragraphs (b), (c)(1), and (c)(2) are applicable as specified herein to
CT x-ray systems manufactured or remanufactured on or after September 3,
1985.
(2) The provisions of paragraphs (b), (c)(1), and (c)(2) are
applicable to CT x-ray systems manufactured or remanufactured on or
after November 29, 1984.
(b) Definitions. As used in this section, the following definitions
apply:
(1) ''Computed tomography dose index (CTDI)'' means the integral of
the dose profile along a line perpendicular to the tomographic plane
divided by the product of the nominal tomographic section thickness and
the number of tomograms produced in a single scan; that is:
Where:
z=position along a line perpendicular to the tomographic plane.
D(z)=Dose at position z.
T=Nominal tomographic section thickness.
n=Number of tomograms produced in a single scan.
This definition assumes that the dose profile is centered around z=0
and that, for a multiple tomogram system, the scan increment between
adjacent scans is nT.
(2) ''Contrast scale'' means the change in linear attenuation
coefficient per CT number relative to water; that is:
Where:
mw=Linear attenuation coefficient of water.
mx=Linear attenuation coefficient of material of interest.
(CT)w=CT number of water.
(CT)x=CT number of material of interest.
(3) ''CT conditions of operation'' means all selectable parameters
governing the operation of a CT x-ray system including nominal
tomographic section thickness, filtration, and the technique factors as
defined in 1020.30(b)(36).
(4) ''CT number'' means the number used to represent the x-ray
attenuation associated with each elemental area of the CT image.
(5) (Reserved)
(6) ''CT dosimetry phantom'' means the phantom used for determination
of the dose delivered by a CT x-ray system. The phantom shall be a
right circular cylinder of polymethl-methacrylate of density 1.19 0.01
grams per cubic centimeter. The phantom shall be at least 14
centimeters in length and shall have diameters of 32.0 centimeters for
testing any CT system designed to image any section of the body (whole
body scanners) and 16.0 centimeters for any system designed to image the
head (head scanners) or for any whole body scanner operated in the head
scanning mode. The phantom shall provide means for the placement of a
dosimeter(s) along its axis of rotation and along a line parallel to the
axis of rotation 1.0 centimeter from the outer surface and within the
phantom. Means for the placement of a dosimeter(s) or alignment device
at other locations may be provided for convenience. The means used for
placement of a dosimeter(s) (i.e., hole size) and the type of
dosimeter(s) used is at the discretion of the manufacturer. Any effect
on the doses measured due to the removal of phantom material to
accommodate dosimeters shall be accounted for through appropriate
corrections to the reported data or included in the statement of maximum
deviation for the values obtained using the phantom.
(7) ''Dose profile'' means the dose as a function of position along a
line.
(8) ''Modulation transfer function'' means the modulus of the Fourier
transform of the impulse response of the system.
(9) ''Multiple tomogram system'' means a CT x-ray system which
obtains x-ray transmission data simultaneously during a single scan to
produce more than one tomogram.
(10) ''Noise'' means the standard deviation of the fluctuations in CT
number expressed as a percent of the attenuation coefficient of water.
Its estimate (Sn) is calculated using the following expression:
Where:
CS=Contrast scale.
w=Linear attenuation coefficient of water.
s=Estimated standard deviation of the CT numbers of picture elements
in a specified area of the CT image.
(11) ''Nominal tomographic section thickness'' means the full-width
at half-maximum of the sensitivity profile taken at the center of the
cross-sectional volume over which x-ray transmission data are collected.
(12) ''Picture element'' means an elemental area of a tomogram.
(13) ''Remanufacturing'' means modifying a CT system in such a way
that the resulting dose and imaging performance become substantially
equivalent to any CT x-ray system manufactured by the original
manufacturer on or after November 29, 1984. Any reference in this
section to ''manufacture'', ''manufacturer'', or ''manufacturing''
includes remanufacture, remanufacturer, or remanufacturing,
respectively.
(14) ''Scan increment'' means the amount of relative displacement of
the patient with respect to the CT x-ray system between successive scans
measured along the direction of such displacement.
(15) ''Scan sequence'' means a preselected set of two or more scans
performed consecutively under preselected CT conditions of operations.
(16) ''Sensitivity profile'' means the relative response of the CT
x-ray system as a function of position along a line perpendicular to the
tomographic plane.
(17) ''Single tomogram system'' means a CT x-ray system which obtains
x-ray transmission data during a scan to produce a single tomogram.
(18) ''Tomographic plane'' means that geometric plane which the
manufacturer identifies as corresponding to the output tomogram.
(19) ''Tomographic section'' means the volume of an object whose
x-ray attenuation properties are imaged in a tomogram.
(c) Information to be provided for users. Each manufacturer of a CT
x-ray system shall provide the following technical and safety
information, in addition to that required under 1020.30(h), to
purchasers and, upon request, to others at a cost not to exceed the cost
of publication and distribution of such information. This information
shall be identified and provided in a separate section of the user's
instruction manual or in a separate manual devoted only to this
information.
(1) Conditions of operation. A statement of the CT conditions of
operation used to provide the information required by paragraph (c) (2)
and (3) of this section.
(2) Dose information. The following dose information obtained by
using the CT dosimetry phantom. For any CT x-ray system designed to
image both the head and body, separate dose information shall be
provided for each application. All dose measurements shall be performed
with the CT dosimetry phantom placed on the patient couch or support
device without additional attenuating materials present.
(i) The CTDI at the following locations in the dosimetry phantom:
(a) Along the axis of rotation of the phantom.
(b) Along a line parallel to the axis of rotation and 1.0 centimeter
interior to the surface of the phantom with the phantom positioned so
that CTDI is the maximum obtainable at this depth.
(c) Along lines parallel to the axis of rotation and 1.0 centimeter
interior to the surface of the phantom at positions 90, 180, and 270
degrees from the position in paragraph (c)(2)(i)(b) of this section.
The CT conditions of operation shall be the typical values suggested by
the manufacturer for CT of the head or body. The location of the
position where the CTDI is maximum as specified in paragraph
(c)(2)(i)(b) of this section shall be given by the manufacturer with
respect to the housing of the scanning mechanism or other readily
identifiable feature of the CT x-ray system in such a manner as to
permit placement of the dosimetry phantom in this orientation.
(ii) The CTDI in the center location of the dosimetry phantom for
each selectable CT condition of operation that varies either the rate or
duration of x-ray exposure. This CTDI shall be presented as a value
that is normalized to the CTDI in the center location of the dosimetry
phantom from paragraph (c)(2)(i) of this section, with the CTDI of
paragraph (c)(2)(i) of this section having a value of one. As each
individual CT condition of operation is changed, all other independent
CT conditions of operation shall be maintained at the typical values
described in paragraph (c)(2)(i) of this section. These data shall
encompass the range of each CT condition of operation stated by the
manufacturer as appropriate for CT of the head or body. When more than
three selections of a CT condition of operation are available, the
normalized CTDI shall be provided, at least, for the minimum, maximum,
and mid-range value of the CT condition of operation.
(iii) The CTDI at the location coincident with the maximum CTDI at 1
centimeter interior to the surface of the dosimetry phantom for each
selectable peak tube potential. When more than three selections of peak
tube potential are available, the normalized CTDI shall be provided, at
least, for the minimum, maximum, and a typical value of peak tube
potential. The CTDI shall be presented as a value that is normalized to
the maximum CTDI located at 1 centimeter interior to the surface of the
dosimetry phantom from paragraph (c)(2)(i) of this section, with the
CTDI of paragraph (c)(2)(i) of this section having a value of one.
(iv) The dose profile in the center location of the dosimetry phantom
for each selectable nominal tomographic section thickness. When more
than three selections of nominal tomographic section thicknesses are
available, the information shall be provided, at least, for the minimum,
maximum, and midrange value of nominal tomographic section thickness.
The dose profile shall be presented on the same graph and to the same
scale as the corresponding sensitivity profile required by paragraph
(c)(3)(iv) of this section.
(v) A statement of the maximum deviation from the values given in the
information provided according to paragraph (c)(2) (i), (ii), (iii), and
(iv) of this section. Deviation of actual values may not exceed these
limits.
(3) Imaging performance information. The following performance data
shall be provided for the CT conditions of operation used to provide the
information required by paragraph (c)(2)(i) of this section. All other
aspects of data collection, including the x-ray attenuation properties
of the material in the tomographic section, shall be similar to those
used to provide the dose information required by paragraph (c)(2)(i) of
this section. For any CT x-ray system designed to image both the head
and body, separate imaging performance information shall be provided for
each application.
(i) A statement of the noise.
(ii) A graphical presentation of the modulation transfer function for
the same image processing and display mode as that used in the statement
of the noise.
(iii) A statement of the nominal tomographic section thickness(es).
(iv) A graphical presentation of the sensitivity profile, at the
location corresponding to the center location of the dosimetry phantom,
for each selectable nominal tomographic section thickness for which the
dose profile is given according to paragraph (c)(2)(iv) of this section.
(v) A description of the phantom or device and test protocol or
procedure used to determine the specifications and a statement of the
maximum deviation from the specifications provided in accordance with
paragraphs (c)(3) (i), (ii), (iii), and (iv) of this section. Deviation
of actual values may not exceed these limits.
(d) Quality assurance. The manufacturer of any CT x-ray system shall
provide the following with each system. All information required by
this subsection shall be provided in a separate section of the user's
instructional manual.
(1) A phantom(s) capable of providing an indication of contrast
scale, noise, nominal tomographic section thickness, the spatial
resolution capability of the system for low and high contrast objects,
and measuring the mean CT number of water or a reference material.
(2) Instructions on the use of the phantom(s) including a schedule of
testing appropriate for the system, allowable variations for the
indicated parameters, and a method to store as records, quality
assurance data.
(3) Representative images obtained with the phantom(s) using the same
processing mode and CT conditions of operation as in paragraph (c)(3) of
this section for a properly functioning system of the same model. The
representative images shall be of two forms as follows:
(i) Photographic copies of the images obtained from the image display
device.
(ii) Images stored in digital form on a storage medium compatible
with the CT x-ray system. The CT x-ray system shall be provided with
the means to display these images on the image display device.
(e) (Reserved)
(f) Control and indication of conditions of operation -- (1) Visual
indication. The CT conditions of operation to be used during a scan or
a scan sequence shall be indicated prior to initiation of a scan or a
scan sequence. On equipment having all or some of these conditions of
operation at fixed values, this requirement may be met by permanent
markings. Indication of the CT conditions of operation shall be visible
from any position from which scan initiation is possible.
(2) Timers. (i) Means shall be provided to terminate the x-ray
exposure automatically by either deenergizing the x-ray source or
shuttering the x-ray beam in the event of equipment failure affecting
data collection. Such termination shall occur within an interval that
limits the total scan time to no more than 110 percent of its preset
value through the use of either a backup timer or devices which monitor
equipment function. A visible signal shall indicate when the x-ray
exposure has been terminated through these means and manual resetting of
the CT conditions of operation shall be required prior to the initiation
of another scan.
(ii) Means shall be provided so that the operator can terminate the
x-ray exposure at any time during a scan, or series of scans under x-ray
system control, of greater than one-half second duration. Termination
of the x-ray exposure shall necessitate resetting of the CT conditions
of operation prior to the initiation of another scan.
(g) Tomographic plane indication and alignment. (1) For any single
tomogram system, means shall be provided to permit visual determination
of the tomographic plane or a reference plane offset from the
tomographic plane.
(2) For any multiple tomogram system, means shall be provided to
permit visual determination of the location of a reference plane. The
relationship of the reference plane to the planes of the tomograms shall
be provided to the user in addition to other information provided
according to 1020.30(h). This reference plane can be offset from the
location of the tomographic planes.
(3) The distance between the indicated location of the tomographic
plane or reference plane and its actual location may not exceed 5
millimeters.
(4) For any offset alignment system, the manufacturer shall provide
specific instructions with respect to the use of this system for patient
positioning, in addition to other information provided according to
1020.30(h).
(5) If a mechanism using a light source is used to satisfy the
requirements of paragraphs (g) (1) and (2) of this section, the light
source shall allow visual determination of the location of the
tomographic plane or reference plane under ambient light conditions of
up to 500 lux.
(h) Beam-on and shutter status indicators. (1) Means shall be
provided on the control and on or near the housing of the scanning
mechanism to provide visual indication when and only when x rays are
produced and, if applicable, whether the shutter is open or closed. If
the x-ray production period is less than one-half second, the indication
of x-ray production shall be actuated for one-half second. Indicators
at or near the housing of the scanning mechanism shall be discernible
from any point external to the patient opening where insertion of any
part of the human body into the primary beam is possible.
(2) For systems that allow high voltage to be applied to the x-ray
tube continuously and that control the emission of x rays with a
shutter, the radiation emitted may not exceed 100 milliroentgens (2.58
10^5 coulomb/kilogram) in 1 hour at any point 5 centimeters outside the
external surface of the housing of the scanning mechanism when the
shutter is closed. Compliance shall be determined by measurements
averaged over an area of 100 square centimeters with no linear
dimensions greater than 20 centimeters.
(i) Scan increment accuracy. The deviation of indicated scan
increment from actual scan increment may not exceed 1 millimeter.
Compliance shall be measured as follows: The determination of the
deviation of indicated versus actual scan increment shall be based on
measurements taken with a mass 100 kilograms or less, on the patient
support device. The patient support device shall be incremented from a
typical starting position to the maximum incrementation distance or 30
centimeters, whichever is less, and then returned to the starting
position. Measurement of actual versus indicated scan increment may be
taken anywhere along this travel.
(j) CT number mean and standard deviation. (1) A method shall be
provided to calculate the mean and standard deviation of CT numbers for
an array of picture elements about any location in the image. The
number of elements in this array shall be under user control.
(2) The manufacturer shall provide specific instructions concerning
the use of the method provided for calculation of CT number mean and
standard deviation in addition to other information provided according
to 1020.30(h).
(The information collection requirements in paragraphs (c), (d), (g),
and (j) were approved by the Office of Management and Budget under
control number 0910-0025)
(49 FR 34712, Aug. 31, 1984; 49 37381, Sept. 24, 1984, as amended at
49 FR 47388, Dec. 4, 1984. Redesignated at 56 FR 36098, Aug. 1, 1991)
21 CFR 1020.40 Cabinet x-ray systems.
(a) Applicability. The provisions of this section are applicable to
cabinet x-ray systems manufactured or assembled on or after April 10,
1975, except that the provisions as applied to x-ray systems designed
primarily for the inspection of carry-on baggage are applicable to such
systems manufactured or assembled on or after April 25, 1974. The
provisions of this section are not applicable to systems which are
designed exclusively for microscopic examination of material, e.g.,
x-ray diffraction, spectroscopic, and electron microscope equipment or
to systems for intentional exposure of humans to x-rays.
(b) Definitions. As used in this section the following definitions
apply:
(1) ''Access panel'' means any barrier or panel which is designed to
be removed or opened for maintenance or service purposes, requires tools
to open, and permits access to the interior of the cabinet.
(2) ''Aperture'' means any opening in the outside surface of the
cabinet, other than a port, which remains open during generation of x
radiation.
(3) ''Cabinet x-ray system'' means an x-ray system with the x-ray
tube installed in an enclosure (hereinafter termed ''cabinet'') which,
independently of existing architectural structures except the floor on
which it may be placed, is intended to contain at least that portion of
a material being irradiated, provide radiation attenuation, and exclude
personnel from its interior during generation of x radiation. Included
are all x-ray systems designed primarily for the inspection of carry-on
baggage at airline, railroad, and bus terminals, and in similar
facilities. An x-ray tube used within a shielded part of a building, or
x-ray equipment which may temporarily or occasionally incorporate
portable shielding is not considered a cabinet x-ray system.
(4) ''Door'' means any barrier which is designed to be movable or
opened for routine operation purposes, does not generally require tools
to open, and permits access to the interior of the cabinet. For the
purposes of paragraph (c)(4)(i) of this section, inflexible hardware
rigidly affixed to the door shall be considered part of the door.
(5) ''Exposure'' means the quotient of dQ by dm where dQ is the
absolute value of the total charge of the ions of one sign produced in
air when all the electrons (negatrons and positrons) liberated by
photons in a volume element of air having mass dm are completely stopped
in air.
(6) ''External surface'' means the outside surface of the cabinet
x-ray system, including the high-voltage generator, doors, access
panels, latches, control knobs, and other permanently mounted hardware
and including the plane across any aperture or port.
(7) ''Floor'' means the underside external surface of the cabinet.
(8) ''Ground fault'' means an accidental electrical grounding of an
electrical conductor.
(9) ''Port'' means any opening in the outside surface of the cabinet
which is designed to remain open, during generation of x-rays, for the
purpose of conveying material to be irradiated into and out of the
cabinet, or for partial insertion for irradiation of an object whose
dimensions do not permit complete insertion into the cabinet.
(10) ''Primary beam'' means the x radiation emitted directly from the
from the target and passing through the window of the x-ray tube.
(11) ''Safety interlock'' means a device which is intended to prevent
the generation of x radiation when access by any part of the human body
to the interior of the cabinet x-ray system through a door or access
panel is possible.
(12) ''X-ray system'' means an assemblage of components for the
controlled generation of x-rays.
(13) ''X-ray tube'' means any electron tube which is designed for the
conversion of electrical energy into x-ray energy.
(c) Requirements -- (1) Emission limit. (i) Radiation emitted from
the cabinet x-ray system shall not exceed an exposure of 0.5
milliroentgen in one hour at any point five centimeters outside the
external surface.
(ii) Compliance with the exposure limit in paragraph (c)(1)(i) of
this section shall be determined by measurements averaged over a
cross-sectional area of ten square centimeters with no linear dimension
greater than 5 centimeters, with the cabinet x-ray system operated at
those combinations of x-ray tube potential, current, beam orientation,
and conditions of scatter radiation which produce the maximum x-ray
exposure at the external surface, and with the door(s) and access
panel(s) fully closed as well as fixed at any other position(s) which
will allow the generation of x radiation.
(2) Floors. A cabinet x-ray system shall have a permanent floor.
Any support surface to which a cabinet x-ray system is permanently
affixed may be deemed the floor of the system.
(3) Ports and apertures. (i) The insertion of any part of the human
body through any port into the primary beam shall not be possible.
(ii) The insertion of any part of the human body through any aperture
shall not be possible.
(4) Safety interlocks. (i) Each door of a cabinet x-ray system shall
have a minimum of two safety interlocks. One, but not both of the
required interlocks shall be such that door opening results in physical
disconnection of the energy supply circuit to the high-voltage
generator, and such disconnection shall not be dependent upon any moving
part other than the door.
(ii) Each access panel shall have at least one safety interlock.
(iii) Following interruption of x-ray generation by the functioning
of any safety interlock, use of a control provided in accordance with
paragraph (c)(6)(ii) of this section shall be necessary for resumption
of x-ray generation.
(iv) Failure of any single component of the cabinet x-ray system
shall not cause failure of more than one required safety interlock.
(5) Ground fault. A ground fault shall not result in the generation
of x-rays.
(6) Controls and indicators for all cabinet x-ray systems. For all
systems to which this section is applicable there shall be provided:
(i) A key-actuated control to insure that x-ray generation is not
possible with the key removed.
(ii) A control or controls to initiate and terminate the generation
of x-rays other than by functioning of a safety interlock or the main
power control.
(iii) Two independent means which indicate when and only when x-rays
are being generated, unless the x-ray generation period is less than
one-half second, in which case the indicators shall be activated for
one-half second, and which are discernible from any point at which
initiation of x-ray generation is possible. Failure of a single
component of the cabinet x-ray system shall not cause failure of both
indicators to perform their intended function. One, but not both, of
the indicators required by this subdivision may be a milliammeter
labeled to indicate x-ray tube current. All other indicators shall be
legibly labeled ''X-RAY ON''.
(iv) Additional means other than milliammeters which indicate when
and only when x-rays are being generated, unless the x-ray generation
period is less than one-half second in which case the indicators shall
be activated for one-half second, as needed to insure that at least one
indicator is visible from each door, access panel, and port, and is
legibly labeled ''X-RAY ON''.
(7) Additional controls and indicators for cabinet x-ray systems
designed to admit humans. For cabinet x-ray systems designed to admit
humans there shall also be provided:
(i) A control within the cabinet for preventing and terminating x-ray
generation, which cannot be reset, overridden or bypassed from the
outside of the cabinet.
(ii) No means by which x-ray generation can be initiated from within
the cabinet.
(iii) Audible and visible warning signals within the cabinet which
are actuated for at least 10 seconds immediately prior to the first
initiation of x-ray generation after closing any door designed to admit
humans. Failure of any single component of the cabinet x-ray system
shall not cause failure of both the audible and visible warning signals.
(iv) A visible warning signal within the cabinet which remains
actuated when and only when x-rays are being generated, unless the x-ray
generation period is less than one-half second in which case the
indicators shall be activated for one-half second.
(v) Signs indicating the meaning of the warning signals provided
pursuant to paragraphs (c)(7) (iii) and (iv) of this section and
containing instructions for the use of the control provided pursuant to
paragraph (c)(7)(i) of this section. These signs shall be legible,
accessible to view, and illuminated when the main power control is in
the ''on'' position.
(8) Warning labels. (i) There shall be permanently affixed or
inscribed on the cabinet x-ray system at the location of any controls
which can be used to initiate x-ray generation, a clearly legible and
visible label bearing the statement:
(ii) There shall be permanently affixed or inscribed on the cabinet
x-ray system adjacent to each port a clearly legible and visible label
bearing the statement:
is Energized -- X-ray Hazard
(9) Instructions. (i) Manufacturers of cabinet x-ray systems shall
provide for purchasers, and to others upon request at a cost not to
exceed the cost of preparation and distribution, manuals and
instructions which shall include at least the following technical and
safety information: Potential, current, and duty cycle ratings of the
x-ray generation equipment; adequate instructions concerning any
radiological safety procedures and precautions which may be necessary
because of unique features of the system; and a schedule of maintenance
necessary to keep the system in compliance with this section.
(ii) Manufacturers of cabinet x-ray systems which are intended to be
assembled or installed by the purchaser shall provide instructions for
assembly, installation, adjustment and testing of the cabinet x-ray
system adequate to assure that the system is in compliance with
applicable provisions of this section when assembled, installed,
adjusted and tested as directed.
(10) Additional requirements for x-ray baggage inspection systems.
X-ray systems designed primarily for the inspection of carry-on baggage
at airline, railroad, and bus terminals, and at similar facilities,
shall be provided with means, pursuant to paragraphs (c)(10) (i) and
(ii) of this section, to insure operator presence at the control area in
a position which permits surveillance of the ports and doors during
generation of x-radiation.
(i) During an exposure or preset succession of exposures of one-half
second or greater duration, the means provided shall enable the operator
to terminate the exposure or preset succession of exposures at any time.
(ii) During an exposure or preset succession of exposures of less
than one-half second duration, the means provided may allow completion
of the exposure in progress but shall enable the operator to prevent
additional exposures.
(d) Modification of a certified system. The modification of a
cabinet x-ray system, previously certified pursuant to 1010.2 by any
person engaged in the business of manufacturing, assembling or modifying
cabinet x-ray systems shall be construed as manufacturing under the act
if the modification affects any aspect of the system's performance for
which this section has an applicable requirement. The manufacturer who
performs such modification shall recertify and reidentify the system in
accordance with the provisions of 1010.2 and 1010.3 of this chapter.
(39 FR 12986, Apr. 10, 1974)
21 CFR 1020.40 PART 1030 -- PERFORMANCE STANDARDS FOR MICROWAVE AND
RADIO FREQUENCY EMITTING PRODUCTS
Authority: Secs. 501, 502, 510, 515-520, 701, 801 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 351, 352, 360, 360e-360j, 371,
381); secs. 354-360F of the Public Health Service Act (42 U.S.C.
263b-263n).
21 CFR 1030.10 Microwave ovens.
(a) Applicability. The provisions of this standard are applicable to
microwave ovens manufactured after October 6, 1971.
(b) Definitions. (1) ''Microwave oven'' means a device designed to
heat, cook, or dry food through the application of electromagnetic
energy at frequencies assigned by the Federal Communications Commission
in the normal ISM heating bands ranging from 890 megahertz to 6,000
megahertz. As defined in this standard, ''microwave ovens'' are limited
to those manufactured for use in homes, restaurants, food vending, or
service establishments, on interstate carriers, and in similar
facilities.
(2) ''Cavity'' means that portion of the microwave oven in which food
may be heated, cooked, or dried.
(3) ''Door'' means the movable barrier which prevents access to the
cavity during operation and whose function is to prevent emission of
microwave energy from the passage or opening which provides access to
the cavity.
(4) ''Safety interlock'' means a device or system of devices which is
intended to prevent generation of microwave energy when access to the
cavity is possible.
(5) ''Service adjustments or service procedures'' means those
servicing methods prescribed by the manufacturer for a specific product
model.
(6) ''Stirrer'' means that feature of a microwave oven which is
intended to provide uniform heating of the load by constantly changing
the standing wave pattern within the cavity or moving the load.
(7) ''External surface'' means the outside surface of the cabinet or
enclosure provided by the manufacturer as part of the microwave oven,
including doors, door handles, latches, and control knobs.
(8) ''Equivalent plane-wave power density'' means the square of the
root-mean-square (rms) electric field strength divided by the impedance
of free space (377 ohms).
(c) Requirements -- (1) Power density limit. The equivalent
plane-wave power density existing in the proximity of the external oven
surface shall not exceed 1 milliwatt per square centimeter at any point
5 centimeters or more from the external surface of the oven, measured
prior to acquisition by a purchaser, and, thereafter, 5 milliwatts per
square centimeter at any such point.
(2) Safety interlocks. (i) Microwave ovens shall have a minimum of
two operative safety interlocks. At least one operative safety
interlock on a fully assembled microwave oven shall not be operable by
any part of the human body, or any object with a straight insertable
length of 10 centimeters. Such interlock must also be concealed, unless
its actuation is prevented when access to the interlock is possible.
Any visible actuator or device to prevent actuation of this safety
interlock must not be removable without disassembly of the oven or its
door. A magnetically operated interlock is considered to be concealed,
or its actuation is considered to be prevented, only if a test magnet
held in place on the oven by gravity or its own attraction cannot
operate the safety interlock. The test magnet shall be capable of
lifting vertically at zero air gap at least 4.5 kilograms, and at 1
centimeter air gap at least 450 grams when the face of the magnet, which
is toward the interlock when the magnet is in the test position, is
pulling against one of the large faces of a mild steel armature having
dimensions of 80 millimeters by 50 millimeters by 8 millimeters.
(ii) Failure of any single mechanical or electrical component of the
microwave oven shall not cause all safety interlocks to be inoperative.
(iii) Service adjustments or service procedures on the microwave oven
shall not cause the safety interlocks to become inoperative or the
microwave radiation emission to exceed the power density limits of this
section as a result of such service adjustments or procedures.
(iv) Microwave radiation emission in excess of the limits specified
in paragraph (c)(1) of this section shall not be caused by insertion of
an insulated wire through any opening in the external surfaces of a
fully assembled oven into the cavity, waveguide, or other
microwave-energy-containing spaces while the door is closed, provided
the wire, when inserted, could consist of two straight segments forming
an obtuse angle of not less than 170 degrees.
(v) One (the primary) required safety interlock shall prevent
microwave radiation emission in excess of the requirement of paragraph
(c)(1) of this section; the other (secondary) required safety interlock
shall prevent microwave radiation emission in excess of 5 milliwatts per
square centimeter at any point 5 centimeters or more from the external
surface of the oven. The two required safety interlocks shall be
designated as primary or secondary in the service instructions for the
oven.
(vi) A means of monitoring one or both of the required safety
interlocks shall be provided which shall cause the oven to become
inoperable and remain so until repaired if the required safety
interlock(s) should fail to perform required functions as specified in
this section. Interlock failures shall not disrupt the monitoring
function.
(3) Measurement and test conditions. (i) Compliance with the power
density limit in paragraph (c)(1) of this section shall be determined by
measurement of the equivalent plane-wave power density made with an
instrument which reaches 90 percent of its steady-state reading within 3
seconds, when the system is subjected to a step-function input signal.
Tests for compliance shall account for all measurement errors and
uncertainties to ensure that the equivalent plane-wave power density
does not exceed the limit prescribed by paragraph (c)(1) of this
section.
(ii) Microwave ovens shall be in compliance with the power density
limits if the maximum reading obtained at the location of greatest
microwave radiation emission, taking into account all measurement errors
and uncertainties, does not exceed the limit specified in paragraph
(c)(1) of this section, when the emission is measured through at least
one stirrer cycle. As provided in 1010.13 of this chapter, a
manufacturer may request alternative test procedures if, as a result of
the stirrer characteristics of a microwave oven, such oven is not
susceptible to testing by the procedures described in this paragraph.
(iii) Measurements shall be made with the microwave oven operating at
its maximum output and containing a load of 275 15 milliliters of tap
water initially at 20 5 centigrade placed within the cavity at the
center of the load-carrying surface provided by the manufacturer. The
water container shall be a low form 600-milliliter beaker having an
inside diameter of approximately 8.5 centimeters and made of an
electrically nonconductive material such as glass or plastic.
(iv) Measurements shall be made with the door fully closed as well as
with the door fixed in any other position which allows the oven to
operate.
(4) User instructions. Manufacturers of microwave ovens to which
this section is applicable shall provide, or cause to be provided, with
each oven, radiation safety instructions which:
(i) Occupy a separate section and are an integral part of the
regularly supplied users' manual and cookbook, if supplied separately,
and are located so as to elicit the attention of the reader.
(ii) Are as legible and durable as other instructions with the title
emphasized to elicit the attention of the reader by such means as
bold-faced type, contrasting color, a heavy-lined border, or by similar
means.
(iii) Contain the following wording:
(a) Do not attempt to operate this oven with the door open since
open-door operation can result in harmful exposure to microwave energy.
It is important not to defeat or tamper with the safety interlocks.
(b) Do not place any object between the oven front face and the door
or allow soil or cleaner residue to accumulate on sealing surfaces.
(c) Do not operate the oven if it is damaged. It is particularly
important that the oven door close properly and that there is no damage
to the: (1) Door (bent), (2) hinges and latches (broken or loosened),
(3) door seals and sealing surfaces.
(d) The oven should not be adjusted or repaired by anyone except
properly qualified service personnel.
(iv) Include additional radiation safety precautions or instructions
which may be necessary for particular oven designs or models, as
determined by the Director, Center for Devices and Radiological Health
or the manufacturer.
(5) Service instructions. Manufacturers of microwave ovens to which
this section is applicable shall provide or cause to be provided to
servicing dealers and distributors and to others upon request, for each
oven model, adequate instructions for service adjustments and service
procedures, and, in addition, radiation safety instructions which:
(i) Occupy a separate section and are an integral part of the
regularly supplied service manual and are located so as to elicit the
attention of the reader.
(ii) Are as legible and durable as other instructions with the title
emphasized so as to elicit the attention of the reader by such means as
bold-faced type, contrasting color, a heavy-lined border, or by similar
means.
(iii) Contain the following wording:
(a) Do not operate or allow the oven to be operated with the door
open.
(b) Make the following safety checks on all ovens to be serviced
before activating the magnetron or other microwave source, and make
repairs as necessary: (1) Interlock operation, (2) proper door closing,
(3) seal and sealing surfaces (arcing, wear, and other damage), (4)
damage to or loosening of hinges and latches, (5) evidence of dropping
or abuse.
(c) Before turning on microwave power for any service test or
inspection within the microwave generating compartments, check the
magnetron, wave guide or transmission line, and cavity for proper
alignment, integrity, and connections.
(d) Any defective or misadjusted components in the interlock,
monitor, door seal, and microwave generation and transmission systems
shall be repaired, replaced, or adjusted by procedures described in this
manual before the oven is released to the owner.
(e) A Microwave leakage check to verify compliance with the Federal
performance standard should be performed on each oven prior to release
to the owner.
(iv) Include additional radiation safety precautions or instructions
which may be necessary for particular oven designs or models, as
determined by the Director, Center for Devices and Radiological Health
or the manufacturer.
(6) Warning labels. Except as provided in paragraph (c)(6)(iv) of
this section, microwave ovens shall have the following warning labels:
(i) A label, permanently attached to or inscribed on the oven, which
shall be legible and readily viewable during normal oven use, and which
shall have the title emphasized and be so located as to elicit the
attention of the user. The label shall bear the following warning
statement:
DO NOT Attempt to Operate This Oven With:
(a) Object Caught in Door.
(b) Door That Does Not Close Properly.
(c) Damaged Door, Hinge, Latch, or Sealing Surface.
(ii) A label, permanently attached to or inscribed on the external
surface of the oven, which shall be legible and readily viewable during
servicing, and which shall have the word ''CAUTION'' emphasized and be
so located as to elicit the attention of service personnel. The label
shall bear the following warning statement:
Caution: This Device is to be Serviced Only by Properly Qualified
Service Personnel. Consult the Service Manual for Proper Service
Procedures to Assure Continued Compliance with the Federal Performance
Standard for Microwave Ovens and for Precautions to be Taken to Avoid
Possible Exposure to Excessive Microwave Energy.
(iii) The labels provided in accordance with paragraphs (c)(6)(i) and
(ii) of this section shall bear only the statements specified in that
paragraph, except for additional radiation safety warnings or
instructions which may be necessary for particular oven designs or
models, as determined by the Director, Center for Devices and
Radiological Health or the manufacturer.
(iv) Upon application by a manufacturer, the Director, Center for
Devices and Radiological Health, Food and Drug Administration, may grant
an exemption from one or more of the statements (radiation safety
warnings) specified in paragraph (c)(6)(i) of this section. Such
exemption shall be based upon a determination by the Director that the
microwave oven model for which the exemption is sought should continue
to comply with paragraphs (c) (1), (2), and (3) of this section under
the adverse condition of use addressed by such precautionary
statement(s). An original and two copies of applications shall be
submitted to the Dockets Management Branch (HFA-305), Food and Drug
Administration, Rm. 4-62, 5600 Fishers Lane, Rockville, MD 20857.
Copies of the written portion of the application, including supporting
data and information, and the Director's action on the application will
be maintained by the Branch for public review. The application shall
include:
(a) The specific microwave oven model(s) for which the exemption is
sought.
(b) The specific radiation safety warning(s) from which exemption is
sought.
(c) Data and information which clearly establish that one or more of
the radiation safety warnings in paragraph (c)(6)(i) of this section is
not necessary for the specified microwave oven model(s).
(d) Such other information and a sample of the applicable product if
required by regulation or by the Director, Center for Devices and
Radiological Health, to evaluate and act on the application.
(38 FR 28640, Oct. 15, 1973, as amended at 40 FR 14752, Apr. 4, 1975;
40 FR 52007, Nov. 7, 1975; 46 FR 8461, Jan. 27, 1981; 48 FR 57482,
Dec. 30, 1983; 50 FR 13566, Apr. 5, 1985; 53 FR 11254, Apr. 6, 1988)
21 CFR 1030.10 PART 1040 -- PERFORMANCE STANDARDS FOR LIGHT-EMITTING
PRODUCTS
Sec.
1040.10 Laser products.
1040.11 Specific purpose laser products.
1040.20 Sunlamp products and ultraviolet lamps intended for use in
sunlamp products.
1040.30 High-intensity mercury vapor discharge lamps.
Authority: Secs. 501, 502, 510, 515-520, 701, 801 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 351, 352, 360, 360e-360j, 371,
381); secs. 354-360F of the Public Health Service Act (42 U.S.C.
263b-263n).
21 CFR 1040.10 Laser products.
(a) Applicability. The provisions of this section and 1040.11, as
amended, are applicable as specified to all laser products manufactured
or assembled after August 1, 1976, except when:
(1) Such a laser product is either sold to a manufacturer of an
electronic product for use as a component (or replacement) in such
electronic product, or
(2) Sold by or for a manufacturer of an electronic product for use as
a component (or replacement) in such electronic product, provided that
such laser product:
(i) Is accompanied by a general warning notice that adequate
instructions for the safe installation of the laser product are provided
in servicing information available from the complete laser product
manufacturer under paragraph (h)(2)(ii) of this section, and should be
followed,
(ii) Is labeled with a statement that it is designated for use solely
as a component of such electronic product and therefore does not comply
with the appropriate requirements of this section and 1040.11 for
complete laser products, and
(iii) Is not a removable laser system as described in paragraph
(c)(2) of this section; and
(3) The manufacturer of such a laser product, if manufactured after
August 20, 1986:
(i) Registers, and provides a listing by type of such laser products
manufactured that includes the product name, model number and laser
medium or emitted wavelength(s). The registration and listing shall
include the name and address of the manufacturer and shall be submitted
to the Director, Office of Compliance (HFZ-300), Center for Devices and
Radiological Health, 5600 Fishers Lane, Rockville, MD 20857.
(ii) Maintains and allows access to any sales, shipping, or
distribution records that identify the purchaser of such a laser product
by name and address, the product by type, the number of units sold, and
the date of sale (shipment). These records shall be maintained and made
available as specified in 1002.31.
(b) Definitions. As used in this section and 1040.11, the following
definitions apply:
(1) ''Accessible emission level'' means the magnitude of accessible
laser or collateral radiation of a specific wavelength and emission
duration at a particular point as measured according to paragraph (e) of
this section. Accessible laser or collateral radiation is radiation to
which human access is possible, as defined in paragraphs (b) (12), (15),
and (22) of this section.
(2) ''Accessible emission limit'' means the maximum accessible
emission level permitted within a particular class as set forth in
paragraphs (c), (d), and (e) of this section.
(3) ''Aperture'' means any opening in the protective housing or other
enclosure of a laser product through which laser or collateral radiation
is emitted, thereby allowing human access to such radiation.
(4) ''Aperture stop'' means an opening serving to limit the size and
to define the shape of the area over which radiation is measured.
(5) ''Class I laser product'' means any laser product that does not
permit access during the operation to levels of laser radiation in
excess of the accessible emission limits contained in Table I of
paragraph (d) of this section. /1/
(6) ''Class IIa laser product'' means any laser product that permits
human access during operation to levels of visible laser radiation in
excess of the accessible emission limits contained in Table I, but does
not permit human access during operation to levels of laser radiation in
excess of the accessible emission limits contained in Table II-A of
paragraph (d) of this section. /2/
(7) ''Class II laser product'' means any laser product that permits
human access during operation to levels of visible laser radiation in
excess of the accessible emission limits contained in Table II-A, but
does not permit human access during operation to levels of laser
radiation in excess of the accessible emission limits contained in Table
II of paragraph (d) of this section. /3/
(8) ''Class IIIa laser product'' means any laser product that permits
human access during operation to levels of visible laser radiation in
excess of the accessible emission limits contained in Table II, but does
not permit human access during operation to levels of laser radiation in
excess of the accessible emission limits contained in Table III-A of
paragraph (d) of this section. /4/
(9) ''Class IIIb laser product'' means any laser product that permits
human access during operation to levels of laser radiation in excess of
the accessible emission limits of Table III-A, but does not permit human
access during operation to levels of laser radiation in excess of the
accessible emission limits contained in Table III-B of paragraph (d) of
this section. /5/
(10) ''Class III laser product'' means any Class IIIa or Class IIIb
laser product.
(11) ''Class IV laser product'' means any laser that permits human
access during operation to levels of laser radiation in excess of the
accessible emission limits contained in Table III-B of paragraph (d) of
this section. /6/
(12) ''Collateral radiation'' means any electronic product radiation,
except laser radiation, emitted by a laser product as a result of the
operation of the laser(s) or any component of the laser product that is
physically necessary for the operation of the laser(s).
(13) ''Demonstration laser product'' means any laser product
manufactured, designed, intended, or promoted for purposes of
demonstration, entertainment, advertising display, or artistic
composition. The term ''demonstration laser product'' does not apply to
laser products which are not manufactured, designed, intended, or
promoted for such purposes, even though they may be used for those
purposes or are intended to demonstrate other applications.
(14) ''Emission duration'' means the temporal duration of a pulse, a
series of pulses, or continuous operation, expressed in seconds, during
which human access to laser or collateral radiation could be permitted
as a result of operation, maintenance, or service of a laser product.
(15) ''Human access'' means the capacity to intercept laser or
collateral radiation by any part of the human body. For laser products
that contain Class IIIb or IV levels of laser radiation, ''human
access'' also means access to laser radiation that can be reflected
directly by any single introduced flat surface from the interior of the
product through any opening in the protective housing of the product.
(16) ''Integrated radiance'' means radiant energy per unit area of a
radiating surface per unit solid angle of emission, expressed in joules
per square centimeter per steradian (Jcm^2 sr^1).
(17) ''Invisible radiation'' means laser or collateral radiation
having wavelengths of equal to or greater than 180 nm but less than or
equal to 400 nm or greater than 710 nm but less than or equal to 1.0 X
106 nm (1 millimeter).
(18) ''Irradiance'' means the time-averaged radiant power incident on
an element of a surface divided by the area of that element, expressed
in watts per square centimeter (W cm^2).
(19) ''Laser'' means any device that can be made to produce or
amplify electromagnetic radiation at wavelenghts greater than 250 nm but
less than or equal to 13,000 nm or, after August 20, 1986, at
wavelengths equal to or greater than 180 nm but less than or equal to
1.0X106 nm primarily by the process of controlled stimulated emission.
(20) ''Laser energy source'' means any device intended for use in
conjunction with a laser to supply energy for the operation of the
laser. General energy sources such as electrical supply mains or
batteries shall not be considered to constitute laser energy sources.
(21) ''Laser product'' means any manufactured product or assemblage
of components which constitutes, incorporates, or is intended to
incorporate a laser or laser system. A laser or laser system that is
intended for use as a component of an electronic product shall itself be
considered a laser product.
(22) ''Laser radiation'' means all electromagnetic radiation emitted
by a laser product within the spectral range specified in paragraph
(b)(19) of this section that is produced as a result of controlled
stimulated emission or that is detectable with radiation so produced
through the appropriate aperture stop and within the appropriate solid
angle of acceptance, as specified in paragraph (e) of this section.
(23) ''Laser system'' means a laser in combination with an
appropriate laser energy source with or without additional incorporated
components. See paragraph (c)(2) of this section for an explanation of
the term ''removable laser system.''
(24) ''Maintenance'' means performance of those adjustments or
procedures specified in user information provided by the manufacturer
with the laser product which are to be performed by the user for the
purpose of assuring the intended performance of the product. It does
not include operation or service as defined in paragraph (b) (27) and
(38) of this section.
(25) ''Maximum output'' means the maximum radiant power and, where
applicable, the maximum radiant energy per pulse of accessible laser
radiation emitted by a laser product during operation, as determined
under paragraph (e) of this section.
(26) ''Medical laser product'' means any laser product which is a
medical device as defined in 21 U.S.C. 321(h) and is manufactured,
designed, intended or promoted for in vivo laser irradiation of any part
of the human body for the purpose of: (i) Diagnosis, surgery, or
therapy; or (ii) relative positioning of the human body.
(27) ''Operation'' means the performance of the laser product over
the full range of its functions. It does not include maintenance or
service as defined in paragraphs (b) (24) and (38) of this section.
(28) ''Protective housing'' means those portions of a laser product
which are designed to prevent human access to laser or collateral
radiation in excess of the prescribed accessible emission limits under
conditions specified in this section and in 1040.11.
(29) ''Pulse duration'' means the time increment measured between the
half-peak-power points at the leading and trailing edges of a pulse.
(30) ''Radiance'' means time-averaged radiant power per unit area of
a radiating surface per unit solid angle of emission, expressed in watts
per square centimeter per steradian (W cm^2sr^1).
(31) ''Radiant energy'' means energy emitted, transferred or received
in the form of radiation, expressed in joules (J).
(32) ''Radiant exposure'' means the radiant energy incident on an
element of a surface divided by the area of the element, expressed in
joules per square centimeter (Jcm^2)
(33) ''Radiant power'' means time-averaged power emitted, transferred
or received in the form of radiation, expressed in watts (W).
(34) ''Remote interlock connector'' means an electrical connector
which permits the connection of external remote interlocks.
(35) ''Safety interlock'' means a device associated with the
protective housing of a laser product to prevent human access to
excessive radiation in accordance with paragraph (f)(2) of this section.
(36) ''Sampling interval'' means the time interval during which the
level of accessible laser or collateral radiation is sampled by a
measurement process. The magnitude of the sampling interval in units of
seconds is represented by the symbol (t).
(37) ''Scanned laser radiation'' means laser radiation having a
time-varying direction, origin or pattern of propagation with respect to
a stationary frame of reference.
(38) ''Service'' means the performance of those procedures or
adjustments described in the manufacturer's service instructions which
may affect any aspect of the product's performance for which this
section and 1040.11 have applicable requirements. It does not include
maintenance or operation as defined in paragraphs (b) (24) and (27) of
this section.
(39) ''Surveying, leveling, or alignment laser product'' means a
laser product manufactured, designed, intended or promoted for one or
more of the following uses:
(i) Determining and delineating the form, extent, or position of a
point, body, or area by taking angular measurement.
(ii) Positioning or adjusting parts in proper relation to one
another.
(iii) Defining a plane, level, elevation, or straight line.
(40) ''Visible radiation'' means laser or collateral radiation having
wavelengths of greater than 400 nm but less than or equal to 710 nm.
(41) ''Warning logotype'' means a logotype as illustrated in either
Figure 1 or Figure 2 of paragraph (g) of this section.
(42) ''Wavelength'' means the propagation wavelength in air of
electromagnetic radiation.
(c) Classification of laser products -- (1) All laser products. Each
laser product shall be classified in Class I, IIa, II, IIIa, IIIb, or IV
in accordance with definitions set forth in paragraphs (b) (5) through
(11) of this section. The product classification shall be based on the
highest accessible emission level(s) of laser radiation to which human
access is possible during operation in accordance with paragraphs (d),
(e), and (f)(1) of this section.
(2) Removable laser systems. Any laser system that is incorporated
into a laser product subject to the requirements of this section and
that is capable, without modification, of producing laser radiation when
removed from such laser product, shall itself be considered a laser
product and shall be separately subject to the applicable requirements
in this subchapter for laser products of its class. It shall be
classified on the basis of accessible emission of laser radiation when
so removed.
(d) Accessible emission limits. Accessible emission limits for laser
radiation in each class are specified in Tables I, II-A, II, III-A, and
III-B of this paragraph. The factors, k1 and k2 vary with wavelength
and emission duration. These factors are given in Table IV of this
paragraph, with selected numerical values in Table V of this paragraph.
Accessible emission limits for collateral radiation are specified in
Table VI of this paragraph.
/1/ Class I levels of laser radiation are not considered to be
hazardous.
/2/ Class IIa levels of laser radiation are not considered to be
hazardous if viewed for any period of time less than or equal to 1 10
/3/ seconds but are considered to be a chronic viewing hazard for any
period of time greater than 1 10 /3/ seconds.
/3/ Class II levels of laser radiation are considered to be a chronic
viewing hazard.
/4/ Class IIIa levels of laser radiation are considered to be,
depending upon the irradiance, either an acute intrabeam viewing hazard
or chronic viewing hazard, and an acute viewing hazard if viewed
directly with optical instruments.
/5/ Class IIIb levels of laser radiation are considered to be an
acute hazard to the skin and eyes from direct radiation.
/6/ Class IV levels of laser radiation are considered to be an acute
hazard to the skin and eyes from direct and scattered radiation.
21 CFR 1040.10 Notes applicable to Tables I, II-A, II, III-A and III-B:
(1) The factors k1 and k2 are wavelength-dependent correction factors
determined from Table IV.
(2) The variable t in the expressions of emission limits is the
magnitude of the sampling interval in units of seconds.
insert illus. 0111
insert illus. 0112
insert illus. 0113 and 0114
insert illus. 0115
insert illus. 0116
insert illus. 0117
(1) Beam of a single wavelength. Laser or collateral radiation of a
single wavelength exceeds the accessible emission limits of a class if
its accessible emission level is greater than the accessible emission
limit of that class within any of the ranges of emission duration
specified in Tables I, II-A, II, III-A, and III-B of this paragraph.
(2) Beam of multiple wavelengths in same range. Laser or collateral
radiation having two or more wavelengths within any one of the
wavelength ranges specified in Tables I, II-A, II, III-A, and III-B of
this paragraph exceeds the accessible emission limits of a class if the
sum of the ratios of the accessible emission level to the corresponding
accessible emission limit at each such wavelength is greater than unity
for that combination of emission duration and wavelength distribution
which results in the maximum sum.
(3) Beam with multiple wavelengths in different ranges. Laser or
collateral radiation having wavelengths within two or more of the
wavelength ranges specified in Tables I, II-A, II, III-A, and III-B of
this paragraph exceeds the accessible emission limits of a class if it
exceeds the applicable limits within any one of those wavelength ranges.
This determination is made for each wavelength range in accordance with
paragraph (d) (1) or (2) of this section.
(4) Class I dual limits. Laser or collateral radiation in the
wavelength range of greater than 400 nm but less than or equal to 1.400
nm exceeds the accessible emission limits of Class I if it exceeds both:
(i) The Class I accessible emission limits for radiant energy within
any range of emission duration specified in Table I of this paragraph,
and
(ii) The Class I accessible emission limits for integrated radiance
within any range of emission duration specified in Table I of this
paragraph.
(e) Tests for determination of compliance -- (1) Tests for
certification. Tests on which certification under 1010.2 is based
shall account for all errors and statistical uncertainties in the
measurement process. Because compliance with the standard is required
for the useful life of a product such tests shall also account for
increases in emission and degradation in radiation safety with age.
(2) Test conditions. Except as provided in 1010.13, tests for
compliance with each of the applicable requirements of this section and
1040.11 shall be made during operation, maintenance, or service as
appropriate:
(i) Under those conditions and procedures which maximize the
accessible emission levels, including start-up, stabilized emission, and
shut-down of the laser product; and
(ii) With all controls and adjustments listed in the operation,
maintenance, and service instructions adjusted in combination to result
in the maximum accessible emission level of radiation; and
(iii) At points in space to which human access is possible in the
product configuration which is necessary to determine compliance with
each requirement, e.g., if operation may require removal of portions of
the protective housing and defeat of safety interlocks, measurements
shall be made at points accessible in that product configuration; and
(iv) With the measuring instrument detector so positioned and so
oriented with respect to the laser product as to result in the maximum
detection of radiation by the instrument; and
(v) For a laser product other than a laser system, with the laser
coupled to that type of laser energy source which is specified as
compatible by the laser product manufacturer and which produces the
maximum emission level of accessible radiation from that product.
(3) Measurement parameters. Accessible emission levels of laser and
collateral radiation shall be based upon the following measurements as
appropriate, or their equivalent:
(i) For laser products intended to be used in a locale where the
emitted laser radiation is unlikely to be viewed with optical
instruments, the radiant power (W) or radiant energy (J) detectable
through a circular aperture stop having a diameter of 7 millimeters and
within a circular solid angle of acceptance of 1 X 10^3 steradian with
collimating optics of 5 diopters or less. For scanned laser radiation,
the direction of the solid angle of acceptance shall change as needed to
maximize detectable radiation, with an angular speed of up to 5
radians/second. A 50 millimeter diameter aperture stop with the same
collimating optics and acceptance angle stated above shall be used for
all other laser products (except that a 7 millimeter diameter aperture
stop shall be used in the measurement of scanned laser radiation emitted
by laser products manufactured on or before August 20, 1986.
(ii) The irradiance (W cm^2) or radiant exposure (J cm^2 equivalent
to the radiant power (W) or radiant energy (J) detectable through a
circular aperture stop having a diameter of 7 millimeters and, for
irradiance, within a circular solid angle of acceptance of 1 x 10^3
steradian with collimating optics of 5 diopters or less, divided by the
area of the aperture stop (cm^2).
(iii) The radiance (W cm^2 sr^1) or integrated radiance (J cm^2 sr^1)
equivalent to the radiant power (W) or radiant energy (J) detectable
through a circular aperture stop having a diameter of 7 millimeters and
within a circular solid angle of acceptance of 1 X 10^5 steradian with
collimating optics of 5 diopters or less, divided by that solid angle
(sr) and by the area of the aperture stop (cm^2).
(f) Performance requirements -- (1) Protective housing. Each laser
product shall have a protective housing that prevents human access
during operation to laser and collateral radiation that exceed the
limits of Class I and Table VI, respectively, wherever and whenever such
human access is not necessary for the product to perform its intended
function. Wherever and whenever human access to laser radiation levels
that exceed the limits of Class I is necessary, these levels shall not
exceed the limits of the lowest class necessary to perform the intended
function(s) of the product.
(2) Safety interlocks. (i) Each laser product, regardless of its
class, shall be provided with at least one safety interlock for each
portion of the protective housing which is designed to be removed or
displaced during operation or maintenance, if removal or displacement of
the protective housing could permit, in the absence of such
interlock(s), human access to laser or collateral radiation in excess of
the accessible emission limit applicable under paragraph (f)(1) of this
section.
(ii) Each required safety interlock, unless defeated, shall prevent
such human access to laser and collateral radiation upon removal or
displacement of such portion of the protective housing
(iii) Either multiple safety interlocks or a means to preclude
removal or displacement of the interlocked portion of the protective
housing shall be provided, if failure of a single interlock would allow;
(a) Human access to a level of laser radiation in excess of the
accessible emission limits of Class IIIa; or
(b) Laser radiation in excess of the accessible emission limits of
Class II to be emitted directly through the opening created by removal
or displacement of the interlocked portion of the protective housing.
(iv) Laser products that incorporate safety interlocks designed to
allow safety interlock defeat shall incorporate a means of visual or
aural indication of interlock defeat. During interlock defeat, such
indication shall be visible or audible whenever the laser product is
energized, with and without the associated portion of the protective
housing removed or displaced.
(v) Replacement of a removed or displaced portion of the protective
housing shall not be possible while required safety interlocks are
defeated.
(3) Remote interlock connector. Each laser system classified as a
Class IIIb or IV laser product shall incorporate a readily available
remote interlock connector having an electrical potential difference of
no greater than 130 root-mean-square volts between terminals. When the
terminals of the connector are not electrically joined, human access to
all laser and collateral radiation from the laser product in excess of
the accessible emission limits of Class I and Table VI shall be
prevented.
(4) Key control. Each laser system classified as a Class IIIb or IV
laser product shall incorporate a key-actuated master control. The key
shall be removable and the laser shall not be operable when the key is
removed.
(5) Laser radiation emission indicator. (i) Each laser system
classified as a Class II or IIIa laser product shall incorporate an
emission indicator that provides a visible or audible signal during
emission of accessible laser radiation in excess of the accessible
emission limits of Class I.
(ii) Each laser system classified as a Class IIIb or IV laser product
shall incorporate an emission indicator which provides a visible or
audible signal during emission of accessible laser radiation in excess
of the accessible emission limits of Class I, and sufficiently prior to
emission of such radiation to allow appropriate action to avoid exposure
to the laser radiation.
(iii) For laser systems manufactured on or before August 20, 1986, if
the laser and laser energy source are housed separately and can be
operated at a separation distance of greater than 2 meters, both laser
and laser energy source shall incorporate an emission indicator as
required in accordance with paragraph (f)(5) (i) or (ii) of this
section. For laser systems manufactured after August 20, 1986, each
separately housed laser and operation control of a laser system that
regulates the laser or collateral radiation emitted by a product during
operation shall incorporate an emission indicator as required in
accordance with paragraph (f)(5) (i) or (ii) of this section, if the
laser or operation control can be operated at a separation distance
greater than 2 meters from any other separately housed portion of the
laser product incorporating an emission indicator.
(iv) Any visible signal required by paragraph (f)(5) (i) or (ii) of
this section shall be clearly visible through protective eyewear
designed specifically for the wavelength(s) of the emitted laser
radiation.
(v) Emission indicators required by paragraph (f)(5) (i) or (ii) of
this section shall be located so that viewing does not require human
exposure to laser or collateral radiation in excess of the accessible
emission limits of Class I and Table VI.
(6) Beam attenuator. (i) Each laser system classified as a Class II,
III, or IV laser product shall be provided with one or more permanently
attached means, other than laser energy source switch(es), electrical
supply main connectors, or the key-actuated master control, capable of
preventing access by any part of the human body to all laser and
collateral radiation in excess of the accessible emission limits of
Class I and Table VI.
(ii) If the configuration, design, or function of the laser product
would make unnecessary compliance with the requirement in paragraph
(f)(6)(i) of this section, the Director, Office of Compliance (HFZ-300),
Center for Devices and Radiological Health, may, upon written
application by the manufacturer, approve alternate means to accomplish
the radiation protection provided by the beam attenuator.
(7) Location of controls. Each Class IIa, II, III, or IV laser
product shall have operational and adjustment controls located so that
human exposure to laser or collateral radiation in excess of the
accessible emission limits of Class I and Table VI is unnecessary for
operation or adjustment of such controls.
(8) Viewing optics. All viewing optics, viewports, and display
screens incorporated into a laser product, regardless of its class,
shall limit the levels of laser and collateral radiation accessible to
the human eye by means of such viewing optics, viewports, or display
screens during operation or maintenance to less than the accessible
emission limits of Class I and Table VI. For any shutter or variable
attenuator incorporated into such viewing optics, viewports, or display
screens, a means shall be provided:
(i) To prevent access by the human eye to laser and collateral
radiation in excess of the accessible emission limits of Class I and
Table VI whenever the shutter is opened or the attenuator varied.
(ii) To preclude, upon failure of such means as required in paragraph
(f)(8)(i) of this section, opening the shutter or varying the attenuator
when access by the human eye is possible to laser or collateral
radiation in excess of the accessible emission limits of Class I and
Table VI.
(9) Scanning safeguard. Laser products that emit accessible scanned
laser radiation shall not, as a result of any failure causing a change
in either scan velocity or amplitude, permit human access to laser
radiation in excess of:
(i) The accessible emission limits of the class of the product, or
(ii) The accessible emission limits of the class of the scanned laser
radiation if the product is Class IIIb or IV and the accessible emission
limits of Class IIIa would be exceeded solely as result of such failure.
(10) Manual reset mechanism. Each laser system manufactured after
August 20, 1986, and classified as a Class IV laser product shall be
provided with a manual reset to enable resumption of laser radiation
emission after interruption of emission caused by the use of a remote
interlock or after an interruption of emission in excess of 5 seconds
duration due to the unexpected loss of main electrical power.
(g) Labeling requirements. In addition to the requirements of
1010.2 and 1010.3, each laser product shall be subject to the applicable
labeling requirements of this paragraph.
(1) Class IIa and II designations and warnings. (i) Each Class IIa
laser product shall have affixed a label bearing the following wording:
''Class IIa Laser Product -- Avoid Long-Term Viewing of Direct Laser
Radiation.''
(ii) Each Class II laser product shall have affixed a label bearing
the warning logotype A (Figure 1 in this paragraph) and including the
following wording:
21 CFR 1040.10
(2) Class IIIa and IIIb designations and warnings. (i) Each Class
IIIa laser product with an irradiance less than or equal to 2.5 10^3 W
cm2^ shall have affixed a label bearing the warning logotype A (Figure 1
of paragraph (g)(1)(ii) of this section) and including the following
wording:
(ii) Each Class IIIa laser product with an irradiance greater than
2.5 10^3 W cm^2 shall have affixed a label bearing the warning logotype
B (Figure 2 in this paragraph) and including the following wording:
21 CFR 1040.10
(iii) Each Class IIIb laser product shall have affixed a label
bearing the warning logotype B (Figure 2 of paragraph (g)(2)(ii) of this
section) and including the following wording:
(3) Class IV designation and warning. Each Class IV laser product
shall have affixed a label bearing the warning logotype B (Figure 2 of
paragraph (g)(2)(ii) of this section), and including the following
wording:
(4) Radiation output information on warning logotype. Each Class II,
III, and IV laser product shall state in appropriate units, at position
2 on the required warning logotype, the maximum output of laser
radiation, the pulse duration when appropriate, and the laser medium or
emitted wavelength(s).
(5) Aperture label. Each laser product, except medical laser
products and Class IIa laser products, shall have affixed, in close
proximity to each aperture through which is emitted accessible laser or
collateral radiation in excess of the accessible emission limits of
Class I and Table VI of paragraph (d) of this section, a label(s)
bearing the following wording as applicable.
(i) ''AVOID EXPOSURE -- Laser radiation is emitted from this
aperture,'' if the radiation emitted through such aperture is laser
radiation.
(ii) ''AVOID EXPOSURE -- Hazardous electromagnetic radiation is
emitted from this aperture,'' if the radiation emitted through such
aperture is collateral radiation described in Table VI, item 1.
(iii) ''AVOID EXPOSURE -- Hazardous x-rays are emitted from this
aperture,'' if the radiation emitted through such aperture is collateral
radiation described in Table VI, item 2.
(6) Labels for noninterlocked protective housings. For each laser
product, labels shall be provided for each portion of the protective
housing which has no safety interlock and which is designed to be
displaced or removed during operation, maintenance, or service, and
thereby could permit human access to laser or collateral radiation in
excess of the limits of Class I and Table VI. Such labels shall be
visible on the protective housing prior to displacement or removal of
such portion of the protective housing and visible on the product in
close proximity to the opening created by removal or displacement of
such portion of the protective housing, and shall include the wording:
(i) ''CAUTION -- Laser radiation when open. DO NOT STARE INTO
BEAM.'' for Class II accessible laser radiation.
(ii) ''CAUTION -- Laser radiation when open. DO NOT STARE INTO BEAM
OR VIEW DIRECTLY WITH OPTICAL INSTRUMENTS.'' for Class IIIa accessible
laser radiation with an irradiance less than or equal to 2.5 10^3 W
cm^2.
(iii) ''DANGER -- Laser radiation when open. AVOID DIRECT EYE
EXPOSURE.'' for Class IIIa accessible laser radiation with an irradiance
greater than 2.5 10^3 W cm^2.
(iv) ''DANGER -- Laser radiation when open. AVOID DIRECT EXPOSURE TO
BEAM.'' for Class IIIb accessible laser radiation.
(v) ''DANGER -- Laser radiation when open. AVOID EYE OR SKIN
EXPOSURE TO DIRECT OR SCATTERED RADIATION.'' for Class IV accessible
laser radiation.
(vi) ''CAUTION -- Hazardous electromagnetic radiation when open.''
for collateral radiation in excess of the accessible emission limits in
Table VI, item 1 of paragraph (d) of this section.
(vii) ''CAUTION -- Hazardous x-rays when open.'' for collateral
radiation in excess of the accessible emission limits in Table VI, item
2 of paragraph (d) of this section.
(7) Labels for defeatably interlocked protective housings. For each
laser product, labels shall be provided for each defeatably interlocked
(as described in paragraph (f)(2)(iv) of this section) portion of the
protective housing which is designed to be displaced or removed during
operation, maintenance, or service, and which upon interlock defeat
could permit human access to laser or collateral radiation in excess of
the limits of Class I or Table VI. Such labels shall be visible on the
product prior to and during interlock defeat and in close proximity to
the opening created by the removal or displacement of such portion of
the protective housing, and shall include the wording:
(i) ''CAUTION -- Laser radiation when open and interlock defeated.
DO NOT STARE INTO BEAM.'' for Class II accessible laser radiation.
(ii) ''CAUTION -- Laser radiation when open and interlock defeated.
DO NOT STARE INTO BEAM OR VIEW DIRECTLY WITH OPTICAL INSTRUMENTS.'' for
Class IIIa accessible laser radiation with an irradiance less than or
equal to 2.5 10^3 W cm^2.
(iii) ''DANGER -- Laser radiation when open and interlock defeated.
AVOID DIRECT EYE EXPOSURE.'' for Class IIIa accessible laser radiation
when an irradiance greater than 2.5 10^3 W cm^2.
(iv) ''DANGER -- Laser radiation when open and interlock defeated.
AVOID DIRECT EXPOSURE TO BEAM.'' for Class IIIb accessible laser
radiation.
(v) ''DANGER -- Laser radiation when open and interlock defeated.
AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION.'' for Clas
IV accessible laser radiation.
(vi) ''CAUTION -- Hazardous electromagnetic radiation when open and
interlock defeated.'' for collateral radiation in excess of the
accessible emission limits in Table VI. item 1 of paragraph (d) of this
section.
(vii) ''CAUTION -- Hazardous x-rays when open and interlock
defeated.'' for collateral radiation in excess of the accesible emission
limits in Table VI. item 2 of paragraph (d) of this section.
(8) Warning for visible and/or invisible radiation. On the labels
specified in this paragraph, if the laser or collateral radiation
referred to is:
(i) Invisible radiation, the word ''invisible'' shall appropriately
precede the word ''radiation''; or
(ii) Visible and invisible radiation, the words ''visible and
invisible'' or ''visible and/or invisible'' shall appropriately precede
the word ''radiation.''
(iii) Visible laser radiation only, the phrase ''laser light'' may
replace the phrase ''laser radiation.''
(9) Positioning of labels. All labels affixed to a laser product
shall be positioned so as to make unnecessary, during reading, human
exposure to laser radiation in excess of the accessible emission limits
of Class I radiation or the limits of collateral radiation established
to Table VI of paragraph (d) of this section.
(10) Label specifications. Labels required by this section and
1040.11 shall be permanently affixed to, or inscribed on, the laser
product, legible, and clearly visible during operation, maintenance, or
service, as appropriate. If the size, configuration, design, or
function of the laser product would preclude compliance with the
requirements for any required label or would render the required wording
of such label inappropriate or ineffective, the Director, Office of
Compliance (HFZ-300), Center for Devices and Radiological Health, on the
Director's own initiative or upon written application by the
manufacturer, may approve alternate means of providing such label(s) or
alternate wording for such label(s) as applicable.
(h) Informational requirements -- (1) User information.
Manufacturers of laser products shall provide as an integral part of any
user instruction or operation manual which is regularly supplied with
the product, or, if not so supplied, shall cause to be provided with
each laser product:
(i) Adequate instructions for assembly, operation, and maintenance,
including clear warnings concerning precautions to avoid possible
exposure to laser and collateral radiation in excess of the accessible
emission limits in Tables I, II-A, II, III-A, III-B, and VI of paragraph
(d) of this section, and a schedule of maintenance necessary to keep the
product in compliance with this section and 1040.11.
(ii) A statement of the magnitude, in appropriate units, of the pulse
durations(s), maximum radiant power and, where applicable, the maximum
radiant energy per pulse of the accessible laser radiation detectable in
each direction in excess of the accessible emission limits in Table I of
paragraph (d) of this section determined under paragraph (e) of this
section.
(iii) Legible reproductions (color optional) of all labels and hazard
warnings required by paragraph (g) of this section and 1040.11 to be
affixed to the laser product or provided with the laser product,
including the information required for positions 1, 2, and 3 of the
applicable logotype (Figure 1 of paragraph (g)(1)(ii) or Figure 2 or
paragraph (g)(2)(ii) of this section). The corresponding position of
each label affixed to the product shall be indicated or, if provided
with the product, a statement that such labels could not be affixed to
the product but were supplied with the product and a statement of the
form and manner in which they were supplied shall be provided.
(iv) A listing of all controls, adjustments, and procedures for
operation and maintenance, including the warning ''Caution -- use of
controls or adjustments or performance of procedures other than those
specified herein may result in hazardous radiation exposure.''
(v) In the case of laser products other than laser systems, a
statment of the compatibility requirements for a laser energy source
that will assure compliance of the laser product with this section and
1040.11.
(vi) In the case of laser products classified with a 7 millimeter
diameter aperture stop as provided in paragraph (e)(3)(i) of this
section, if the use of a 50 millimeter diameter aperture stop would
result in a higher clsssification of the product, the following warning
shall be included in the user information: ''CAUTION -- The use of
optical instruments with this product will increase eye hazard.''
(2) Purchasing and servicing information. Manufacturers of laser
products shall provide or cause to be provided:
(i) In all catalogs, specification sheets, and descriptive brochures
pertaining to each laser product, a legible reproduction (color
optional) of the class designation and warning required by paragraph (g)
of this section to be affixed to that product, including the information
required for positions 1, 2, and 3 of the applicable logotype (Figure 1
of paragraph (g)(1)(ii) or Figure 2 of paragraph (g)(2)(ii) of this
section).
(ii) To servicing dealers and distributors and to others upon request
at a cost not to exceed the cost of preparation and distribution,
adequate instructions for service adjustments and service procedures for
each laser product model, including clear warnings and precautions to be
taken to avoid possible exposure to laser and collateral radiation in
excess of the accessible emission limits in Tables I, II-A, II, III-A,
III-B, and VI of paragraph (d) of this section, and a schedule of
maintenance necessary to keep the product in compliance with this
section and 1040.11; and in all such service instructions, a listing
of those controls and procedures that could be utilized by persons other
than the manufacturers or the manufacturer's agents to increase
accessible emission levels of radiation and a clear description of the
location of displaceable portions of the protective housing that could
allow human access to laser or collateral radiation in excess of the
accessible emission limits in Tables I, II-A, II, III-A, III-B, and VI
of paragraph (d) of this section. The instructions shall include
protective procedures for service personnel to avoid exposure to levels
of laser and collateral radiation known to be hazardous for each
procedure or sequence of procedures to be accomplished, and legible
reproductions (color optional) of required labels and hazard warnings.
(i) Modification of a certified product. The modification of a laser
product, previously certified under 1010.2, by any person engaged in
the business of manufacturing, assembling, or modifying laser products
shall be construed as manufacturing under the act if the modification
affects any aspect of the product's performance or intended function(s)
for which this section and 1040.11 have an applicable requirement. The
manufacturer who performs such modification shall recertify and
reidentify the product in accordance with the provisions of 1010.2.
and 1010.3.
(The information collection requirements contained in paragraph
(a)(3)(ii) were approved by the Office of Management and Budget under
control number 0910-0176)
(50 FR 33688, Aug. 20, 1985; 50 FR 42156, Oct. 18, 1985)
21 CFR 1040.11 Specific purpose laser products.
(a) Medical laser products. Each medical laser product shall comply
with all of the applicable requirements of 1040.10 for laser products
of its class. In addition, the manufacturer shall:
(1) Incorporate in each Class III or IV medical laser product a means
for the measurement of the level of that laser radiation intended for
irradiation of the human body. Such means may have an error in
measurement of no more than 20 percent when calibrated in accordance
with paragraph (a)(2) of this section. Indication of the measurement
shall be in International System Units. The requirements of this
paragraph do not apply to any laser radiation that is all of the
following:
(i) Of a level less than the accessible limits of Class IIIa; and
(ii) Used for relative positioning of the human body; and
(iii) Not used for irradiation of the human eye for ophthalmic
purposes.
(2) Supply with each Class III or IV medical laser product
instructions specifying a procedure and schedule for calibration of the
measurement system required by paragraph (a)(1) of this section.
(3) Affix to each medical laser product, in close proximity to each
aperture through which is emitted accessible laser radiation in excess
of the accessible emission limits of Class I, a label bearing the
wording: ''Laser aperture.''
(b) Surveying, leveling, and alignment laser products. Each
surveying, leveling. or alignment laser product shall comply with all
of the applicable requirements of 1040.10 for a Class I, IIa, II or
IIIa laser product and shall not permit human access to laser radiation
in excess of the accessible emission limits of Class IIIa.
(c) Demonstration laser products. Each demonstration laser product
shall comply with all of the applicable requirements of 1040.10 for a
Class I, IIa, II, or IIIa laser product and shall not permit human
access to laser radiation in excess of the accessible emission limits of
Class I and, if applicable, Class IIa, Class II, or Class IIIa.
(50 FR 33702, Aug. 20, 1985)
21 CFR 1040.20 Sunlamp products and ultraviolet lamps intended for use
in sunlamp products.
(a) Applicability. (1) The provisions of this section, as amended,
are applicable as specified herein to the following products
manufactured on or after September 8, 1986.
(i) Any sunlamp product.
(ii) Any ultraviolet lamp intended for use in any sunlamp product.
(2) Sunlamp products and ultraviolet lamps manufactured on or after
May 7, 1980, but before September 8, 1986, are subject to the provisions
of this section as published in the Federal Register of November 9, 1979
(44 FR 65357).
(b) Definitions. As used in this section the following definitions
apply:
(1) ''Exposure position'' means any position, distance, orientation,
or location relative to the radiating surfaces of the sunlamp product at
which the user is intended to be exposed to ultraviolet radiation from
the product, as recommended by the manufacturer.
(2) ''Intended'' means the same as ''intended uses'' in 801.4.
(3) ''Irradiance'' means the radiant power incident on a surface at a
specified location and orientation relative to the radiating surface
divided by the area of the surface, as the area becomes vanishingly
small, expressed in units of watts per square centimeter (W/cm2).
(4) ''Maximum exposure time'' means the greatest continuous exposure
time interval recommended by the manufacturer of the product.
(5) ''Maximum timer interval'' means the greatest time interval
setting on the timer of a product.
(6) ''Protective eyewear'' means any device designed to be worn by
users of a product to reduce exposure of the eyes to radiation emitted
by the product.
(7) ''Spectral irradiance'' means the irradiance resulting from
radiation within a wavelength range divided by the wavelength range as
the range becomes vanishingly small, expressed in units of watts per
square centimeter per nanometer (W/(cm2/nm)).
(8) ''Spectral transmittance'' means the spectral irradiance
transmitted through protective eyewear divided by the spectral
irradiance incident on the protective eyewear.
(9) ''Sunlamp product'' means any electronic product designed to
incorporate one or more ultraviolet lamps and intended for irradiation
of any part of the living human body, by ultraviolet radiation with
wavelengths in air between 200 and 400 nanometers, to induce skin
tanning.
(10) ''Timer'' means any device incorporated into a product that
terminates radiation emission after a preset time interval.
(11) ''Ultraviolet lamp'' means any lamp that produces ultraviolet
radiation in the wavelength interval of 200 to 400 nanometers in air and
that is intended for use in any sunlamp product.
(c) Performance requirements -- (1) Irradiance ratio limits. For
each sunlamp product and ultraviolet lamp, the ratio of the irradiance
within the wavelength range of greater than 200 nanometers through 260
nanometers to the irradiance within the wavelength range of greater than
260 nanometers through 320 nanometers may not exceed 0.003 at any
distance and direction from the product or lamp.
(2) Timer system. (i) Each sunlamp product shall incorporate a timer
system with multiple timer settings adequate for the recommended
exposure time intervals for different exposure positions and expected
results of the products as specified in the label required by paragraph
(d) of this section.
(ii) The maximum timer interval(s) may not exceed the manufacturer's
recommended maximum exposure time(s) that is indicated on the label
required by paragraph (d)(1)(iv) of this section.
(iii) No timer interval may have an error greater than 10 percent of
the maximum timer interval of the product.
(iv) The timer may not automatically reset and cause radiation
emission to resume for a period greater than the unused portion of the
timer cycle, when emission from the sunlamp product has been terminated.
(v) The timer requirements do not preclude a product from allowing a
user to reset the timer before the end of the preset time interval.
(3) Control for termination of radiation emission. Each sunlamp
product shall incorporate a control on the product to enable the person
being exposed to terminate manually radiation emission from the product
at any time without disconnecting the electrical plug or removing the
ultraviolet lamp.
(4) Protective eyewear. (i) Each sunlamp product shall be
accompanied by the number of sets of protective eyewear that is equal to
the maximum number of persons that the instructions provided under
paragraph (e)(1)(ii) of this section recommend to be exposed
simultaneously to radiation from such product.
(ii) The spectral transmittance to the eye of the protective eyewear
required by paragraph (c)(4)(i) of this section shall not exceed a value
of 0.001 over the wavelength range of greater than 200 nanometers 320
nanometers and an value of 0.01 over the wavelength range of greater
than 320 nanometers through 400 nanometers, and shall be sufficient over
the wavelength greater than 400 nanometers to enable the user to see
clearly enough to reset the timer.
(5) Compatibility of lamps. An ultraviolet lamp may not be capable
of insertion and operation in either the ''single-contact medium screw''
or the ''double-contact medium screw'' lampholders described in American
National Standard C81.10-1976, Specifications for Electric Lamp Bases
and Holders -- Screw-Shell Types, which is incorporated by reference.
Copies are available from the American National Standards Institute,
1430 Broadway, New York, NY 10018, or available for inspection at the
Office of the Federal Register, 1100 L St. NW., Washington, DC 20408.
(d) Label requirements. In addition to the labeling requirements in
Part 801 and the certification and identification requirements of
1010.2 and 1010.3, each sunlamp product and ultraviolet lamp shall be
subject to the labeling requirements prescribed in this paragraph and
paragraph (e) of this section.
(1) Labels for sunlamp products. Each sunlamp product shall have a
label(s) which contains:
(i) A warning statement with the words ''DANGER -- Ultraviolet
radiation. Follow instructions. Avoid overexposure. As with natural
sunlight, overexposure can cause eye and skin injury and allergic
reactions. Repeated exposure may cause premature aging of the skin and
skin cancer. WEAR PROTECTIVE EYEWEAR; FAILURE TO MAY RESULT IN SEVERE
BURNS OR LONG-TERM INJURY TO THE EYES. Medications or cosmetics may
increase your sensitivity to the ultraviolet radiation. Consult
physician before using sunlamp if you are using medications or have a
history of skin problems or believe yourself especially sensitive to
sunlight. If you do not tan in the sun, you are unlikely to tan from
the use of this product.''
(ii) Recommended exposure position(s). Any exposure position may be
expressed either in terms of a distance specified both in meters and in
feet (or in inches) or through the use of markings or other means to
indicate clearly the recommended exposure position.
(iii) Directions for achieving the recommended exposure position(s)
and a warning that the use of other positions may result in
overexposure.
(iv) A recommended exposure schedule including duration and spacing
of sequential exposures and maximum exposure time(s) in minutes.
(v) A statement of the time it may take before the expected results
appear.
(vi) Designation of the ultraviolet lamp type to be used in the
product.
(2) Labels for ultraviolet lamps. Each ultraviolet lamp shall have a
label which contains:
(i) The words ''Sunlamp -- DANGER -- Ultraviolet radiation. Follow
instructions.''
(ii) The model identification.
(iii) The words ''Use ONLY in fixture equipped with a timer.''
(3) Label specifications. (i) Any label prescribed in this paragraph
for sunlamp products shall be permanently affixed or inscribed on an
exterior surface of the product when fully assembled for use so as to be
legible and readily accessible to view by the person being exposed
immediately before the use of the product.
(ii) Any label prescribed in this paragraph for ultraviolet lamps
shall be permanently affixed or inscribed on the product so as to be
legible and readily accessible to view.
(iii) If the size, configuration, design, or function of the sunlamp
product or ultraviolet lamp would preclude compliance with the
requirements for any required label or would render the required wording
of such label inappropriate or ineffective, or would render the required
label unnecessary, the Director, Office of Compliance (HFZ-300), Center
for Devices and Radiological Health, on the Center's own initiative or
upon written application by the manufacturer, may approve alternate
means of providing such label(s), alernate wording for such label(s), or
deletion, as applicable.
(iv) In lieu of permanently affixing or inscribing tags or labels on
the ultraviolet lamp as required by 1010.2(b) and 1010.3(a), the
manfacturer of the ultraviolet lamp may permanently affix or inscribe
such required tags or labels on the lamp packaging uniquely associated
with the lamp, if the name of the manufacturer and month and year of
manufacture are permanently affixed or inscribed on the exterior surface
of the ultraviolet lamp so as to be legible and readily accessible to
view. The name of the manufacturer and month and year of manufacture
affixed or inscribed on the exterior surface of the lamp may be
expressed in code or symbols, if the manufacturer has previously
supplied the Director, Office of Compliance (HFZ-300), Center for
Devices and Radiological Health, with the key to such code or symbols
and the location of the coded information or symbols on the ultraviolet
lamp. The label or tag affixed or inscribed on the lamp packaging may
provide either the month and year of manufacture without abbreviation,
or information to allow the date to be readily decoded.
(v) A label may contain statements or illustrations in addition to
those required by this paragraph if the additional statements are not
false or misleading in any particular; e.g., if they do not diminish
the impact of the required statements; and are not prohibited by this
chapter.
(e) Instructions to be provided to users. Each manufacturer of a
sunlamp product and ultraviolet lamp shall provide or cause to be
provided to purchasers and, upon request, to others at a cost not to
exceed the cost of publication and distribution, adequate instructions
for use to avoid or to minimize potential injury to the user, including
the following technical and safety information as applicable:
(1) Sunlamp products. The users' instructions for a sunlamp product
shall contain:
(i) A reproduction of the label(s) required in paragraph (d)(1) of
this section prominently displayed at the beginning of the instructions.
(ii) A statement of the maximum number of people who may be exposed
to the product at the same time and a warning that only that number of
protective eyewear has been provided.
(iii) Instructions for the proper operation of the product including
the function, use, and setting of the timer and other controls, and the
use of protective eyewear.
(iv) Instructions for determining the correct exposure time and
schedule for persons according to skin type.
(v) Instructions for obtaining repairs and recommended replacement
components and accessories which are compatible with the product,
including compatible protective eyewear, ultraviolet lamps, timers,
reflectors, and filters, and which will, if installed or used as
instructed, result in continued compliance with the standard.
(2) Ultraviolet lamps. The users' instructions for an ultraviolet
lamp not accompanying a sunlamp product shall contain:
(i) A reproduction of the label(s) required in paragraphs (d)(1)(i)
and (2) of this section, prominently displayed at the beginning of the
instructions.
(ii) A warning that the instructions accompanying the sunlamp product
should always be followed to avoid or to minimize potential injury.
(iii) A clear identification by brand and model designation of all
lamp models for which replacement lamps are promoted, if applicable.
(f) Test for determination of compliance. Tests on which
certification pursuant to 1010.2 is based shall account for all errors
and statistical uncertainties in the process and, wherever applicable,
for changes in radiation emission or degradation in radiation safety
with age of the product. Measurements for certification purposes shall
be made under those operational conditions, lamp voltage, current, and
position as recommended by the manufacturer. For these measurements,
the measuring instrument shall be positioned at the recommended exposure
position and so oriented as to result in the maximum detection of the
radiation by the instrument.
(The information collection requirements contained in paragraphs (d)
and (e) were approved by the Office of Management and Budget under
control number 0910-0195)
(50 FR 36550, Sept. 6, 1985)
21 CFR 1040.30 High-intensity mercury vapor discharge lamps.
(a) Applicability. The provisions of this section apply to any
high-intensity mercury vapor discharge lamp that is designed, intended,
or promoted for illumination purposes and is manufactured or assembled
after March 7, 1980, except as described in paragraph (d)(1)(ii) of this
section.
(b) Definitions. (1) ''High-intensity mercury vapor discharge lamp''
means any lamp including any ''mercury vapor'' and ''metal halide''
lamp, with the exception of the tungsten filament self-ballasted mercury
vapor lamp, incorporating a high-pressure arc discharge tube that has a
fill consisting primarily of mercury and that is contained within an
outer envelope.
(2) ''Advertisement'' means any catalog, specification sheet, price
list, and any other descriptive or commercial brochure and literature,
including videotape and film, pertaining to high-intensity mercury vapor
discharge lamps.
(3) ''Packaging'' means any lamp carton, outer wrapping, or other
means of containment that is intended for the storage, shipment, or
display of a high-intensity mercury vapor lamp and is intended to
identify the contents or recommend its use.
(4) ''Outer envelope'' means the lamp element, usually glass,
surrounding a high-pressure arc discharge tube, that, when intact,
attenuates the emission of shortwave ultraviolet radiation.
(5) ''Shortwave ultraviolet radiation'' means ultraviolet radiation
with wavelengths shorter than 320 nanometers.
(6) ''Cumulative operating time'' means the sum of the times during
which electric current passes through the high-pressure arc discharge.
(7) ''Self-extinguishing lamp'' means a high-intensity mercury vapor
discharge lamp that is intended to comply with the requirements of
paragraph (d)(1) of this section as applicable.
(8) ''Reference ballast'' is an inductive reactor designed to have
the operating characteristics as listed in Section 7 in the American
National Standard Specifications for High-Intensity Discharge Lamp
Reference Ballasts (ANSI C82.5-1977)1 or its equivalent.
(c) General requirements for all lamps. (1) Each high-intensity
mercury vapor discharge lamp shall:
(i) Meet the requirements of either paragraph (d) or paragraph (e) of
this section; and
(ii) Be permanently labeled or marked in such a manner that the name
of the manufacturer and the month and year of manufacture of the lamp
can be determined on an intact lamp and after the outer envelope of the
lamp is broken or removed. The name of the manufacturer and month and
year of manufacture may be expressed in code or symbols, provided the
manufacturer has previously supplied the Director, Center for Devices
and Radiological Health, with the key to the code or symbols and the
location of the coded information or symbols on the lamp.
(2) In lieu of permanently affixing or inscribing tags or labels on
the product as required by 1010.2(b) and 1010.3(a) of this chapter,
the manufacturer of any high-intensity mercury vapor discharge lamp may
permanently affix or inscribe such required tags or labels on the lamp
packaging uniquely associated with the applicable lamp.
(d) Requirements for self-extinguishing lamps -- (1) Maximum
cumulative operating time. (i) Each self-extinguishing lamp
manufactured after March 7, 1980 shall cease operation within a
cumulative operating time not to exceed 15 minutes following complete
breakage or removal of the outer envelope (with the exception of
fragments extending 50 millimeters or less from the base shell); and
(ii) Each self-extinguishing lamp manufactured after September 7,
1981, shall cease operation within a cumulative operating time not to
exceed 15 minutes following breakage or removal of at least 3 square
centimeters of contiguous surface of the outer envelope.
(2) Lamp labeling. Each self-extinguishing lamp shall be clearly
marked with the letter ''T'' on the outer envelope and on another part
of the lamp in such a manner that it is visible after the outer envelope
of the lamp is broken or removed.
(3) Lamp packaging. Lamp packaging for each self-extinguishing lamp
shall clearly and prominently display:
(i) The letter ''T''; and
(ii) The words ''This lamp should self-extinguish within 15 minutes
after the outer envelope is broken or punctured. If such damage occurs,
TURN OFF AND REMOVE LAMP to avoid possible injury from hazardous
shortwave ultraviolet radiation.''
(e) Requirements for lamps that are not self-extinguishing lamps --
(1) Lamp labeling. Any high-intensity mercury vapor discharge lamp that
does not comply with paragraph (d)(1) of this section shall be clearly
and legibly marked with the letter ''R'' on the outer envelope and on
another part of the lamp in such a manner that it is visible after the
outer envelope of the lamp is broken or removed.
(2) Lamp packaging. Lamp packaging for each high-intensity mercury
vapor discharge lamp that does not comply with paragraph (d)(1) of this
section shall clearly and prominently display:
(i) The letter ''R''; and
(ii) The words ''WARNING: This lamp can cause serious skin burn and
eye inflammation from shortwave ultraviolet radiation if outer envelope
of the lamp is broken or punctured. Do not use where people will remain
for more than a few minutes unless adequate shielding or other safety
precautions are used. Lamps that will automatically extinguish when the
outer envelope is broken or punctured are commercially available.''
(3) Lamp advertisement. Advertising for any high-intensity mercury
vapor discharge lamp that does not comply with paragraph (d)(1) of this
section shall prominently display the following wording: ''WARNING:
This lamp can cause serious skin burn and eye inflammation from
shortwave ultraviolet radiation if outer envelope of the lamp is broken
or punctured. Do not use where people will remain for more than a few
minutes unless adequate shielding or other safety precautions are used.
Lamps that will automatically extinguish when the outer envelope is
broken or punctured are commercially available.''
(f) Test conditions. Any high-intensity mercury vapor discharge lamp
under test for compliance with the requirements set forth in paragraph
(d)(1) of this section shall be started and operated under the following
conditions as applicable:
(1) Lamp voltage, current, and orientation shall be those indicated
or recommended by the manufacturer for operation of the intact lamp.
(2) The lamp shall be operated on a reference ballast.
(3) The lamp shall be started in air that has a temperature of 25 5
C. Heating and movement of the air surrounding the lamp shall be that
produced by the lamp and ballast alone.
(4) If any test is performed in an enclosure, the enclosure shall be
not less than 0.227 cubic meter (8 cubic feet).
(5) Any lamp designed to be operated only in a specific fixture or
luminaire that the lamp manufacturer supplies or specifies shall be
tested in that fixture or luminaire. Any other lamp shall be tested
with no reflector or other surrounding material.
(44 FR 52195, Sept. 7, 1979, as amended at 53 FR 11254, Apr. 6, 1988)
1Copies are available from American National Standards Institute,
1430 Broadway, New York, NY 10018.
21 CFR 1040.30 PART 1050 -- PERFORMANCE STANDARDS FOR SONIC,
INFRASONIC, AND ULTRASONIC RADIATION-EMITTING PRODUCTS
Authority: Secs. 501, 502, 510, 515-520, 701, 801 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 351, 352, 360, 360e-360j, 371,
381); secs. 354-360F of the Public Health Service Act (42 U.S.C.
263b-263n).
21 CFR 1050.10 Ultrasonic therapy products.
(a) Applicability. The provisions of this section are applicable as
specified herein to any ultrasonic therapy product for use in physical
therapy manufactured on or after February 17, 1979.
(b) Definitions. The following definitions apply to words and
phrases used in this section:
(1) ''Amplitude modulated waveform'' means a waveform in which the
ratio of the temporal-maximum pressure amplitude spatially averaged over
the effective radiating surface to the root-mean-square pressure
amplitude spatially averaged over the effective radiating surface is
greater than 1.05.
(2) ''Applicator means that portion of a fully assembled ultrasonic
therapy product that is designed to emit ultrasonic radiation and which
includes one or more ultrasonic transducers and any associated housing.
(3) ''Beam cross-section'' means the surface in any plane consisting
of the points at which the intensity is greater than 5 percent of the
spatial-maximum intensity in that plane.
(4) ''Beam nonuniformity ratio'' means the ratio of the
temporal-average spatial-maximum intensity to the temporal-average
effective intensity.
(5) ''Centroid of a surface'' means the point whose coordinates are
the mean values of the coordinates of the points of the surface.
(6) ''Collimating applicator'' means an applicator that does not meet
the definition of a focusing applicator as specified in paragraph
(b)(15) of this section and for which the ratio of the area of at least
one beam cross-section, whose centroid is 12 centimeters from the
centroid of the effective radiating surface, to the area of the
effective radiating surface is less than two.
(7) ''Continuous-wave waveform'' means a waveform in which the ratio
of the temporal-maximum pressure amplitude spatially averaged over the
effective radiating surface to the root-mean-square pressure amplitude
spatially averaged over the effective radiating surface is less than or
equal to 1.05.
(8) ''Diverging applicator'' means an applicator that does not meet
the definition of a collimating applicator or a focusing applicator as
specified in paragraphs (b) (6) and (15) of this section.
(9) ''Effective intensity'' means the ratio of the ultrasonic power
to the focal area for a focusing applicator. For all other applicators,
the effective intensity is the ratio of the ultrasonic power to the
effective radiating area. Effective intensity is expressed in watts per
square centimeter (W cm^2).
(10) ''Effective radiating area'' means the area consisting of all
points of the effective radiating surface at which the intensity is 5
percent or more of the maximum intensity at the effective radiating
surface, expressed in square centimeters (cm2).
(11) ''Effective radiating surface'' means the surface consisting of
all points 5 millimeters from the applicator face.
(12) ''Focal area'' means the area of the focal surface, expressed in
square centimeters (cm2).
(13) ''Focal length'' means the distance between the centroids of the
effective radiating surface and the focal surface, for a focusing
applicator, expressed in centimeters (cm).
(14) ''Focal surface'' means the beam cross-section with smallest
area of a focusing applicator.
(15) ''Focusing applicator'' means an applicator in which the ratio
of the area of the beam cross-section with the smallest area to the
effective radiating area is less than one-half.
(16) ''Generator'' means that portion of a fully assembled ultrasonic
therapy product that supplies electrical energy to the applicator. The
generator may include, but is not limited to, a power supply, ultrasonic
frequency oscillator, service controls, operation controls, and a
cabinet to house these components.
(17) ''Maximum beam nonuniformity ratio'' means the maximum value of
the beam nonuniformity ratio characteristic of a model of an ultrasonic
therapy product.
(18) ''Operation control'' means any control used during operation of
an ultrasonic therapy product that affects the ultrasonic radiation
emitted by the applicator.
(19) ''Pressure amplitude'' means the instantaneous value of the
modulating waveform, and is p1(t) in the expression for a pressure wave,
p(t)=p1(t) p2(t), where p(t) is the instantaneous pressure, p1(t) is the
modulating envelope, and p2(t) is the relative amplitude of the carrier
wave normalized to a peak height of one. All are periodic functions of
time, t, at any point in space. The period of p1(t) is greater than the
period of p2(t).
(20) ''Pulse duration'' means a time interval, expressed in seconds,
beginning at the first time the pressure amplitude exceeds the minimum
pressure amplitude plus 10 percent of the difference between the maximum
and minimum pressure amplitudes, and ending at the last time the
pressure amplitude returns to this value.
(21) ''Pulse repetition rate'' means the repetition frequency of the
waveform modulating the ultrasonic carrier wave expressed in pulses per
second (pps).
(22) ''Service control'' means any control provided for the purpose
of adjustment that is not used during operation and can affect the
ultrasonic radiation emitted by the applicator, or can alter the
calibration or accuracy of an indicator or operation control.
(23) ''Ultrasonic frequency'' means the frequency of the ultrasonic
radiation carrier wave, expressed in Hertz (Hz), kilohertz (kHz), or
megahertz (MHz).
(24) ''Ultrasonic power'' means the total power emitted in the form
of ultrasonic radiation by the applicator averaged over each cycle of
the ultrasonic radiation carrier wave, expressed in watts.
(25) ''Ultrasonic therapy product'' means:
(i) Any device intended to generate and emit ultrasonic radiation for
therapeutic purposes at ultrasonic frequencies above 16 kilohertz (kHz);
or
(ii) Any generator or applicator designed or specifically designated
for use in a device as specified in paragraph (b)(25)(i) of this
section.
(26) ''Ultrasonic transducer'' means a device used to convert
electrical energy of ultrasonic frequency into ultrasonic radiation or
vice versa.
(c) Performance requirements. The requirements of this paragraph are
applicable to each ultrasonic therapy product as defined in paragraph
(b)(25) of this section when the generator and applicator are designated
or intended for use together, or to each generator when the
applicator(s) intended for use with the generator does not contain
controls that affect the functioning of the generator.
(1) Ultrasonic power and intensity -- (i) Continuous-wave waveform
operation. A means shall be incorporated to indicate the magnitudes of
the temporal-average ultrasonic power and the temporal-average effective
intensity when emission is of continuous-wave waveform. The error in
the indication of the temporal-average ultrasonic power shall not exceed
20 percent for all emissions greater than 10 percent of the maximum
emission.
(ii) Amplitude-modulated waveform operation. A means shall be
incorpor-ated to indicate the magnitudes of the temporal-maximum
ultrasonic power and the temporal-maximum effective intensity when the
emission is of amplitude-modulated waveform. The sum of the errors in
the indications of the temporal-maximum ultrasonic power and the ratio
of the temporal-maximum effective intensity to the temporal-average
effective intensity specified in paragraph (d)(3)(ii) of this section
shall not exceed 20 percent for all emissions greater than 10 percent
of the maximum emission.
(2) Treatment time. A means shall be incorporated to enable the
duration of emission of ultrasonic radiation for treatment to be preset
and such means shall terminate emission at the end of the preset time.
Means shall also be incorporated to enable termination of emission at
any time. Means shall be incorporated to indicate the magnitude of the
duration of emission (expressed in minutes) to within 0.5 minute of the
preset duration of emission for setting less than 5 minutes, to within
10 percent of the preset duration of emission for settings of from 5
minutes to 10 minutes, and to within 1 minute of the preset duration of
emission for settings greater than 10 minutes.
(3) Pulse duration and repetition rate. A means shall be
incorporated for indicating the magnitudes of pulse duration and pulse
repetition rate of the emitted ultrasonic radiation, if there are
operation controls for varying these quantities.
(4) Ultrasonic frequency. A means shall be incorporated for
indicating the magnitude of the ultrasonic frequency of the emitted
ultrasonic radiation, if there is an operation control for varying this
quantity.
(5) Visual indicator. A means shall be incorporated to provide a
clear, distinct, and readily understood visual indicator when and only
when electrical energy of appropriate ultrasonic frequency is being
applied to the ultrasonic transducer(s).
(d) Labeling requirements. In addition to the labeling requirements
in Part 801 and the requirements of 1010.2 and 1010.3 of this chapter,
each ultrasonic therapy product shall be subject to the applicable
labeling requirements of this paragraph.
(1) Operation controls. Each operation control shall be clearly
labeled identifying the function controlled and, where appropriate, the
units of measure of that function. If a separate control and indicator
are associated with the same function, then labeling the appropriate
units of measure of that function is required for the indicator but not
for the control.
(2) Service controls. Each service control that is accessible
without displacement or removal of any part of the ultrasonic therapy
product shall be clearly labeled identifying the function controlled and
shall include the phrase ''for service adjustment only.''
(3) Generators. (i) Each generator shall bear a label that states:
The brand name, model designation, and unique serial number or other
unique identification so that it is individually identifiable;
ultrasonic frequency (unless there is an operation control for varying
this quantity); and type of waveform (continuous wave or amplitude
modulated).
(ii) Generators employing amplitude-modulated waveforms shall also
bear a label that provides the following information: Pulse duration
and pulse repetition rate (unless there are operation controls for
varying these quantities), an illustration of the amplitude-modulated
waveform, and the ratio of the temporal-maximum effective intensity to
the temporal-average effective intensity. (If this ratio is a function
of any operation control setting, then the range of the ratio shall be
specified, and the waveform illustration shall be provided for the
maximum value of this ratio.)
(4) Applicators. Each applicator shall bear a label that provides
the following information:
(i) The brand name, model designation, and unique serial number or
other unique identification so the applicator is individually
identifiable;
(ii) A designation of the generator(s) for which the applicator is
intended; and
(iii) The ultrasonic frequency, effective radiating area, maximum
beam nonuniformity ratio, type of applicator (focusing, collimating,
diverging), and for a focusing applicator the focal length and focal
area.
(5) Label specification. Labels required by this paragraph shall be
permanently affixed to or inscribed on the ultrasonic therapy product;
they shall be legible and clearly visible. If the size, configuration,
or design of the ultrasonic therapy product would preclude compliance
with the requirements of this paragraph, the Director, Center for
Devices and Radiological Health, may approve alternate means of
providing such labels).
(e) Tests for determination of compliance -- (1) Tests for
certification. Tests on which certification pursuant to 1010.2 of this
chapter is based shall account for all measurement errors and
uncertainties. Such tests shall also account for increases in emission
and degradation in radiation safety that occur with age.
(2) Test conditions. Except as provided in 1010.13 of this chapter,
tests for compliance with each of the applicable requirements of this
section shall be made:
(i) For all possible combinations of adjustments of the controls
listed in the operation instructions.
(ii) With the ultrasonic radiation emitted into the equivalent of an
infinite medium of distilled, degassed water at 30 C for measurements
concerning the ultrasonic radiation.
(iii) With line voltage variations in the range of 10 percent of the
rated value specified by the manufacturer.
(3) Measurement parameters. Measurements for determination of the
spatial distribution of the ultrasonic radiation field shall be made
with a detector having dimensions of less than one wavelength in water
or an equivalent measurement technique.
(f) Informational requirements -- (1) Servicing information. The
manufacturer of an ultrasonic therapy product shall provide or cause to
be provided to servicing dealers and distributors, and to others upon
request, at a cost not to exceed the cost of preparation and
distribution adequate instructions for operations, service, and
calibration, including a description of those controls and procedures
that could be used to increase radiation emission levels, and a schedule
of maintenance necessary to keep equipment in compliance with this
section. The instructions shall include adequate safety precautions
that may be necessary regarding ultrasonic radiation exposure.
(2) User information. The manufacturer of an ultrasonic therapy
product shall provide as an integral part of any user instruction or
operation manual that is regularly supplied with the product, or, if not
so supplied, shall cause to be provided with each ultrasonic therapy
product, and to others upon request, at a cost not to exceed the cost of
preparation and distribution:
(i) Adequate instructions concerning assembly, operation, safe use,
any safety procedures and precautions that may be necessary regarding
the use of ultrasonic radiation, and a schedule of maintenance necessary
to keep the equipment in compliance with this section. The operation
instructions shall include a discussion of all operation controls, and
shall describe the effect of each control.
(ii) Adequate description of the spatial distribution of the
ultrasonic radiation field and the orientation of the field with respect
to the applicator. This will include a textual discussion with
diagrams, plots, or photographs representative of the beam pattern. If
there is more than one ultrasonic transducer in an applicator and their
positions are not fixed relative of each other, then the description
must specify the spatial distribution of the ultrasonic radiation field
emitted by each ultrasonic transducer and present adequate examples of
the combination field of the ultrasonic tranducers with regard to safe
use. The description of the ultrasonic radiation field shall state that
such description applies under conditions specified in paragraph
(e)(2)(ii) of this section.
(iii) Adequate description, as appropriate to the product, of the
uncertainties in magnitude expressed in terms of percentage error, of
the ultrasonic frequency effective radiating area, and, where
applicable, the ratio of the temporal-maximum effective intensity to the
temporal-average effective intensity, pulse duration, pulse repetition
rate, focal area, and focal length. The errors in indications specified
in paragraphs (c)(1) and (c)(2) of this section shall be stated in the
instruction manual.
(iv) A listing of controls, adjustments, and procedures for operation
and maintenance, including the warning ''Caution -- use of controls or
adjustments or performance of procedures other than those specified
herein may result in hazardous exposure to ultrasonic energy.''
(43 FR 7166, Feb. 17, 1978, as amended at 45 FR 16483, Mar. 14, 1980;
53 FR 11255, Apr. 6, 1988)
21 CFR 1050.10 SUBCHAPTER K -- (RESERVED)
21 CFR 1050.10 SUBCHAPTER L -- REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION
21 CFR 1050.10 PART 1210 -- REGULATIONS UNDER THE FEDERAL IMPORT MILK ACT
21 CFR 1050.10 Subpart A -- General Provisions
Sec.
1210.1 Authority.
1210.2 Scope of act.
1210.3 Definitions.
21 CFR 1050.10 Subpart B -- Inspection and Testing
1210.10 Availability for examination and inspection.
1210.11 Sanitary inspection of dairy farms.
1210.12 Physical examination of cows.
1210.13 Tuberculin test.
1210.14 Sanitary inspection of plants.
1210.15 Pasteurization; equipment and methods.
1210.16 Method of bacterial count.
1210.17 Authority to sample and inspect.
1210.18 Scoring.
21 CFR 1050.10 Subpart C -- Permit Control
1210.20 Application for permit.
1210.21 Permit number.
1210.22 Form of tag.
1210.23 Permits granted on certificates.
1210.24 Temporary permits.
1210.25 Permits for pasteurized milk or cream.
1210.26 Permits for raw milk or cream.
1210.27 Permits waiving clauses 2 and 5, section 2 of the Federal
Import Milk Act.
1210.28 Permits waiving clause 4, section 2 of the Federal Import
Milk Act.
21 CFR 1050.10 Subpart D -- Hearings
1210.30 Hearing procedure for permit denial, suspension, and
revocation.
1210.31 Hearing before prosecution.
Authority: 21 U.S.C. 141-149.
Source: 38 FR 32104, Nov. 20, 1973, unless otherwise noted.
Cross References: For Animal and Plant Health Inspection Service
regulations concerning tubercular cattle, see 9 CFR Parts 50 and 77.
For Animal and Plant Health Inspection Service regulations, see 9 CFR
Chapter I. For customs regulations concerning importation of milk and
cream, see 19 CFR 12.7. For regulations of the Agricultural Marketing
Service (Marketing Agreements and Orders) covering marketing areas for
milk, see 7 CFR Chapter X.
21 CFR 1050.10 Subpart A -- General Provisions
21 CFR 1210.1 Authority.
For the purposes of the regulations in this part the act (44 Stat.
1101; 21 U.S.C. 141-149) ''To regulate the importation of milk and
cream into the United States for the purpose of promoting the dairy
industry of the United States and protecting the public health'' shall
be known and referred to as ''the Federal Import Milk Act.''
21 CFR 1210.2 Scope of act.
The provisions of the act apply to all milk and cream offered for
import into the continental United States.
21 CFR 1210.3 Definitions.
(a) Secretary. Secretary means the Secretary of Health and Human
Services.
(b) Commissioner. Commissioner means the Commissioner of Food and
Drugs.
(c) Milk. For the purposes of the act and of the regulations in this
part:
Milk is the whole, fresh, clean, lacteal secretion obtained by the
complete milking of one or more healthy cows, properly fed and kept,
excluding that obtained within 15 days before and 5 days after calving,
or such longer period as may be necessary to render the milk practically
colostrum free.
(d) Condensed milk. Condensed milk, as the term is used in section
3, paragraph 2, of the Federal Import Milk Act, includes evaporated milk
in the manufacture of which sterilization of the milk and cream is a
necessary and usual process; it includes sweetened condensed milk only
if it is prepared by a process which insures sterilization of the milk
and cream. Condensed milk, as the term is used in section 3, paragraph
3, of the Federal Import Milk Act, means sweetened condensed milk.
(e) Sweetened condensed milk. Sweetened condensed milk conforms to
the definition and standard of identity for such food as set out in
131.120 of this chapter.
(f) Evaporated milk. Evaporated milk conforms to the definition and
standard of identity for such food as set out in 131.130 of this
chapter.
(g) Cream. Cream is that portion of the milk, rich in milk fat,
which rises to the surface of milk on standing or is separated from it
by centrifugal force. (See 131.150 through 131.157 of this chapter).
(h) Pasteurization. Pasteurization is the process of heating every
particle of milk or cream to at least 143 F., and holding it at such
temperature continuously for at least 30 minutes, or to at least 161
F., and holding it at such temperature continuously for at least 15
seconds.
(i) Shipper. A shipper is anyone, other than a common carrier, who
ships, transports, or causes to be shipped or transported into the
United States milk or cream owned by him.
(38 FR 32104, Nov. 20, 1973, as amended at 42 FR 14091, Mar. 15,
1977)
21 CFR 1210.3 Subpart B -- Inspection and Testing
21 CFR 1210.10 Availability for examination and inspection.
Dairy farms and plants from which milk or cream is shipped or
transported into the United States shall be open at all reasonable times
to authorized agents for necessary examinations and inspections.
Failure to permit such examinations and inspections may be considered
cause for the suspension or revocation of the permit.
21 CFR 1210.11 Sanitary inspection of dairy farms.
The sanitary conditions of any dairy farm producing milk or cream to
be shipped or transported into the United States or to a plant from
which milk or cream is to be shipped or transported into the United
States must score at least 50 points out of 100 points, according to the
methods for scoring as provided by the score card for sanitary
inspection of dairy farms in the form prescribed by the Secretary.
21 CFR 1210.12 Physical examination of cows.
(a) Physical examination of any and all cows in herds producing milk
or cream which is to be shipped or transported into the United States
shall be made by an authorized veterinarian of the United States or of
any State or municipality thereof or of the country in which such milk
or cream is produced to determine whether such cow or cows are in a
healthy condition. Such examination shall be made as often as the
Secretary may deem necessary and, in any event, shall have been made
within one year previous to the time of the importation.
(b) The result of the physical examination shall be set forth in the
form prescribed by the Secretary.
21 CFR 1210.13 Tuberculin test.
(a) Except as provided in 1210.27 any and all animals in herds
producing milk or cream which is to be shipped or transported raw into
the United States shall be free from tuberculosis, as determined by a
tuberculin test applied by an official veterinarian of the United States
or of any State or municipality thereof or of the country in which such
milk or cream is produced. Such test shall be made as often as the
Secretary may deem necessary and, in any event, shall have been made
within 1 year previous to the time of the importation. All animals
showing positive or suspicious reactions to the tuberculin test must be
permanently removed from the herd.
(b) The results of the tuberculin test and all facts concerning the
disposal of reacting or suspected animals shall be set forth in the form
prescribed by the Secretary.
21 CFR 1210.14 Sanitary inspection of plants.
The sanitary conditions of any plant handling milk or cream any part
of which is to be shipped or transported into the United States shall
score at least 50 points out of 100 points according to the methods for
scoring as provided by the score card for sanitary inspection of such
plants in the form prescribed by the Secretary.
21 CFR 1210.15 Pasteurization; equipment and methods.
All dairy farms and plants at which any milk or cream is pasteurized
for shipment or transportation into the United States shall employ
adequate pasteurization machinery of a type easily cleaned and of
sanitary construction capable of holding every portion of the milk or
cream at the required temperature for the required time. Such
pasteurizing machinery shall be properly equipped with accurate time and
temperature recording devices, which shall be kept at all times in good
working order. The temperature at the time of heating and holding must
invariably be recorded on thermograph charts, initialed, numbered, and
dated by the official having jurisdiction over such farms and plants.
All thermograph charts shall be held for a period of 2 years unless
within that period they have been examined and released by such
authorized agents as are designated by the Secretary.
21 CFR 1210.16 Method of bacterial count.
The bacterial count of milk and cream refers to the number of viable
bacteria as determined by the standard plate method of the American
Public Health Association in use at the time of the examination.
21 CFR 1210.17 Authority to sample and inspect.
Inspectors engaged in the enforcement of the Federal Import Milk Act
are empowered to test for temperature, to take samples of milk or cream,
and to use such means as may be necessary for these purposes.
21 CFR 1210.18 Scoring.
Scoring of sanitary conditions required by 1210.11, 1210.14 shall
be done by an official inspector of the United States or of any State or
municipality thereof or of the country in which the dairy farm or plant
is located.
21 CFR 1210.18 Subpart C -- Permit Control
21 CFR 1210.20 Application for permit.
Application for a permit to ship or transport milk or cream into the
United States shall be made by the actual shipper upon forms prescribed
by the Secretary. The request for forms of applications for permits
should be addressed to Commissioner of Food and Drugs, Food and Drug
Administration, Department of Health and Human Services, 5600 Fishers
Lane, Rockville, MD 20857.
21 CFR 1210.21 Permit number.
Each permit issued under the Federal Import Milk Act, including each
temporary permit, shall bear an individual number. The right to the use
of such number is restricted solely to the permittee.
21 CFR 1210.22 Form of tag.
Each container of milk or cream shipped or transported into the
United States by such permittee shall have firmly attached thereto a tag
in the following form, bearing the required information in clear and
legible type:
Product
(State whether raw milk, pasteurized milk, raw cream, or pasteurized
cream.)
Permit number
Federal Import Milk Act, Department of Health and Human Services.
Shipper
Address of shipper
Provided, That in case of unit shipments consisting of milk only or
cream only under one permit number, in lieu of each container being so
marked, the vehicle of transportation, if sealed, may be tagged with the
above tag, which should, in addition, show the number of containers and
quantity of contents of each.
21 CFR 1210.23 Permits granted on certificates.
In the discretion of the Secretary, a permit may be granted on a duly
certified statement signed by a duly accredited official of an
authorized department of any foreign government or of any State of the
United States or any municipality thereof. Such statement shall be in
the form of a certificate prescribed by the Secretary, and shall have
attached thereto, as a part thereof, signed copies of reports prescribed
by 1210.12, 1230.13, and also by 1210.11, 1210.14, as applicable.
The necessary inspections and examinations upon which the reports are
based shall be made by persons who are acting under the direct
supervision of the certifying official.
21 CFR 1210.24 Temporary permits.
A temporary permit will be granted only upon a satisfactory showing
that the applicant therefor has been unable to obtain the necessary
inspections required by the applicable provisions of section 2 of the
Federal Import Milk Act. Temporary permits shall be valid until the
Secretary shall provide for inspection to ascertain that clauses 1, 2,
and 3 of section 2 of the Federal Import Milk Act have been complied
with.
21 CFR 1210.25 Permits for pasteurized milk or cream.
Permits to ship or transport pasteurized milk or cream into the
United States will be granted only upon compliance with the requirements
of clauses 1 and 3 of section 2 of the Federal Import Milk Act,
1210.11, 1210.12, 1210.14, as applicable.
21 CFR 1210.26 Permits for raw milk or cream.
Except as provided in 1210.27, permits to ship or transport raw milk
or cream into the United States will be granted only when the milk or
cream comes from dairy farms or plants where pasteurization is not
carried on and then only upon compliance with the requirements of
clauses 1, 2, and 3 of section 2 of the Federal Import Milk Act,
1210.11 to 1210.14 as applicable.
21 CFR 1210.27 Permits waiving clauses 2 and 5, section 2 of the
Federal Import Milk Act.
A permit to ship or transport raw milk into the United States will
contain a waiver of clauses 2 and 5 of section 2 of the Federal Import
Milk Act when the shipper is an operator of a creamery or condensery, or
is a producer shipping or transporting to a creamery or condensery and
the creamery or condensery is located in the United States within a
radius of 20 miles of the point of production of such milk, and the
milk, prior to its sale, use, or disposal, is pasteurized, condensed, or
evaporated.
21 CFR 1210.28 Permits waiving clause 4, section 2 of the Federal
Import Milk Act.
The Secretary, in his discretion, will issue to a shipper who is an
operator of a condensery a permit waiving the requirements of clause 4,
of section 2 of the Federal Import Milk Act and allowing milk and cream
containing not to exceed 1,200,000 bacteria per cubic centimeter to be
shipped or transported into the United States if the condensery is
located within a radius of 15 miles of the point of production of the
milk and cream and such milk and cream are to be sterilized in the
manufacture of condensed milk.
21 CFR 1210.28 Subpart D -- Hearings
21 CFR 1210.30 Hearing procedure for permit denial, suspension, and
revocation.
Any person who contests denial, suspension, or revocation of a permit
shall have an opportunity for a regulatory hearing before the Food and
Drug Administration pursuant to Subpart F of Part 16 of this chapter.
(41 FR 48269, Nov. 2, 1976, as amended at 42 FR 15676, Mar. 22, 1977)
21 CFR 1210.31 Hearing before prosecution.
Before violation of the act is referred to the Department of Justice
for prosecution under section 5 of the Federal Import Milk Act, an
opportunity to be heard will be given to the party against whom
prosecution is under consideration. The hearing will be private and
confined to questions of fact. The party notified may present evidence,
either oral or written, in person or by attorney, to show cause why he
should not be prosecuted. After a hearing is held, if it appears that
the law has been violated, the facts will be reported to the Department
of Justice.
(41 FR 48269, Nov. 2, 1976)
21 CFR 1210.31 PART 1220 -- REGULATIONS UNDER THE TEA IMPORTATION ACT
21 CFR 1210.31 Subpart A -- General Provisions
Sec.
1220.5 Importation of inferior goods prohibited.
1220.6 Importation without appraisement.
1220.7 Bonding of tea for consumption.
1220.8 Tea packages and contents shall constitute a unit.
1220.9 Duties of supervising tea examiner.
21 CFR 1210.31 Subpart B -- Shipment and Storage
1220.10 Teas destined for interior ports.
1220.15 Warehouses for storage of tea.
1220.16 Method of storing in warehouse.
1220.17 Removal of tea from warehouse.
21 CFR 1210.31 Subpart C -- Customs Requirements
1220.20 Examination of packages.
1220.21 Tea blended, mixed and repacked for export.
1220.22 Unclaimed teas.
21 CFR 1210.31 Subpart D -- Sampling Procedures
1220.30 Taking of samples at ports where tea examiner is stationed.
1220.31 Taking of samples at ports where there is no tea examiner.
1220.32 Result of examination; form of report.
1220.33 Chop list.
1220.34 Surplus samples.
1220.37 Exemption of sample packages from examination.
1220.38 Tea brought in by passengers.
21 CFR 1210.31 Subpart E -- Establishment of Standards
1220.40 Tea standards.
1220.41 Effective date of tea standards.
1220.42 To whom standards will be furnished.
1220.43 Disposition of obsolete standards.
21 CFR 1210.31 Subpart F -- Individual Standards
1220.50 Macao or Canton congou and brick tea standards.
1220.51 Teas imitating China green teas.
1220.52 Powchong Formosa oolong teas.
21 CFR 1210.31 Subpart G -- Inspection, Testing, and Grounds for
Rejection
1220.60 Instructions to examiners.
1220.61 Testing of teas.
1220.62 Testing quality of infused leaf.
1220.63 Test for paraffin and similar substances.
1220.64 Tests for impurities.
1220.65 Tea dust.
1220.66 Tolerance for fine tea particles.
1220.67 Tea inferior to the standard in any requisite is justly
rejected.
21 CFR 1210.31 Subpart H -- Administrative Procedures Based on
Examination
1220.70 Action based on result of examination.
1220.71 Procedure for protest against findings.
1220.72 Procedure by importer for review.
1220.73 Rejected tea.
1220.74 Exportation of rejected tea.
1220.75 Reimportation of exported teas forbidden.
1220.76 Destruction of condemned tea.
Authority: 21 U.S.C. 41-50; 19 U.S.C. 1311.
Source: 38 FR 32107, Nov. 20, 1973, unless otherwise noted.
Cross Reference: For U.S. Customs Service regulations governing
importation of tea, see 19 CFR 12.33.
21 CFR 1210.31 Subpart A -- General Provisions
21 CFR 1220.5 Importation of inferior goods prohibited.
The importation of any merchandise as tea which is inferior in
purity, quality, and fitness for consumption to the standards fixed and
established by the Secretary of Health and Human Services, in accordance
with section 3 of the Tea Importation Act (29 Stat. 605; 21 U.S.C. 43),
is prohibited.
21 CFR 1220.6 Importation without appraisement.
Importations of tea may be entered for consumption, for transit to
foreign countries, or for immediate transportation without appraisement.
All entries must be on the regular forms, and the regular serial
numbers, for both bonds and entries should be used.
21 CFR 1220.7 Bonding of tea for consumption.
Tea entered for consumption must be stored as provided in 1220.15,
pending examination, and bond must be taken by the District Director of
Customs, as provided in section 4 of the Tea Importation Act (29 Stat.
605; 21 U.S.C. 44), on Customs Form No. 7551 or 7553. This bond shall
be canceled upon the issuance of a permit for release, as the
consumption entry bond includes provisions for the redelivery, the
exportation, the destruction, and the holding of the merchandise for
customs examination.
21 CFR 1220.8 Tea packages and contents shall constitute a unit.
Tea packages and contents shall be treated as a unit, and no
separation of tea from its covering can be allowed, for either
exportation or destruction, except under the two following conditions:
(a) In cases of importations of tea containing an excessive quantity
of dust and siftings, the tea may be sifted and admitted to entry if
found up to the standard, and the dust and siftings may also be admitted
if found up to the standard or, if no standard exists, if found up to
the respective leaf standard. If not up to the standard, or respective
leaf standard when no standard exists, the dust and siftings must be
exported or destroyed under Government supervision.
(b) If, by reason of damage, a tea otherwise equal in quality to the
standard has been rejected, the damaged portion may be removed and
exported or destroyed under custom's supervision, and the sound
remainder resubmitted for examination and admitted to entry if found up
to the standard.
21 CFR 1220.9 Duties of supervising tea examiner.
(a) The supervising tea examiner is charged with the immediate
supervision of all matters relating to the enforcement of the Tea
Importation Act, and particularly the securing of uniformity in the
treatment of imported teas at all the points of examination. He is also
to perform such duties in connection with tea under the Federal Food,
Drug, and Cosmetic Act as may be assigned to him.
(b) For the purpose of securing uniformity in the treatment of teas
each tea examiner will send to the supervising tea examiner one-half
pound samples of the teas rejected by him, also such other samples of
teas as the supervising tea examiner may direct. To each sample a label
(T. I. S. Cat. No. 2) shall be affixed.
(c) The examiner of tea at each port where a qualified tea examiner
is stationed shall prepare and forward to the supervising tea examiner
and to the chairman of the United States Board of Tea Appeals, as soon
as practicable after the close of each month, a report (T. I. S. Cat.
No. 3), showing details as to every shipment of tea examined by the tea
examiner. This information the tea examiner should compile from his
report of ''Teas Imported and Examined'' (T. I. S. Cat. No. 4) which
should always be kept up to date.
21 CFR 1220.9 Subpart B -- Shipment and Storage
21 CFR 1220.10 Teas destined for interior ports.
Imported teas entered at an exterior port destined for immediate
transportation to an interior port shall be forwarded without detention.
21 CFR 1220.15 Warehouses for storage of tea.
(a) Warehouses for the storage of tea will be designated by the
District Director of Customs and the proprietor thereof will be required
to give a bond in the form prescribed (Customs Form No. 3581). Teas not
stored in such designated warehouses will be placed in general order
store or in public store pending examination and release on proper
permit. In the absence of proper storage facilities at customhouses,
teas may be retained in locked cars as constructive warehouses, under
proper supervision, pending examination.
(b) The importer's premises may be designated as warehouses for the
storage of tea on the filing of the bond provided for by the regulations
in this part, but whenever, in the discretion of the District Director
of Customs, it shall be considered desirable, a storekeeper shall be
assigned to the supervision of such premises at the importer's expense
while the teas shall remain under bond therein.
21 CFR 1220.16 Method of storing in warehouse.
(a) When tea under examination is stored in any warehouse it must be
so placed as to be separate from other merchandise and so as to allow
convenient supervision by customs officers and officers of the
Department of Health and Human Services. At ports where there are no
bonded warehouses, class 2 or 3, the chief customs officer of the port
will, when necessary, procure suitable premises for the temporary
storage of any tea reaching his port. The repacking of tea in warehouse
for export purposes is not allowed.
(b) All expenses of storage, cartage, and labor must be paid by the
importer.
21 CFR 1220.17 Removal of tea from warehouse.
No tea shall be delivered to the importer or removed from warehouse
for any purpose before the examination required by the Tea Importation
Act.
21 CFR 1220.17 Subpart C -- Customs Requirements
21 CFR 1220.20 Examination of packages.
Chief officers of customs may order such an examination of packages
containing tea as will satisfy them that no dutiable goods are packed
therein. For this purpose the customary designation should be made of
packages for examination in public store.
21 CFR 1220.21 Tea blended, mixed and repacked for export.
Tea importers desiring to import teas into the United States to be
blended, mixed, and repacked for export can do so by bonding a warehouse
under the provisions of section 311 of the Tariff Act of 1930 (46 Stat.
691; 19 U.S.C. 1311), upon compliance with 19.13 to 19.15, inclusive,
of the Customs Regulation of 1943 (19 CFR 19.13-19.15), giving bond on
Customs Form No. 3583. All teas placed in bonded manufacturing
warehouses must be exported.
Cross Reference: For customs regulations governing manufacturing
warehouses, see 19 CFR 19.13-19.16.
21 CFR 1220.22 Unclaimed teas.
Unclaimed teas should be taken possession of by District Directors of
Customs the same as other unclaimed goods and placed in ''general
order'', but not sold at the expiration of the year unless declared fit
for consumption by a designated tea examiner.
Cross Reference: For U.S. Customs Service regulations governing
disposition of merchandise unclaimed or in warehouse beyond the time
fixed by law, see 19 CFR Part 127.
21 CFR 1220.22 Subpart D -- Sampling Procedures
21 CFR 1220.30 Taking of samples at ports where tea examiner is
stationed.
The examination of teas at ports where a duly qualified tea examiner
is stationed shall be made by means of samples drawn by the sampler from
packages designated by the tea examiner. The importer, when his teas
are ready for sampling, shall submit in duplicate to the tea examiner a
chop list and release permit (T.I.S. Cat. No. 1) of the several lines
included in the invoice, and the tea examiner shall select for
examination packages representing the different lines.
21 CFR 1220.31 Taking of samples at ports where there is no tea
examiner.
(a) In case an entry of imported tea shall be made at a port or
subport where no tea examiner is stationed the importer should prepare
the chop list and release permit (T. I. S. Cat. No. 1) in triplicate and
forward them to the chief officer of the customs at the port of entry.
(b) Samples shall be obtained by such officers, together with the
original and one copy of the chop list and release permit (T. I. S.
Cat. No. 1), and shall be forwarded to the nearest qualified tea
examiner for his report and return. Samples sent for the purpose of
examination from ports of importation to ports where tea examiners are
located shall be packed in clean tin cans, free from odor, fitted with
tight covers, and of a capacity to hold about 4 ounces avoirdupois of
tea. Each can shall be properly labeled (T. I. S. Cat. No. 5).
21 CFR 1220.32 Result of examination; form of report.
(a) The examination and report upon such samples shall be made in
accordance with the provisions of section 7 of the Tea Importation Act
(29 Stat. 606; 21 U.S.C. 46), and the result of this examination shall
be noted on the invoice by the tea examiner before he returns the
invoice to the collector of customs. The tea examiner at the same time
should make his returns on the original copy of the chop list and
release permit (T. I. S. Cat. No. 1), which, after being duly signed by
him, should be forwarded by him to the importer or consignee.
(b) In case the tea coverings are dutiable and appraised at a value
or rate higher than the entered value or rate, the tea examiner shall
follow the same procedure as above, except that the chop list and
release permit shall be returned to the District Director of Customs for
such action as he sees fit to take.
(c) In case a partial release is desired the importer shall furnish
an additional chop list and release permit (T. I. S. Cat. No. 1) of the
goods that he desires, the original chop list and release permit being
retained by the tea examiner until action on all the teas in the entry
has been taken.
21 CFR 1220.33 Chop list.
(a) In all cases the importer shall indicate on the chop list and
release permit where the goods are to be sampled, whether on the dock or
in warehouse. If the consular invoice has not been received the
importer may prepare an additional copy of the chop list and release
permit as a pro forma invoice, marking across the face thereof ''Pro
Forma Invoice.''
(b) Importers may print their chop list and release permit forms,
provided they conform strictly with the official form (T.I.S. Cat. No.
1). Otherwise, they can be obtained free from the United States tea
examiner at ports where tea examiners are stationed, or from the chief
officer of customs at ports, or subports, where no tea examiners are
stationed.
21 CFR 1220.34 Surplus samples.
(a) Surplus samples drawn from importations for purposes of
examination, and which represent pure tea as declared by the examiner,
shall be returned to the importer after examination is completed, if so
requested by the importer, but if no request is made for the return of
samples they shall be disposed of as provided in 1220.43 for unused
standard samples.
(b) Surplus samples representing tea which has been finally rejected
should be destroyed, or, after being denatured, should be sold for
manufacturing purposes under the Tea Importation Act (35 Stat. 163; 21
U.S.C. 41).
21 CFR 1220.37 Exemption of sample packages from examination.
Where tea is put up in packages of not over 2 pounds in weight,
imported by mail, express, or otherwise from the country of production,
and the fact is established that the packages are samples for
distribution, or for use in soliciting orders and not for sale, no
examination should be made under the Tea Importation Act (29 Stat. 604;
21 U.S.C. 41-50), and they may be delivered at once to the importer.
21 CFR 1220.38 Tea brought in by passengers.
Packages of tea not exceeding 5 pounds in weight brought by
passengers may be delivered without examination under the Tea
Importation Act (29 Stat. 604; 21 U.S.C. 41-50).
21 CFR 1220.38 Subpart E -- Establishment of Standards
21 CFR 1220.40 Tea standards.
(a) Samples for standards of the following teas, prepared,
identified, and submitted by the Board of Tea Experts on June 5, 1991,
are hereby fixed and established as the standards of purity, quality,
and fitness for consumption under the Tea Importation Act for the year
beginning May 1, 1991, and ending April 30, 1992:
(1) Black Tea (for all teas except those from the People's Republic
of China (China), Taiwan (Formosa), Iran, Japan, the Union of Soviet
Socialist Republics (Russia), Turkey, and Argentina.
(2) Black Tea (for Argentina teas).
(3) Black Tea (for teas from the People's Republic of China (China),
Taiwan (Formosa), Iran, Japan, the Union of Soviet Socialist Republics
(Russia), and Turkey).
(4) Green Tea (of all origins).
(5) Formosa Oolong.
(6) Canton Oolong (for all Canton types from the People's Republic of
China (China) and Taiwan (Formosa)).
(7) Scented Black Tea.
(8) Spiced Tea.
These standards apply to tea shipped from abroad on or after May 1,
1991.
(b) The Board of Tea Experts shall prepare duplicate samples of the
standards for teas.
(38 FR 32107, Nov. 20, 1973, as amended at 55 FR 33671, Aug. 17,
1990; 55 FR 34797, Aug. 24, 1990, 56 FR 50250, Oct. 4, 1991.)
21 CFR 1220.41 Effective date of tea standards.
The standards prepared and submitted to the Secretary of Health and
Human Services by the Board of Tea Experts, appointed by him on or
before February 15 of each year, shall be fixed and established as
standards under the act and shall be in effect from the 1st day of May
of each year until April 30, inclusive, of the following year, except
that tea shipped from abroad prior to May 1 of any year shall be
governed by the standards in effect at the time of shipment. Such
standards for each year will be published in the Federal Register.
21 CFR 1220.42 To whom standards will be furnished.
(a) A quantity of tea of the approved standards will be repacked in
half-pound tin containers by competent tea packers under the constant
supervision of an officer of the Food and Drug Administration and full
sets will be furnished the Board of Tea Appeals, the supervising tea
examiner, and the examiners of tea at all the tea examining stations.
(b) Standards will be furnished to actual importers and regular tea
brokers on application to the supervising tea examiner, at the actual
cost of the same.
21 CFR 1220.43 Disposition of obsolete standards.
After standard samples have served their purpose and new season
samples have been submitted, the old samples may be included in
quarterly sales of unclaimed goods, and the proceeds paid into the
Treasury, after deducting expenses of advertisement and sale, the
designation on the packages showing such teas to have been used as
Government standards to be obliterated before delivery to purchaser.
21 CFR 1220.43 Subpart F -- Individual Standards
21 CFR 1220.50 Macao or Canton congou and brick tea standards.
Macao or Canton congou and brick tea should be compared with the
standard for China congou. The mustiness or damaged flavor exhibited in
certain Canton teas would be just cause for rejection.
21 CFR 1220.51 Teas imitating China green teas.
Whenever Japans, Ceylons, Indias, or any other teas are made up to
imitate the green teas of China, they are to be examined in comparison
with the China green standards.
21 CFR 1220.52 Powchong Formosa oolong teas.
All Powchong (scented) Formosa oolong teas should be examined in
comparison with the Formosa standard.
21 CFR 1220.52 Subpart G -- Inspection, Testing, and Grounds for Rejection
21 CFR 1220.60 Instructions to examiners.
(a) Examiners are instructed not to pass upon samples representing
importations of tea imported separately from the importation; neither
shall they give nonofficial opinions concerning samples.
(b) The examination of tea in comparison with the standards under
this act shall be made according to the usages and customs of the tea
trade, including the testing of an infusion in boiling water and, if
necessary, chemical analysis; and examiners are advised, inasmuch as
they must not under the law admit any tea inferior to the standards in
purity, quality, and fitness for consumption, to employ the present
methods of determining the presence of artificial coloring and other
impurities. (See 1220.64.)
21 CFR 1220.61 Testing of teas.
(a) In comparing with standards, examiners are to test all the teas
for quality, for impurity consisting of artificial coloring or facing
matter, and other impurity, and for quality of infused leaf. Quality
shall be ascertained by drawing, according to the custom of the tea
trade, with the weight of a silver half dime to the cup. The quality
must be equal to standard, but the flavor may be that of a different
district, as long as it is equally fit for consumption. As an
illustration, a Teenkai may be equal to a Moyune, but a distinctly smoky
or rank Fychow or Wenchow of sour character is not considered equal to
the first two mentioned.
(b) Tea dust, fannings, siftings, and offgrades, including broken tea
(BT), broken mix (BM), and Bohea when so marked and for which there is
no specific standard, should be tested for quality, purity, and fitness
for consumption in comparison with their respective leaf standards.
21 CFR 1220.62 Testing quality of infused leaf.
In order to test the quality of the infused leaf in comparison with
the standard, a second drawing should be made of double weight. Before
pouring off the water, examine for an excess of ''floaters'' (woody
stems which remain floating after the leaf is thoroughly infused) to
determine whether they are in sufficient quantity to reduce the quality
of the infusion below that of the standard. After pouring off the water
the infused leaf should be taken out so as to exhibit the lower side
which rested against the cup. Should the mass show a larger quantity of
exhausted or decayed leaf than the standard, it affords sufficient
evidence to be judged inferior in quality and consequently to be
rejected.
21 CFR 1220.63 Test for paraffin and similar substances.
If the examiner suspects the presence of paraffin or any similar
substance, he should make the following test in comparison with the
standard: Spread the tea between two sheets of unglazed white paper.
Place thereon a hot iron. The greasy substance, if any, will appear on
the paper, and if not equal to the standard the tea would justly be
rejected.
21 CFR 1220.64 Tests for impurities.
(a) To examine for impurities the following tests may be used in
comparison with the standard:
(1) Read test, with additions and modifications, and the cup test,
doubleweight. Place 2 ounces of tea in a sieve 5 or 6 inches in
diameter, having 60 meshes to the inch and provided with a top. Sift a
small quantity of the dust onto a semiglazed white paper about 8 by 10
inches. The amount of dust placed on the paper should be approximately
1 grain. To get the requisite amount of dust it is sometimes necessary
to rub the leaf gently against the bottom of the sieve, but this must
not be done until the sieve has been well shaken over the test paper.
Pour the dust thus collected from the paper into the scales, weigh out 1
grain, and return this quantity to the same paper, distributing it well
over the surface of the paper. Then place the paper on a plain, firm
surface, preferably glass or marble, and crush the dust by pushing over
it, with considerable pressure, a flat steel spatula about 5 inches
long. Do this repeatedly until the tea dust is ground almost to a
powder and the particles of coloring matter or other impurities, if any,
are spread or streaked on the paper, so as to become more apparent.
Brush off the loose dust and examine the paper by means of a simple lens
magnifying 7 1/2 diameters. In distinguishing these particles and
streaks bright light is essential.
(2) The crushed leaf in either black or green tea appears in such
quantity that there is no chance of mistaking the leaf for artificial
coloring, facing material, or other impurities.
(3) The test is performed in comparison with the standard, and, if
the tea is clearly equal to the standard with respect to artificial
coloring, facing matter, or other impurities, the operation need not be
repeated. If particles of artificial coloring, facing, or other
impurities are found in the sample under comparison with the standard
repeat this operation a sufficient number of times to be sure whether or
not the tea contains impurities in excess of the standard.
(4) Repeat the operation, using semiglazed black paper instead of the
white paper. This black-paper test shows the presence of facing and
other impurities, such as talc, gypsum, barium sulfate, clay, and
kaolin.
(5) If the tea under examination is found, by the foregoing tests, to
contain more impurities than the standard, draw samples from packages
representing at least 5 percent of the line in question, and subject
each sample to the tests to ascertain whether or not the majority
contain impurities in excess of the standard.
(6) The foregoing tests may be applied to tea of all varieties.
(b) Should the examination of the sample by the cup test,
double-weight, for scum, sediment, etc., or the Read test, or both,
disclose the presence of more impurities than the standard, a pound
sample should be sent to the nearest district of the Food and Drug
Administration and an analysis made in comparison with the standard to
determine whether it contains more impurities than the standard. If the
tea in question is found to contain more impurities than the standard,
it would properly be rejected as not being equal to the standard in
purity.
(c) All extraneous substances are impurities, and the presence of any
may be detected in any way found efficient.
21 CFR 1220.65 Tea dust.
Tea dust or broken leaf mixed with other teas or separate, made to
imitate gunpowder or other teas, with the use of paste or gum, or any
other substance, would justly be rejected.
21 CFR 1220.66 Tolerance for fine tea particles.
Except for teas listed under 1220.61(b), the amount by weight of
fine tea particles that will pass through a wire sieve having 30
openings per linear inch in either direction and made of wire with a
diameter of 0.01 inch, must not exceed 4 percent. Before condemning any
tea for fine particles in excess of 4 percent, examiners shall sieve at
least 4 representative samples, each taken from a different package in a
shipment containing four or more packages, or where a lesser number of
packages is involved, examiners shall sieve a representative sample from
each package.
21 CFR 1220.67 Tea inferior to the standard in any requisite is justly
rejected.
Should a tea prove on examination to be inferior to the standard in
any one of the requisites -- namely, quality, quality of infused leaf,
or purity -- it would justly be rejected, notwithstanding the fact that
it may be superior to the standards in some of the qualifications. No
consideration shall be given to the appearance or so-called style of the
dry leaf.
21 CFR 1220.67 Subpart H -- Administrative Procedures Based on Examination
21 CFR 1220.70 Action based on result of examination.
(a) If, after examination, the tea is found not be prohibited under
the act, a release permit shall at once be granted to the importer,
declaring that the tea is not within the prohibition of the Tea
Importation Act; but if, on examination, such tea, or merchandise
described as tea, is found in the opinion of the examiner, to come
within the prohibitions of the law and of the regulations in this part,
the importer shall be immediately notified (T.I.S. Cat. No. 6), and the
tea, or merchandise described as tea, so returned, shall not be released
by the customhouse authorities, unless on a re-examination called for by
the importer the return of the examiner shall be found erroneous.
Should a portion only of the invoice be passed by the examiner as
correct, a permit of delivery shall be granted for that portion and the
remainder held as provided in section 6 of the act (29 Stat. 606; 21
U.S.C. 47).
(b) In all cases of rejections by examiners, the importers should be
notified of the reason for rejection; that is, whether it be on the
ground of quality, character of infused leaf, dust, or admixture with
foreign substance.
21 CFR 1220.71 Procedure for protest against findings.
In case the collector of customs, importer, or consignee shall
protest against the finding of the examiner, the matter in dispute shall
be referred for decision to the United States Board of Tea Appeals,
designated by the Secretary of Health and Human Services, and if such
board shall, after due examination, find the tea in question to be equal
in purity, quality, and fitness for consumption, as compared with the
proper standards, a permit shall be issued by the District Director of
Customs for its release and delivery to the importer; but if, upon such
final re-examination by such board, the tea shall be found to be
inferior in purity, quality, and fitness for consumption, as compared
with the said standards, the importer or consignee shall give a bond,
unless he has previously done so, with security satisfactory to the
District Director of Customs, to export said tea out of the limits of
the United States within a period of 6 months after such final
re-examination; and if the same shall not have been exported within the
time specified, the District Director of Customs, at the expiration of
that time, shall cause the same to be destroyed.
21 CFR 1220.72 Procedure by importer for review.
(a) If the importer desires teas rejected by the examiner to be
reviewed by the United States Board of Tea Appeals, as provided in
section 6 of the said act, he shall, within 30 days after he has been
notified of such return, file a written application with the collector
in the form T.I.S. Cat. No. 20. The District Director of Customs will
thereupon forward such application to the United States Board of Tea
Appeals, designated by the Secretary of Health and Human Services for
review of the matter in dispute, and the proceedings shall be according
to section 8 of the act.
(b) The re-examination of the tea samples must be restricted to the
samples put up and sealed by the examiner at ports where qualified tea
examiners are stationed, or by the chief officer of the customs, if
there is no qualified tea examiner so stationed, in the presence of the
importer or consignee, if he so desires. In either case the samples
should be transmitted to the United States Board of Tea Appeals by the
tea examiner, together with a copy of the finding of the examiner,
setting forth the cause of condemnation.
(c) These samples for re-examination should weigh at least 1 pound,
and should be put up in tins securely labeled (T.I.S. Cat. No. 21) and
well wiped and seasoned. Half of such samples shall be utilized for the
examination by the Board of Tea Appeals and for return to the port of
entry with the decision, as heretofore, and the remaining half pound, if
the tea be rejected by said board, shall be distributed among the
various examiners for their information and guidance.
(d) Teas rejected by team examiners and rejections affirmed by the
United States Board of Tea Appeals cannot be re-examined.
21 CFR 1220.73 Rejected tea.
Rejected tea can only be released or withdrawn for exportation, for
transportation and exportation, or for manufacturing purposes under the
Tea Importation Act (35 Stat. 163; 21 U.S.C. 41), as the case may be.
21 CFR 1220.74 Exportation of rejected teas.
(a) Teas to be exported for the reason that they are within the
prohibition of the statute will be entered for exportation on Customs
Form No. 7515, and bond on Customs Form No. 7557 shall be given for
their exportation in a penal sum equal to double the value of the tea,
provided consumption entry bond (Form No. 7551 or Form No. 7553) was not
previously given.
(b) Whenever a bond is given to export any condemned tea in pursuance
of the act, it will be canceled upon the filing of an outward bill of
lading and a duly authenticated certificate of clearance from the
customs officer supervising the lading thereof, as in the case of
rejected foods and drugs (T.D. 28841), and all accrued charges must be
paid before issuance of permit for exportation.
(c) At interior ports the export entry shall be made for
transportation and immediate exportation in bond.
21 CFR 1220.75 Reimportation of exported teas forbidden.
(a) No imported teas which have been rejected by an examiner, or by
the United States Board of Tea Appeals, and exported under the
provisions of this act, shall be reimported into the United States under
the penalty of forfeiture for a violation of this prohibition.
(b) Customs officers will make seizure of any tea so imported.
21 CFR 1220.76 Destruction of condemned tea.
Whenever condemned tea is to be destroyed it must be conveyed to some
suitable place, and proper means, to be prescribed by the examiner, must
be used for its effectual destruction, which shall be effected in the
presence of an officer of customs, detailed by the District Director of
Customs for the purpose. Before the tea is destroyed a particular
description or statement of the same must be prepared containing the
name of the importer or owner, the date of importation, the name of the
vessel, and the place from which imported, with the character and
quantity of the tea and the invoice value. The fact of its destruction
must be certified on said statement by the officer detailed as
aforesaid, which statement must be filed in the customhouse.
21 CFR 1220.76 PART 1230 -- REGULATIONS UNDER THE FEDERAL CAUSTIC POISON ACT
21 CFR 1220.76 Subpart A -- General Provisions
Sec.
1230.2 Scope of the act.
1230.3 Definitions.
21 CFR 1220.76 Subpart B -- Labeling
1230.10 Placement.
1230.11 Required wording.
1230.12 Manufacturer; distributor.
1230.13 Labeling of ''poison''.
1230.14 Directions for treatment.
1230.15 Responsibility for labeling directions for treatment.
1230.16 Exemption from labeling directions for treatment.
21 CFR 1220.76 Subpart C -- Guaranty
1230.20 General guaranty.
1230.21 Specific guaranty.
21 CFR 1220.76 Subpart D -- Administrative Procedures
1230.30 Collection of samples.
1230.31 Where samples may be collected.
1230.32 Analyzing of samples.
1230.33 Investigations.
1230.34 Analysis.
1230.35 Hearings.
1230.36 Hearings; when not provided for.
1230.37 Publication.
21 CFR 1220.76 Subpart E -- Imports
1230.40 Required label information.
1230.41 Delivery of containers.
1230.42 Invoices.
1230.43 Enforcement.
1230.44 Samples.
1230.45 No violation; release.
1230.46 Violation.
1230.47 Rejected containers.
1230.48 Relabeling of containers.
1230.49 Penalties.
Authority: 15 U.S.C. 1261-1276.
Source: 38 FR 32110, Nov. 20, 1973, unless otherwise noted.
Cross References: For regulations relating to invoices, entry, and
assessment of duties, see 19 CFR Parts 141, 142, 143, 151, 152. For
regulations regarding the examination, classification, and disposition
of foods, drugs, devices, cosmetics, insecticides, fungicides, and
caustic or corrosive substances, see 19 CFR Part 12. For regulations
relating to consular invoices, and documentation of merchandise, see 22
CFR Parts 91 and 92.
21 CFR 1220.76 Subpart A -- General Provisions
21 CFR 1230.2 Scope of the act.
The provisions of the act apply to any container which has been
shipped or delivered for shipment in interstate or foreign commerce, as
defined in section 2(c) of the act (44 Stat. 1407; 15 U.S.C. 402) or
which has been received from shipment in such commerce for sale or
exchange, or which is sold or offered for sale or held for sale or
exchange in any Territory or possession or in the District of Columbia.
21 CFR 1230.3 Definitions.
(a) The word ''container'' as used in the regulations in this part
means a retail parcel, package, or container suitable for household use
and employed exclusively to hold any dangerous caustic or corrosive
substance defined in the act.
(b) The words ''suitable for household use'' mean and imply
adaptability for ready or convenient handling in places where people
dwell.
21 CFR 1230.3 Subpart B -- Labeling
21 CFR 1230.10 Placement.
The label or sticker shall be so firmly attached to the container
that it will remain thereon while the container is being used, and be so
placed as readily to attract attention.
21 CFR 1230.11 Required wording.
(a) The common name of the dangerous caustic or corrosive substance
which shall appear on the label or sticker is the name given in section
2(a) of the act (44 Stat. 1406; 15 U.S.C. 402) or any other name
commonly employed to designate and identify such substance.
(b) Preparations within the scope of the act bearing trade or
fanciful names shall, in addition, be labeled with the common name of
the dangerous caustic or corrosive substance contained therein and
comply with all the other requirements of the act and of the regulations
in this part.
21 CFR 1230.12 Manufacturer; distributor.
If the name on the label or sticker is other than that of the
manufacturer, it shall be qualified by such words as ''packed for,''
''packed by,'' ''sold by,'' or ''distributed by,'' as the case may be,
or by other appropriate expression.
21 CFR 1230.13 Labeling of ''poison''.
The following are styles of uncondensed Gothic capital letters
24-point (type face) size:
When letters of not less than 24-point size are required on a label
in stating the word ''poison'' they must not be smaller than those above
set forth.
21 CFR 1230.14 Directions for treatment.
Except as provided in 1230.16, the container shall bear in all cases
upon the label or sticker thereof, immediately following the word
''Poison,'' directions for treatment in the case of internal personal
injury; in addition, if the substance may cause external injury,
directions for appropriate treatment shall be given. The directions
shall prescribe such treatments for personal injury as are sanctioned by
competent medical authority, and the materials called for by such
directions shall be, whenever practicable, such as are usually available
in the household.
21 CFR 1230.15 Responsibility for labeling directions for treatment.
A person who receives from a manufacturer or wholesaler any container
which under the conditions set forth in section 2(b)(4) of the act and
1230.16 does not bear at the time of shipment directions for treatment
in the case of personal injury must place such directions on the label
or sticker if he offers such container for general sale or exchange.
21 CFR 1230.16 Exemption from labeling directions for treatment.
Manufacturers and wholesalers only, at the time of shipment or
delivery for shipment, are exempted from placing directions for
treatment on the label or sticker of any container for other than
household use, but in any event the information required by section 2(b)
(1), (2), and (3) of the act (44 Stat. 1407; 15 U.S.C. 402) and the
regulations in this part shall be given.
21 CFR 1230.16 Subpart C -- Guaranty
21 CFR 1230.20 General guaranty.
In lieu of a particular guaranty for each lot of dangerous caustic or
corrosive substances, a general continuing guaranty may be furnished by
the guarantor to actual or prospective purchasers. The following are
forms of continuing guaranties:
(a) Substances for both household use and other than household use:
The undersigned guarantees that the retail parcels, packages, or
containers of the dangerous caustic or corrosive substance or substances
to be sold to ------------ are not misbranded within the meaning of the
Federal Caustic Poison Act.
(Date)
(Signature and address of
guarantor)
(b) Substances for other than household use (this form may be issued
only by a manufacturer or wholesaler) ( 1230.15, 1230.16):
The dangerous caustic or corrosive substance or substances in retail
parcels, packages, or containers suitable for household use to be sold
to ------------ are for other than household use, and guaranteed not to
be misbranded within the meaning of the Federal Caustic Poison Act.
(Date)
(Signature and address of
manufacturer or wholesaler)
21 CFR 1230.21 Specific guaranty.
If a guaranty in respect to any specific lot of dangerous caustic or
corrosive substances be given, it shall be incorporated in or attached
to the bill of sale, invoice, or other schedule bearing the date and the
name and quantity of the substance sold, and shall not appear on the
label or package. The following are forms of specific guaranties:
(a) Substances for both household use and other than household use:
The undersigned guarantees that the retail parcels, packages, or
containers of the dangerous caustic or corrosive substance or substances
listed herein (or specifying the substances) are not misbranded within
the meaning of the Federal Caustic Poison Act.
(Signature and address of
guarantor)
(b) Substances for other than household use (this form may be issued
only by a manufacturer or wholesaler ( 1230.15, 1230.16):
The dangerous caustic or corrosive substance or substances listed
herein (or specifying the substances) in retail parcels, packages, or
containers suitable for household use are for other than household use
and are guaranteed not to be misbranded within the meaning of the
Federal Caustic Poison Act.
(Name and address of manufacturer
or wholesaler)
21 CFR 1230.21 Subpart D -- Administrative Procedures
21 CFR 1230.30 Collection of samples.
Samples for examination by or under the direction and supervision of
the Food and Drug Administration shall be collected by:
(a) An authorized agent in the employ of the Department of Health and
Human Services;
(b) Any officer of any State, Territory, or possession, or of the
District of Columbia, authorized by the Secretary of Health and Human
Services.
21 CFR 1230.31 Where samples may be collected.
Caustic or corrosive substances within the scope of this act (44
Stat. 1406; 15 U.S.C. 401-411) may be sampled wherever found.
21 CFR 1230.32 Analyzing of samples.
Samples collected by an authorized agent shall be analyzed at the
laboratory designated by the Food and Drug Administration. Only such
samples as are collected in accordance with 1230.30, 1230.31 may be
analyzed by or under the direction and supervision of the Food and Drug
Administration. Upon request one subdivision of the sample, if
available, shall be delivered to the party or parties interested.
21 CFR 1230.33 Investigations.
Authorized agents in the employ of the Department of Health and Human
Services may make investigations, including the inspection of premises
where dangerous caustic and corrosive substances subject to the act are
manufactured, packed, stored, or held for sale or distribution, and make
examinations of freight and other transportation records.
21 CFR 1230.34 Analysis.
(a) The methods of examination or analysis employed shall be those
prescribed by the Association of Official Agricultural Chemists, when
applicable, provided, however, that any method of analysis or
examination satisfactory to the Food and Drug Administration may be
employed.
(b) All percentages stated in the definitions in section 2(a) of the
Federal Caustic Poison Act shall be determined by weight.
21 CFR 1230.35 Hearings.
Whenever it appears from the inspection, analysis, or test of any
container that the provisions of section 3 or 6 of the Federal Caustic
Poison Act (44 Stat. 1407, 1409; 15 U.S.C. 403, 406) have been violated
and criminal proceedings are contemplated, notice shall be given to the
party or parties against whom prosecution is under consideration and to
other interested parties, and a date shall be fixed at which such party
or parties may be heard. The hearing shall be held at the office of the
Food and Drug Administration designated in the notice and shall be
private and confined to questions of fact. The parties notified may
present evidence, either oral or written, in person or by attorney, to
show cause why the matter should not be referred for prosecution as a
violation of the Federal Caustic Poison Act.
21 CFR 1230.36 Hearings; when not provided for.
No hearing is provided for when the health, medical, or drug officer
or agent of any State, Territory, or possession, or of the District of
Columbia, acts under the authority contained in section 8 of the Federal
Caustic Poison Act (44 Stat. 1409; 15 U.S.C. 408) in reporting a
violation direct to the United States attorney.
21 CFR 1230.37 Publication.
(a) After judgment of the court in any proceeding under the Federal
Caustic Poison Act, notice shall be given by publication. Such notice
shall include the findings of the court and may include the findings of
the analyst and such explanatory statements of fact as the Secretary of
Health and Human Services may deem appropriate.
(b) This publication may be made in the form of a circular, notice,
or bulletin, as the Secretary of Health and Human Services may direct.
(c) If an appeal be taken from the judgment of the court before such
publication, that fact shall appear.
21 CFR 1230.37 Subpart E -- Imports
21 CFR 1230.40 Required label information.
Containers which are offered for import shall in all cases bear
labels or stickers having thereon the information required by section
2(b) (1), (2), and (3) of the Federal Caustic Poison Act and the
directions for treatment in the case of personal injury, except such
directions need not appear on the label or sticker at the time of
shipment by a wholesaler or manufacturer for other than household use.
21 CFR 1230.41 Delivery of containers.
Containers shall not be delivered to the consignee prior to report of
examination, unless a bond has been given on the appropriate form for
the amount of the full invoice value of such containers, together with
the duty thereon, and the refusal of the consignee to return such
containers for any cause to the custody of the District Director of
Customs when demanded, for the purpose of excluding them from the
country or for any other purpose, the consignee shall pay an amount
equal to the sum named in the bond, and such part of the duty, if any,
as may be payable, as liquidated damages for failure to return to the
District Director of Customs on demand all containers covered by the
bond.
21 CFR 1230.42 Invoices.
As soon as the importer makes entry, the invoices covering containers
and the public stores packages shall be made available, with the least
possible delay, for inspection by the representative of the district.
When no sample is desired the invoice shall be stamped by the district
''No sample desired, Food and Drug Administration, Department of Health
and Human Services, per (initials of inspecting officer).''
21 CFR 1230.43 Enforcement.
(a) Enforcement agency. The Federal Caustic Poison Act shall be
enforced by the Food and Drug Administration, Department of Health and
Human Services.
(b) Enforcement of provisions. The enforcement of the provisions of
the Federal Caustic Poison Act as they relate to imported dangerous
caustic or corrosive substances, will, as a general rule, be under the
direction of the chief of the local inspection district of the Food and
Drug Administration, Department of Health and Human Services, and
District Directors of Customs acting as administrative officers in
carrying out directions relative to the detention, exportation, and
sale, or other disposition of such substances and action under the bond
in case of noncompliance with the provisions of the Federal Caustic
Poison Act.
(c) Chief of district as customs officer. The chief of district
shall be deemed a customs officer in enforcing import regulations.
(d) Nonlaboratory ports. (1) At the ports of entry where there is no
district of the Food and Drug Administration, the District Director of
Customs or deputy, on the day when the first notice of expected shipment
of containers is received, either by invoice or entry, shall notify the
chief of district in whose territory the port is located.
(2) On the day of receipt of such notice the chief of district shall
mail to the District Director of Customs appropriate notice, if no
sample is desired. This notice serves as an equivalent to stamping the
invoices at district ports with the legend ''No sample desired, Food and
Drug Administration, Department of Health and Human Services, per
(initials of inspecting officer).''
(3) If samples are desired, the Chief of district shall immediately
notify the District Director of Customs.
(4) The District Director of Customs at once shall forward samples,
accompanied by description of shipment.
(5) When samples are desired from each shipment of containers, the
chief of district shall furnish to District Director of Customs and
deputies at ports within the district's territory a list of such
containers, indicating the size of sample necessary. Samples should
then be sent promptly on arrival of containers without awaiting special
request.
(6) In all other particulars the procedure shall be the same at
nonlaboratory ports as at laboratory ports, except that the time
consumed in delivery of notices by mail shall be allowed for.
21 CFR 1230.44 Samples.
On the same day that samples are requested by the district, the
District Director of Customs or appraiser shall notify the importer that
samples will be taken, that the containers must be held intact pending a
notice of the result of inspection and analysis, and that in case the
containers do not comply with the requirements of the Federal Caustic
Poison Act, they must be returned to the District Director of Customs
for disposition. This notification may be given by the District
Director of Customs or appraiser through individual notices to the
importer or by suitable bulletin notices posted daily in the
customhouse.
21 CFR 1230.45 No violation; release.
As soon as examination of the samples is completed, if no violation
of the act is detected, the chief of the district shall send a notice of
release to the importer and a copy of this notice to the District
Director of Customs for his information.
21 CFR 1230.46 Violation.
(a) If a violation of the Federal Caustic Poison Act is disclosed,
the chief of the district shall send to the importer due notice of the
nature of the violation and of the time and place where evidence may be
presented, showing that the containers should not be refused admission.
At the same time similar notice regarding detention of the containers
shall be sent to the District Director of Customs, requesting him to
refuse delivery thereof or to require their return to customs custody if
by any chance the containers were released without the bond referred to
in 1230.41. The time allowed the importer for representations regarding
the shipment may be extended at his request for a reasonable period to
permit him to secure such evidence.
(b) If the importer does not reply to the notice of hearing in person
or by letter within the time allowed on the notice, a second notice,
marked ''second and last notice,'' shall be sent at once by the chief of
the district, advising him that failure to reply will cause definite
recommendation to the District Director of Customs that the containers
be refused admission and that the containers be exported within 3 months
under customs supervision.
21 CFR 1230.47 Rejected containers.
(a) In all cases where the containers are to be refused admission,
the chief of the district within 1 day after hearing, or, if the
importer does not appear or reply within 3 days after second notice,
shall notify the District Director of Customs in duplicate accordingly.
(b) Not later than 1 day after receipt of this notice the District
Director of Customs shall sign and transmit to the importer one of the
copies, which shall serve as notification to the importer that the
containers must be exported under customs supervision within 3 months
from such date, as provided by law; the other notice shall be retained
as office record and later returned as a report to the chief of the
district. In all cases the importer shall return his notice to the
District Director of Customs, properly certified as to the information
required, as the form provides.
21 CFR 1230.48 Relabeling of containers.
(a) If containers are to be released after relabeling, a notice shall
be sent by the chief of district direct to the importer, a carbon copy
being sent to the District Director of Customs. This notice must state
specifically the conditions to be performed, so as to bring the
performance thereof under the provisions of the customs bonds on
consumption and warehouse entries, these bonds including provisions
requiring compliance with all of the requirements of the Federal Caustic
Poison Act and all regulations and instructions issued thereunder. The
notice will also state the officer to be notified by the importer when
the containers are ready for inspection.
(b) The importer must return the notice to the District Director of
Customs or chief of district, as designated, with the certificate
thereon filled out, stating that he has complied with the prescribed
conditions and that the containers are ready for inspection at the place
named.
(c) This notice will be delivered to the inspection officer, who,
after inspection, will endorse the result thereof on the back of the
notice and return the same to the District Director of Customs or to the
chief of district, as the case may be.
(d) When the conditions to be complied with are under the supervision
of the chief of district, and these conditions have been fully met, he
shall release the containers to the importer, sending a copy of the
notice of release to the District Director of Customs for his
information. If the containers have not been properly relabeled within
the period allowed, the chief of district shall immediately give notice
in duplicate to the District Director of Customs of the results of
inspection. The District Director of Customs shall sign and immediately
transmit one copy of the notice to the importer and proceed in the usual
manner.
(e) If the containers are detained subject to relabeling to be
performed under the supervision of the District Director of Customs, the
District Director of Customs, as soon as relabeling is accomplished,
will notify the importer that the containers are released.
(f) If the containers have not been properly relabeled within the
period allowed, their sale after labeling as required by the act or
other disposition must be effected by the District Director of Customs.
(g) When the final action has been taken on containers which have
been refused admission, sold, or otherwise disposed of as provided for
by the act or which have been relabeled under the supervision of the
District Director of Customs, he shall send to the chief of district a
notice of such final action, giving the date and disposition.
(h) When relabeling is allowed the importer must furnish satisfactory
evidence as to the identity of the containers before release is given.
The relabeling must be done at a stated place and apart from other
containers of a similar nature.
(i) When containers are shipped to another port for relabeling or
exportation, they must be shipped under customs carrier's manifest, in
the same manner as shipments in bond.
(j) District Directors of Customs will perform the inspection service
whenever containers are to be exported, sold, or otherwise disposed of,
and in other cases when there is no officer of the district available.
(k) District Directors of Customs and representatives of the district
will confer and arrange the apportionment of the inspection service
according to local conditions. Officers of the district will, whenever
feasible, perform the inspection service in connection with relabeling.
21 CFR 1230.49 Penalties.
(a) In case of failure to comply with the instructions or
recommendations of the chief of district as to conditions under which
containers may be disposed of, the District Director of Customs shall
notify the chief of district in all cases coming to his attention within
3 days after inspection or after the expiration of the 3 months allowed
by law if no action is taken.
(b) The chief of district, upon receipt of the above-described
notice, and in all cases of failure to meet the conditions imposed in
order to comply with the provisions of the Federal Caustic Poison Act
coming directly under his supervision, shall transmit to the District
Director of Customs such evidence as he may have at hand tending to
indicate the importer's liability and make a recommendation accordingly.
(c) The District Director of Customs, within 3 days of the receipt of
this recommendation, whether favorable or otherwise, shall notify the
importer that, the legal period of 3 months for exportation or
relabeling having expired, action will be taken within 30 days to
enforce the terms of the bond.
21 CFR 1230.49 PART 1240 -- CONTROL OF COMMUNICABLE DISEASES
21 CFR 1230.49 Subpart A -- General Provisions
Sec.
1240.3 General definitions.
1240.10 Effective bactericidal treatment.
21 CFR 1230.49 Subpart B -- Administrative Procedures
1240.20 Issuance and posting of certificates following inspections.
1240.30 Measures in the event of inadequate local control.
21 CFR 1230.49 Subpart C -- Restrictions on Travel of Persons
1240.40 All communicable diseases.
1240.45 Report of disease.
1240.50 Certain communicable diseases; special requirements.
1240.54 Apprehension and detention of persons with specific diseases.
1240.55 Responsibility with respect to minors, wards, and patients.
1240.57 Members of military and naval forces.
21 CFR 1230.49 Subpart D -- Specific Administrative Decisions Regarding
Interstate Shipments
1240.60 Shellfish.
1240.61 Mandatory pasteurization for all milk and milk products in
final package form intended for direct human consumption.
1240.62 Turtles intrastate and interstate requirements.
1240.65 Psittacine birds.
1240.70 Lather brushes.
1240.75 Garbage.
21 CFR 1230.49 Subpart E -- Source and Use of Potable Water
1240.80 General requirements for water for drinking and culinary
purposes.
1240.83 Approval of watering points.
1240.86 Protection of pier water system.
1240.90 Approval of treatment aboard conveyances.
1240.95 Sanitation of water boats.
Authority: Secs. 215, 311, 361, 368 of the Public Health Service Act
(42 U.S.C. 216, 243, 264, 271).
Source: 40 FR 5620, Feb. 6, 1975, unless otherwise noted.
Cross-References: For Department of Health and Human Services
regulations relating to foreign quarantine, sanitation measures, and
control of communicable diseases, see Centers for Disease Control's
requirements as set forth in 42 CFR Parts 71 and 72.
21 CFR 1230.49 Subpart A -- General Provisions
21 CFR 1240.3 General definitions.
As used in this part, terms shall have the following meaning:
(a) Bactericidal treatment. The application of a method or substance
for the destruction of pathogens and other organisms as set forth in
1240.10.
(b) Communicable diseases. Illnesses due to infectious agents or
their toxic products, which may be transmitted from a reservoir to a
susceptible host either directly as from an infected person or animal or
indirectly through the agency of an intermediate plant or animal host,
vector, or the inanimate environment.
(c) Communicable period. The period or periods during which the
etiologic agent may be transferred directly or indirectly from the body
of the infected person or animal to the body of another.
(d) Contamination. The presence of a certain amount of undesirable
substance or material, which may contain pathogenic microorganisms.
(e) Conveyance. Conveyance means any land or air carrier, or any
vessel as defined in paragraph (n) of this section.
(f) Garbage. (1) The solid animal and vegetable waste, together with
the natural moisture content, resulting from the handling, preparation,
or consumption of foods in houses, restaurants, hotels, kitchens, and
similar establishments, or (2) any other food waste containing pork.
(g) Incubation period. The period between the implanting of disease
organisms in a susceptible person and the appearance of clinical
manifestation of the disease.
(h) Interstate traffic. (1) The movement of any conveyance or the
transportation of persons or property, including any portion of such
movement or transportation which is entirely within a State or
possession,
(i) From a point of origin in any State or possession to a point of
destination in any other State or possession, or
(ii) Between a point of origin and a point of destination in the same
State or possession but through any other State, possession, or
contiguous foreign country.
(2) Interstate traffic does not include the following:
(i) The movement of any conveyance which is solely for the purpose of
unloading persons or property transported from a foreign country, or
loading persons or property for transportation to a foreign country.
(ii) The movement of any conveyance which is solely for the purpose
of effecting its repair, reconstruction, rehabilitation, or storage.
(i) Minimum heat treatment. The causing of all particles in garbage
to be heated to a boiling temperature and held at that temperature for a
period of not less than 30 minutes.
(j) Possession. Any of the possessions of the United States,
including Puerto Rico and the Virgin Islands.
(k) Potable water. Water which meets the standards prescribed in the
Environmental Protection Agency's Primary Drinking Water Regulations as
set forth in 40 CFR Part 141 and the Food and Drug Administration's
sanitation requirements as set forth in this part and Part 1250 of this
chapter.
(l) State. Any State, the District of Columbia, Puerto Rico and the
Virgin Islands.
(m) Utensil. Includes any kitchenware, tableware, glassware,
cutlery, containers, or equipment with which food or drink comes in
contact during storage, preparation, or serving.
(n) Vessel. Any passenger-carrying, cargo, or towing vessel
exclusive of:
(1) Fishing boats including those used for shell-fishing;
(2) Tugs which operate only locally in specific harbors and adjacent
waters;
(3) Barges without means of self-propulsion;
(4) Construction-equipment boats and dredges; and
(5) Sand and gravel dredging and handling boats.
(o) Watering point. The specific place or water boat from which
potable water is loaded on a conveyance.
(p) Shellfish. Any fresh, frozen, or incompletely cooked oysters,
clams, or mussels, either shucked or in the shell, and any fresh,
frozen, or incompletely cooked edible products thereof.
(40 FR 5620, Feb. 6, 1975, as amended at 48 FR 11431, Mar. 18, 1983)
21 CFR 1240.10 Effective bactericidal treatment.
Whenever, under the provisions of this part, bactericidal treatment
is required, it shall be accomplished by one or more of the following
methods:
(a) By immersion of the utensil or equipment for at least 2 minutes
in clean hot water at a temperature of at least 170 F or for one-half
minute in boiling water;
(b) By immersion of the utensil or equipment for at least 2 minutes
in a lukewarm chlorine bath containing at least 50 ppm of available
chlorine if hypochlorites are used or a concentration of equal
bactericidal strength if chloramines are used;
(c) By exposure of the utensil or equipment in a steam cabinet at a
temperature of at least 170 F for at least 15 minutes or at a
temperature of 200 F for at least 5 minutes;
(d) By exposure of the utensil or equipment in an oven or hot air
cabinet at a temperature of at least 180 F for at least 20 minutes;
(e) In the case of utensils or equipment so designed or installed as
to make immersion or exposure impractical, the equipment may be treated
for the prescribed periods of time either at the temperatures or with
chlorine solutions as specified above, (1) with live steam from a hose
if the steam can be confined, (2) with boiling rinse water, or (3) by
spraying or swabbing with chlorine solution;
(f) Any other method determined by the Commissioner of Food and
Drugs, upon application of an owner or operator of a conveyance, to be
effective to prevent the spread of communicable disease.
(40 FR 5620, Feb. 6, 1975, as amended at 54 FR 24900, June 12, 1989)
21 CFR 1240.10 Subpart B -- Administrative Procedures
21 CFR 1240.20 Issuance and posting of certificates following
inspections.
The Commissioner of Food and Drugs may issue certificates based upon
inspections provided for in this part and Part 1250. Such certificates
shall be prominently posted on conveyances.
(40 FR 5620, Feb. 6, 1975, as amended at 48 FR 11431, Mar. 18, 1983)
21 CFR 1240.30 Measures in the event of inadequate local control.
Whenever the Commissioner of Food and Drugs determines that the
measures taken by health authorities of any State or possession
(including political subdivisions thereof) are insufficient to prevent
the spread of any of the communicable diseases from such State or
possession to any other State or possession, he may take such measures
to prevent such spread of the diseases as he deems reasonably necessary,
including inspection, fumigation, disinfection, sanitation, pest
extermination, and destruction of animals or articles believed to be
sources of infection.
(40 FR 5620, Feb. 6, 1975, as amended at 48 FR 11431, Mar. 18, 1983)
21 CFR 1240.30 Subpart C -- Restrictions on Travel of Persons
21 CFR 1240.40 All communicable diseases.
A person who has a communicable disease in the communicable period
shall not travel from one State or possession to another without a
permit from the health officer of the State, possession, or locality of
destination, if such permit is required under the law applicable to the
place of destination. Stop-overs other than those necessary for
transportation connections shall be considered as places of destination.
21 CFR 1240.45 Report of disease.
The master of any vessel or person in charge of any conveyance
engaged in interstate traffic, on which a case or suspected case of a
communicable disease develops shall, as soon as practicable, notify the
local health authority at the next port of call, station, or stop, and
shall take such measures to prevent the spread of the disease as the
local health authority directs.
21 CFR 1240.50 Certain communicable diseases; special requirements.
The following provisions are applicable with respect to any person
who is in the communicable period of cholera, plague, smallpox, typhus
or yellow fever, or who, having been exposed to any such disease, is in
the incubation period thereof:
(a) Requirements relating to travelers. (1) No such person shall
travel from one State or possession to another, or on a conveyance
engaged in interstate traffic, without a written permit of the Surgeon
General or his authorized representative.
(2) Application for a permit may be made directly to the Surgeon
General or to his representative authorized to issue permits.
(3) Upon receipt of an application, the Surgeon General or his
authorized representative shall, taking into consideration the risk of
introduction, transmission, or spread of the disease from one State or
possession to another, reject it, or issue a permit which may be
conditioned upon compliance with such precautionary measures as he shall
prescribe.
(4) A person to whom a permit has been issued shall retain it in his
possession throughout the course of his authorized travel and comply
with all conditions prescribed therein, including presentation of the
permit to the operators of conveyances as required by its terms.
(b) Requirements relating to operation of conveyances. (1) The
operator of any conveyance engaged in interstate traffic shall not
knowingly (i) accept for transportation any person who fails to present
a permit as required by paragraph (a) of this section, or (ii) transport
any person in violation of conditions prescribed in his permit.
(2) Whenever a person subject to the provisions of this section is
transported on a conveyance engaged in interstate traffic, the operator
thereof shall take such measures to prevent the spread of the disease,
including submission of the conveyance to inspection, disinfection and
the like, as an officer of the Public Health Service designated by the
Surgeon General for such purposes deems reasonably necessary and
directs.
21 CFR 1240.54 Apprehension and detention of persons with specific
diseases.
Regulations prescribed in Parts 1240 and 1250 are not applicable to
the apprehension, detention, or conditional release of individuals
except for the purpose of preventing the introduction, transmission, or
spread of the following diseases: Anthrax, chancroid, cholera, dengue,
diphtheria, granuloma inguinale, infectious encephalitis, favus,
gonorrhea, leprosy, lymphogranuloma venereum, meningococcus meningitis,
plague, poliomyelitis, psittacosis, relapsing fever, ringworm of the
scalp, scarlet fever, streptococcic sore throat, smallpox, syphilis,
trachoma, tuberculosis, typhoid fever, typhus, and yellow fever.
21 CFR 1240.55 Responsibility with respect to minors, wards, and
patients.
A parent, guardian, physican, nurse, or other such person shall not
transport, or procure or furnish transportation for any minor child or
ward, patient or other such person who is in the communicable period of
a communicable disease, except in accordance with provisions of this
subpart.
21 CFR 1240.57 Members of military and naval forces.
The provisions of 1240.40, 1240.45, 1240.50, 1240.55 and 1240.57
shall not apply to members of the military or naval forces, and medical
care or hospital beneficiaries of the Army, Navy, Veterans'
Administration, or Public Health Service, when traveling under competent
orders: Provided, That in the case of persons otherwise subject to the
provisions of 1240.50 the authority authorizing the travel requires
precautions to prevent the possible transmission of infection to others
during the travel period.
21 CFR 1240.57 Subpart D -- Specific Administrative Decisions Regarding Interstate Shipments
21 CFR 1240.60 Shellfish.
A person shall not offer for transportation, or transport, in
interstate traffic any shellfish handled or stored in such an insanitary
manner, or grown in an area so contaminated, as to render such shellfish
likely to become agents in, and their transportation likely to
contribute to the spread of communicable disease from one State or
possession to another.
21 CFR 1240.61 Mandatory pasteurization for all milk and milk products
in final package form intended for direct human consumption.
(a) No person shall cause to be delivered into interstate commerce or
shall sell, otherwise distribute, or hold for sale or other distribution
after shipment in interstate commerce any milk or milk product in final
package form for direct human consumption that has not been pasteurized
except where alternative procedures are provided by regulation, such as
Part 133 of this chapter for curing of certain cheese varieties.
(b) Except as provided in paragraphs (c) and (d) of this section, the
terms ''pasteurization,'' ''pasteurized,'' and similar terms shall mean
the process of heating every particle of milk and milk product in
properly designed and operated equipment to one of the temperatures
given in the following table and held continuously at or above that
temperature for at least the corresponding specified time:
(c) Eggnog shall be heated to at least the following temperature and
time specification:
(d) Neither paragraph (b) nor (c) of this section shall be construed
as barring any other pasteurization process that has been recognized by
the Food and Drug Administration to be equally efficient in the
destruction of microbial organisms of public health significance.
(52 FR 29514, Aug. 10, 1987)
21 CFR 1240.62 Turtles intrastate and interstate requirements.
(a) Definition. As used in this section the term ''turtles''
includes all animals commonly known as turtles, tortoises, terrapins,
and all other animals of the order Testudinata, class Reptilia, except
marine species (families Dermachelidae and Chelonidae).
(b) Sales; general prohibition. Except as otherwise provided in
this section, viable turtle eggs and live turtles with a carapace length
of less than 4 inches shall not be sold, held for sale, or offered for
any other type of commercial or public distribution.
(c) Destruction of turtles or turtle eggs; criminal penalties. (1)
Any viable turtle eggs or live turtles with a carapace length of less
than 4 inches which are held for sale or offered for any other type of
commercial or public distribution shall be subject to destruction in a
humane manner by or under the supervision of an officer or employee of
the Food and Drug Administration in accordance with the following
procedures:
(i) Any District Office of the Food and Drug Administration, upon
detecting viable turtle eggs or live turtles with a carapace length of
less than 4 inches which are held for sale or offered for any other type
of commercial or public distribution, shall serve upon the person in
whose possession such turtles or turtle eggs are found a written demand
that such turtles or turtle eggs be destroyed in a humane manner under
the supervision of said District Office, within 10 working days from the
date of promulgation of the demand. The demand shall recite with
particularity the facts which justify the demand. After service of the
demand, the person in possession of the turtles or turtle eggs shall not
sell, distribute, or otherwise dispose of any of the turtles or turtle
eggs except to destroy them under the supervision of the District
Office, unless and until the Director of the Center for Food Safety and
Applied Nutrition withdraws the demand for destruction after an appeal
pursuant to paragraph (c)(1)(ii) of this section.
(ii) The person on whom the demand for destruction is served may
either comply with the demand or, within 10 working days from the date
of its promulgation, appeal the demand for destruction to the Director
of the Center for Food Safety and Applied Nutrition, Food and Drug
Administration, 200 C St. SW., Washington, DC 20204. The demand for
destruction may also be appealed within the same period of 10 working
days by any other person having a pecuniary interest in such turtles or
turtle eggs. In the event of such an appeal, the Center Director shall
provide an opportunity for hearing by written notice to the appellant(s)
specifying a time and place for the hearing, to be held within 14 days
from the date of the notice but not within less than 7 days unless by
agreement with the appellant(s).
(iii) Appearance by any appellant at the hearing may be by mail or in
person, with or without counsel. The hearing shall be conducted by the
Center Director or his designee, and a written summary of the
proceedings shall be prepared by the person presiding. Any appellant
shall have the right to hear and to question the evidence on which the
demand for destruction is based, including the right to cross-examine
witnesses, and he may present oral or written evidence in response to
the demand.
(iv) If, based on the evidence presented at the hearing, the Center
Director finds that the turtles or turtle eggs were held for sale or
offered for any other type of commercial or public distribution in
violation of this section, he shall affirm the demand that they be
destroyed under the supervision of an officer or employee of the Food
and Drug Administration; otherwise, the Center Director shall issue a
written notice that the prior demand by the District Office is
withdrawn. If the Center Director affirms the demand for destruction he
shall order that the destruction be accomplished in a humane manner
within 10 working days from the date of the promulgation of his
decision. The Center Director's decision shall be accompanied by a
statement of the reasons for the decision. The decision of the Center
Director shall constitute final agency action, reviewable in the courts.
(v) If there is no appeal to the Director of the Center for Food
Safety and Applied Nutrition from the demand by the Food and Drug
Administration District Office and the person in possession of the
turtles or turtle eggs fails to destroy them within 10 working days, or
if the demand is affirmed by the Director of the Center for Food Safety
and Applied Nutrition after an appeal and the person in possession of
the turtles or turtle eggs fails to destroy them within 10 working days,
the District Office shall designate an officer or employee to destroy
the turtles or turtle eggs. It shall be unlawful to prevent or to
attempt to prevent such destruction of turtles or turtle eggs by the
officer or employee designated by the District Office. Such destruction
will be stayed if so ordered by a court pursuant to an action for review
in the courts as provided in paragraph (c)(1)(iv) of this section.
(2) Any person who violates any provision of this section, including
but not limited to any person who sells, offers for sale, or offers for
any other type of commercial or public distribution viable turtle eggs
or live turtles with a carapace length of less than 4 inches, or who
refuses to comply with a valid final demand for destruction of turtles
or turtle eggs (either an unappealed demand by an FDA District Office or
a demand which has been affirmed by the Director of the Center for Food
Safety and Applied Nutrition pursuant to appeal), or who fails to comply
with the requirement in such a demand that the manner of destruction be
humane, shall be subject to a fine of not more than $1,000 or
imprisonment for not more than 1 year, or both, for each violation, in
accordance with section 368 of the Public Health Service Act (42 U.S.C.
271).
(d) Exceptions. The provisions of this section are not applicable
to:
(1) The sale, holding for sale, and distribution of live turtles and
viable turtle eggs for bona fide scientific, educational, or
exhibitional purposes, other than use as pets.
(2) The sale, holding for sale, and distribution of live turtles and
viable turtle eggs not in connection with a business.
(3) The sale, holding for sale, and distribution of live turtles and
viable turtle eggs intended for export only, provided that the outside
of the shipping package is conspicuously labeled ''For Export Only.''
(4) Marine turtles excluded from this regulation under the provisions
of paragraph (a) of this section and eggs of such turtles.
(e) Petitions. The Commissioner of Food and Drugs, either on his own
initiative or on behalf of any interested person who has submitted a
petition, may publish a proposal to amend this regulation. Any such
petition shall include an adequate factual basis to support the
petition, and will be published for comment if it contains reasonable
grounds for the proposed regulation. A petition requesting such a
regulation, which would amend this regulation, shall be submitted to the
Dockets Management Branch, Food and Drug Administration, Room 4-62,
Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857.
(40 FR 22545, May 23, 1975, as amended at 46 FR 8461, Jan. 27, 1981;
48 FR 11431, Mar. 18, 1983; 54 FR 24900, June 12, 1989)
21 CFR 1240.65 Psittacine birds.
(a) The term psittacine birds shall include all birds commonly known
as parrots, Amazons, Mexican double heads, African grays, cocatoos,
macaws, parakeets, love birds, lories, lorikeets, and all other birds of
the psittacine family.
(b) No person shall transport, or offer for transportation, in
interstate traffic any psittacine bird unless the shipment is
accompanied by a permit from the State health department of the State of
destination where required by such department.
(c) Whenever the Surgeon General finds that psittacine birds or human
beings in any area are infected with psittacosis and there is such
danger of transmission of psittacosis from such area as to endanger the
public health, he may declare it an area of infection. No person shall
thereafter transport, or offer for transportation, in interstate traffic
any psittacine bird from such area, except shipments authorized by the
Surgeon General for purposes of medical research and accompanied by a
permit issued by him, until the Surgeon General finds that there is no
longer any danger of transmission of psittacosis from such area. As
used in this paragraph, the term ''area'' includes, but is not limited
to, specific premises or buildings.
21 CFR 1240.70 Lather brushes.
(a) General requirements. A person shall not transport, or offer for
transportation by the owner or operator of a conveyance, nor shall the
owner or operator of a conveyance knowingly transport for another
person, in interstate traffic lather brushes made from animal hair or
bristles unless such brushes have been manufactured in the United
States, its territories, or possessions in compliance with the
provisions of paragraphs (b), (c), (d), (e), and (f) of this section.
(b) Treatment. The hair or bristles used in such brushes, if other
than badger hair, shall be subjected to sterilization or to a treatment
found by the Surgeon General, upon application of an interested person
and the submission by such person of supporting data, to be effective to
destroy anthrax spores in the hair or bristles to be treated. Badger
hair shall be subject to the requirement of sterilization or other
treatment only if the Surgeon General finds, and so notifies the
manufacturer, that the hair was secured from areas, or has been stored
or handled under circumstances, likely to render it an agent in the
spread of communicable diseases from one State or possession to another.
(c) Sterilization. Sterilization shall consist of:
(1) Exposure to steam under pressure in an autoclave at a minimum
temperature of 120 C (248 F) for 15 minutes for bristles and 20
minutes for hair; or
(2) Exposure to streaming steam in an autoclave (not under pressure)
at 100 C (212 F) for 30 minutes for bristles and 40 minutes for hair.
In either case, the steam temperature shall be measured in the
exhaust line at its exit from the autoclave by an indicating thermometer
found by the Surgeon General to give reasonable assurance of accuracy,
and by a recording thermometer adjusted to read no higher at any time
than the indicating thermometer. The time of exposure shall be measured
from the moment at which the indicating thermometer reaches the
specified sterilization temperature. Recording thermometer charts for
each sterilization shall be kept readily available. The hair or
bristles shall be sterilized in tied or wrapped bundles not exceeding 2
1/2 inches in diameter and 5 inches in length, or in untied and
unwrapped lots not exceeding 2 1/2 inches in depth. The bundle or lots
shall be placed on racks or trays in single layers, with the racks or
trays separated from each other sufficiently to assure free circulation
of the steam and the exposure of all the hair or bristles to such steam.
If the hair or bristles are placed in the autoclave in wrapped bundles,
the ends of the bundles shall be left open.
(d) Handling and storage. Hair or bristles which have been treated,
by sterilization or otherwise, shall be marked with the date of
treatment, the method used, and name and location of the establishment
at which treatment occurred, and shall be so handled and stored as to
prevent their contamination or recontamination with anthrax spores.
(e) Identifying marks. Lather brushes shall be marked permanently
with the name of the manufacturer or with an identifying mark of the
manufacturer registered with the Surgeon General.
(f) Inspection. Persons engaged in processing or other handling of
hair or bristles for use in lather brushes manufactured for
transportation in interstate traffic and persons engaged in
manufacturing such lather brushes from hair or bristles shall permit
authorized representatives of the Surgeon General to make at any
reasonable time such inspection of the plants or other places, including
the equipment, operations, and products thereof, at which such
manufacturing, processing or handling is carried on as may be necessary
in the judgment of such representatives to determine compliance with the
provisions of this section.
(40 FR 5620, Feb. 6, 1975, as amended at 54 FR 24900, June 12, 1989)
21 CFR 1240.75 Garbage.
(a) A person shall not transport, receive, or cause to be transported
or received, garbage in interstate traffic and feed such garbage to
swine unless, prior to the feeding, such garbage has received minimum
heat treatment.
(b) A person transporting garbage in interstate traffic shall not
make, or agree to make, delivery thereof to any person with knowledge of
the intent or customary practice of such person to feed to swine garbage
which has not been subjected to minimum heat treatment.
21 CFR 1240.75 Subpart E -- Source and Use of Potable Water
21 CFR 1240.80 General requirements for water for drinking and culinary
purposes.
Only potable water shall be provided for drinking and culinary
purposes by any operator of a conveyance engaged in interstate traffic,
except as provided in 1250.84(b) of this chapter. Such water shall
either have been obtained from watering points approved by the
Commissioner of Food and Drugs, or, if treated aboard a conveyance,
shall have been subjected to treatment approved by the Commissioner of
Food and Drugs.
(40 FR 5620, Feb. 6, 1975, as amended at 48 FR 11431, Mar. 18, 1983)
21 CFR 1240.83 Approval of watering points.
(a) The Commissioner of Food and Drugs shall approve any watering
point if (1) the water supply thereat meets the standards prescribed in
the Environmental Protection Agency's Primary Drinking Water Regulations
as set forth in 40 CFR Part 141, and (2) the methods of and facilities
for delivery of such water to the conveyance and the sanitary conditions
surrounding such delivery prevent the introduction, transmission, or
spread of communicable diseases.
(b) The Commissioner of Food and Drugs may base his approval or
disapproval of a watering point upon investigations made by
representatives of State departments of health or of the health
authorities of contiguous foreign nations.
(c) If a watering point has not been approved, the Commissioner of
Food and Drugs may permit its temporary use under such conditions as, in
his judgment, are necessary to prevent the introduction, transmission,
or spread of communicable diseases.
(d) Upon request of the Commissioner of Food and Drugs, operators of
conveyances shall provide information as to watering points used by
them.
(40 FR 5620, Feb. 6, 1975, as amended at 48 FR 11431, Mar. 18, 1983;
48 FR 13978, Apr. 1, 1983)
21 CFR 1240.86 Protection of pier water system.
No vessel engaged in interstate traffic shall make a connection
between its nonpotable water system and any pier potable water system
unless provisions are made to prevent backflow from the vessel to the
pier.
21 CFR 1240.90 Approval of treatment aboard conveyances.
(a) The treatment of water aboard conveyances shall be approved by
the Commissioner of Food and Drugs if the apparatus used is of such
design and is so operated as to be capable of producing and in fact does
produce, potable water.
(b) The Commissioner of Food and Drugs may base his approval or
disapproval of the treatment of water upon investigations made by
representatives of State departments of health or of the health
authorities of contiguous foreign nations.
(c) Overboard water treated on vessels shall be from areas relatively
free of contamination and pollution.
(40 FR 5620, Feb. 6, 1975, as amended at 48 FR 11431, Mar. 18, 1983)
21 CFR 1240.95 Sanitation of water boats.
No vessel engaged in interstate traffic shall obtain water for
drinking and culinary purposes from any water boat unless the tanks,
piping, and other appurtenances used by the water boat in the loading,
transportation, and delivery of such drinking and culinary water, have
been approved by the Commissioner of Food and Drugs.
(40 FR 5620, Feb. 6, 1975, as amended at 48 FR 11431, Mar. 18, 1983)
21 CFR 1240.95 PART 1250 -- INTERSTATE CONVEYANCE SANITATION
21 CFR 1240.95 Subpart A -- General Provisions
Sec.
1250.3 Definitions.
21 CFR 1240.95 Subpart B -- Food Service Sanitation on Land and Air
Conveyances, and Vessels
1250.20 Applicability.
1250.21 Inspection.
1250.22 General requirements.
1250.25 Source identification and inspection of food and drink.
1250.26 Special food requirements.
1250.27 Storage of perishables.
1250.28 Source and handling of ice.
1250.30 Construction, maintenance and use of places where food is
prepared, served, or stored.
1250.32 Food-handling operations.
1250.33 Utensils and equipment.
1250.34 Refrigeration equipment.
1250.35 Health of persons handling food.
1250.38 Toilet and lavatory facilities for use of food-handling
employees.
1250.39 Garbage equipment and disposition.
21 CFR 1240.95 Subpart C -- Equipment and Operation of Land and Air
Conveyances
1250.40 Applicability.
1250.41 Submittal of construction plans.
1250.42 Water systems; constant temperature bottles.
1250.43 Ice.
1250.44 Drinking utensils and toilet articles.
1250.45 Food handling facilities on railroad conveyances.
1250.49 Cleanliness of conveyances.
1250.50 Toilet and lavatory facilities.
1250.51 Railroad conveyances; discharge of wastes.
1250.52 Discharge of wastes on highway conveyances.
1250.53 Discharge of wastes on air conveyances.
21 CFR 1240.95 Subpart D -- Servicing Areas for Land and Air
Conveyances
1250.60 Applicability.
1250.61 Inspection and approval.
1250.62 Submittal of construction plans.
1250.63 General requirements.
1250.65 Drainage.
1250.67 Watering equipment.
1250.70 Employee conveniences.
1250.75 Disposal of human wastes.
1250.79 Garbage disposal.
21 CFR 1240.95 Subpart E -- Sanitation Facilities and Conditions on
Vessels
1250.80 Applicability.
1250.81 Inspection.
1250.82 Potable water systems.
1250.83 Storage of water prior to treatment.
1250.84 Water in galleys and medical care spaces.
1250.85 Drinking fountains and coolers; ice; constant temperature
bottles.
1250.86 Water for making ice.
1250.87 Wash water.
1250.89 Swimming pools.
1250.90 Toilets and lavatories.
1250.93 Discharge of wastes.
1250.95 Insect control.
1250.96 Rodent control.
Authority: Secs. 215, 311, 361, 368 of the Public Health Service Act
(42 U.S.C. 216, 243, 264, 271).
Source: 40 FR 5624, Feb. 6, 1975, unless otherwise noted.
Cross-References: For Department of Health and Human Services
regulations relating to foreign quarantine and control of communicable
diseases, see Centers for Disease Control's requirements as set forth in
42 CFR Parts 71 and 72.
21 CFR 1240.95 Subpart A -- General Provisions
21 CFR 1250.3 Definitions.
As used in this part, terms shall have the following meaning:
(a) Bactericidal treatment. The application of a method or substance
for the destruction of pathogens and other organisms as set forth in
1240.10 of this chapter.
(b) Communicable diseases. Illnesses due to infectious agents or
their toxic products, which may be transmitted from a reservoir to a
susceptible host either directly as from an infected person or animal or
indirectly through the agency of an intermediate plant or animal host,
vector, or the inanimate environment.
(c) Communicable period. The period or periods during which the
etiologic agent may be transferred directly or indirectly from the body
of the infected person or animal to the body of another.
(d) Contamination. The presence of a certain amount of undesirable
substance or material, which may contain pathogenic microorganisms.
(e) Conveyance. Conveyance means any land or air carrier, or any
vessel as defined in paragraph (m) of this section.
(f) Existing vessel. Any vessel the construction of which was
started prior to the effective date of the regulations in this part.
(g) Garbage. (1) The solid animal and vegetable waste, together with
the natural moisture content, resulting from the handling, preparation,
or consumption of foods in houses, restaurants, hotels, kitchens, and
similar establishments, or (2) any other food waste containing pork.
(h) Interstate traffic. (1) The movement of any conveyance or the
transportation of persons or property, including any portion of such
movement or transportation which is entirely within a State or
possession, (i) from a point of origin in any State or possession to a
point of destination in any other State or possession, or (ii) between a
point of origin and a point of destination in the same State or
possession but through any other State, possession, or contiguous
foreign country.
(2) Interstate traffic does not include the following:
(i) The movement of any conveyance which is solely for the purpose of
unloading persons or property transported from a foreign country, or
loading persons or property for transportation to a foreign country.
(ii) The movement of any conveyance which is solely for the purpose
of effecting its repair, reconstruction, rehabilitation, or storage.
(i) Possession. Any of the possessions of the United States,
including Puerto Rico and the Virgin Islands.
(j) Potable water. Water which meets the standards prescribed in the
Environmental Protection Agency's Primary Drinking Water Regulations as
set forth in 40 CFR Part 141 and the Food and Drug Administration's
sanitation regulations as set forth in this part and Part 1240 of this
chapter.
(k) State. Any State, the District of Columbia, Puerto Rico and the
Virgin Islands.
(l) Utensil. Includes any kitchenware, tableware, glassware,
cutlery, containers, or equipment with which food or drink comes in
contact during storage, preparation, or serving.
(m) Vessel. Any passenger-carrying, cargo, or towing vessel
exclusive of:
(1) Fishing boats including those used for shell-fishing;
(2) Tugs which operate only locally in specific harbors and adjacent
waters;
(3) Barges without means of self-propulsion;
(4) Construction-equipment boats and dredges; and
(5) Sand and gravel dredging and handling boats.
(n) Wash water. Water suitable for domestic uses other than for
drinking and culinary purposes, and medical care purposes excluding
hydrotherapy.
(o) Shellfish. Any fresh, frozen, or incompletely cooked oysters,
clams, or mussels, either shucked or in the shell, and any fresh,
frozen, or incompletely cooked edible products thereof.
(40 FR 5624, Feb. 6, 1975, as amended at 48 FR 11432, Mar. 18, 1983)
21 CFR 1250.3 Subpart B -- Food Service Sanitation on Land and Air Conveyances, and Vessels
21 CFR 1250.20 Applicability.
All conveyances engaged in interstate traffic shall comply with the
requirements prescribed in this subpart and 1240.20 of this chapter.
21 CFR 1250.21 Inspection.
The Commissioner of Food and Drugs may inspect such conveyance to
determine compliance with the requirements of this subpart and 1240.20
of this chapter.
(40 FR 5624, Feb. 6, 1975, as amended at 48 FR 11432, Mar. 18, 1983)
21 CFR 1250.22 General requirements.
All food and drink served on conveyances shall be clean, wholesome,
and free from spoilage, and shall be prepared, stored, handled, and
served in accordance with the requirements prescribed in this subpart
and 1240.20 of this chapter.
21 CFR 1250.25 Source identification and inspection of food and drink.
(a) Operators of conveyances shall identify, when requested by the
Commissioner of Food and Drugs, the vendors, distributors or dealers
from whom they have acquired or are acquiring their food supply,
including milk, fluid milk products, ice cream and other frozen
desserts, butter, cheese, bottled water, sandwiches and box lunches.
(b) The Commissioner of Food and Drugs may inspect any source of such
food supply in order to determine whether the requirements of the
regulations in this subpart and in 1240.20 of this chapter are being
met, and may utilize the results of inspections of such sources made by
representatives of State health departments or of the health authorities
of contiguous foreign nations.
(40 FR 5624, Feb. 6, 1975, as amended at 48 FR 11432, Mar. 18, 1983)
21 CFR 1250.26 Special food requirements.
Milk, fluid milk products, ice cream and other frozen desserts,
butter, cheese, and shellfish served or sold on conveyances shall
conform to the following requirements:
(a) Milk and fluid milk products, including cream, buttermilk, skim
milk, milk beverages, and reconstituted milk, shall be pasteurized and
obtained from a source of supply approved by the Commissioner of Food
and Drugs. The Commissioner of Food and Drugs shall approve any source
of supply at or from which milk or fluid milk products are produced,
processed, and distributed so as to prevent the introduction,
transmission, or spread of communicable diseases. If a source of supply
of milk or fluid milk products has not been approved, the Commissioner
of Food and Drugs may permit its temporary use under such conditions as,
in his judgment, are necessary to prevent the introduction,
transmission, or spread of communicable diseases. Containers of milk
and fluid milk products shall be plainly labeled to show the contents,
the word ''pasteurized'', and the identity of the plant at which the
contents were packaged by name and address, provided that a code may be
used in lieu of address.
(b) Ice cream, other frozen desserts, and butter shall be
manufactured from milk or milk products that have been pasteurized or
subjected to equivalent heat treatment.
(c) Cheese shall be (1) pasteurized or subjected to equivalent heat
treatment, (2) made from pasteurized milk products or from milk products
which have been subjected to equivalent heat treatment, or (3) cured for
not less than 60 days at a temperature not less than 35 F.
(d) Milk, buttermilk, and milk beverages shall be served in or from
the original individual containers in which received from the
distributor, or from a bulk container equipped with a dispensing device
so designed, constructed, installed, and maintained as to prevent the
transmission of communicable diseases.
(e) Shellfish purchased for consumption on any conveyance shall
originate from a dealer currently listed by the Public Health Service as
holding an unexpired and unrevoked certificate issued by a State
authority.
(f) Shucked shellfish shall be purchased in the containers in which
they are placed at the shucking plant and shall be kept therein until
used. The State abbreviation and the certificate number of the packers
shall be permanently recorded on the container.
(40 FR 5624, Feb. 6, 1975, as amended at 48 FR 11432, Mar. 18, 1983)
21 CFR 1250.27 Storage of perishables.
All perishable food or drink shall be kept at or below 50 F, except
when being prepared or kept hot for serving.
21 CFR 1250.28 Source and handling of ice.
Ice coming in contact with food or drink and not manufactured on the
conveyance shall be obtained from sources approved by competent health
authorities. All ice coming in contact with food or drink shall be
stored and handled in such manner as to avoid contamination.
21 CFR 1250.30 Construction, maintenance and use of places where food
is prepared, served, or stored.
(a) All kitchens, galleys, pantries, and other places where food is
prepared, served, or stored shall be adequately lighted and ventilated:
Provided, however, That ventilation of cold storage rooms shall not be
required. All such places where food is prepared, served, or stored
shall be so constructed and maintained as to be clean and free from
flies, rodents, and other vermin.
(b) Such places shall not be used for sleeping or living quarters.
(c) Water of satisfactory sanitary quality, under head or pressure,
and adequate in amount and temperature, shall be easily accessible to
all rooms in which food is prepared and utensils are cleaned.
(d) All plumbing shall be so designed, installed, and maintained as
to prevent contamination of the water supply, food, and food utensils.
21 CFR 1250.32 Food-handling operations.
(a) All food-handling operations shall be accomplished so as to
minimize the possibility of contaminating food, drink, or utensils.
(b) The hands of all persons shall be kept clean while engaged in
handling food, drink, utensils, or equipment.
21 CFR 1250.33 Utensils and equipment.
(a) All utensils and working surfaces used in connection with the
preparation, storage, and serving of food or beverages, and the cleaning
of food utensils, shall be so constructed as to be easily cleaned and
self-draining and shall be maintained in good repair. Adequate
facilities shall be provided for the cleaning and bactericidal treatment
of all multiuse eating and drinking utensils and equipment used in the
preparation of food and beverages. An indicating thermometer, suitably
located, shall be provided to permit the determination of the hot water
temperature when and where hot water is used as the bactericidal agent.
(b) All multiuse eating and drinking utensils shall be thoroughly
cleaned in warm water and subjected to an effective bactericidal
treatment after each use. All other utensils that come in contact with
food and drink shall be similarly treated immediately following the
day's operation. All equipment shall be kept clean.
(c) After bactericidal treatment, utensils shall be stored and
handled in such manner as to prevent contamination before reuse.
21 CFR 1250.34 Refrigeration equipment.
Each refrigerator shall be equipped with a thermometer located in the
warmest portion thereof. Waste water drains from ice boxes,
refrigerating equipment, and refrigerated spaces shall be so installed
as to prevent backflow of contaminating liquids.
21 CFR 1250.35 Health of persons handling food.
(a) Any person who is known or suspected to be in a communicable
period or a carrier of any communicable disease shall not be permitted
to engage in the preparation, handling, or serving of water, other
beverages, or food.
(b) Any person known or suspected to be suffering from
gastrointestinal disturbance or who has on the exposed portion of the
body an open lesion or an infected wound shall not be permitted to
engage in the preparation, handling, or serving of food or beverages.
21 CFR 1250.38 Toilet and lavatory facilities for use of food-handling
employees.
(a) Toilet and lavatory facilities of suitable design and
construction shall be provided for use of food-handling employees.
Railroad dining car crew lavatory facilities are regulated under
1250.45.
(b) Signs directing food-handling employees to wash their hands after
each use of toilet facilities shall be posted so as to be readily
observable by such employees. Hand washing facilities shall include
soap, sanitary towels and hot and cold running water or warm running
water in lieu of hot and cold running water.
(c) All toilet rooms shall be maintained in a clean condition.
21 CFR 1250.39 Garbage equipment and disposition.
Watertight, readily cleanable nonabsorbent containers with
close-fitting covers shall be used to receive and store garbage.
Garbage and refuse shall be disposed of as frequently as is necessary
and practicable.
21 CFR 1250.39 Subpart C -- Equipment and Operation of Land and Air Conveyances
21 CFR 1250.40 Applicability.
The sanitary equipment and facilities on land and air conveyances
engaged in interstate traffic and the use of such equipment and
facilities shall comply with the requirements prescribed in this
subpart.
21 CFR 1250.41 Submittal of construction plans.
Plans for the construction or major reconstruction of sanitary
equipment or facilities for such conveyances shall be submitted to the
Commissioner of Food and Drugs for review of the conformity of such
plans with the requirements of this subpart, except that submittal of
plans shall not be required for any conveyance under reconstruction if
the owner or operator thereof has made arrangements satisfactory to the
Commissioner of Food and Drugs for inspections of such conveyances while
under reconstruction for the purpose of determining conformity with
those requirements.
(40 FR 5624, Feb. 6, 1975, as amended at 48 FR 11432, Mar. 18, 1983)
21 CFR 1250.42 Water systems; constant temperature bottles.
(a) The water system, whether of the pressure or gravity type, shall
be complete and closed from the filling ends to the discharge taps,
except for protected vent openings. The water system shall be protected
against backflow.
(b) Filling pipes or connections through which water tanks are
supplied shall be provided on both sides of all new railway conveyances
and on existing conveyances when they undergo heavy repairs. All
filling connections shall be easily cleanable and so located and
protected as to minimize the hazard of contamination of the water
supply.
(c) On all new or reconstructed conveyances, water coolers shall be
an integral part of the closed system.
(d) Water filters if used on dining cars and other conveyances will
be permitted only if they are so operated and maintained at all times as
to prevent contamination of the water.
(e) Constant temperature bottles and other containers used for
storing or dispensing potable water shall be kept clean at all times and
shall be subjected to effective bactericidal treatment as often as may
be necessary to prevent the contamination of water so stored and
dispensed.
21 CFR 1250.43 Ice.
Ice shall not be permitted to come in contact with water in coolers
or constant temperature bottles.
21 CFR 1250.44 Drinking utensils and toilet articles.
(a) No cup, glass, or other drinking utensil which may be used by
more than one person shall be provided on any conveyance unless such
cup, glass, or drinking utensil shall have been thoroughly cleaned and
subjected to effective bactericidal treatment after each individual use.
(b) Towels, combs, or brushes for common use shall not be provided.
21 CFR 1250.45 Food handling facilities on railroad conveyances.
(a) Both kitchens and pantries of cars hereafter constructed or
reconstructed shall be equipped with double sinks, one of which shall be
of sufficient size and depth to permit complete immersion of a basket of
dishes during bactericidal treatment; in the pantry a dishwashing
machine may be substituted for the double sinks. If chemicals are used
for bactericidal treatment, 3-compartment sinks shall be provided.
(b) A sink shall be provided for washing and handling cracked ice
used in food or drink and shall be used for no other purpose.
(c) Lavatory facilities for the use of the dining car crew shall be
provided on each dining car. Such facilities shall be conveniently
located and used for hand and face washing only: Provided, however,
That where the kitchen and pantry on a dining car hereafter constructed
or reconstructed are so partitioned or separated as to impede free
passage between them lavatory facilities shall be provided in both the
kitchen and the pantry.
(d) Wherever toilet and lavatory facilities required by paragraph (c)
of this section are not on the dining car, a lavatory shall be provided
on the dining car for the use of employees. The lavatory shall be
conveniently located and used only for the purpose for which it is
installed.
21 CFR 1250.49 Cleanliness of conveyances.
Conveyances while in transit shall be kept clean and free of flies
and mosquitoes. A conveyance which becomes infected with vermin shall
be placed out of service until such time as it shall have been
effectively treated for the destruction of the vermin.
21 CFR 1250.50 Toilet and lavatory facilities.
Where toilet and lavatory facilities are provided on conveyances they
shall be so designed as to permit ready cleaning. On conveyances not
equipped with retention facilities, toilet hoppers shall be of such
design and so located as to prevent spattering of water filling pipes or
hydrants.
21 CFR 1250.51 Railroad conveyances; discharge of wastes.
(a) New railroad conveyances. Human wastes, garbage, waste water, or
other polluting materials shall not be discharged from any new railroad
conveyance except at servicing areas approved by the Commissioner of
Food and Drugs. In lieu of retention pending discharge at approved
servicing areas, human wastes, garbage, waste water, or other polluting
materials that have been suitably treated to prevent the spread of
communicable diseases may be discharged from such conveyances, except at
stations. For the purposes of this section, ''new railroad conveyance''
means any such conveyance placed into service for the first time after
July 1, 1972, and the terms ''waste water or other polluting materials''
do not include drainage of drinking water taps or lavatory facilities.
(b) Nonnew railroad conveyances. Human wastes, garbage, waste water,
or other polluting materials shall not be discharged from any railroad
conveyance, other than passenger conveyances for which an extension has
been granted pursuant to paragraph (f) of this section, after December
31, 1977, except at servicing areas approved by the Commissioner of Food
and Drugs. In lieu of retention pending discharge at approved servicing
areas, human wastes, garbage, waste water, or other polluting materials
that have been suitably treated to prevent the spread of communicable
diseases may be discharged from such conveyances, except at stations.
The terms ''waste water or other polluting materials'' do not include
drainage of drinking water taps or lavatory facilities.
(c) Toilets. When railroad conveyances, occupied or open to
occupancy by travelers, are at a station or servicing area, toilets
shall be kept locked unless means are provided to prevent contamination
of the area or station.
(d) Submission of annual report. Each railroad company shall submit
to the Food and Drug Administration, Center for Food Safety and Applied
Nutrition, Manager, Interstate Travel Sanitation Sub-Program, HFF-312,
200 C St. SW., Washington, DC 20204, an annual report of
accomplishments made in modifying conveyances to achieve compliance with
paragraph (b) of this section. Annual reports shall be required until a
report is submitted showing that 100 percent of the company's
conveyances can comply with the requirements of paragraph (b) of this
section; annual reports shall be required subsequent to such report if
conveyances not capable of complying with the requirements of paragraph
(b) of this section are acquired. Every railroad company shall have not
less than 10 percent of its nonpassenger conveyances that are in
operation capable of complying with the requirements of paragraph (b) of
this section by December 31, 1974, not less than 40 percent by December
31, 1975, and not less than 70 percent by December 31, 1976. All
conveyances, other than passenger conveyances for which an extension has
been granted pursuant to paragraph (f) of this section, in operation
after December 31, 1977, shall be capable of complying with paragraph
(b) of this section.
(e) Requirements of annual report. Annual reports required by
paragraph (d) of this section shall be submitted within 60 days of the
end of each calendar year. Each report shall contain at least the
following information:
(1) Company name and address.
(2) Name, title, and address of the company's chief operating
official.
(3) Name, title, address, and telephone number of the person
designated by the company to be directly responsible for compliance with
this section.
(4) A statement that all new railroad conveyances placed into service
after July 1, 1972 meet the requirements of this section.
(5) A complete, factual, narrative statement explaining why
retrofitting of noncomplying nonnew conveyances is incomplete, if it is
incomplete.
(6) A statement of the percentage of conveyances retrofitted with
waste discharge facilities in compliance with this section as of the
reporting date and the percentage expected to be completed by December
31st of the following year.
(7) A tabular report with the following vertical columns: equipment
type, e.g., locomotive, caboose, passenger car, and any others having
toilets; number of toilets per conveyance; number of each equipment
type in operation; and number of each to be retrofitted by December
31st of each year until 100 percent compliance with this section is
achieved.
(f) Variances and extensions -- (1) Variances. Upon application by a
railroad company, the Director, Center for Food Safety and Applied
Nutrition, may grant a variance from the compliance schedule prescribed
in paragraph (d) of this section for nonpassenger conveyances when the
requested variance is required to prevent substantial disruption of the
railroad company's operations. Such variance shall not affect the final
deadline of compliance established in paragraph (d) of this section.
(2) Extensions. Upon application by a railroad company, the
Director, Center for Food Safety and Applied Nutrition, may grant an
extension of time for compliance with the requirements of paragraph (b)
of this section beyond December 31, 1977, for passenger conveyances
operated by railroad companies when compliance cannot be achieved
without substantial disruption of the railroad company's operations.
(3) Application for variance or extension. Application for variances
or extensions shall be submitted to the Food and Drug Administration,
Center for Food Safety and Applied Nutrition, Manager, Interstate Travel
Sanitation Sub-Program, HFF-312, 200 C St., SW., Washington, DC 20204,
and shall include the following information:
(i) A detailed description of the proposed deviation from the
requirements of paragraphs (b) or (d) of this section.
(ii) A report, current to the date of the request for a variance or
extension, containing the information required by paragraph (e) of this
section.
(4) Administration of variances and extensions. (i) Written
notification of the granting or refusal of a variance or extension will
be provided to the applying railroad company by the Director, Center for
Food Safety and Applied Nutrition. The notification of a granted
variance will state the approved deviation from the compliance schedule
provided for in paragraph (d) of this section. The notification of a
granted extension will state the final date for compliance with the
provisions of paragraph (b) of this section.
(ii) A public file of requested variances and extensions, their
disposition, and information relating to pending actions will be
maintained in the Dockets Management Branch, Room 4-62, Parklawn
Building, 5600 Fishers Lane, Rockville, MD 20857.
(iii) After notice to the railroad company and opportunity for
hearing in accordance with Part 16 of this chapter, a variance or
extension may be withdrawn prior to its scheduled termination if the
Director, Center for Food Safety and Applied Nutrition, determines that
such withdrawal is necessary to protect the public health.
Cross-Reference: For statutory exemptions for ''intercity rail
passenger service,'' see section 306(i) of 45 U.S.C. 546(i).
(40 FR 5624, Feb. 6, 1975, as amended at 40 FR 30110, July 17, 1975;
46 FR 8461, Jan. 27, 1981; 48 FR 11432, Mar. 18, 1983; 54 FR 24900,
June 12, 1989)
Effective Date Note: For a document staying the effectiveness of
1250.51 (b) and (d), see 42 FR 57122, Nov. 1, 1977.
21 CFR 1250.52 Discharge of wastes on highway conveyances.
There shall be no discharge of excrement, garbage, or waste water
from a highway conveyance except at servicing areas approved by the
Commissioner of Food and Drugs.
(40 FR 5624, Feb. 6, 1975, as amended at 48 FR 11432, Mar. 18, 1983)
21 CFR 1250.53 Discharge of wastes on air conveyances.
There shall be no discharge of excrement or garbage from any air
conveyance except at servicing areas approved by the Commissioner of
Food and Drugs.
(40 FR 5624, Feb. 6, 1975, as amended at 48 FR 11432, Mar. 18, 1983)
21 CFR 1250.53 Subpart D -- Servicing Areas for Land and Air Conveyances
21 CFR 1250.60 Applicability.
Land and air conveyances engaged in interstate traffic shall use only
such servicing areas within the United States as have been approved by
the Commissioner of Food and Drugs as being in compliance with the
requirements prescribed in this subpart.
(40 FR 5624, Feb. 6, 1975, as amended at 48 FR 11432, Mar. 18, 1983)
21 CFR 1250.61 Inspection and approval.
The Commissioner of Food and Drugs may inspect any such areas to
determine whether they shall be approved. He may base his approval or
disapproval on investigations made by representatives of State
departments of health.
(40 FR 5624, Feb. 6, 1975, as amended at 48 FR 11432, Mar. 18, 1983)
21 CFR 1250.62 Submittal of construction plans.
Plans for construction or major reconstruction of sanitation
facilities at servicing areas shall be submitted to the Commissioner of
Food and Drugs for review of the conformity of the proposed facilities
with the requirements of this subpart.
(40 FR 5624, Feb. 6, 1975, as amended at 48 FR 11432, Mar. 18, 1983)
21 CFR 1250.63 General requirements.
Servicing areas shall be provided with all necessary sanitary
facilities so operated and maintained as to prevent the spread of
communicable diseases.
21 CFR 1250.65 Drainage.
All platforms and other places at which water or food supplies are
loaded onto or removed from conveyances shall be adequately drained so
as to prevent pooling.
21 CFR 1250.67 Watering equipment.
(a) General requirements. All servicing area piping systems,
hydrants, taps, faucets, hoses, buckets, and other appurtenances
necessary for delivery of drinking and culinary water to a conveyance
shall be designed, constructed, maintained and operated in such a manner
as to prevent contamination of the water.
(b) Outlets for nonpotable water. Outlets for nonpotable water shall
be provided with fittings different from those provided for outlets for
potable water and each nonpotable water outlet shall be posted with
permanent signs warning that the water is unfit for drinking.
(c) Ice. If bulk ice is used for the cooling of drinking water or
other beverages, or for food preservation purposes, equipment
constructed so as not to become a factor in the transmission of
communicable diseases shall be provided for the storage, washing,
handling, and delivery to conveyances of such bulk ice, and such
equipment shall be used for no other purposes.
21 CFR 1250.70 Employee conveniences.
(a) There shall be adequate toilet, washroom, locker, and other
essential sanitary facilities readily accessible for use of employees
adjacent to places or areas where land and air conveyances are serviced,
maintained, and cleaned. These facilities shall be maintained in a
clean and sanitary condition at all times.
(b) In the case of diners not in a train but with a crew on board,
adequate toilet facilities shall be available to the crew within a
reasonable distance but not exceeding 500 feet of such diners.
(c) Drinking fountains and coolers shall be constructed of
impervious, nonoxidizing material, and shall be so designed and
constructed as to be easily cleaned. The jet of a drinking fountain
shall be slanting and the orifice of the jet shall be protected by a
guard in such a manner as to prevent contamination thereof by droppings
from the mouth. The orifice of such a jet shall be located a sufficient
distance above the rim of the basin to prevent backflow.
21 CFR 1250.75 Disposal of human wastes.
(a) At servicing areas and at stations where land and air conveyances
are occupied by passengers the operations shall be so conducted as to
avoid contamination of such areas and stations by human wastes.
(b) Toilet wastes shall be disposed of through sanitary sewers or by
other methods assuring sanitary disposal of such wastes. All soil cans
and removable containers shall be thoroughly cleaned before being
returned to use. Equipment for cleaning such containers and for
flushing nonremovable containers and waste carts shall be so designed as
to prevent backflow into the water line, and such equipment shall be
used for no purpose connected with the handling of food, water or ice.
(c) All persons who have handled soil cans or other containers which
have come in contact with human wastes shall be required to wash their
hands thoroughly with soap and warm water and to remove any garments
which have become soiled with such wastes before engaging in any work
connected with the loading, unloading, transporting or other handling of
food, water or ice.
21 CFR 1250.79 Garbage disposal.
(a) Water-tight, readily cleanable, nonabsorbent containers with
close-fitting covers shall be used to receive and store garbage.
(b) Can washing and draining facilities shall be provided.
(c) Garbage cans shall be emptied daily and shall be thoroughly
washed before being returned for use.
21 CFR 1250.79 Subpart E -- Sanitation Facilities and Conditions on Vessels
21 CFR 1250.80 Applicability.
The sanitation facilities and the sanitary conditions on vessels
engaged in interstate traffic shall comply with the requirements
prescribed in this subpart, provided that no major structural change
will be required on existing vessels.
21 CFR 1250.81 Inspection.
The Commissioner of Food and Drugs may inspect such vessels to
determine compliance with the requirements of this subpart.
(40 FR 5624, Feb. 6, 1975, as amended at 48 FR 11432, Mar. 18, 1983)
21 CFR 1250.82 Potable water systems.
The following conditions must be met by vessel water systems used for
the storage and distribution of water which has met the requirements of
1240.80 of this chapter.
(a) The potable water system, including filling hose and lines,
pumps, tanks, and distributing pipes, shall be separate and distinct
from other water systems and shall be used for no other purposes.
(b) All potable water tanks shall be independent of any tanks holding
nonpotable water or other liquid. All potable water tanks shall be
independent of the shell of the ship unless (1) the bottom of the tank
is at least 2 feet above the maximum load water line, (2) the seams in
the shell are continuously welded, and (3) there are no rivets in that
part of the shell which forms a side of a tank. A deck may be used as
the top of a tank provided there are no access or inspection openings or
rivets therein, and the seams are continuously welded. No toilet or
urinal shall be installed immediately above that part of the deck which
forms the top of a tank. All potable water tanks shall be located at a
sufficient height above the bilge to allow for draining and to prevent
submergence in bilge water.
(c) Each potable water tank shall be provided with a means of
drainage and, if it is equipped with a manhole, overflow, vent, or a
device for measuring depth of water, provision shall be made to prevent
entrance into the tank of any contaminating substance. No deck or
sanitary drain or pipe carrying any nonpotable water or liquid shall be
permitted to pass through the tank.
(d) Tanks and piping shall bear clear marks of identification.
(e) There shall be no backflow or cross connection between potable
water systems and any other systems. Pipes and fittings conveying
potable water to any fixture, apparatus, or equipment shall be installed
in such way that backflow will be prevented. Waste pipes from any part
of the potable water system, including treatment devices, discharging to
a drain, shall be suitably protected against backflow.
(f) Water systems shall be cleaned, disinfected, and flushed whenever
the Commissioner of Food and Drugs shall find such treatment necessary
to prevent the introduction, transmission, or spread of communicable
diseases.
(40 FR 5624, Feb. 6, 1975, as amended at 48 FR 11432, Mar. 18, 1983)
21 CFR 1250.83 Storage of water prior to treatment.
The following requirements with respect to the storage of water on
vessels prior to treatment must be met in order to obtain approval of
treatment facilities under 1240.90 of this chapter.
(a) The tank, whether independent or formed by the skin of the ship,
deck, tank top, or partitions common with other tanks, shall be free of
apparent leakage.
(b) No sanitary drain shall pass through the tank.
(c) The tank shall be adequately protected against both the backflow
and discharge into it of bilge or highly contaminated water.
21 CFR 1250.84 Water in galleys and medical care spaces.
(a) Potable water, hot and cold, shall be available in the galley and
pantry except that, when potable water storage is inadequate, nonpotable
water may be piped to the galley for deck washing and in connection with
garbage disposal. Any tap discharging nonpotable water which is
installed for deck washing purposes shall not be more than 18 inches
above the deck and shall be distinctly marked ''For deck washing only''.
(b) In the case of existing vessels on which heat treated wash water
has been used for the washing of utensils prior to the effective date of
the regulations in this part, such water may continue to be so used
provided controls are employed to insure the heating of all water to at
least 170 F before discharge from the heater.
(c) Potable water, hot and cold, shall be available in medical care
spaces for hand-washing and for medical care purposes excluding
hydrotherapy.
21 CFR 1250.85 Drinking fountains and coolers; ice; constant
temperature bottles.
(a) Drinking fountains and coolers shall be constructed of
impervious, nonoxidizing material, and shall be so designed and
constructed as to be easily cleaned. The jet of a drinking fountain
shall be slanting and the orifice of the jet shall be protected by a
guard in such a manner as to prevent contamination thereof by droppings
from the mouth. The orifice of such a jet shall be located a sufficient
distance above the rim of the basin to prevent backflow.
(b) Ice shall not be permitted to come in contact with water in
coolers or constant temperature bottles.
(c) Constant temperature bottles and other containers used for
storing or dispensing potable water shall be kept clean at all times and
shall be subjected to effective bactericidal treatment after each
occupancy of the space served and at intervals not exceeding one week.
21 CFR 1250.86 Water for making ice.
Only potable water shall be piped into a freezer for making ice for
drinking and culinary purposes.
21 CFR 1250.87 Wash water.
Where systems installed on vessels for wash water, as defined in
1250.3(n), do not comply with the requirements of a potable water
system, prescribed in 1250.82, they shall be constructed so as to
minimize the possibility of the water therein being contaminated. The
storage tanks shall comply with the requirements of 1250.83, and the
distribution system shall not be cross connected to a system carrying
water of a lower sanitary quality. All faucets shall be labeled ''Unfit
for drinking''.
21 CFR 1250.89 Swimming pools.
(a) Fill and draw swimming pools shall not be installed or used.
(b) Swimming pools of the recirculation type shall be equipped so as
to provide complete circulation, replacement, and filtration of the
water in the pool every six hours or less. Suitable means of
chlorination and, if necessary, other treatment of the water shall be
provided to maintain the residual chlorine in the pool water at not less
than 0.4 part per million and the pH (a measure of the hydrogen ion
concentration) not less than 7.0.
(c) Flowing-through types of salt water pools shall be so operated
that complete circulation and replacement of the water in the pool will
be effected every 6 hours or less. The water delivery pipe to the pool
shall be independent of all other pipes and shall originate at a point
where maximum flushing of the pump and pipe line is effected after
leaving polluted waters.
21 CFR 1250.90 Toilets and lavatories.
Toilet and lavatory equipment and spaces shall be maintained in a
clean condition.
21 CFR 1250.93 Discharge of wastes.
Vessels operating on fresh water lakes or rivers shall not discharge
sewage, or ballast or bilge water, within such areas adjacent to
domestic water intakes as are designated by the Commissioner of Food and
Drugs.
Cross-Reference: For Environmental Protection Agency's regulations
for vessel sanitary discharges as related to authority under the Federal
Water Pollution Control Act, as amended (33 U.S.C. 1314 et seq.), see
40 CFR Part 140.
(40 FR 5624, Feb. 6, 1975, as amended at 48 FR 11432, Mar. 18, 1983)
21 CFR 1250.95 Insect control.
Vessels shall be maintained free of infestation by flies, mosquitoes,
fleas, lice, and other insects known to be vectors in the transmission
of communicable diseases, through the use of screening, insecticides,
and other generally accepted methods of insect control.
21 CFR 1250.96 Rodent control.
Vessels shall be maintained free of rodent infestation through the
use of traps, poisons, and other generally accepted methods of rodent
control.
21 CFR 1250.96 PARTS 1251-1299 -- (RESERVED)
21 CFR 1250.96 FINDING AIDS
A list of CFR titles, subtitles, chapters, subchapters and parts and
an alphabetical list of agencies publishing in the CFR are included in
the CFR Index and Finding Aids volume to the Code of Federal Regulations
which is published separately and revised annually.
Material Approved for Incorporation by Reference
Table of CFR Titles and Chapters
Alphabetical List of Agencies Appearing in the CFR
List of CFR Sections Affected
Material Approved for Incorporation by Reference
Material Approved for Incorporation by Reference
The Director of the Federal Register has approved under 5 U.S.C.
552(a) and 1 CFR Part 51 the incorporation by reference of the following
publications. This list contains only those incorporations by reference
effective as of the revision date of this volume. Incorporations by
reference found within a regulation are effective upon the effective
date of that regulation. For more information on incorporation by
reference, see the preliminary pages of this volume.
21 CFR 1250.96 21 CFR CHAPTER I (PARTS 800 TO 1299)
FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR
American Society for Testing and Materials
1916 Race St. Philadelphia, PA 19103
ASTM D 412-68 Standard Method of Tension Testing of Vulcanized Rubber
801.410
ASTM D 1415-68 Test for International Hardness of Vulcanized Rubber
801.410
ASTM D 3492-83 Standard Specification for Rubber Contraceptives
(Condoms) 801.430(f)(2)
American National Standards Institute
1430 Broadway, NY, NY 10018
ANSI C81.10-1976 Specifications for Electric Lamp Bases and
Holders-Screw Shall Types 1040.20(c)
ANSI S3.22-1987 Specification of Hearing Aid Characteristics (ASA
70-1987) 801.420(c)(4)
Chap.
21 CFR 1250.96 Table of CFR Titles and Chapters
21 CFR 1250.96 Title 1 -- General Provisions
I Administrative Committee of the Federal Register (Parts 1 -- 49)
II Office of the Federal Register (Parts 50 -- 299)
III Administrative Conference of the United States (Parts 300 -- 399)
IV Miscellaneous Agencies (Parts 400 -- 500)
21 CFR 1250.96 Title 2 -- (Reserved)
21 CFR 1250.96 Title 3 -- The President
I Executive Office of the President (Parts 100 -- 199)
21 CFR 1250.96 Title 4 -- Accounts
I General Accounting Office (Parts 1 -- 99)
II Federal Claims Collection Standards (General Accounting Office --
Department of Justice) (Parts 100 -- 299)
III General Accounting Office (CASB) (Parts 300 -- 499)
21 CFR 1250.96 Title 5 -- Administrative Personnel
I Office of Personnel Management (Parts 1 -- 1199)
II Merit Systems Protection Board (Parts 1200 -- 1299)
III Office of Management and Budget (Parts 1300 -- 1399)
IV Advisory Committee on Federal Pay (Parts 1400 -- 1499)
V The International Organizations Employees Loyalty Board (Parts 1500
-- 1599)
VI Federal Retirement Thrift Investment Board (Parts 1600 -- 1699)
VII Advisory Commission on Intergovernmental Relations (Parts 1700 --
1799)
VIII Office of Special Council (Parts 1800 -- 1899)
IX Appalachian Regional Commission (Parts 1900 -- 1999)
XI United States Soldiers' and Airmen's Home (Parts 2100 -- 2199)
XIV Federal Labor Relations Authority, General Counsel of the Federal
Labor Relations Authority and Federal Service Impasses Panel (Parts 2400
-- 2499)
XV Office of Administration, Executive Office of the President (Parts
2500 -- 2599)
XVI Office of Government Ethics (Parts 2600 -- 2699)
21 CFR 1250.96 Title 6 -- Economic Stabilization (Reserved)
21 CFR 1250.96 Title 7 -- Agriculture
Subtitle A -- Office of the Secretary of Agriculture (Parts 0 -- 26)
Subtitle B -- Regulations of the Department of Agriculture
I Agricultural Marketing Service (Standards, Inspections, Marketing
Practices), Department of Agriculture (Parts 27 -- 209)
II Food and Nutrition Service, Department of Agriculture (Parts 210
-- 299)
III Animal and Plant Health Inspection Service, Department of
Agriculture (Parts 300 -- 399)
IV Federal Crop Insurance Corporation, Department of Agriculture
(Parts 400 -- 499)
V Agricultural Research Service, Department of Agriculture (Parts 500
-- 599)
VI Soil Conservation Service, Department of Agriculture (Parts 600 --
699)
VII Agricultural Stabilization and Conservation Service (Agricultural
Adjustment), Department of Agriculture (Parts 700 -- 799)
VIII Federal Grain Inspection Service, Department of Agriculture
(Parts 800 -- 899)
IX Agricultural Marketing Service (Marketing Agreements and Orders;
Fruits, Vegetables, Nuts), Department of Agriculture (Parts 900 -- 999)
X Agricultural Marketing Service (Marketing Agreements and Orders;
Milk), Department of Agriculture (Parts 1000 -- 1199)
XI Agricultural Marketing Service (Marketing Agreements and Orders;
Miscellaneous Commodities), Department of Agriculture (Parts 1200 --
1299)
XIV Commodity Credit Corporation, Department of Agriculture (Parts
1400 -- 1499)
XV Foreign Agricultural Service, Department of Agriculture (Parts
1500 -- 1599)
XVI Rural Telephone Bank, Department of Agriculture (Parts 1600 --
1699)
XVII Rural Electrification Administration, Department of Agriculture
(Parts 1700 -- 1799)
XVIII Farmers Home Administration, Department of Agriculture (Parts
1800 -- 2099)
XXI Foreign Economic Development Service, Department of Agriculture
(Parts 2100 -- 2199)
XXII Office of International Cooperation and Development, Department
of Agriculture (Parts 2200 -- 2299)
XXV Office of the General Sales Manager, Department of Agriculture
(Parts 2500 -- 2599)
XXVI Office of Inspector General, Department of Agriculture (Parts
2600 -- 2699)
XXVII Office of Information Resources Management, Department of
Agriculture (Parts 2700 -- 2799)
XXVIII Office of Operations, Department of Agriculture (Parts 2800 --
2899)
XXIX Office of Energy, Department of Agriculture (Parts 2900 -- 2999)
XXX Office of Finance and Management, Department of Agriculture
(Parts 3000 -- 3099)
XXXI Office of Environmental Quality, Department of Agriculture
(Parts 3100 -- 3199)
XXXII Office of Grants and Program Systems, Department of Agriculture
(Parts 3200 -- 3299)
XXXIII Office of Transportation, Department of Agriculture (Parts
3300 -- 3399)
XXXIV Cooperative State Research Service, Department of Agriculture
(Parts 3400 -- 3499)
XXXVI National Agricultural Statistics Service, Department of
Agriculture (Parts 3600 -- 3699)
XXXVII Economic Research Service, Department of Agriculture (Parts
3700 -- 3799)
XXXVIII World Agricultural Outlook Board, Department of Agriculture
(Parts 3800 -- 3899)
XXXIX Economic Analysis Staff, Department of Agriculture (Parts 3900
-- 3999)
XL Economics Management Staff, Department of Agriculture (Parts 4000
-- 4099)
XLI National Agricultural Library, Department of Agriculture (Part
4100)
21 CFR 1250.96 Title 8 -- Aliens and Nationality
I Immigration and Naturalization Service, Department of Justice
(Parts 1 -- 499)
21 CFR 1250.96 Title 9 -- Animals and Animal Products
I Animal and Plant Health Inspection Service, Department of
Agriculture (Parts 1 -- 199)
II Packers and Stockyards Administration, Department of Agriculture
(Parts 200 -- 299)
III Food Safety and Inspection Service, Meat and Poultry Inspection,
Department of Agriculture (Parts 300 -- 399)
21 CFR 1250.96 Title 10 -- Energy
I Nuclear Regulatory Commission (Parts 0 -- 199)
II Department of Energy (Parts 200 -- 699)
III Department of Energy (Parts 700 -- 999)
X Department of Energy (General Provisions) (Parts 1000 -- 1099)
XV Office of the Federal Inspector for the Alaska Natural Gas
Transportation System (Parts 1500 -- 1599)
XVII Defense Nuclear Facilities Safety Board (Parts 1700 -- 1799)
21 CFR 1250.96 Title 11 -- Federal Elections
I Federal Election Commission (Parts 1 -- 9099)
21 CFR 1250.96 Title 12 -- Banks and Banking
I Comptroller of the Currency, Department of the Treasury (Parts 1 --
199)
II Federal Reserve System (Parts 200 -- 299)
III Federal Deposit Insurance Corporation (Parts 300 -- 399)
IV Export-Import Bank of the United States (Parts 400 -- 499)
V Office of Thrift Supervision, Department of The Treasury (Parts 500
-- 599)
VI Farm Credit Administration (Parts 600 -- 699)
VII National Credit Union Administration (Parts 700 -- 799)
VIII Federal Financing Bank (Parts 800 -- 899)
IX Federal Housing Finance Board (Parts 900 -- 999)
XI Federal Financial Institutions Examination Council (Parts 1100 --
1199)
XIII Farm Credit System Assistance Board (Parts 1300 -- 1399)
XIV Farm Credit System Insurance Corporation (Parts 1400 -- 1499)
XV Thrift Depositor Protection Oversight Board (Parts 1500 -- 1599)
XVI Resolution Trust Corporation (Parts 1600 -- 1699)
21 CFR 1250.96 Title 13 -- Business Credit and Assistance
I Small Business Administration (Parts 1 -- 199)
III Economic Development Administration, Department of Commerce
(Parts 300 -- 399)
21 CFR 1250.96 Title 14 -- Aeronautics and Space
I Federal Aviation Administration, Department of Transportation
(Parts 1 -- 199)
II Office of the Secretary, Department of Transportation (Aviation
Proceedings) (Parts 200 -- 399)
III Office of Commercial Space Transportation, Department of
Transportation (Parts 400 -- 499)
V National Aeronautics and Space Administration (Parts 1200 -- 1299)
21 CFR 1250.96 Title 15 -- Commerce and Foreign Trade
Subtitle A -- Office of the Secretary of Commerce (Parts 0 -- 29)
Subtitle B -- Regulations Relating to Commerce and Foreign Trade
I Bureau of the Census, Department of Commerce (Parts 30 -- 199)
II National Institute of Standards and Technology, Department of
Commerce (Parts 200 -- 299)
III International Trade Administration, Department of Commerce (Parts
300 -- 399)
IV Foreign-Trade Zones Board (Parts 400 -- 499)
VII Bureau of Export Administration, Department of Commerce (Parts
700 -- 799)
VIII Bureau of Economic Analysis, Department of Commerce (Parts 800
-- 899)
IX National Oceanic and Atmospheric Administration, Department of
Commerce (Parts 900 -- 999)
XI Technology Administration, Department of Commerce (Parts 1100 --
1199)
XII United States Travel and Tourism Administration, Department of
Commerce (Parts 1200 -- 1299)
XIII East-West Foreign Trade Board (Parts 1300 -- 1399)
XIV Minority Business Development Agency (Parts 1400 -- 1499)
Subtitle C -- Regulations Relating to Foreign Trade Agreements
XX Office of the United States Trade Representative (Parts 2000 --
2099)
Subtitle D -- Regulations Relating to Telecommunications and
Information
XXIII National Telecommunications and Information Administration,
Department of Commerce (Parts 2300 -- 2399)
21 CFR 1250.96 Title 16 -- Commercial Practices
I Federal Trade Commission (Parts 0 -- 999)
II Consumer Product Safety Commission (Parts 1000 -- 1799)
21 CFR 1250.96 Title 17 -- Commodity and Securities Exchanges
I Commodity Futures Trading Commission (Parts 1 -- 199)
II Securities and Exchange Commission (Parts 200 -- 399)
IV Department of the Treasury (Parts 400 -- 499)
21 CFR 1250.96 Title 18 -- Conservation of Power and Water Resources
I Federal Energy Regulatory Commission, Department of Energy (Parts 1
-- 399)
III Delaware River Basin Commission (Parts 400 -- 499)
VI Water Resources Council (Parts 700 -- 799)
VIII Susquehanna River Basin Commission (Parts 800 -- 899)
XIII Tennessee Valley Authority (Parts 1300 -- 1399)
21 CFR 1250.96 Title 19 -- Customs Duties
I United States Customs Service, Department of the Treasury (Parts 1
-- 199)
II United States International Trade Commission (Parts 200 -- 299)
III International Trade Administration, Department of Commerce (Parts
300 -- 399)
21 CFR 1250.96 Title 20 -- Employees' Benefits
I Office of Workers' Compensation Programs, Department of Labor
(Parts 1 -- 199)
II Railroad Retirement Board (Parts 200 -- 399)
III Social Security Administration, Department of Health and Human
Services (Parts 400 -- 499)
IV Employees' Compensation Appeals Board, Department of Labor (Parts
500 -- 599)
V Employment and Training Administration, Department of Labor (Parts
600 -- 699)
VI Employment Standards Administration, Department of Labor (Parts
700 -- 799)
VII Benefits Review Board, Department of Labor (Parts 800 -- 899)
VIII Joint Board for the Enrollment of Actuaries (Parts 900 -- 999)
IX Office of the Assistant Secretary for Veterans' Employment and
Training, Department of Labor (Parts 1000 -- 1099)
21 CFR 1250.96 Title 21 -- Food and Drugs
I Food and Drug Administration, Department of Health and Human
Services (Parts 1 -- 1299)
II Drug Enforcement Administration, Department of Justice (Parts 1300
-- 1399)
21 CFR 1250.96 Title 22 -- Foreign Relations
I Department of State (Parts 1 -- 199)
II Agency for International Development, International Development
Cooperation Agency (Parts 200 -- 299)
III Peace Corps (Parts 300 -- 399)
IV International Joint Commission, United States and Canada (Parts
400 -- 499)
V United States Information Agency (Parts 500 -- 599)
VI United States Arms Control and Disarmament Agency (Parts 600 --
699)
VII Overseas Private Investment Corporation, International
Development Cooperation Agency (Parts 700 -- 799)
IX Foreign Service Grievance Board Regulations (Parts 900 -- 999)
X Inter-American Foundation (Parts 1000 -- 1099)
XI International Boundary and Water Commission, United States and
Mexico, United States Section (Parts 1100 -- 1199)
XII United States International Development Cooperation Agency (Parts
1200 -- 1299)
XIII Board for International Broadcasting (Parts 1300 -- 1399)
XIV Foreign Service Labor Relations Board; Federal Labor Relations
Authority; General Counsel of the Federal Labor Relations Authority;
and the Foreign Service Impasse Disputes Panel (Parts 1400 -- 1499)
XV African Development Foundation (Parts 1500 -- 1599)
XVI Japan-United States Friendship Commission (Parts 1600 -- 1699)
21 CFR 1250.96 Title 23 -- Highways
I Federal Highway Administration, Department of Transportation (Parts
1 -- 999)
II National Highway Traffic Safety Administration and Federal Highway
Administration, Department of Transportation (Parts 1200 -- 1299)
III National Highway Traffic Safety Administration, Department of
Transportation (Parts 1300 -- 1399)
21 CFR 1250.96 Title 24 -- Housing and Urban Development
Subtitle A -- Office of the Secretary, Department of Housing and
Urban Development (Parts 0 -- 99)
Subtitle B -- Regulations Relating to Housing and Urban Development
I Office of Assistant Secretary for Equal Opportunity, Department of
Housing and Urban Development (Parts 100 -- 199)
II Office of Assistant Secretary for Housing-Federal Housing
Commissioner, Department of Housing and Urban Development (Parts 200 --
299)
III Government National Mortgage Association, Department of Housing
and Urban Development (Parts 300 -- 399)
V Office of Assistant Secretary for Community Planning and
Development, Department of Housing and Urban Development (Parts 500 --
599)
VI Office of Assistant Secretary for Community Planning and
Development, Department of Housing and Urban Development (Parts 600 --
699)
VII Office of the Secretary, Department of Housing and Urban
Development (Section 8 Housing Assistance Programs and Public and Indian
Housing Programs) (Parts 700 -- 799)
VIII Office of the Assistant Secretary for Housing -- Federal Housing
Commissioner, Department of Housing and Urban Development (Section 8
Housing Assistance Programs and Section 202 Direct Loan Program) (Parts
800 -- 899)
IX Office of Assistant Secretary for Public and Indian Housing,
Department of Housing and Urban Development (Parts 900 -- 999)
X Office of Assistant Secretary for Housing -- Federal Housing
Commissioner, Department of Housing and Urban Development (Interstate
Land Sales Registration Program) (Parts 1700 -- 1799)
XI Solar Energy and Energy Conservation Bank, Department of Housing
and Urban Development (Parts 1800 -- 1899)
XII Office of Inspector General, Department of Housing and Urban
Development (Parts 2000 -- 2099)
XV Mortgage Insurance and Loan Programs under the Emergency
Homeowners' Relief Act, Department of Housing and Urban Development
(Parts 2700 -- 2799)
XX Office of Assistant Secretary for Housing -- Federal Housing
Commissioner, Department of Housing and Urban Development (Parts 3200 --
3699)
XXV Neighborhood Reinvestment Corporation (Parts 4100 -- 4199)
21 CFR 1250.96 Title 25 -- Indians
I Bureau of Indian Affairs, Department of the Interior (Parts 1 --
299)
II Indian Arts and Crafts Board, Department of the Interior (Parts
300 -- 399)
III National Indian Gaming Commission (Parts 500 -- 599)
IV Office of Navajo and Hopi Indian Relocation (Parts 700 -- 799)
21 CFR 1250.96 Title 26 -- Internal Revenue
I Internal Revenue Service, Department of the Treasury (Parts 1 --
799)
21 CFR 1250.96 Title 27 -- Alcohol, Tobacco Products and Firearms
I Bureau of Alcohol, Tobacco and Firearms, Department of the Treasury
(Parts 1 -- 299)
21 CFR 1250.96 Title 28 -- Judicial Administration
I Department of Justice (Parts 0 -- 199)
III Federal Prison Industries, Inc., Department of Justice (Parts 300
-- 399)
V Bureau of Prisons, Department of Justice (Parts 500 -- 599)
VI Offices of Independent Counsel, Department of Justice (Parts 600
-- 699)
VII Office of Independent Counsel (Parts 700 -- 799)
21 CFR 1250.96 Title 29 -- Labor
Subtitle A -- Office of the Secretary of Labor (Parts 0 -- 99)
Subtitle B -- Regulations Relating to Labor
I National Labor Relations Board (Parts 100 -- 199)
II Bureau of Labor-Management Relations and Cooperative Programs,
Department of Labor (Parts 200 -- 299)
III National Railroad Adjustment Board (Parts 300 -- 399)
IV Office of Labor-Management Standards, Department of Labor (Parts
400 -- 499)
V Wage and Hour Division, Department of Labor (Parts 500 -- 899)
IX Construction Industry Collective Bargaining Commission (Parts 900
-- 999)
X National Mediation Board (Parts 1200 -- 1299)
XII Federal Mediation and Conciliation Service (Parts 1400 -- 1499)
XIV Equal Employment Opportunity Commission (Parts 1600 -- 1699)
XVII Occupational Safety and Health Administration, Department of
Labor (Parts 1900 -- 1999)
XX Occupational Safety and Health Review Commission (Parts 2200 --
2499)
XXV Pension and Welfare Benefits Administration, Department of Labor
(Parts 2500 -- 2599)
XXVI Pension Benefit Guaranty Corporation (Parts 2600 -- 2699)
XXVII Federal Mine Safety and Health Review Commission (Parts 2700 --
2799)
21 CFR 1250.96 Title 30 -- Mineral Resources
I Mine Safety and Health Administration, Department of Labor (Parts 1
-- 199)
II Minerals Management Service, Department of the Interior (Parts 200
-- 299)
III Board of Surface Mining and Reclamation Appeals, Department of
the Interior (Parts 300 -- 399)
IV Geological Survey, Department of the Interior (Parts 400 -- 499)
VI Bureau of Mines, Department of the Interior (Parts 600 -- 699)
VII Office of Surface Mining Reclamation and Enforcement, Department
of the Interior (Parts 700 -- 999)
21 CFR 1250.96 Title 31 -- Money and Finance: Treasury
Subtitle A -- Office of the Secretary of the Treasury (Parts 0 -- 50)
Subtitle B -- Regulations Relating to Money and Finance
I Monetary Offices, Department of the Treasury (Parts 51 -- 199)
II Fiscal Service, Department of the Treasury (Parts 200 -- 399)
IV Secret Service, Department of the Treasury (Parts 400 -- 499)
V Office of Foreign Assets Control, Department of the Treasury (Parts
500 -- 599)
VI Bureau of Engraving and Printing, Department of the Treasury
(Parts 600 -- 699)
VII Federal Law Enforcement Training Center, Department of the
Treasury (Parts 700 -- 799)
VIII Office of International Investment, Department of the Treasury
(Parts 800 -- 899)
21 CFR 1250.96 Title 32 -- National Defense
Subtitle A -- Department of Defense
I Office of the Secretary of Defense (Parts 1 -- 399)
V Department of the Army (Parts 400 -- 699)
VI Department of the Navy (Parts 700 -- 799)
VII Department of the Air Force (Parts 800 -- 1099)
Subtitle B -- Other Regulations Relating to National Defense
XII Defense Logistics Agency (Parts 1200 -- 1299)
XVI Selective Service System (Parts 1600 -- 1699)
XIX Central Intelligence Agency (Parts 1900 -- 1999)
XX Information Security Oversight Office (Parts 2000 -- 2099)
XXI National Security Council (Parts 2100 -- 2199)
XXIV Office of Science and Technology Policy (Parts 2400 -- 2499)
XXVII Office for Micronesian Status Negotiations (Parts 2700 -- 2799)
XXVIII Office of the Vice President of the United States (Parts 2800
-- 2899)
21 CFR 1250.96 Title 33 -- Navigation and Navigable Waters
I Coast Guard, Department of Transportation (Parts 1 -- 199)
II Corps of Engineers, Department of the Army (Parts 200 -- 399)
IV Saint Lawrence Seaway Development Corporation, Department of
Transportation (Parts 400 -- 499)
21 CFR 1250.96 Title 34 -- Education
Subtitle A -- Office of the Secretary, Department of Education (Parts
1 -- 99)
Subtitle B -- Regulations of the Offices of the Department of
Education
I Office for Civil Rights, Department of Education (Parts 100 -- 199)
II Office of Elementary and Secondary Education, Department of
Education (Parts 200 -- 299)
III Office of Special Education and Rehabilitative Services,
Department of Education (Parts 300 -- 399)
IV Office of Vocational and Adult Education, Department of Education
(Parts 400 -- 499)
V Office of Bilingual Education and Minority Languages Affairs,
Department of Education (Parts 500 -- 599)
VI Office of Postsecondary Education, Department of Education (Parts
600 -- 699)
VII Office of Educational Research and Improvement, Department of
Education (Parts 700 -- 799)
21 CFR 1250.96 Title 35 -- Panama Canal
I Panama Canal Regulations (Parts 1 -- 299)
21 CFR 1250.96 Title 36 -- Parks, Forests, and Public Property
I National Park Service, Department of the Interior (Parts 1 -- 199)
II Forest Service, Department of Agriculture (Parts 200 -- 299)
III Corps of Engineers, Department of the Army (Parts 300 -- 399)
IV American Battle Monuments Commission (Parts 400 -- 499)
V Smithsonian Institution (Parts 500 -- 599)
VII Library of Congress (Parts 700 -- 799)
VIII Advisory Council on Historic Preservation (Parts 800 -- 899)
IX Pennsylvania Avenue Development Corporation (Parts 900 -- 999)
XI Architectural and Transportation Barriers Compliance Board (Parts
1100 -- 1199)
XII National Archives and Records Administration (Parts 1200 -- 1299)
21 CFR 1250.96 Title 37 -- Patents, Trademarks, and Copyrights
I Patent and Trademark Office, Department of Commerce (Parts 1 --
199)
II Copyright Office, Library of Congress (Parts 200 -- 299)
III Copyright Royalty Tribunal (Parts 300 -- 399)
IV Assistant Secretary for Technology Policy, Department of Commerce
(Parts 400 -- 499)
V Under Secretary for Technology, Department of Commerce (Parts 500
-- 599)
21 CFR 1250.96 Title 38 -- Pensions, Bonuses, and Veterans' Relief
I Department of Veterans Affairs (Parts 0 -- 99)
21 CFR 1250.96 Title 39 -- Postal Service
I United States Postal Service (Parts 1 -- 999)
III Postal Rate Commission (Parts 3000 -- 3099)
21 CFR 1250.96 Title 40 -- Protection of Environment
I Environmental Protection Agency (Parts 1 -- 799)
V Council on Environmental Quality (Parts 1500 -- 1599)
21 CFR 1250.96 Title 41 -- Public Contracts and Property Management
Subtitle B -- Other Provisions Relating to Public Contracts
50 Public Contracts, Department of Labor (Parts 50-1 -- 50-999)
51 Committee for Purchase from the Blind and Other Severely
Handicapped (Parts 51-1 -- 51-99)
60 Office of Federal Contract Compliance Programs, Equal Employment
Opportunity, Department of Labor (Parts 60-1 -- 60-999)
61 Office of the Assistant Secretary for Veterans Employment and
Training, Department of Labor (Parts 61-1 -- 61-999)
Subtitle C -- Federal Property Management Regulations System
101 Federal Property Management Regulations (Parts 101-1 -- 101-99)
105 General Services Administration (Parts 105-1 -- 105-999)
109 Department of Energy Property Management Regulations (Parts 109-1
-- 109-99)
114 Department of the Interior (Parts 114-1 -- 114-99)
115 Environmental Protection Agency (Parts 115-1 -- 115-99)
128 Department of Justice (Parts 128-1 -- 128-99)
132 Department of the Air Force (Parts 132-1 -- 132-99)
Subtitle D -- Other Provisions Relating to Property Management
(Reserved)
Subtitle E -- Federal Information Resources Management Regulations
System
201 Federal Information Resources Management Regulation (Parts 201-1
-- 201-99)
Subtitle F -- Federal Travel Regulation System
301 Travel Allowances (Parts 301-1 -- 301-99)
302 Relocation Allowances (Parts 302-1 -- 302-99)
303 Payment of Expenses Connected with the Death of Certain Employees
(Parts 303-1 -- 303-2)
304 Payment from a non-Federal source for travel expenses (Parts
304-1 -- 304-99)
21 CFR 1250.96 Title 42 -- Public Health
I Public Health Service, Department of Health and Human Services
(Parts 1 -- 199)
IV Health Care Financing Administration, Department of Health and
Human Services (Parts 400 -- 499)
V Office of Inspector General-Health Care, Department of Health and
Human Services (Parts 1000 -- 1999)
21 CFR 1250.96 Title 43 -- Public Lands: Interior
Subtitle A -- Office of the Secretary of the Interior (Parts 1 --
199)
Subtitle B -- Regulations Relating to Public Lands
I Bureau of Reclamation, Department of the Interior (Parts 200 --
499)
II Bureau of Land Management, Department of the Interior (Parts 1000
-- 9999)
21 CFR 1250.96 Title 44 -- Emergency Management and Assistance
I Federal Emergency Management Agency (Parts 0 -- 399)
IV Department of Commerce and Department of Transportation (Parts 400
-- 499)
21 CFR 1250.96 Title 45 -- Public Welfare
Subtitle A -- Department of Health and Human Services, General
Administration (Parts 1 -- 199)
Subtitle B -- Regulations Relating to Public Welfare
II Office of Family Assistance (Assistance Programs), Family Support
Administration, Department of Health and Human Services (Parts 200 --
299)
III Office of Child Support Enforcement (Child Support Enforcement
Program), Family Support Administration, Department of Health and Human
Services (Parts 300 -- 399)
IV Office of Refugee Resettlement, Administration for Children and
Families Department of Health and Human Services (Parts 400 -- 499)
V Foreign Claims Settlement Commission of the United States,
Department of Justice (Parts 500 -- 599)
VI National Science Foundation (Parts 600 -- 699)
VII Commission on Civil Rights (Parts 700 -- 799)
VIII Office of Personnel Management (Parts 800 -- 899)
X Office of Community Services, Family Support Administration,
Department of Health and Human Services (Parts 1000 -- 1099)
XI National Foundation on the Arts and the Humanities (Parts 1100 --
1199)
XII ACTION (Parts 1200 -- 1299)
XIII Office of Human Development Services, Department of Health and
Human Services (Parts 1300 -- 1399)
XVI Legal Services Corporation (Parts 1600 -- 1699)
XVII National Commission on Libraries and Information Science (Parts
1700 -- 1799)
XVIII Harry S. Truman Scholarship Foundation (Parts 1800 -- 1899)
XX Commission on the Bicentennial of the United States Constitution
(Parts 2000 -- 2099)
XXI Commission on Fine Arts (Parts 2100 -- 2199)
XXII Christopher Columbus Quincentenary Jubilee Commission (Parts
2200 -- 2299)
XXIV James Madison Memorial Fellowship Foundation (Parts 2400 --
2499)
21 CFR 1250.96 Title 46 -- Shipping
I Coast Guard, Department of Transportation (Parts 1 -- 199)
II Maritime Administration, Department of Transportation (Parts 200
-- 399)
III Coast Guard (Great Lakes Pilotage), Department of Transportation
(Parts 400 -- 499)
IV Federal Maritime Commission (Parts 500 -- 599)
21 CFR 1250.96 Title 47 -- Telecommunication
I Federal Communications Commission (Parts 0 -- 199)
II Office of Science and Technology Policy and National Security
Council (Parts 200 -- 299)
III National Telecommunications and Information Administration,
Department of Commerce (Parts 300 -- 399)
21 CFR 1250.96 Title 48 -- Federal Acquisition Regulations System
1 Federal Acquisition Regulation (Parts 1 -- 99)
2 Department of Defense (Parts 200 -- 299)
3 Department of Health and Human Services (Parts 300 -- 399)
4 Department of Agriculture (Parts 400 -- 499)
5 General Services Administration (Parts 500 -- 599)
6 Department of State (Parts 600 -- 699)
7 Agency for International Development (Parts 700 -- 799)
8 Department of Veterans Affairs (Parts 800 -- 899)
9 Department of Energy (Parts 900 -- 999)
10 Department of the Treasury (Parts 1000 -- 1099)
12 Department of Transportation (Parts 1200 -- 1299)
13 Department of Commerce (Parts 1300 -- 1399)
14 Department of the Interior (Parts 1400 -- 1499)
15 Environmental Protection Agency (Parts 1500 -- 1599)
16 Office of Personnel Management Federal Employees Health Benefits
Acquisition Regulation (Parts 1600 -- 1699)
17 Office of Personnel Management (Parts 1700 -- 1799)
18 National Aeronautics and Space Administration (Parts 1800 -- 1899)
19 United States Information Agency (Parts 1900 -- 1999)
22 Small Business Administration (Parts 2200 -- 2299)
24 Department of Housing and Urban Development (Parts 2400 -- 2499)
25 National Science Foundation (Parts 2500 -- 2599)
28 Department of Justice (Parts 2800 -- 2899)
29 Department of Labor (Parts 2900 -- 2999)
34 Department of Education Acquisition Regulation (Parts 3400 --
3499)
35 Panama Canal Commission (Parts 3500 -- 3599)
44 Federal Emergency Management Agency (Parts 4400 -- 4499)
51 Department of the Army Acquisition Regulations (Parts 5100 --
5199)
52 Department of the Navy Acquisition Regulations (Parts 5200 --
5299)
53 Department of the Air Force Federal Acquisition Regulation
Supplement (Parts 5300 -- 5399)
57 African Development Foundation (Parts 5700 -- 5799)
61 General Services Administration Board of Contract Appeals (Parts
6100 -- 6199)
63 Department of Transportation Board of Contract Appeals (Parts 6300
-- 6399)
99 Cost Accounting Standards Board, Office of Federal Procurement
Policy, Office of Management and Budget (Parts 9900 -- 9999)
21 CFR 1250.96 Title 49 -- Transportation
Subtitle A -- Office of the Secretary of Transportation (Parts 1 --
99)
Subtitle B -- Other Regulations Relating to Transportation
I Research and Special Programs Administration, Department of
Transportation (Parts 100 -- 199)
II Federal Railroad Administration, Department of Transportation
(Parts 200 -- 299)
III Federal Highway Administration, Department of Transportation
(Parts 300 -- 399)
IV Coast Guard, Department of Transportation (Parts 400 -- 499)
V National Highway Traffic Safety Administration, Department of
Transportation (Parts 500 -- 599)
VI Urban Mass Transportation Administration, Department of
Transportation (Parts 600 -- 699)
VII National Railroad Passenger Corporation (AMTRAK) (Parts 700 --
799)
VIII National Transportation Safety Board (Parts 800 -- 899)
X Interstate Commerce Commission (Parts 1000 -- 1399)
21 CFR 1250.96 Title 50 -- Wildlife and Fisheries
I United States Fish and Wildlife Service, Department of the Interior
(Parts 1 -- 199)
II National Marine Fisheries Service, National Oceanic and
Atmospheric Administration, Department of Commerce (Parts 200 -- 299)
III International Regulatory Agencies (Fishing and Whaling) (Parts
300 -- 399)
IV Joint Regulations (United States Fish and Wildlife Service,
Department of the Interior and National Marine Fisheries Service,
National Oceanic and Atmospheric Administration, Department of
Commerce); Endangered Species Committee Regulations (Parts 400 -- 499)
V Marine Mammal Commission (Parts 500 -- 599)
VI Fishery Conservation and Management, National Oceanic and
Atmospheric Administration, Department of Commerce (Parts 600 -- 699)
21 CFR 1250.96 CFR Index and Finding Aids Subject/Agency Index
List of Agency Prepared Indexes Parallel Table of Statutory Authorities
and Rules Acts Requiring Publication in the Federal Register List of CFR
Titles, Chapters, Subchapters, and Parts
21 CFR 1250.96 Alphabetical List of Agencies Appearing in the CFR
CFR Title, Subtitle or
Agency
Chapter
ACTION 45, XII
Administrative Committee of the Federal Register 1, I
Administrative Conference of the United States 1, III
Advisory Commission on Intergovernmental Relations 5, VII
Advisory Committee on Federal Pay 5, IV
Advisory Council on Historic Preservation 36, VIII
African Development Foundation 22, XV; 48, 57
Agency for International Development 22, II; 48, 7
Agricultural Marketing Service 7, I, IX, X, XI
Agricultural Research Service 7, V
Agricultural Stabilization and Conservation Service 7, VII
Agriculture Department
Agricultural Marketing Service 7, I, IX, X, XI
Agricultural Research Service 7, V
Agricultural Stabilization and Conservation Service 7, VII
Animal and Plant Health Inspection Service 7, III; 9, I
Commodity Credit Corporation 7, XIV
Cooperative State Research Service 7, XXXIV
Economic Analysis Staff 7, XXXIX
Economic Research Service 7, XXXVII
Economics Management Staff 7, XL
Energy, Office of 7, XXIX
Environmental Quality, Office of 7, XXXI
Farmers Home Administration 7, XVIII
Federal Acquisition Regulation 48, 4
Federal Crop Insurance Corporation 7, IV
Federal Grain Inspection Service 7, VIII
Finance and Management, Office of 7, XXX
Food and Nutrition Service 7, II
Food Safety and Inspection Service 9, III
Foreign Agricultural Service 7, XV
Foreign Economic Development Service 7, XXI
Forest Service 36, II
General Sales Manager, Office of 7, XXV
Grants and Program Systems, Office of 7, XXXII
Information Resources Management, Office of 7, XXVII
Inspector General, Office of 7, XXVI
International Cooperation and Development Office 7, XXII
National Agricultural Library 7, XLI
National Agricultural Statistics Service 7, XXXVI
Operations Office 7, XXVIII
Packers and Stockyards Administration 9, II
Rural Electrification Administration 7, XVII
Rural Telephone Bank 7, XVI
Secretary of Agriculture, Office of 7, Subtitle A
Soil Conservation Service 7, VI
Transportation, Office of 7, XXXIII
World Agriculture Outlook Board 7, XXXVIII
Air Force Department 32, VII; 41, Subtitle C, Ch. 132
Federal Acquisition Regulation Supplement 48, 53
Alaska Natural Gas Transportation System, Office of the Federal
Inspector 10, XV
Alcohol, Tobacco and Firearms, Bureau of 27, I
AMTRAK 49, VII
American Battle Monuments Commission 36, IV
Animal and Plant Health Inspection Service 7, III; 9, I
Appalachian Regional Commission 5, IX
Architectural and Transportation Barriers Compliance Board 36, XI
Arms Control and Disarmament Agency, U.S. 22, VI
Army Department 32, V
Engineers, Corps of 33, II; 36, III
Federal Acquisition Regulation 48, 51
Assistant Secretary for Technology Policy, Department of Commerce 37,
IV
Benefits Review Board 20, VII
Bicentennial of the United States Constitution, Commission on the 45,
XX
Bilingual Education and Minority Languages Affairs, Office of 34, V
Blind and Other Severely Handicapped, Committee for Purchase from 41,
51
Board for International Broadcasting 22, XIII
Budget, Office of Management and 5, III
Census Bureau 15, I
Central Intelligence Agency 32, XIX
Child Support Enforcement, Office of 45, III
Christopher Columbus Quincentenary Jubilee Commission 45, XXII
Civil Rights Commission 45, VII
Civil Rights, Office for (Education Department) 34, I
Claims Collection Standards, Federal 4, II
Coast Guard 33, I; 46, I, III; 49, IV
Commerce Department 44, IV
Census Bureau 15, I
Assistant Secretary for Technology Policy 37, IV
Economic Affairs, Under Secretary 37, V
Economic Analysis, Bureau of 15, VIII
Economic Development Administration 13, III
Endangered Species Committee 50, IV
Export Administration Bureau 15, VII
Federal Acquisition Regulation 48, 13
Fishery Conservation and Management 50, VI
International Trade Administration 15, III; 19, III
National Institute of Standards and Technology 15, II
National Marine Fisheries Service 50, II, IV
National Oceanic and Atmospheric Administration 15, IX; 50, II, III,
IV, VI
National Telecommunications and Information Administration 15, XXIII;
47, III
Patent and Trademark Office 37, I
Productivity, Technology and Innovation, Assistant Secretary for 37,
IV
Secretary of Commerce, Office of 15, Subtitle A
Technology Administration 15, XI
Under Secretary for Technology 37, V
United States Travel and Tourism Administration 15, XII
Commercial Space Transportation, Office of, Department of
Transportation 14, III
Commission on the Bicentennial of the United States Constitution 45,
XX
Committee for Purchase from the Blind and Other Severely Handicapped
41, 51
Commodity Credit Corporation 7, XIV
Commodity Futures Trading Commission 17, I
Community Planning and Development, Office of Assistant Secretary for
24, V, VI
Community Services, Office of 45, X
Comptroller of the Currency 12, I
Construction Industry Collective Bargaining Commission 29, IX
Consumer Product Safety Commission 16, II
Cooperative State Research Service 7, XXXIV
Copyright Office 37, II
Copyright Royalty Tribunal 37, III
Cost Accounting Standards Board, Office of Federal Procurement Policy
48, 99
Council on Environmental Quality 40, V
Customs Service, United States 19, I
Defense Department 32, Subtitle A
Air Force Department 32, VII; 41, Subtitle C, Ch. 132
Army Department 32, V; 33, II; 36, III, 48, 51
Engineers, Corps of 33, II; 36, III
Federal Acquisition Regulation 48, 2
Navy Department 32, VI; 48, 52
Secretary of Defense, Office of 32, I
Defense Logistics Agency 32, XII
Defense Nuclear Facilities Safety Board 10, XVII
Delaware River Basin Commission 18, III
Drug Enforcement Administration 21, II
East-West Foreign Trade Board 15, XIII
Economic Affairs, Under Secretary (Commerce) 37, V
Economic Analysis, Bureau of 15, VIII
Economic Analysis Staff, Department of Agriculture 7, XXXIX
Economic Development Administration 13, III
Economics Management Staff 7, XL
Economic Research Service 7, XXXVII
Education, Department of
Bilingual Education and Minority Languages Affairs, Office of 34, V
Civil Rights, Office for 34, I
Educational Research and Improvement, Office of 34, VII
Elementary and Secondary Education, Office of 34, II
Federal Acquisition Regulation 48, 34
Postsecondary Education, Office of 34, VI
Secretary of Education, Office of 34, Subtitle A
Special Education and Rehabilitative Services, Office of 34, III
Vocational and Adult Education, Office of 34, IV
Educational Research and Improvement, Office of 34, VII
Elementary and Secondary Education, Office of 34, II
Employees' Compensation Appeals Board 20, IV
Employees Loyalty Board, International Organizations 5, V
Employment and Training Administration 20, V
Employment Standards Administration 20, VI
Endangered Species Committee 50, IV
Energy, Department of 10, II, III, X; 41, 109
Federal Acquisition Regulation 48, 9
Federal Energy Regulatory Commission 18, I
Energy, Office of, Department of Agriculture 7, XXIX
Engineers, Corps of 33, II; 36, III
Engraving and Printing, Bureau of 31, VI
Environmental Protection Agency 40, I; 41, 115; 48, 15
Environmental Quality, Office of (Agriculture Department) 7, XXXI
Equal Employment Opportunity Commission 29, XIV
Equal Opportunity, Office of Assistant Secretary for 24, I
Executive Office of the President 3, I
Administration, Office of 5, XV
Export Administration Bureau 15, VII
Export-Import Bank of the United States 12, IV
Family Assistance, Office of 45, II
Family Support Administration 45, II, III, IV, X
Farm Credit Administration 12, VI
Farm Credit System Assistance Board 12, XIII
Farm Credit System Insurance Corporation 12, XIV
Farmers Home Administration 7, XVIII
Federal Acquisition Regulation 48, 1
Federal Aviation Administration 14, I
Federal Claims Collection Standards 4, II
Federal Communications Commission 47, I
Federal Contract Compliance Programs, Office of 41, 60
Federal Crop Insurance Corporation 7, IV
Federal Deposit Insurance Corporation 12, III
Federal Election Commission 11, I
Federal Emergency Management Agency 44, I; 48, 44
Federal Energy Regulatory Commission 18, I
Federal Financial Institutions Examination Council 12, XI
Federal Financing Bank 12, VIII
Federal Grain Inspection Service 7, VIII
Federal Highway Administration 23, I, II; 49, III
Federal Home Loan Mortgage Corporation 1, IV
Federal Housing Finance Board 12, IX
Federal Information Resources Management Regulations 41, Subtitle E,
Ch. 201
Federal Inspector for the Alaska Natural Gas Transportation System,
Office of 10, XV
Federal Labor Relations Authority, and General Counsel of the Federal
Labor Relations Authority 5, XIV; 22, XIV
Federal Law Enforcement Training Center 31, VII
Federal Maritime Commission 46, IV
Federal Mediation and Conciliation Service 29, XII
Federal Mine Safety and Health Review Commission 29, XXVII
Federal Pay, Advisory Committee on 5, IV
Federal Prison Industries, Inc. 28, III
Federal Procurement Policy Office 48, 99
Federal Property Management Regulations 41, 101
Federal Property Management Regulations System 41, Subtitle C
Federal Railroad Administration 49, II
Federal Register, Administrative Committee of 1, I
Federal Register, Office of 1, II
Federal Reserve System 12, II
Federal Retirement Thrift Investment Board 5, VI
Federal Service Impasses Panel 5, XIV
Federal Trade Commission 16, I
Federal Travel Regulation System 41, Subtitle F
Finance and Management, Department of Agriculture 7, XXX
Fine Arts Commission 45, XXI
Fiscal Service 31, II
Fish and Wildlife Service, United States 50, I, IV
Fishery Conservation and Management 50, VI
Fishing and Whaling, International Regulatory Agencies 50, III
Food and Drug Administration 21, I
Food and Nutrition Service 7, II
Food Safety and Inspection Service 9, III
Foreign Agricultural Service 7, XV
Foreign Assets Control, Office of 31, V
Foreign Claims Settlement Commission of United States 45, V
Foreign Economic Development Service 7, XXI
Foreign Service Grievance Board 22, IX
Foreign Service Impasse Disputes Panel 22, XIV
Foreign Service Labor Relations Board 22, XIV
Foreign-Trade Zones Board 15, IV
Forest Service 36, II
General Accounting Office 4, I, II, III
General Sales Manager, Office of 7, XXV
General Services Administration
Contract Appeals Board 48, 61
Federal Acquisition Regulation 48, 5
Federal Information Resources Management Regulations 41, Subtitle E,
Ch. 201
Federal Property Management Regulations System 41, 101, 105
Federal Travel Regulation System 41, Subtitle F
Payment of Expenses Connected With the Death of Certain Employees 41,
303
Reduction in Meeting and Training Allowance Payments 41, 304
Relocation Allowances 41, 302
Travel Allowances 41, 301
Geological Survey 30, IV
Government Ethics, Office of 5, XVI
Government National Mortgage Association 24, III
Grants and Program Systems, Office of 7, XXXII
Great Lakes Pilotage 46, III
Harry S. Truman Scholarship Foundation 45, XVIII
Health and Human Services, Department of 45, Subtitle A
Child Support Enforcement, Office of 45, III
Community Services, Office of 45, X
Family Assistance, Office of 45, II
Family Support Administration 45, II, III, IV, X
Federal Acquisition Regulation 48, 3
Food and Drug Administration 21, I
Health Care Financing Administration 42, IV
Human Development Services Office 45, XIII
Inspector General, Office of 42, V
Public Health Service 42, I
Refugee Resettlement, Office of 45, IV
Social Security Administration 20, III; 45, IV
Health Care Financing Administration 42, IV
Housing and Urban Development, Department of
Community Planning and Development, Office of Assistant Secretary for
24, V, VI
Equal Opportunity, Office of Assistant Secretary for 24, I
Federal Acquisition Regulation 48, 24
Government National Mortgage Association 24, III
Housing -- Federal Housing Commissioner, Office of Assistant
Secretary for 24, II, VIII, X, XX
Inspector General, Office of 24, XII
Mortgage Insurance and Loan Programs Under Emergency Homeowners'
Relief Act 24, XV
Public and Indian Housing, Office of Assistant Secretary for 24, IX
Secretary, Office of 24, Subtitle B, VII
Solar Energy and Energy Conservation Bank 24, XI
Housing -- Federal Housing Commissioner, Office of Assistant
Secretary for 24, II, VIII, X, XX
Human Development Services Office 45, XIII
Immigration and Naturalization Service 8, I
Indian Affairs, Bureau of 25, I
Indian Arts and Crafts Board 25, II
Information Agency, United States 22, V; 48, 19
Information Resources Management, Office of, Agriculture Department
7, XXVII
Information Security Oversight Office 32, XX
Inspector General, Office of, Agriculture Department 7, XXVI
Inspector General, Office of, Health and Human Services Department
42, V
Inspector General, Office of, Housing and Urban Development
Department 24, XII
Inter-American Foundation 22, X
Intergovernmental Relations, Advisory Commission on 5, VII
Interior Department
Endangered Species Committee 50, IV
Federal Acquisition Regulation 48, 14
Federal Property Management Regulations System 41, 114
Fish and Wildlife Service, United States 50, I, IV
Geological Survey 30, IV
Indian Affairs, Bureau of 25, I
Indian Arts and Crafts Board 25, II
Land Management Bureau 43, II
Minerals Management Service 30, II
Mines, Bureau of 30, VI
National Park Service 36, I
Reclamation Bureau 43, I
Secretary of the Interior, Office of 43, Subtitle A
Surface Mining and Reclamation Appeals, Board of 30, III
Surface Mining Reclamation and Enforcement, Office of 30, VII
United States Fish and Wildlife Service 50, I, IV
Internal Revenue Service 26, I
International Boundary and Water Commission, United States and Mexico
22, XI
International Cooperation and Development Office, Department of
Agriculture 7, XXII
International Development, Agency for 22, II
International Development Cooperation Agency 22, XII
International Development, Agency for 22, II
Overseas Private Investment Corporation 22, VII
International Joint Commission, United States and Canada 22, IV
International Organizations Employees Loyalty Board 5, V
International Regulatory Agencies (Fishing and Whaling) 50, III
International Trade Administration 15, III; 19, III
International Trade Commission, United States 19, II
Interstate Commerce Commission 49, X
Japan-United States Friendship Commission 22, XVI
Joint Board for the Enrollment of Actuaries 20, VIII
Justice Department 28, I; 41, 128
Drug Enforcement Administration 21, II
Federal Acquisition Regulation 48, 28
Federal Claims Collection Standards 4, II
Federal Prison Industries, Inc. 28, III
Foreign Claims Settlement Commission of the United States 45, V
Immigration and Naturalization Service 8, I
Offices of Independent Counsel 28, VI
Prisons, Bureau of 28, V
Labor Department
Benefits Review Board 20, VII
Employees' Compensation Appeals Board 20, IV
Employment and Training Administration 20, V
Employment Standards Administration 20, VI
Federal Acquisition Regulation 48, 29
Federal Contract Compliance Programs, Office of 41, 60
Federal Procurement Regulations System 41, 50
Labor-Management Relations and Cooperative Programs, Bureau of 29, II
Labor-Management Standards, Office of 29, IV
Mine Safety and Health Administration 30, I
Occupational Safety and Health Administration 29, XVII
Pension and Welfare Benefits Administration 29, XXV
Public Contracts 41, 50
Secretary of Labor, Office of 29, Subtitle A
Veterans' Employment and Training, Office of the Assistant Secretary
for 41, 61; 20, IX
Wage and Hour Division 29, V
Workers' Compensation Programs, Office of 20, I
Labor-Management Relations and Cooperative Programs, Bureau of 29, II
Labor-Management Standards, Office of 29, IV
Land Management, Bureau of 43, II
Legal Services Corporation 45, XVI
Library of Congress 36, VII
Copyright Office 37, II
Management and Budget, Office of 5, III; 48, 99
Marine Mammal Commission 50, V
Maritime Administration 46, II
Merit Systems Protection Board 5, II
Micronesian Status Negotiations, Office for 32, XXVII
Mine Safety and Health Administration 30, I
Minerals Management Service 30, II
Mines, Bureau of 30, VI
Minority Business Development Agency 15, XIV
Miscellaneous Agencies 1, IV
Monetary Offices 31, I
Mortgage Insurance and Loan Programs Under the Emergency Homeowners'
Relief Act, Department of Housing and Urban Development 24, XV
National Aeronautics and Space Administration 14, V; 48, 18
National Agricultural Library 7, XLI
National Agricultural Statistics Service 7, XXXVI
National Archives and Records Administration 36, XII
National Bureau of Standards 15, II
National Capital Planning Commission 1, IV
National Commission for Employment Policy 1, IV
National Commission on Libraries and Information Science 45, XVII
National Credit Union Administration 12, VII
National Foundation on the Arts and the Humanities 45, XI
National Highway Traffic Safety Administration 23, II, III; 49, V
National Indian Gaming Commission 25, III
National Institute of Standards and Technology 15, II
National Labor Relations Board 29, I
National Marine Fisheries Service 50, II, IV
National Mediation Board 29, X
National Oceanic and Atmospheric Administration 15, IX; 50, II, III,
IV, VI
National Park Service 36, I
National Railroad Adjustment Board 29, III
National Railroad Passenger Corporation (AMTRAK) 49, VII
National Science Foundation 45, VI; 48, 25
National Security Council 32, XXI
National Security Council and Office of Science and Technology Policy
47, II
National Telecommunications and Information Administration 15, XXIII;
47, III
National Transportation Safety Board 49, VIII
Navy Department 32, VI; 48, 52
Neighborhood Reinvestment Corporation 24, XXV
Nuclear Regulatory Commission 10, I
Occupational Safety and Health Administration 29, XVII
Occupational Safety and Health Review Commission 29, XX
Office of Independent Counsel 28, VII
Office of Navajo and Hopi Indian Relocation 25, IV
Offices of Independent Counsel, Department of Justice 28, VI
Operations Office, Department of Agriculture 7, XXVIII
Overseas Private Investment Corporation 22, VII
Oversight Board 12, XV
Packers and Stockyards Administration 9, II
Panama Canal Commission 48, 35
Panama Canal Regulations 35, I
Patent and Trademark Office 37, I
Payment of Expenses Connected With the Death of Certain Employees 41,
303
Peace Corps 22, III
Pennsylvania Avenue Development Corporation 36, IX
Pension and Welfare Benefits Administration, Department of Labor 29,
XXV
Pension Benefit Guaranty Corporation 29, XXVI
Personnel Management, Office of 5, I; 45, VIII; 48, 17
Federal Employees Health Benefits Acquisition Regulation 48, 16
Postal Rate Commission 39, III
Postal Service, United States 39, I
Postsecondary Education, Office of 34, VI
President's Commission on White House Fellowships 1, IV
Presidential Documents 3
Prisons, Bureau of 28, V
Productivity, Technology and Innovation, Assistant Secretary
(Commerce) 37, IV
Property Management Regulations System, Federal 41, Subtitle C
Public Contracts, Department of Labor 41, 50
Public Health Service 42, I
Railroad Retirement Board 20, II
Reclamation Bureau 43, I
Reduction in Meeting and Training Allowance Payments 41, 304
Refugee Resettlement, Office of 45, IV
Regional Action Planning Commissions 13, V
Relocation Allowances 41, 302
Research and Special Programs Administration 49, I
Resolution Trust Corporation 12, XVI
Rural Electrification Administration 7, XVII
Rural Telephone Bank 7, XVI
Saint Lawrence Seaway Development Corporation 33, IV
Science and Technology Policy, Office of 32, XXIV
Science and Technology Policy, Office of, and National Security
Council 47, II
Secret Service 31, IV
Securities and Exchange Commission 17, II
Selective Service System 32, XVI
Small Business Administration 13, I; 48, 22
Smithsonian Institution 36, V
Social Security Administration 20, III; 45, IV
Soil Conservation Service 7, VI
Solar Energy and Energy Conservation Bank, Department of Housing and
Urban Development 24, XI
Soldiers' and Airmen's Home, United States 5, XI
Special Counsel, Office of 5, VIII
Special Education and Rehabilitative Services, Office of 34, III
State Department 22, I
Federal Acquisition Regulation 48, 6
Surface Mining and Reclamation Appeals, Board of 30, III
Susquehanna River Basin Commission 18, VIII
Technology Administration 15, XI
Tennessee Valley Authority 18, XIII
Thrift Supervision Office, Department of the Treasury 12, V
Trade Representative, United States, Office of 15, XX
Transportation, Department of 44, IV
Coast Guard 33, I; 46, I, III; 49, IV
Commercial Space Transportation, Office of 14, III
Contract Appeals Board 48, 63
Federal Acquisition Regulation 48, 12
Federal Aviation Administration 14, I
Federal Highway Administration 23, I, II; 49, III
Federal Railroad Administration 49, II
Maritime Administration 46, II
National Highway Traffic Safety Administration 23, II, III; 49, V
Research and Special Programs Administration 49, I
Saint Lawrence Seaway Development Corporation 33, IV
Secretary of Transportation, Office of 14, II; 49, Subtitle A
Urban Mass Transportation Administration 49, VI
Transportation, Office of, Department of Agriculture 7, XXXIII
Travel Allowance 41, 301
Travel and Tourism Administration, United States 15, XII
Treasury Department 17, IV
Alcohol, Tobacco and Firearms, Bureau of 27, I
Comptroller of the Currency 12, I
Customs Service, United States 19, I
Engraving and Printing, Bureau of 31, VI
Federal Acquisition Regulation 48, 10
Federal Law Enforcement Training Center 31, VII
Fiscal Service 31, II
Foreign Assets Control, Office of 31, V
Internal Revenue Service 26, I
Monetary Offices 31, I
Secret Service 31, IV
Secretary of the Treasury, Office of 31, Subtitle A
Thrift Supervision Office 12, V
United States Customs Service 19, I
Truman, Harry S. Scholarship Foundation 45, XVIII
Under Secretary for Technology, Department of Commerce 37, V
United States and Canada, International Joint Commission 22, IV
United States Arms Control and Disarmament Agency 22, VI
United States Customs Service 19, I
United States Fish and Wildlife Service 50, I, IV
United States Information Agency 22, V; 48, 19
United States International Development Cooperation Agency 22, XII
United States International Trade Commission 19, II
United States Postal Service 39, I
United States Soldiers' and Airmen's Home 5, XI
United States Trade Representative, Office of 15, XX
United States Travel and Tourism Adminstration 15, XII
Urban Mass Transportation Administration 49, VI
Veterans Affairs Department 38, I; 48, 8
Veterans' Employment and Training, Office of the Assistant Secretary
for 41, 61; 20, IX
Vice President of the United States, Office of 32, XXVIII
Vocational and Adult Education, Office of 34, IV
Wage and Hour Division 29, V
Water Resources Council 18, VI
Workers' Compensation Programs, Office of 20, I
World Agriculture Outlook Board 7, XXXVIII
21 CFR 1250.96 Alphabetical List of Agencies Appearing in the CFR
CFR Title, Subtitle or
Agency
Chapter
ACTION 45, XII
Administrative Committee of the Federal Register 1, I
Administrative Conference of the United States 1, III
Advisory Commission on Intergovernmental Relations 5, VII
Advisory Committee on Federal Pay 5, IV
Advisory Council on Historic Preservation 36, VIII
African Development Foundation 22, XV; 48, 57
Agency for International Development 22, II; 48, 7
Agricultural Marketing Service 7, I, IX, X, XI
Agricultural Research Service 7, V
Agricultural Stabilization and Conservation Service 7, VII
Agriculture Department
Agricultural Marketing Service 7, I, IX, X, XI
Agricultural Research Service 7, V
Agricultural Stabilization and Conservation Service 7, VII
Animal and Plant Health Inspection Service 7, III; 9, I
Commodity Credit Corporation 7, XIV
Contract Appeals, Board of 7, XXIV
Cooperative State Research Service 7, XXXIV
Economic Analysis Staff 7, XXXIX
Economics Management Staff 7, XL
Economic Research Service 7, XXXVII
Energy, Office of 7, XXIX
Environmental Quality, Office of 7, XXXI
Farmers Home Administration 7, XVIII
Federal Acquisition Regulation 48, 4
Federal Crop Insurance Corporation 7, IV
Federal Grain Inspection Service 7, VIII
Finance and Management, Office of 7, XXX
Food and Nutrition Service 7, II
Food Safety and Inspection Service 9, III
Foreign Agricultural Service 7, XV
Foreign Economic Development Service 7, XXI
Forest Service 36, II
General Sales Manager, Office of 7, XXV
Grants and Program Systems, Office of 7, XXXII
Information Resources Management, Office of 7, XXVII
Inspector General, Office of 7, XXVI
International Cooperation and Development Office 7, XXII
National Agricultural Library 7, XLI
National Agricultural Statistics Service 7, XXXVI
Operations Office 7, XXVIII
Packers and Stockyards Administration 9, II
Rural Electrification Administration 7, XVII
Rural Telephone Bank 7, XVI
Secretary of Agriculture, Office of 7, Subtitle A
Soil Conservation Service 7, VI
Transportation, Office of 7, XXXIII
World Agriculture Outlook Board 7, XXXVIII
Air Force Department 32, VII
Federal Acquisition Regulation Supplement 48, 53
Alaska Natural Gas Transportation System, Office of the Federal
Inspector 10, XV
Alcohol, Tobacco and Firearms, Bureau of 27, I
AMTRAK 49, VII
American Battle Monuments Commission 36, IV
Animal and Plant Health Inspection Service 7, III; 9, I
Appalachian Regional Commission 5, IX
Architectural and Transportation Barriers Compliance Board 36, XI
Arms Control and Disarmament Agency, U.S. 22, VI
Army Department 32, V
Engineers, Corps of 33, II; 36, III
Federal Acquisition Regulation 48, 51
Assistant Secretary for Technology Policy, Department of Commerce 37,
IV
Benefits Review Board 20, VII
Bicentennial of the United States Constitution, Commission on the 45,
XX
Bilingual Education and Minority Languages Affairs, Office of 34, V
Blind and Other Severely Handicapped, Committee for Purchase from 41,
51
Board for International Broadcasting 22, XIII
Budget, Office of Management and 5, III
Census Bureau 15, I
Central Intelligence Agency 32, XIX
Child Support Enforcement, Office of 45, III
Christopher Columbus Quincentenary Jubilee Commission 45, XXII
Civil Rights Commission 45, VII
Civil Rights, Office for (Education Department) 34, I
Claims Collection Standards, Federal 4, II
Coast Guard 33, I; 46, I, III; 49, IV
Commerce Department 44, IV
Census Bureau 15, I
Assistant Secretary for Technology Policy 37, IV
Economic Affairs, Under Secretary 37, V
Economic Analysis, Bureau of 15, VIII
Economic Development Administration 13, III
Endangered Species Committee 50, IV
Export Administration Bureau 15, VII
Federal Acquisition Regulation 48, 13
Fishery Conservation and Management 50, VI
International Trade Administration 15, III; 19, III
National Institute of Standards and Technology 15, II
National Marine Fisheries Service 50, II, IV
National Oceanic and Atmospheric Administration 15, IX; 50, II, III,
IV, VI
National Telecommunications and Information Administration 15, XXIII;
47, III
Patent and Trademark Office 37, I
Productivity, Technology and Innovation, Assistant Secretary for 37,
IV
Secretary of Commerce, Office of 15, Subtitle A
Technology Administration 15, XI
Under Secretary for Technology 37, V
United States Travel and Tourism Administration 15, XII
Commercial Space Transportation, Office of, Department of
Transportation 14, III
Commission on the Bicentennial of the United States Constitution 45,
XX
Committee for Purchase from the Blind and Other Severely Handicapped
41, 51
Commodity Credit Corporation 7, XIV
Commodity Futures Trading Commission 17, I
Community Planning and Development, Office of Assistant Secretary for
24, V, VI
Community Services, Office of 45, X
Comptroller of the Currency 12, I
Construction Industry Collective Bargaining Commission 29, IX
Consumer Product Safety Commission 16, II
Contract Appeals, Board of 7, XXIV
Cooperative State Research Service 7, XXXIV
Copyright Office 37, II
Copyright Royalty Tribunal 37, III
Cost Accounting Standards Board, Office of Federal Procurement Policy
48, 99
Council on Environmental Quality 40, V
Customs Service, United States 19, I
Defense Department 32, Subtitle A
Air Force Department 32, VII
Army Department 32, V; 33, II; 36, III, 48, 51
Engineers, Corps of 33, II; 36, III
Federal Acquisition Regulation 48, 2
Navy Department 32, VI; 48, 52
Secretary of Defense, Office of 32, I
Defense Logistics Agency 32, XII
Defense Nuclear Facilities Safety Board 10, XVII
Delaware River Basin Commission 18, III
Drug Enforcement Administration 21, II
East-West Foreign Trade Board 15, XIII
Economic Affairs, Under Secretary (Commerce) 37, V
Economic Analysis, Bureau of 15, VIII
Economic Analysis Staff, Department of Agriculture 7, XXXIX
Economic Development Administration 13, III
Economics Management Staff 7, XL
Economic Research Service 7, XXXVII
Education, Department of
Bilingual Education and Minority Languages Affairs, Office of 34, V
Civil Rights, Office for 34, I
Educational Research and Improvement, Office of 34, VII
Elementary and Secondary Education, Office of 34, II
Federal Acquisition Regulation 48, 34
Postsecondary Education, Office of 34, VI
Secretary of Education, Office of 34, Subtitle A
Special Education and Rehabilitative Services, Office of 34, III
Vocational and Adult Education, Office of 34, IV
Educational Research and Improvement, Office of 34, VII
Elementary and Secondary Education, Office of 34, II
Employees' Compensation Appeals Board 20, IV
Employees Loyalty Board, International Organizations 5, V
Employment and Training Administration 20, V
Employment Standards Administration 20, VI
Endangered Species Committee 50, IV
Energy, Department of 10, II, III, X; 41, 109
Federal Acquisition Regulation 48, 9
Federal Energy Regulatory Commission 18, I
Energy, Office of, Department of Agriculture 7, XXIX
Engineers, Corps of 33, II; 36, III
Engraving and Printing, Bureau of 31, VI
Environmental Protection Agency 40, I; 41, 115; 48, 15
Environmental Quality, Office of (Agriculture Department) 7, XXXI
Equal Employment Opportunity Commission 29, XIV
Equal Opportunity, Office of Assistant Secretary for 24, I
Executive Office of the President 3, I
Administration, Office of 5, XV
Export Administration Bureau 15, VII
Export-Import Bank of the United States 12, IV
Family Assistance, Office of 45, II
Family Support Administration 45, II, III, IV, X
Farm Credit Administration 12, VI
Farm Credit System Assistance Board 12, XIII
Farm Credit System Insurance Corporation 12, XIV
Farmers Home Administration 7, XVIII
Federal Acquisition Regulation 48, 1
Federal Aviation Administration 14, I
Federal Claims Collection Standards 4, II
Federal Communications Commission 47, I
Federal Contract Compliance Programs, Office of 41, 60
Federal Crop Insurance Corporation 7, IV
Federal Deposit Insurance Corporation 12, III
Federal Election Commission 11, I
Federal Emergency Management Agency 44, I; 48, 44
Federal Energy Regulatory Commission 18, I
Federal Financial Institutions Examination Council 12, XI
Federal Financing Bank 12, VIII
Federal Grain Inspection Service 7, VIII
Federal Highway Administration 23, I, II; 49, III
Federal Home Loan Mortgage Corporation 1, IV
Federal Housing Finance Board 12, IX
Federal Information Resources Management Regulations 41, Subtitle E,
Ch. 201
Federal Inspector for the Alaska Natural Gas Transportation System,
Office of 10, XV
Federal Labor Relations Authority, and General Counsel of the Federal
Labor Relations Authority 5, XIV; 22, XIV
Federal Law Enforcement Training Center 31, VII
Federal Maritime Commission 46, IV
Federal Mediation and Conciliation Service 29, XII
Federal Mine Safety and Health Review Commission 29, XXVII
Federal Pay, Advisory Committee on 5, IV
Federal Prison Industries, Inc. 28, III
Federal Procurement Policy Office 48, 99
Federal Property Management Regulations 41, 101
Federal Property Management Regulations System 41, Subtitle C
Federal Railroad Administration 49, II
Federal Register, Administrative Committee of 1, I
Federal Register, Office of 1, II
Federal Reserve System 12, II
Federal Retirement Thrift Investment Board 5, VI
Federal Service Impasses Panel 5, XIV
Federal Trade Commission 16, I
Federal Travel Regulation System 41, Subtitle F
Finance and Management, Department of Agriculture 7, XXX
Fine Arts Commission 45, XXI
Fiscal Service 31, II
Fish and Wildlife Service, United States 50, I, IV
Fishery Conservation and Management 50, VI
Fishing and Whaling, International Regulatory Agencies 50, III
Food and Drug Administration 21, I
Food and Nutrition Service 7, II
Food Safety and Inspection Service 9, III
Foreign Agricultural Service 7, XV
Foreign Assets Control, Office of 31, V
Foreign Claims Settlement Commission of United States 45, V
Foreign Economic Development Service 7, XXI
Foreign Service Grievance Board 22, IX
Foreign Service Impasse Disputes Panel 22, XIV
Foreign Service Labor Relations Board 22, XIV
Foreign-Trade Zones Board 15, IV
Forest Service 36, II
General Accounting Office 4, I, II, III
General Sales Manager, Office of 7, XXV
General Services Administration
Contract Appeals Board 48, 61
Federal Acquisition Regulation 48, 5
Federal Information Resources Management Regulations 41, Subtitle E,
Ch. 201
Federal Property Management Regulations System 41, 101, 105
Federal Travel Regulation System 41, Subtitle F
Payment of Expenses Connected With the Death of Certain Employees 41,
303
Reduction in Meeting and Training Allowance Payments 41, 304
Relocation Allowances 41, 302
Travel Allowances 41, 301
Geological Survey 30, IV
Government Ethics, Office of 5, XVI
Government National Mortgage Association 24, III
Grants and Program Systems, Office of 7, XXXII
Great Lakes Pilotage 46, III
Harry S. Truman Scholarship Foundation 45, XVIII
Health and Human Services, Department of 45, Subtitle A
Child Support Enforcement, Office of 45, III
Community Services, Office of 45, X
Family Assistance, Office of 45, II
Family Support Administration 45, II, III, IV, X
Federal Acquisition Regulation 48, 3
Food and Drug Administration 21, I
Health Care Financing Administration 42, IV
Human Development Services Office 45, XIII
Inspector General, Office of 42, V
Public Health Service 42, I
Refugee Resettlement, Office of 45, IV
Social Security Administration 20, III; 45, IV
Health Care Financing Administration 42, IV
Housing and Urban Development, Department of
Community Planning and Development, Office of Assistant Secretary for
24, V, VI
Equal Opportunity, Office of Assistant Secretary for 24, I
Federal Acquisition Regulation 48, 24
Government National Mortgage Association 24, III
Housing -- Federal Housing Commissioner, Office of Assistant
Secretary for 24, II, VIII, X, XX
Inspector General, Office of 24, XII
Mortgage Insurance and Loan Programs Under Emergency Homeowners'
Relief Act 24, XV
Public and Indian Housing, Office of Assistant Secretary for 24, IX
Secretary, Office of 24, Subtitle B, VII
Solar Energy and Energy Conservation Bank 24, XI
Housing -- Federal Housing Commissioner, Office of Assistant
Secretary for 24, II, VIII, X, XX
Human Development Services Office 45, XIII
Immigration and Naturalization Service 8, I
Indian Affairs, Bureau of 25, I
Indian Arts and Crafts Board 25, II
Information Agency, United States 22, V; 48, 19
Information Resources Management, Office of, Agriculture Department
7, XXVII
Information Security Oversight Office 32, XX
Inspector General, Office of, Agriculture Department 7, XXVI
Inspector General, Office of, Health and Human Services Department
42, V
Inspector General, Office of, Housing and Urban Development
Department 24, XII
Inter-American Foundation 22, X
Intergovernmental Relations, Advisory Commission on 5, VII
Interior Department
Endangered Species Committee 50, IV
Federal Acquisition Regulation 48, 14
Federal Property Management Regulations System 41, 114
Fish and Wildlife Service, United States 50, I, IV
Geological Survey 30, IV
Indian Affairs, Bureau of 25, I
Indian Arts and Crafts Board 25, II
Land Management Bureau 43, II
Minerals Management Service 30, II
Mines, Bureau of 30, VI
National Park Service 36, I
Reclamation Bureau 43, I
Secretary of the Interior, Office of 43, Subtitle A
Surface Mining and Reclamation Appeals, Board of 30, III
Surface Mining Reclamation and Enforcement, Office of 30, VII
United States Fish and Wildlife Service 50, I, IV
Internal Revenue Service 26, I
International Boundary and Water Commission, United States and Mexico
22, XI
International Cooperation and Development Office, Department of
Agriculture 7, XXII
International Development, Agency for 22, II
International Development Cooperation Agency 22, XII
International Development, Agency for 22, II
Overseas Private Investment Corporation 22, VII
International Joint Commission, United States and Canada 22, IV
International Organizations Employees Loyalty Board 5, V
International Regulatory Agencies (Fishing and Whaling) 50, III
International Trade Administration 15, III; 19, III
International Trade Commission, United States 19, II
Interstate Commerce Commission 49, X
Japan-United States Friendship Commission 22, XVI
Joint Board for the Enrollment of Actuaries 20, VIII
Justice Department 28, I; 41, 128
Drug Enforcement Administration 21, II
Federal Acquisition Regulation 48, 28
Federal Claims Collection Standards 4, II
Federal Prison Industries, Inc. 28, III
Foreign Claims Settlement Commission of the United States 45, V
Immigration and Naturalization Service 8, I
Offices of Independent Counsel 28, VI
Prisons, Bureau of 28, V
Labor Department
Benefits Review Board 20, VII
Employees' Compensation Appeals Board 20, IV
Employment and Training Administration 20, V
Employment Standards Administration 20, VI
Federal Acquisition Regulation 48, 29
Federal Contract Compliance Programs, Office of 41, 60
Federal Procurement Regulations System 41, 50
Labor-Management Relations and Cooperative Programs, Bureau of 29, II
Labor-Management Standards, Office of 29, IV
Mine Safety and Health Administration 30, I
Occupational Safety and Health Administration 29, XVII
Pension and Welfare Benefits Administration 29, XXV
Public Contracts 41, 50
Secretary of Labor, Office of 29, Subtitle A
Veterans' Employment and Training, Office of the Assistant Secretary
for 41, 61; 20, IX
Wage and Hour Division 29, V
Workers' Compensation Programs, Office of 20, I
Labor-Management Relations and Cooperative Programs, Bureau of 29, II
Labor-Management Standards, Office of 29, IV
Land Management, Bureau of 43, II
Legal Services Corporation 45, XVI
Library of Congress 36, VII
Copyright Office 37, II
Management and Budget, Office of 5, III; 48, 99
Marine Mammal Commission 50, V
Maritime Administration 46, II
Merit Systems Protection Board 5, II
Micronesian Status Negotiations, Office for 32, XXVII
Mine Safety and Health Administration 30, I
Minerals Management Service 30, II
Mines, Bureau of 30, VI
Minority Business Development Agency 15, XIV
Miscellaneous Agencies 1, IV
Monetary Offices 31, I
Mortgage Insurance and Loan Programs Under the Emergency Homeowners'
Relief Act, Department of Housing and Urban Development 24, XV
National Aeronautics and Space Administration 14, V; 48, 18
National Agricultural Library 7, XLI
National Agricultural Statistics Service 7, XXXVI
National Archives and Records Administration 36, XII
National Bureau of Standards 15, II
National Capital Planning Commission 1, IV
National Commission for Employment Policy 1, IV
National Commission on Libraries and Information Science 45, XVII
National Credit Union Administration 12, VII
National Foundation on the Arts and the Humanities 45, XI
National Highway Traffic Safety Administration 23, II, III; 49, V
National Institute of Standards and Technology 15, II
National Labor Relations Board 29, I
National Marine Fisheries Service 50, II, IV
National Mediation Board 29, X
National Oceanic and Atmospheric Administration 15, IX; 50, II, III,
IV, VI
National Park Service 36, I
National Railroad Adjustment Board 29, III
National Railroad Passenger Corporation (AMTRAK) 49, VII
National Science Foundation 45, VI; 48, 25
National Security Council 32, XXI
National Security Council and Office of Science and Technology Policy
47, II
National Telecommunications and Information Administration 15, XXIII;
47, III
National Transportation Safety Board 49, VIII
Navajo and Hopi Indian Relocation Commission 25, IV
Navy Department 32, VI; 48, 52
Neighborhood Reinvestment Corporation 24, XXV
Nuclear Regulatory Commission 10, I
Occupational Safety and Health Administration 29, XVII
Occupational Safety and Health Review Commission 29, XX
Office of Independent Counsel 28, VII
Offices of Independent Counsel, Department of Justice 28, VI
Operations Office, Department of Agriculture 7, XXVIII
Overseas Private Investment Corporation 22, VII
Oversight Board 12, XV
Packers and Stockyards Administration 9, II
Panama Canal Commission 48, 35
Panama Canal Regulations 35, I
Patent and Trademark Office 37, I
Payment of Expenses Connected With the Death of Certain Employees 41,
303
Peace Corps 22, III
Pennsylvania Avenue Development Corporation 36, IX
Pension and Welfare Benefits Administration, Department of Labor 29,
XXV
Pension Benefit Guaranty Corporation 29, XXVI
Personnel Management, Office of 5, I; 45, VIII; 48, 17
Federal Employees Health Benefits Acquisition Regulation 48, 16
Postal Rate Commission 39, III
Postal Service, United States 39, I
Postsecondary Education, Office of 34, VI
President's Commission on White House Fellowships 1, IV
Presidential Documents 3
Prisons, Bureau of 28, V
Productivity, Technology and Innovation, Assistant Secretary
(Commerce) 37, IV
Property Management Regulations System, Federal 41, Subtitle C
Public Contracts, Department of Labor 41, 50
Public Health Service 42, I
Railroad Retirement Board 20, II
Reclamation Bureau 43, I
Reduction in Meeting and Training Allowance Payments 41, 304
Refugee Resettlement, Office of 45, IV
Regional Action Planning Commissions 13, V
Relocation Allowances 41, 302
Research and Special Programs Administration 49, I
Resolution Trust Corporation 12, XVI
Rural Electrification Administration 7, XVII
Rural Telephone Bank 7, XVI
Saint Lawrence Seaway Development Corporation 33, IV
Science and Technology Policy, Office of 32, XXIV
Science and Technology Policy, Office of, and National Security
Council 47, II
Secret Service 31, IV
Securities and Exchange Commission 17, II
Selective Service System 32, XVI
Small Business Administration 13, I; 48, 22
Smithsonian Institution 36, V
Social Security Administration 20, III; 45, IV
Soil Conservation Service 7, VI
Solar Energy and Energy Conservation Bank, Department of Housing and
Urban Development 24, XI
Soldiers' and Airmen's Home, United States 5, XI
Special Counsel, Office of 5, VIII
Special Education and Rehabilitative Services, Office of 34, III
State Department 22, I
Federal Acquisition Regulation 48, 6
Surface Mining and Reclamation Appeals, Board of 30,III
Susquehanna River Basin Commission 18, VIII
Technology Administration 15, XI
Tennessee Valley Authority 18, XIII
Thrift Supervision Office, Department of the Treasury 12, V
Trade Representative, United States, Office of 15, XX
Transportation, Department of 44, IV
Coast Guard 33, I; 46, I, III; 49, IV
Commercial Space Transportation, Office of 14, III
Contract Appeals Board 48, 63
Federal Acquisition Regulation 48, 12
Federal Aviation Administration 14, I
Federal Highway Administration 23, I, II; 49, III
Federal Railroad Administration 49, II
Maritime Administration 46, II
National Highway Traffic Safety Administration 23, II, III; 49, V
Research and Special Programs Administration 49, I
Saint Lawrence Seaway Development Corporation 33, IV
Secretary of Transportation, Office of 14, II; 49, Subtitle A
Urban Mass Transportation Administration 49, VI
Transportation, Office of, Department of Agriculture 7, XXXIII
Travel Allowance 41, 301
Travel and Tourism Administration, United States 15, XII
Treasury Department 17, IV
Alcohol, Tobacco and Firearms, Bureau of 27, I
Comptroller of the Currency 12, I
Customs Service, United States 19, I
Engraving and Printing, Bureau of 31, VI
Federal Acquisition Regulation 48, 10
Federal Law Enforcement Training Center 31, VII
Fiscal Service 31, II
Foreign Assets Control, Office of 31, V
Internal Revenue Service 26, I
Monetary Offices 31, I
Secret Service 31, IV
Secretary of the Treasury, Office of 31, Subtitle A
Thrift Supervision Office 12, V
United States Customs Service 19, I
Truman, Harry S. Scholarship Foundation 45, XVIII
Under Secretary for Technology, Department of Commerce 37, V
United States and Canada, International Joint Commission 22, IV
United States Arms Control and Disarmament Agency 22, VI
United States Customs Service 19, I
United States Fish and Wildlife Service 50, I, IV
United States Information Agency 22, V; 48, 19
United States International Development Cooperation Agency 22, XII
United States International Trade Commission 19, II
United States Postal Service 39, I
United States Soldiers' and Airmen's Home 5, XI
United States Trade Representative, Office of 15, XX
United States Travel and Tourism Adminstration 15, XII
Urban Mass Transportation Administration 49, VI
Veterans Affairs Department 38, I; 48, 8
Veterans' Employment and Training, Office of the Assistant Secretary
for 41, 61; 20, IX
Vice President of the United States, Office of 32, XXVIII
Vocational and Adult Education, Office of 34, IV
Wage and Hour Division 29, V
Water Resources Council 18, VI
Workers' Compensation Programs, Office of 20, I
World Agriculture Outlook Board 7, XXXVIII
21 CFR 1250.96 21 CFR (4-1-92 Edition)
21 CFR 1250.96 List of CFR Sections Affected
21 CFR 1250.96 List of CFR Sections Affected
All changes in this volume of the Code of Federal Regulations which
were made by documents published in the Federal Register since January
1, 1986, are enumerated in the following list. Entries indicate the
nature of the changes effected. Page numbers refer to Federal Register
pages. The user should consult the entries for chapters and parts as
well as sections for revisions.
For the period before January 1, 1986, see the ''List of CFR Sections
Affected'', 1949-1963, 1964-1972, and 1973-1985, published in seven
separate volumes.
21 CFR 1250.96 1986
21 CFR
51 FR
Page
Chapter I
Mandatory compliance date 1-1-89 34085
807 Authority citation revised 33032
807.31 (c) revised 33033
814 Added 26364
Technical correction 34589
Authority citation revised 43344
814.15 (b) heading correctly revised 40415
Amended (OMB number) 43344
814.20 (b)(3)(v) introductory text corrected 40415
Amended (OMB number) 43344
814.39 Amended (OMB number) 43344
814.82 Amended (OMB number) 43344
814.84 Amended (OMB number) 43344
868 Authority citation revised 40388
868.5795 Added 40388
868.5800 Added 40389
874 Added 40389
882 Authority citation revised 12101
882.5830 (c) added 12101
Technical correction 15883
884 Authority citation revised 16649, 39845
884.1600 (c) added 39845
884.5360 (d) added 16649
21 CFR 1250.96 1987
21 CFR
52 FR
Page
Chapter I
805 Added 27763
862 Added 16122
862.1385 (a) corrected 29468
862.3750 (b) corrected 48623
864 Authority citation revised; section authority citations removed
17732
864.1 Revised 17732
864.3 Added 17732
864.5220 (c) added 17733
864.5680 (c) added 17733
864.7250 (c) added 17733
864.7300 (c) added 17733
864.9205 (c) added 17733
864.9245 (c) added 17733
866 Authority citation revised; section authority citations removed
17733
866.1 Revised 17733
866.3 Added 17733
(b) and (c) corrected 22577
866.2420 (c) added 17734
866.3290 (c) added 17734
866.3305 (c) added 17734
866.3510 (c) added 17734
866.6010 (c) added 17734
868 Authority citation revised; section authority citations removed
17734
868.1 Revised 17734
868.3 Added 17734
868.1120 (c) added 17735
(c) corrected 22577
868.1150 (c) added 17735
868.1170 (c) added 17735
868.1200 (c) added 17735
868.2450 (c) added 17735
868.2500 (c) added 17735
868.5400 (c) added 17735
868.5610 (c) added 17735
870 Authority citation revised; section authority citations removed
17735
870.1 Revised 17735
870.3 Added 17735
870.1025 (c) added 17736
870.1350 (c) added 17736
870.1360 (c) added 17736
870.3300 (c) added 17736
870.3375 (c) added 17736
870.3450 (c) added 17736
870.3535 (c) added 17736
870.3545 (c) added 17736
870.3600 (c) added 17736
870.3610 (c) added 17736
870.3620 (c) added 17736
870.3680 (c) added 17736
870.3700 (c) added 17736
870.3710 (c) added 17736
870.3800 (c) added 17736
870.3850 (c) added 17736
870.3925 (c) added 17737
(c) revised; eff. 12-9-87 18163
(c) corrected 23137
870.4230 (c) added 17737
870.4260 (c) added 17737
870.4320 (c) added 17737
870.4350 (c) added 17737
870.4360 (c) added 17737
870.5200 (c) added 17737
870.5225 (c) added 17737
870.5300 (c) added 17737
870.5550 (c) added 17737
872 Added 30097
872.3680 (a) corrected 34456
872.6080 (a), (b), and (c) corrected 49250
874.9 Added 32111
874.1100 Correctly designated 18495
(b) revised 32111
874.3540 (b) revised 32111
874.4420 (b) revised 32111
874.5800 (b) revised 32111
876 Authority citation revised; section authority citations removed
17737
876.1 Revised 17737
(d) corrected 22577
876.3 Added 17737
876.3350 (c) added 17738
876.3630 (c) added 17738
876.3750 (c) added 17738
876.4480 (c) added 17738
876.5220 (c) added 17738
876.5270 (c) added 17738
876.5280 (c) added 17738
876.5540 (c) added 17738
876.5860 (c) added 17738
876.5870 (c) added 17738
876.5955 (c) added 17738
880 Authority citation revised; section authority citations removed
17738
880.1 Revised 17738
880.3 Added 17738
880.5130 (c) added 17739
880.5760 (c) added 17739
882 Authority citation revised; section authority citations removed
17739
882.1 Revised 17739
882.3 Added 17739
882.1790 (c) added 17739
882.1825 (c) added 17740
882.5150 (c) added 17740
882.5800 (c) added 17740
882.5840 (c) added 17740
882.5850 (c) added 17740
882.5860 (c) added 17740
882.5940 (c) added 17740
882.5950 (c) added 17740
884 Authority citation revised; section authority citations removed
17740
884.1 Revised 17740
884.3 Added 17740
884.1060 (c) added 17741
884.1100 (c) added 17741
884.1185 (c) added 17741
884.2050 (c) added 17741
884.2620 (c) added 17741
884.2685 (c) added 17741
884.4100 (c) added 17741
884.4150 (c) added 17741
884.4250 (c) added 17741
884.4270 (c) added 17741
884.5050 (c) added 17741
884.5225 (c) added 17741
884.5380 (c) added 17741
(c) revised 36883
Technical correction 38171
884.5940 (c) added 17741
886 Added 33355
888 Added 33702
Technical correction 36863
890 Authority citation revised; section authority citations removed
17741
890.1 Revised 17741
890.3 Added 17741
890.3610 (c) added 17742
890.3890 (c) added 17742
(c) corrected 22577
890.5275 (c) added 17742
890.5290 (c) added 17742
890.5300 (c) added 17742
890.5525 (c) added 17742
890.5860 (c) added 17742
1240 Authority citation revised 29514
1240.61 Added 29514
21 CFR 1250.96 1988
21 CFR
53 FR
Page
Chapter I
Uniform compliance date 1-1-91 44861
800 Authority citation revised; section authority citations removed
11252
800.12 Second (c) removed 11252
803.33 (b) amended 11252
807.22 (a) amended 11252
807.35 (b) amended 11252
807.37 (a) and (b)(2) amended 11252
807.90 (a) amended 11252
807.95 (c)(1) amended 11252
808.87 (a) amended 11252
808.98 (a) revised 35314
809.5 (a) (1), (2), (3), and (4) and (b) amended 11252
812.2 (e) amended 11252
812.19 Amended 11252
812.20 (b)(9) and (d) amended 11252
812.38 (d) amended 11253
813.20 (a) amended 11253
813.38 (b) and (c) amended 11253
813.119 (e)(2) amended 11253
813.160 (a) introductory text amended 11253
820.1 (d) amended 11253
820.3 (f) amended 11253
860.7 (g)(4) amended 11253
860.123 (b)(1) amended 11253
861.32 (b) and (c)(5) amended 11253
862.9 Added 21448
862.1190 (b) corrected 11645
(b) revised 21449
862.1210 (b) revised 21449
862.1255 (b) revised 21449
862.1290 (b) revised 21449
862.1295 (b) corrected 11645
862.1305 (b) revised 21449
862.1320 (b) revised 21449
862.1365 (b) revised 21449
862.1380 (b) revised 21449
862.1420 (b) revised 21449
862.1470 (b) revised 21449
862.1490 (b) revised 21449
862.1515 (b) revised 21449
862.1565 (b) revised 21449
862.1575 (b) revised 21449
862.1640 (b) revised 21449
862.1670 (b) revised 21449
862.1680 (b) corrected 11645
862.1695 Redundant printing correctly removed 11645
862.1700 Redundant printing correctly removed 11645
862.1705 Redundant printing correctly removed 11645
862.1720 (b) corrected 11645
(b) revised 21449
862.1815 (b) revised 21449
862.2100 (b) revised 21449
862.3750 (b) revised 21450
862.3850 (b) revised 21450
Technical correction 25050
864.9050 (a) amended 11253
864.9160 (a) amended 11253
866 Technical correction 16837
866.5240 (a) amended 11253
866.5890 (a) amended 11253
876 Technical correction 16837
876.5830 (a) amended 11253
878 Added 23872
882.5840 (c) revised 48621
884.2980 Added 1566
Technical correction 5080
884.2982 Added 1566
Technical correction 5080
886.9 Added 35603
886.1040 (b) revised 35603
886.1140 (b) revised 35603
886.1150 (b) revised 35603
(b) corrected 40825
886.1170 (b) revised 35603
886.1190 (b) revised 35603
886.1200 (b) revised 35604
886.1270 (b) revised 35604
886.1320 (b) revised 35604
886.1330 (b) revised 35604
886.1350 (b) revised 35604
886.1375 (b) revised 35604
886.1380 (b) revised 35604
886.1390 (b) revised 35604
886.1395 (b) revised 35604
886.1400 (b) revised 35604
886.1410 (b) revised 35604
886.1415 (b) revised 35604
886.1420 (b) revised 35604
886.1460 (b) revised 35605
886.1500 (b) revised 35605
886.1605 (b) revised 35605
886.1650 (b) revised 35605
886.1655 (b) revised 35605
886.1660 (b) revised 35605
886.1665 (b) revised 35605
886.1700 (b) revised 35605
886.1770 (b) revised 35605
886.1790 (b) revised 35605
(b) corrected 40825
886.1800 (b) revised 35605
886.1810 (b) revised 35605
886.1840 (b) revised 35605
Heading corrected 40825
886.1860 (b) revised 35606
886.1870 (b) revised 35606
886.1880 (b) revised 35606
886.1905 (b) revised 35606
886.1910 (b) revised 35606
886.4230 (b) revised 35606
886.4335 (b) revised 35606
886.4350 (b) revised 35606
886.4360 (b) revised 35606
886.4392 Added 38947
886.4445 (b) revised 35606
886.4570 (b) revised 35606
886.4770 (b) revised 35606
886.4855 (b) revised 35606
886.5120 (b) revised 35607
886.5420 (b) revised 35607
886.5540 (b) revised 35607
886.5600 (b) revised 35607
886.5800 (b) revised 35607
886.5810 (b) revised 35607
886.5840 (b) revised 35607
886.5844 (b) revised 35607
886.5870 (b) revised 35607
886.5910 (b) revised 35607
886.5915 (b) revised 35607
888.9 Added 52953
888.4200 (b) revised 52953
888.4210 (b) revised 52953
888.4220 (b) revised 52954
888.4230 (b) revised 52954
888.5890 (b) revised 52954
888.5940 (b) revised 52954
888.5980 (b) revised 52954
892 Added 1567
Technical correction 5080
895 Technical correction 16837
895.21 (d)(1) amended 11254
1002 Technical correction 16837
1002.7 Nomenclature change 11254
1002.10 Introductory text amended 11254
1002.20 (a) and (b) introductory text and (5) amended 11254
1002.31 (c) amended 11254
1002.41 (a)(1) amended 11254
1002.50 (a) introductory text and (b) amended 11254
1002.51 Amended 11254
1005.11 Amended 11254
1005.25 (b) and (c) amended 11254
1010 Authority citation revised 52683
1010.2 (c) and (d) amended 11254
1010.3 (a)(1) and (2)(i), (b), and (c) amended 11254
1010.4 (a) introductory text, (b)(1)(viii), (c) (1) and (3) amended
11254
(a) revised; (c)(2) removed; (c) (3) and (4) redesignated as (c)
(2) and (3) 52683
1010.5 (a) introductory text, (b), (c)(12), and (e) (1) and (2)
amended 11254
1010.13 Amended 11254
1020.30 (c) and (d) introductory text and (3)(ii) amended 11254
1020.32 (a)(1) amended 11254
1030 Authority citation revised 11254
1030.10 (c)(4)(iv), (5)(iv), and (6) (iii), (iv) introductory text
and (d) amended 11254
1040.30 (c)(1)(ii) amended 11254
1050 Authority citation revised 11255
1050.10 (d)(5) amended 11255
21 CFR 1250.96 1989
21 CFR
54 FR
Page
Chapter I
800 Authority citation revised 39640
801 Authority citation revised; sectional authority citations
removed 39640
801.420 (c)(4) amended; eff. 6-19-90 52396
801.430 (e) and (f) redesignated as (g) and (h); (b), (d)
introductory text, (2), (3), and (4), new (g), and new (h) revised; new
(e) and new (f) added 43771
803 Authority citation revised 39640
805 Authority citation revised 39640
807 Authority citation revised; sectional authority citations
removed 39640
808 Authority citation revised 39640
809 Authority citation revised; sectional authority citations
removed 39640
812 Authority citation revised; sectional authority citations
removed 39640
813 Authority citation revised; sectional authority citations
removed 39641
814 Authority citation revised 39641
820 Authority citation revised 39641
860 Authority citation revised 39641
861 Authority citation revised 39641
861.26 Authority citation removed 39641
862 Authority citation revised 39641
862.1113 Added 30206
864 Authority citation revised 39641
864.9 Added 25043
Effective date added 26958
864.1850 (b) revised 25044
Effective date added 26958
864.2220 (b) revised 25044
Effective date added 26958
864.2240 (b) revised 25044
Effective date added 26958
864.2260 (b) revised 25044
Effective date added 26958
864.2360 (b) revised 25044
Effective date added 26958
864.2800 (b) revised 25044
Effective date added 26958
864.2875 (b) revised 25044
Effective date added 26958
864.3010 (b) revised 25044
Effective date added 26958
864.3250 (b) revised 25044
Effective date added 26958
Revised 47206
864.3300 (b) revised 25044
Effective date added 26958
864.3400 (b) revised 25044
Effective date added 26958
864.3600 (b) revised 25044
Effective date added 26958
864.3800 (b) revised 25044
Effective date added 26958
864.3875 (b) revised 25045
Effective date added 26958
864.4010 (b) revised 25045
Effective date added 26958
864.4400 (b) revised 25045
Effective date added 26958
864.5800 (b) revised 25045
Effective date added 26958
864.5850 (b) revised 25045
Effective date added 26958
864.6150 (b) revised 25045
Effective date added 26958
864.6160 (b) revised 25045
Effective date added 26958
864.6600 (b) revised 25045
Effective date added 26958
864.6700 (b) revised 25045
Effective date added 26958
864.8200 (b) revised 25045
Effective date added 26958
864.8540 (b) revised 25045
Effective date added 26958
866 Authority citation revised 39641
866.9 Added 25045
Effective date added 26958
866.2050 (b) revised 25045
Effective date added 26958
866.2170 (b) revised 25045
Effective date added 26958
866.2300 (b) revised 25046
Effective date added 26958
866.2320 (b) revised 25046
Effective date added 26958
866.2330 (b) revised 25046
Effective date added 26958
866.2350 (b) revised 25046
Effective date added 26958
866.2360 (b) revised 25046
Effective date added 26958
866.2450 (b) revised 25046
Effective date added 26958
866.2480 (b) revised 25046
Effective date added 26958
866.2500 (b) revised 25046
Effective date added 26958
866.2560 (b) revised 25046
Effective date added 26958
866.2580 (b) revised 25046
Effective date added 26958
866.3010 (b) revised 25046
Effective date added 26958
866.3020 (b) revised 25046
Effective date added 26958
866.3035 (b) revised 25046
Effective date added 26958
866.3065 (b) revised 25046
Effective date added 26958
866.3125 (b) revised 25046
Effective date added 26958
866.3205 (b) revised 25046
Effective date added 26958
866.3250 (b) revised 25046
Effective date added 26958
866.3255 (b) revised 25046
Effective date added 26958
866.3270 (b) revised 25046
Effective date added 26958
866.3330 (b) revised 25047
Effective date added 26958
866.3340 (b) revised 25047
Effective date added 26958
866.3400 (b) revised 25047
Effective date added 26958
866.3410 (b) revised 25047
Effective date added 26958
866.3470 (b) revised 25047
Effective date added 26958
866.3490 (b) revised 25047
Effective date added 26958
866.3520 (b) revised 25047
Effective date added 26958
866.3630 (b) revised 25047
Effective date added 26958
866.3700 (b) revised 25047
Effective date added 26958
866.4500 (b) revised 25047
Effective date added 26958
866.4520 (b) revised 25047
Effective date added 26958
866.4540 (b) revised 25047
Effective date added 26958
866.4600 (b) revised 25047
Effective date added 26958
866.4830 (b) revised 25047
Effective date added 26958
866.4900 (b) revised 25047
Effective date added 26958
866.5800 (b) revised 25047
Effective date added 26958
868 Authority citation revised 39641
868.9 Added 25047
Effective date added 26958
868.1030 (b) revised 25048
Effective date added 26958
868.1930 (b) revised 25048
Effective date added 26958
868.1965 (b) revised 25048
Effective date added 26958
868.2480 Added 27160
868.5220 (b) revised 25048
Effective date added 26958
868.5280 (b) revised 25048
Effective date added 26958
868.5365 (b) revised 25048
Effective date added 26958
868.5420 (b) revised 25048
Effective date added 26958
868.5560 (b) revised 25048
Effective date added 26958
868.5760 (b) revised 25048
Effective date added 26958
868.6100 (b) revised 25048
Effective date added 26958
868.6175 (b) revised 25048
Effective date added 26958
868.6225 (b) revised 25048
Effective date added 26958
868.6700 (b) revised 25049
Effective date added 26958
870 Authority citation revised 39641
870.9 Added 25049
Effective date added 26958
870.3730 (b) revised 25049
Effective date added 26958
870.4200 (b) revised 25049
Effective date added 26958
870.4500 (b) revised 25049
Effective date added 26958
872 Authority citation revised 39641
872.9 Added 13829
872.1730 (b) revised 13830
872.1905 (b) revised 13830
872.3080 (b) revised 13830
872.3110 (b) revised 13830
872.3140 (b) revised 13830
872.3150 (b) revised 13830
872.3220 (b) revised 13830
872.3830 (b) revised 13830
872.3840 (b) revised 13830
872.3850 (b) revised 13830
872.4565 (b) revised 13830
872.6010 (b) revised 13830
872.6050 (b) revised 13830
872.6200 (b) revised 13830
872.6290 (b) revised 13831
872.6390 (b) revised 13831
872.6570 (b) revised 13831
872.6650 (b) revised 13831
872.6670 (b) revised 13831
872.6855 (b) revised 13831
872.6870 (b) revised 13831
872.6880 (b) revised 13831
874 Authority citation revised 39641
876 Authority citation revised 39641
876.9 Added 25049
Effective date added 26958
876.4370 (b)(2) revised 25049
Effective date added 26958
876.4530 (b) revised 25049
Effective date added 26958
876.4560 (b) revised 25049
Effective date added 26958
876.4730 (b) revised 25049
Effective date added 26958
876.4890 (b)(2) revised 25050
Effective date added 26958
876.5030 (b) revised 25050
Effective date added 26958
876.5820 (b)(2) revised 25050
Effective date added 26958
876.5900 (b) revised 25050
Effective date added 26958
876.5920 (b) revised 25050
Effective date added 26958
878 Authority citation revised 39641
878.9 Added 13827
(b) corrected 16438-T
878.1800 (b) revised 13827
878.3250 (b) revised 13827
878.3910 (b) revised 13827
878.3925 (b) revised 13827
878.4160 (b) revised 13827
878.4800 (b) revised 13827
878.4830 Added 50738
878.4950 (b) revised 13828
878.5900 (b) revised 13828
880 Authority citation revised 39641
880.9 Added 25050
Effective date added 26958
880.5110 (b) revised 25050
Effective date added 26958
880.5120 (b) revised 25050
Effective date added 26958
880.5510 (b) revised 25050
Effective date added 26958
880.6150 (b) revised 25050
Effective date added 26958
880.6175 Removed 47206
880.6250 (b) revised; eff. 4-13-89 1604
Technical correction 6804
880.6280 (b) revised 25050
Effective date added 26958
880.6970 (b) revised 25050
Effective date added 26958
882 Authority citation revised 39641
882.9 Added 25051
Effective date added 26958
882.1200 (b) revised 25051
Effective date added 26958
882.1500 (b) revised 25051
Effective date added 26958
882.1525 (b) revised 25051
Effective date added 26958
882.1700 (b) revised 25051
Effective date added 26958
882.1750 (b) revised 25051
Effective date added 26958
882.4215 (b) revised 25051
Effective date added 26958
882.4650 (b) revised 25051
Effective date added 26958
884 Authority citation revised 39641
884.9 Added 25051
Effective date added 26958
884.2900 (b) revised 25052
Effective date added 26958
884.4520 (b) revised 25052
Effective date added 26958
884.5920 (b) revised 25052
Effective date added 26958
886 Authority citation revised 39641
888 Authority citation revised 39641
888.3353 Added 48239
(a) corrected 51342
890 Authority citation revised 39641
890.9 Added 25052
Effective date added 26958
890.3700 (b) revised 25052
Effective date added 26958
890.5125 (b) revised 25052
Effective date added 26958
892 Authority citation corrected 6804
Authority citation revised 39641
892.9 Added 13831
892.1000 Added 5078
892.1370 (b) revised 13832
892.1380 (b) revised 13832
892.1400 (b) revised 13832
892.1420 (b) revised 13832
895 Authority citation revised 39641
895.101 Authority citation removed 39641
1000 Authority citation revised 39642
1000.50 Authority citation removed 39641
1002 Authority citation revised; sectional authority citations
removed 39642
1003 Authority citation revised; sectional authority citations
removed 39642
1004 Authority citation revised 39642
1005 Authority citation revised; sectional authority citations
removed 39642
1010 Authority citation revised; sectional authority citations
removed 39642
1020 Authority citation revised 39642
1020.33 Authority citation removed 39642
1030 Authority citation revised 39642
1040 Authority citation revised 39642
1040.30 Authority citation removed 39642
1050 Authority citation revised 39642
1210 Authority citation revised 39642
1220 Authority citation revised 39642
1220.40 Authority citation removed 39642
1230 Authority citation revised 39642
1240 Cross-references revised 24900
Authority citation revised 39642
1240.10 (f) amended 24900
1240.62 (c)(1) (i) through (v) and (2) amended 24900
1240.70 (a) revised 24900
1250 Cross-references revised 24900
Authority citation revised 39642
1250.51 (d), (f) (1), (2), (3) introductory text, and (4) (i) and
(iii) amended 24900
21 CFR 1250.96 1990
21 CFR
55 FR
Page
Chapter I
800.20 Added 51256
801 Policy statement 7491
Technical correction 10347
801.420 Technical correction 548
801.430 (f)(2) amended; (f)(2) figure 1 revised 17600
803.33 (b) amended 11168
807.22 (a) amended 11169
807.37 (a) and (b)(2) amended 11169
807.90 (a) revised 11169
812.19 Amended 11169
813.20 (a) amended 11169
814.20 (h) amended 11169
820.1 (d) amended 11169
860.123 (b)(1) amended 11169
864.5220 (b) and (c) revised 23511
872.3100 Added 48439
872.3530 Added 48439
872.4200 Added 48439
872.4620 Added 48439
872.6250 Added 48439
872.6475 Added 48439
872.6510 Added 48439
872.6640 Added 48439
872.6710 Added 48439
872.6865 Added 48440
874.1070 Added 48440
874.1800 Added 48440
874.4750 Added 48440
874.4770 Added 48440
874.5300 Added 48440
874.5550 Added 48440
878.4635 Added 48440
878.4700 Added 48440
878.4820 Added 48440
878.4960 Added 48440
884.2980 (a) added 48440
884.2982 (a) revised 48441
886.1050 Added 48441
886.1070 Added 48441
886.1090 Added 48441
886.1120 Added 48441
886.1140 Revised 48441
886.1160 Added 48441
886.1250 Revised 48441
886.1290 Added 48441
886.1300 Added 48441
886.1340 Added 48441
886.1350 Revised 48441
886.1425 Added 48442
886.1430 Added 48442
886.1435 Added 48442
886.1450 Added 48442
886.1605 Revised 48442
886.1680 Added 48442
886.1690 Added 48442
886.1700 Revised 48442
886.1780 Revised 48442
(a) corrected 51799
886.1810 Revised 48442
886.1860 Revised 48442
886.1870 Revised 48442
886.1910 Revised 48442
(a) corrected 51799
886.1940 Added 48443
886.1945 Revised 48443
886.4070 Revised 48443
(a) corrected 51799
886.4250 Revised 48443
886.4335 Revised 48443
886.4370 Revised 48443
886.4855 Revised 48443
886.5820 Added 48443
886.5900 Revised 48443
886.5915 Revised 48443
888.1500 Added 48443
888.5960 Added 48443
892.1100 Added 48443
892.1110 Added 48444
892.1130 Added 48444
892.1300 Added 48444
892.1320 Added 48444
892.1330 Added 48444
892.1350 Added 48444
892.1410 Added 48444
892.1640 Added 48444
892.1890 Added 48444
892.1900 Added 48444
892.1970 Added 48444
1220.40 (a) revised 33671
Correctly designated 34797
21 CFR 1250.96 1991
21 CFR
56 FR
Page
Chapter I
801 Policy statement corrected 2677
812 Clarification 29177
Regulation at 29177 corrected 32241
Extension of applicability 35815
878 Technical corrections 36871
878.3540 (c) revised 14627
878.4493 Added 47151
878.5000 Added 24685
878.5010 Added 24685
878.5020 Added 24685
1020 Authority citation revised 36098
1020.33 (f)(2)(ii) removed; (f)(2)(iii) redesignated as (f)(2)(ii)
36098
1220.40 (a) revised 50250
21
Food and Drugs
PARTS 800 TO 1299
Revised as of April 1, 1992
CONTAINING
A CODIFICATION OF DOCUMENTS
OF GENERAL APPLICABILITY
AND FUTURE EFFECT
AS OF APRIL 1, 1992
With Ancillaries
Published by
the Office of the Federal Register
National Archives and Records
Administration
as a Special Edition of
the Federal Register
Washington, DC 20402-9328
21 CFR 1250.96 Table of Contents
Page
Explanation v
Title 21:
Chapter I -- Food and Drug Administration, Department of Health and
Human Services (Continued)
Finding Aids:
Material Approved for Incorporation by Reference
Table of CFR Titles and Chapters
Alphabetical List of Agencies Appearing in the CFR
List of CFR Sections Affected
21 CFR 1250.96 Explanation
The Code of Federal Regulations is a codification of the general and
permanent rules published in the Federal Register by the Executive
departments and agencies of the Federal Government. The Code is divided
into 50 titles which represent broad areas subject to Federal
regulation. Each title is divided into chapters which usually bear the
name of the issuing agency. Each chapter is further subdivided into
parts covering specific regulatory areas.
Each volume of the Code is revised at least once each calendar year
and issued on a quarterly basis approximately as follows:
Title 1 through Title 16 as of January 1
Title 17 through Title 27 as of April 1
Title 28 through Title 41 as of July 1
Title 42 through Title 50 as of October 1
The appropriate revision date is printed on the cover of each volume.
LEGAL STATUS
The contents of the Federal Register are required to be judicially
noticed (44 U.S.C. 1507). The Code of Federal Regulations is prima facie
evidence of the text of the original documents (44 U.S.C. 1510).
HOW TO USE THE CODE OF FEDERAL REGULATIONS
The Code of Federal Regulations is kept up to date by the individual
issues of the Federal Register. These two publications must be used
together to determine the latest version of any given rule.
To determine whether a Code volume has been amended since its
revision date (in this case, April 1, 1992), consult the ''List of CFR
Sections Affected (LSA),'' which is issued monthly, and the ''Cumulative
List of Parts Affected,'' which appears in the Reader Aids section of
the daily Federal Register. These two lists will identify the Federal
Register page number of the latest amendment of any given rule.
EFFECTIVE AND EXPIRATION DATES
Each volume of the Code contains amendments published in the Federal
Register since the last revision of that volume of the Code. Source
citations for the regulations are referred to by volume number and page
number of the Federal Register and date of publication. Publication
dates and effective dates are usually not the same and care must be
exercised by the user in determining the actual effective date. In
instances where the effective date is beyond the cut-off date for the
Code a note has been inserted to reflect the future effective date. In
those instances where a regulation published in the Federal Register
states a date certain for expiration, an appropriate note will be
inserted following the text.
OMB CONTROL NUMBERS
The Paperwork Reduction Act of 1980 (Pub. L. 96-511) requires Federal
agencies to display an OMB control number with their information
collection request. Many agencies have begun publishing numerous OMB
control numbers as amendments to existing regulations in the CFR. These
OMB numbers are placed as close as possible to the applicable
recordkeeping or reporting requirements.
OBSOLETE PROVISIONS
Provisions that become obsolete before the revision date stated on
the cover of each volume are not carried. Code users may find the text
of provisions in effect on a given date in the past by using the
appropriate numerical list of sections affected. For the period before
January 1, 1986, consult either the List of CFR Sections Affected,
1949-1963, 1964-1972, or 1973-1985, published in seven separate volumes.
For the period beginning January 1, 1986, a ''List of CFR Sections
Affected'' is published at the end of each CFR volume.
INCORPORATION BY REFERENCE
What is incorporation by reference? Incorporation by reference was
established by statute and allows Federal agencies to meet the
requirement to publish regulations in the Federal Register by referring
to materials already published elsewhere. For an incorporation to be
valid, the Director of the Federal Register must approve it. The legal
effect of incorporation by reference is that the material is treated as
if it were published in full in the Federal Register (5 U.S.C. 552(a)).
This material, like any other properly issued regulation, has the force
of law.
What is a proper incorporation by reference? The Director of the
Federal Register will approve an incorporation by reference only when
the requirements of 1 CFR part 51 are met. Some of the elements on
which approval is based are:
(a) The incorporation will substantially reduce the volume of
material published in the Federal Register.
(b) The matter incorporated is in fact available to the extent
necessary to afford fairness and uniformity in the administrative
process.
(c) The incorporating document is drafted and submitted for
publication in accordance with 1 CFR part 51.
Properly approved incorporations by reference in this volume are
listed in the Finding Aids at the end of this volume.
What if the material incorporated by reference cannot be found? If
you have any problem locating or obtaining a copy of material listed in
the Finding Aids of this volume as an approved incorporation by
reference, please contact the agency that issued the regulation
containing that incorporation. If, after contacting the agency, you
find the material is not available, please notify the Director of the
Federal Register, National Archives and Records Administration,
Washington DC 20408, or call (202) 523-4534.
CFR INDEXES AND TABULAR GUIDES
A subject index to the Code of Federal Regulations is contained in a
separate volume, revised annually as of January 1, entitled CFR Index
and Finding Aids. This volume contains the Parallel Table of Statutory
Authorities and Agency Rules (Table I), and Acts Requiring Publication
in the Federal Register (Table II). A list of CFR titles, chapters, and
parts and an alphabetical list of agencies publishing in the CFR are
also included in this volume.
An index to the text of ''Title 3 -- The President'' is carried
within that volume.
The Federal Register Index is issued monthly in cumulative form.
This index is based on a consolidation of the ''Contents'' entries in
the daily Federal Register.
A List of CFR Sections Affected (LSA) is published monthly, keyed to
the revision dates of the 50 CFR titles.
REPUBLICATION OF MATERIAL
There are no restrictions on the republication of material appearing
in the Code of Federal Regulations.
INQUIRIES AND SALES
For a summary, legal interpretation, or other explanation of any
regulation in this volume, contact the issuing agency. Inquiries
concerning editing procedures and reference assistance with respect to
the Code of Federal Regulations may be addressed to the Director, Office
of the Federal Register, National Archives and Records Administration,
Washington, DC 20408 (telephone 202-523-3517). All mail order sales are
handled exclusively by the Superintendent of Documents, Attn: New
Orders, P.O. Box 371954, Pittsburgh, PA 15250-7954. Charge orders may
be telephoned to the Government Printing Office order desk at
202-783-3238.
Martha L. Girard,
Director,
Office of the Federal Register.
April 1, 1992.
21 CFR 1250.96 THIS TITLE
Title 21 -- Food and Drugs is composed of nine volumes. The parts in
these volumes are arranged in the following order: Parts 1-99, 100-169,
170-199, 200-299, 300-499, 500-599, 600-799, 800-1299 and 1300-End. The
first eight volumes, containing parts 1-1299, comprise Chapter I -- Food
and Drug Administration, Department of Health and Human Services. The
ninth volume, containing part 1300 to End, includes Chapter II -- Drug
Enforcement Administration, Department of Justice. The contents of
these volumes represent all current regulations codified under this
title of the CFR as of April 1, 1992.
The Table of Exempted Prescription Products to part 1308 appears in
the volume containing part 1300-End.
Redesignation tables for Chapter I -- Food and Drug Administration
appear in the Finding Aids section for the volumes containing parts
170-199 and 500-599.
For this volume, Don Zero II was Chief Editor. The Code of Federal
Regulations publication program is under the direction of Richard L.
Claypoole, assisted by Alomha S. Morris.
21 CFR 0.0 21 CFR Ch. II (4-1-92 Edition)
21 CFR 0.0 Drug Enforcement Administration, Justice
21 CFR 0.0 Title 21-Food and Drugs
21 CFR 0.0 (This book contains part 1300 to End)
Part
chapter ii -- Drug Enforcement Administration, Department of Justice
1301
Cross References: U.S. Customs Service, Department of the Treasury:
See Customs Duties, 19 CFR chapter I.
Regulations of the Public Health Service, Department of Health and
Human Services, applying to narcotic addicts: See Public Health, 42 CFR
part 2.
Regulations of the Food and Drug Administration, Department of
Health, and Human Services, applying to drugs used for the treatment of
narcotic addicts: See Food and Drugs, 21 CFR part 29.
Editorial Note: Other regulations issued by the Department of
Justice appear in title 4, title 8, title 28.
21 CFR 0.0 21 CFR Ch. II (4-1-92 Edition)
21 CFR 0.0 Drug Enforcement Administration, Justice
21 CFR 0.0 CHAPTER II -- DRUG ENFORCEMENT
21 CFR 0.0 ADMINISTRATION, DEPARTMENT OF JUSTICE
Part
Page
1300 (Reserved)
1301 Registration of manufacturers, distributors, and dispensers of
controlled substances
1302 Labeling and packaging requirements for controlled substances
1303 Quotas
1304 Records and reports of registrants
1305 Order forms
1306 Prescriptions
1307 Miscellaneous
1308 Schedules of controlled substances
1309 (Reserved)
1310 Records and reports of listed chemicals and certain machines
1311 Registration of importers and exporters of controlled substances
1312 Importation and exportation of controlled substances
1313 Importation and exportation of precursors and essential
chemicals
1314-1315 (Reserved)
1316 Administrative functions, practices, and procedures
21 CFR 0.0
21 CFR 0.0 21 CFR Ch. II (4-1-92 Edition)
21 CFR 0.0 Drug Enforcement Administration, Justice
21 CFR 0.0 Pt. 1301
21 CFR 0.0 PART 1300 -- (RESERVED)
21 CFR 0.0 PART 1301 -- REGISTRATION OF MANUFACTURERS, DISTRIBUTORS,
AND DISPENSERS OF CONTROLLED SUBSTANCES
Sec.
1301.01 Scope of Part 1301.
1301.02 Definitions.
1301.03 Information; special instructions.
1301.11 Fee amounts.
1301.12 Time and method of payment; refund.
1301.13 Persons exempt from fee.
1301.21 Persons required to register.
1301.22 Separate registration for independent activities.
1301.23 Separate registrations for separate locations.
1301.24 Exemption of agents and employees; affiliated practitioners.
1301.25 Exemption of certain military and other personnel.
1301.26 Exemption of law enforcement officials.
1301.27 Exemption of civil defense officials.
1301.28 Registration regarding ocean vessels.
1301.29 Provisional registration of narcotic treatment programs;
compounders.
1301.31 Time for application for registration; expiration date.
1301.32 Application forms; contents; signature.
1301.33 Research protocols.
1301.34 Filing of application; joint filings.
1301.35 Acceptance for filing; defective applications.
1301.36 Additional information.
1301.37 Amendments to and withdrawal of applications.
1301.38 Special procedures for certain applications.
Suspension of Registration
1301.41 Administrative review generally.
1301.42 Action on applications for research in Schedule I substances.
1301.43 Application for bulk manufacture of Sschedule I and II
substances.
1301.44 Certificate of registration; denial of registration.
1301.45 Suspension or revocation of registration.
1301.46 Suspension of registration pending final order.
1301.47 Extension of registration pending final order.
1301.48 Order to show cause.
1301.51 Hearings generally.
1301.52 Purpose of hearing.
1301.53 Waiver or modification of rules.
1301.54 Request for hearing or appearance; waiver.
1301.55 Burden of proof.
1301.56 Time and place of hearing.
1301.57 Final order.
1301.61 Modification in registration.
1301.62 Termination of registration.
1301.63 Transfer of registration.
1301.71 Security requirements generally.
1301.72 Physical security controls for nonpractitioners; narcotic
treatment programs and compounders for narcotic treatment programs;
storage areas.
1301.73 Physical security controls for nonpractitioners; compounders
for narcotic treatment programs; manufacturing and compounding areas.
1301.74 Other security controls for nonpractitioners; narcotic
treatment programs and compounders for narcotic treatment programs.
1301.75 Physical security controls for practitioners.
1301.76 Other security controls for practitioners.
1301.90 Employee screening procedures.
1301.91 Employee responsibility to report drug diversion.
1301.92 Illicit activities by employees.
1301.93 Sources of information for employee checks.
Authority: 21 U.S.C. 821, 822, 823, 824, 871(b), 875, 877.
Source: 36 FR 7778, Apr. 24, 1971, unless otherwise noted.
Redesignated at 38 FR 26609, Sept. 24, 1973.
21 CFR 0.0 General Information
21 CFR 1301.01 Scope of Part 1301.
Procedures governing the registration of manufacturers, distributors,
and dispensers of controlled substances pursuant to sections 1301
through 1304 of the Act (21 U.S.C. 821-824) are set forth generally by
those sections and specifically by the sections of this part.
21 CFR 1301.02 Definitions.
As used in this part, the following terms shall have the meanings
specified:
(a) The term Act means the Controlled Substances Act (84 Stat. 1242;
21 U.S.C. 801) and/or the Controlled Substances Import and Export Act
(84 Stat. 1285; 21 U.S.C. 951).
(b) The term basic class means, as to controlled substances listed in
Schedules I and II:
(1) Each of the opiates, including its isomers, esters, ethers,
salts, and salts of isomers, esters, and ethers whenever the existence
of such isomers, esters, ethers, and salts is possible within the
specific chemical designation, listed in 1308.11 (b) of this chapter;
(2) Each of the opium derivatives, including its salts, isomers, and
salts of isomers whenever the existence of such salts, isomers, and
salts of isomers is possible within the specific chemical designation,
listed in 1308.11(c) of this chapter;
(3) Each of the hallucinogenic substances, including its salts,
isomers, and salts of isomers whenever the existence of such salts,
isomers, and salts of isomers is possible within the specific chemical
designation, listed in 1308.11(d) of this chapter;
(4) Each of the following substances, whether produced directly or
indirectly by extraction from substances of vegetable origin, or
independently by means of chemical synthesis, or by a combination of
extraction and chemical synthesis:
(i) Opium, including raw opium, opium extracts, opium fluid extracts,
powdered opium, granulated opium, deodorized opium and tincture of
opium;
(ii) Apomorphine;
(iii) Codeine;
(iv) Etorphine hydrochloride;
(v) Ethylmorphine;
(vi) Hydrocodone;
(vii) Hydromorphone;
(viii) Metopon;
(ix) Morphine;
(x) Oxycodone;
(xi) Oxymorphone;
(xii) Thebaine;
(xiii) Mixed alkaloids of opium listed in 1308.12(b) (2) of this
chapter;
(xiv) Cocaine; and
(xv) Ecgonine;
(5) Each of the opiates, including its isomers, esters, ethers,
salts, and salts of isomers, esters, and ethers whenever the existence
of such isomers, esters, ethers, and salts is possible within the
specific chemical designation, listed in 1308.12 (c) of this chapter;
and
(6) Methamphetamine, its salts, isomers, and salts of its isomers;
(7) Amphetamine, its salts, optical isomers, and salts of its optical
isomers;
(8) Phenmetrazine and its salts;
(9) Methylphenidate;
(10) Each of the substances having a depressant effect on the central
nervous system, including its salts, isomers, and salts of isomers
whenever the existence of such salts, isomers, and salts of isomers is
possible within the specific chemical designation, listed in 1308.12
(e) of this chapter.
(c) The term Administration means the Drug Enforcement
Administration.
(d) The term compounder means any person engaging in maintenance or
detoxification treatment who also mixes, prepares, packages or changes
the dosage form of a narcotic drug listed in Schedules II, III, IV or V
for use in maintenance or detoxification treatment by another narcotic
treatment program.
(e) The term detoxification treatment means the dispensing, for a
period of time as specified below, of a narcotic drug or narcotic drugs
in decreasing doses to an individual to alleviate adverse physiological
or psychological effects incident to withdrawal from the continuous or
sustained use of a narcotic drug and as a method of bringing the
individual to a narcotic drug-free state within such period of time.
There are two types of detoxification treatment: Short-term
detoxification treatment and long-term detoxification treatment.
(1) Short-term detoxification treatment is for a period not in excess
of 30 days.
(2) Long-term detoxification treatment is for a period more than 30
days but not in excess of 180 days.
(f) The term Administrator means the Administrator of the Drug
Enforcement Administration. The Administrator has been delegated
authority under the Act by the Attorney General (28 CFR 0.100).
(g) The term hearing means any hearing held pursuant to this part for
the granting, denial, revocation, or suspension of a registration
pursuant to sections 303 and 304 of the Act (21 U.S.C. 823-824).
(h) The term maintenance treatment means the dispensing for a period
in excess of twenty-one days, of a narcotic drug or narcotic drugs in
the treatment of an individual for dependence upon heroin or other
morphine-like drug.
(i) The term narcotic treatment program means a program engaged in
maintenance and/or detoxification treatment with narcotic drugs.
(j) The term person includes any individual, corporation, government
or governmental subdivision or agency, business trust, partnership,
association, or other legal entity.
(k) The terms register and registration refer only to registration
required and permitted by section 303 of the Act (21 U.S.C. 823).
(l) The term registrant means any person who is registered pursuant
to either section 303 or section 1008 of the Act (21 U.S.C. 823 or
958).
(m) Any term not defined in this section shall have the definition
set forth in section 102 of the Act (21 U.S.C. 802).
(36 FR 7778, Apr. 24, 1971, as amended at 36 FR 12735, July 7, 1971;
36 FR 20687, Oct. 28, 1971. Redesignated at 38 FR 26609, Sept. 24,
l973)
Editorial Note: For FR citations affecting 1301.02, see the List of
CFR Sections Affected in the Finding Aids section of this volume.
21 CFR 1301.03 Information; special instructions.
Information regarding procedures under these rules and instructions
supplementing these rules will be furnished upon request by writing to
the Registration Unit, Drug Enforcement Administration, Department of
Justice, Post Office Box 28083, Central Station, Washington, DC 20005.
(36 FR 7778, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 23,
1973, and amended at 51 FR 5319, Feb. 13, 1986)
21 CFR 1301.03 Fees for Registration and Reregistration
21 CFR 1301.11 Fee amounts.
(a) For each registration or reregistration to manufacture controlled
substances, the registrant shall pay an application fee of $250.
(b) For each registration or reregistration to distribute controlled
substances, the registrant shall pay an application fee of $125.
(c) For each registration or reregistration to dispense, or to
conduct instructional activities with, controlled substances listed in
Schedules II through V, the registrant shall pay an application fee of
$60 for a three-year registration.
(d) For each registration to conduct research or instructional
activities with a controlled substance listed in Schedule I, or to
conduct research with a controlled substance in Schedules II through V,
the registrant shall pay an application fee of $20.
(e) For each registration or reregistration to conduct chemical
analysis with controlled substances listed in any schedule, the
registrant shall pay an application fee of $20.
(f) For each registration or reregistration to engage in a narcotic
treatment program, including a compounder, the registrant shall pay an
application fee of $20.
(48 FR 56043, Dec. 19, 1983, as amended at 52 FR 20598, June 2, 1987;
53 FR 4963, Feb. 19, 1988)
21 CFR 1301.12 Time and method of payment; refund.
Application fees shall be paid at the time when the application for
registration or reregistration is submitted for filing. Payments should
be made in the form of a personal, certified, or cashier's check or
money order made payable to ''Drug Enforcement Administration.''
Payments made in the form of stamps, foreign currency, or third party
endorsed checks will not be accepted. These application fees are not
refundable.
(52 FR 20599, June 2, 1987, as amended at 53 FR 4963, Feb. 19, 1988)
21 CFR 1301.13 Persons exempt from fee.
(a) The Administrator shall exempt from payment of an application fee
for registration or reregistration the following persons:
(1) Any official or agency of the U.S. Army, Navy, Marine Corps, Air
Force, Coast Guard, Veterans' Administration, Public Health Service, or
Bureau of Prisons who or which is authorized to procure or purchase
controlled substances for official use; and
(2) Any official, employee, or other civil officer or agency of the
United States, of any State, or any political subdivision or agency
thereof, who or which is authorized to purchase controlled substances,
to obtain such substances from official stocks, to dispense or
administer such substances, to conduct research, instructional
activities, or chemical analysis with such substances, or any
combination thereof, in the course of his or its official duties or
employment.
(b) In order to claim exemption from payment of a registration or
reregistration application fee, the registrant shall have completed the
certification on the appropriate application form, wherein the
registrant's superior (if an individual) or officer (if an agency)
certifies to the status and address of the registrant and to the
authority of the registrant to acquire, possess, or handle controlled
substances.
(c) Exemption from payment of a registration or reregistration
application fee does not relieve the registrant of any other
requirements or duties prescribed by law.
(36 FR 7778, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971;
36 FR 18728, Sept. 21, 1971; 38 FR 756, Jan. 4, 1973. Redesignated at
38 FR 26609, Sept. 24, l973 and amended at 53 FR 4963, Feb. 19, 1988)
21 CFR 1301.13 Requirements for Registration
21 CFR 1301.21 Persons required to register.
Every person who manufactures, distributes, or dispenses any
controlled substance or who proposes to engage in the manufacture,
distribution, or dispensing of any controlled substance shall obtain
annually a registration unless exempted by law or pursuant to
1301.24-1301.29. Only persons actually engaged in such activities are
required to obtain a registration; related or affiliated persons who
are not engaged in such activities are not required to be registered.
(For example, a stockholder or parent corporation of a corporation
manufacturing controlled substances is not required to obtain a
registration.)
(36 FR 7778, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971.
Redesignated at 38 FR 26609, Sept. 24, l973)
21 CFR 1301.22 Separate registration for independent activities.
(a) The following groups of activities are deemed to be independent
of each other:
(1) Manufacturing controlled substances;
(2) Distributing controlled substances;
(3) Dispensing controlled substances listed in Schedules II through
V;
(4) Conducting research with controlled substances listed in
Schedules II through V;
(5) Conducting instructional activities with controlled substances
listed in schedules II through V;
(6) Conducting a narcotic treatment program using any narcotic drug
listed in Schedules II, III, IV or V, however, pursuant to 1301.24,
employees, agents, or affiliated practitioners, in programs, need not
register separately. Each program site located away from the principal
location and at which place narcotic drugs are stored or dispensed must
be separately registered and obtain narcotic drugs by use of order forms
pursuant to 1305.03;
(7) Conducting research and instructional activities with controlled
substances listed in Schedule I;
(8) Conducting chemical analysis with controlled substances listed in
any schedule;
(9) Importing controlled substances;
(10) Exporting controlled substances; and
(11) A compounder as defined by 1301.02(d).
(b) Every person who engages in more than one group of independent
activities shall obtain a separate registration for each group of
activities, except as provided in this paragraph. Any person, when
registered to engage in the group of activities described in each
subparagraph in this paragraph, shall be authorized to engage in the
coincident activities described in that subparagraph without obtaining a
registration to engage in such coincident activities, provided that,
unless specifically exempted, he complies with all requirements and
duties prescribed by law for persons registered to engage in such
coincident activities:
(1) A person registered to manufacture or import any controlled
substance or basic class of controlled substance shall be authorized to
distribute that substance or class, but no other substance or class
which he is not registered to manufacture or import;
(2) A person registered to manufacture any controlled substance
listed in Schedules II through V shall be authorized to conduct chemical
analysis and preclinical research (including quality control analysis)
with narcotic and non-narcotic controlled substances listed in those
schedules in which he is authorized to manufacture;
(3) A person registered to conduct research with a basic class of
controlled substance listed in Schedule I shall be authorized to
manufacture or import such class if and to the extent that such
manufacture or importation is set forth in the research protocol
described in 1301.33 and to distribute such class to other persons
registered or authorized to conduct research with such class or
registered or authorized to conduct chemical analysis with controlled
substances;
(4) A person registered or authorized to conduct chemical analysis
with controlled substances shall be authorized to manufacture and import
such substances for analytical or instructional purposes, to distribute
such substances to other persons registered or authorized to conduct
chemical analysis or instructional activities or research with such
substances and to persons exempted from registration pursuant to
1301.26, to export such substances to persons in other countries
performing chemical analysis or enforcing laws relating to controlled
substances or drugs in those countries, and to conduct instructional
activities with controlled substances; and
(5) A person registered or authorized to conduct research with
controlled substances listed in Schedules II through V shall be
authorized to conduct chemical analysis with controlled substances
listed in those schedules in which he is authorized to conduct research,
to manufacture such substances if and to the extent that such
manufacture is set forth in a statement filed with the application for
registration, to import such substances for research purposes, to
distribute such substances to other persons registered or authorized to
conduct chemical analysis, instructional activities, or research with
such substances and to persons exempted from registration pursuant to
1301.26, and to conduct instructional activities with controlled
substances;
(6) A person registered to dispense controlled substances listed in
Schedules II through V shall be authorized to conduct research and to
conduct instructional activities with those substances.
(c) A single registration to engage in any group of independent
activities may include one or more controlled substances listed in the
schedules authorized in that group of independent activities. A person
registered to conduct research with controlled substances listed in
Schedule I may conduct research with any substance listed in Schedule I
for which he has filed and had approved a research protocol.
(36 FR 7778, Apr. 24, 1971, as amended at 36 FR 18728, Sept. 21,
1971; 37 FR 15918, Aug. 8, 1972; 38 FR 756, Jan. 4, 1973.
Redesignated at 38 FR 26609, Sept. 24, l973)
Editorial Note: For FR citations affecting 1301.22, see the List of
CFR Sections Affected in the Finding Aids section of this volume.
21 CFR 1301.23 Separate registrations for separate locations.
(a) A separate registration is required for each principal place of
business or professional practice at one general physical location where
controlled substances are manufactured, distributed, or dispensed by a
person.
(b) The following locations shall be deemed not to be places where
controlled substances are manufactured, distributed, or dispensed:
(1) A warehouse where controlled substances are stored by or on
behalf of a registered person, unless such substances are distributed
directly from such warehouse to registered locations other than the
registered location from which the substances were delivered or to
persons not required to register by virtue of subsection 302(c)(2) of
the Act (21 U.S.C. 822(c)(2));
(2) An office used by agents of a registrant where sales of
controlled substances are solicited, made, or supervised but which
neither contains such substances (other than substances for display
purposes or lawful distribution as samples only) nor serves as a
distribution point for filling sales orders; and
(3) An office used by a practitioner (who is registered at another
location) where controlled substances are prescribed but neither
administered nor otherwise dispensed as a regular part of the
professional practice of the practitioner at such office, and where no
supplies of controlled substances are maintained.
(36 FR 7778, Apr. 24, 1971, as amended at 36 FR 18728, Sept. 21,
1971. Redesignated at 38 FR 26609, Sept. 24, l973)
21 CFR 1301.24 Exemption of agents and employees; affiliated
practitioners.
(a) The requirement of registration is waived for any agent or
employee of a person who is registered to engage in any group of
independent activities, if such agent or employee is acting in the usual
course of his business or employment.
(b) An individual practitioner, as defined in 1304.02 of this
chapter (other than an intern, resident, foreign-trained physician, or
physician on the staff of a Veterans Administration facility or
physician who is an agent or employee of the Health Bureau of the Canal
Zone Government), who is an agent or employee of another practitioner
registered to dispense controlled substances may, when acting in the
usual course of his employment, administer and dispense (other than by
issuance of prescription) controlled substances if and to the extent
that such individual practitioner is authorized or permitted to do so by
the jurisdiction in which he practices, under the registration of the
employer or principal practitioner in lieu of being registered himself.
(For example, a staff physician employed by a hospital need not be
registered individually to administer and dispense, other than by
prescribing, controlled substances within the hospital.)
(c) An individual practitioner, as defined in 1304.02 of this
chapter, who is an intern, resident, or foreign-trained physician or
physician on the staff of a Veterans Administration facility or
physician who is an agent or employee of the Health Bureau of the Canal
Zone Government, may dispense, administer and prescribe controlled
substances under the registration of the hospital or other institution
which is registered and by whom he is employed in lieu of being
registered himself, provided that:
(1) Such dispensing, administering or prescribing is done in the
usual course of his professional practice;
(2) Such individual practitioner is authorized or permitted to do so
by the jurisdiction in which he is practicing;
(3) The hospital or other institution by whom he is employed has
verified that the individual practitioner is so permitted to dispense,
administer, or prescribe drugs within the jurisdiction;
(4) Such individual practitioner is acting only within the scope of
his employment in the hospital or institution;
(5) The hospital or other institution authorizes the intern,
resident, or foreign-trained physician to dispense or prescribe under
the hospital registration and designates a specific internal code number
for each intern, resident, or foreign-trained physician so authorized.
The code number shall consist of numbers, letters, or a combination
thereof and shall be a suffix to the institution's DEA registration
number, preceded by a hyphen (e.g., APO 123456-10 or APO123456-A12);
and
(6) A current list of internal codes and the corresponding individual
practitioners is kept by the hospital or other institution and is made
available at all times to other registrants and law enforcement agencies
upon request for the purpose of verifying the authority of the
prescribing individual practitioner.
(36 FR 18728, Sept. 21, 1971, as amended at 37 FR 15918, Aug. 8,
1972. Redesignated at 38 FR 26609, Sept. 24, l973, and amended at 51 FR
5319, Feb. 13, 1986)
21 CFR 1301.25 Exemption of certain military and other personnel.
(a) The requirement of registration is waived for any official of the
U.S. Army, Navy, Marine Corps, Air Force, Coast Guard, Public Health
Service, or Bureau of Prisons who is authorized to prescribe, dispense,
or administer, but not to procure or purchase, controlled substances in
the course of his official duties. Such officials shall follow
procedures set forth in part 1306 of this chapter regarding
prescriptions, but shall state the branch of service or agency (e.g.,
''U.S. Army'' or ''Public Health Service'') and the service
identification number of the issuing official in lieu of the
registration number required on prescription forms. The service
identification number for a Public Health Service employee is his Social
Security identification number.
(b) If any official exempted by this section also engages as a
private individual in any activity or group of activities for which
registration is required, such official shall obtain a registration for
such private activities.
(36 FR 7778, Apr. 24, 1971, as amended at 36 FR 18729, Sept. 21,
1971; 38 FR 756, Jan. 4, 1973. Redesignated at 38 FR 26609, Sept. 24,
l973)
21 CFR 1301.26 Exemption of law enforcement officials.
(a) The requirement of registration is waived for the following
persons in the circumstances described in this section:
(1) Any officer or employee of the Administration, any officer of the
U.S. Customs Service, any officer or employee of the United States Food
and Drug Administration, and any other Federal officer who is lawfully
engaged in the enforcement of any Federal law relating to controlled
substances, drugs or customs, and is duly authorized to possess
controlled substances in the course of his official duties; and
(2) Any officer or employee of any State, or any political
subdivision or agency thereof, who is engaged in the enforcement of any
State or local law relating to controlled substances and is duly
authorized to possess controlled substances in the course of his
official duties.
(b) Any official exempted by this section may, when acting in the
course of his official duties, possess any controlled substance and
distribute any such substance to any other official who is also exempted
by this section and acting in the course of his official duties.
(c) Any official exempted by this section may procure any controlled
substance in the course of an inspection, in accordance with
1316.03(d), or in the course of any criminal investigation involving the
person from whom the substance was procured.
(d) In order to enable law enforcement agency laboratories to obtain
and transfer controlled substances for use as standards in chemical
analysis, such laboratories must obtain annually a registration to
conduct chemical analysis. Such laboratories shall be exempted from
payment of a fee for registration. Laboratory personnel, when acting in
the scope of their official duties, are deemed to be officials exempted
by this section and within the activity described in section 515(d) of
the Act (21 U.S.C. 885(d)). For purposes of this paragraph, laboratory
activities shall not include field or other preliminary chemical tests
by officials exempted by this section.
(e) Laboratories of the Administration shall obtain annually a
registration to conduct chemical analysis in accordance with paragraph
(d) of this section. In addition to the activities authorized under a
registration to conduct chemical analysis pursuant to 1301.22(b) (4),
laboratories of the Administration shall be authorized to manufacture or
import controlled substances for any lawful purpose, to distribute or
export such substances to any person, and to import and export such
substances in emergencies without regard to the requirements of part
1312 of this chapter if a report concerning the importation or
exportation is made to the Diversion Operations Section of the
Administration within 30 days of such importation or exportation.
(36 FR 7778, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24,
1973, and amended at 46 FR 28841, May 29, 1981; 51 FR 5319, Feb. 13,
1986)
21 CFR 1301.27 Exemption of civil defense officials.
(a) The requirement of registration is waived for any official of a
civil defense or disaster relief organization who, in the course of his
official duties, is authorized to:
(1) Maintain, and distribute for such maintenance, controlled
substances held for emergency use; or
(2) Procure controlled substances for the purpose of maintaining
supplies for emergency use, provided that all of such procurement is
from the U.S. General Services Administration and in accordance with the
rules of the U.S. Office of Emergency Preparedness.
(b) The requirement of registration is waived for any official of a
civil defense or disaster relief organization during a state of
emergency or disaster within his jurisdiction proclaimed by the
President or by a concurrent resolution of the Congress, which official,
in the course of his official duties, during such emergency or disaster,
is authorized to:
(1) Dispense controlled substances; or
(2) Procure or distribute controlled substances, provided that all
such procurement is on a special ''Civil Defense Emergency Order Form,''
as described in this section.
(c) Civil Defense Emergency Order Forms shall be furnished by the
U.S. Office of Emergency Preparedness and will contain the name of the
civil defense or disaster relief organization. Such forms may be used
and are valid only during a state of emergency or disaster proclaimed by
the President or by a concurrent resolution of the Congress for the area
in which the organization using such forms has civil defense or disaster
relief jurisdiction, who shall state his position and the nature and
legal designation of the emergency or disaster. Such forms may be
filled by any person registered under the Act. The organization shall,
upon the execution of a Civil Defense Emergency Order Form, be deemed to
be registered under the Act for purposes of recordkeeping pursuant to
part 1304 of this chapter.
21 CFR 1301.28 Registration regarding ocean vessels.
(a) If acquired by and dispensed under the general supervision of a
medical officer described in paragraph (b) of this section, or the
master or first officer of the vessel under the circumstances described
in paragraph (d) of this section, controlled substances may be held for
stocking, be maintained in, and dispensed from medicine chests, first
aid packets, or dispensaries:
(1) On board any vessel engaged in international trade or in trade
between ports of the United States and any merchant vessel belonging to
the U.S. Government;
(2) On board any aircraft operated by an air carrier under a
certificate of permit issued pursuant to the Federal Aviation Act of
1958 (49 U.S.C. 1301); and
(3) In any other entity of fixed or transient location approved by
the Administrator as appropriate for application of this section (e.g.,
emergency kits at field sites of an industrial firm).
(b) A medical officer shall be:
(1) Licensed in a state as a physician;
(2) Employed by the owner or operator of the vessel, aircraft or
other entity; and
(3) Registered under the Act at either of the following locations:
(i) The principal office of the owner or operator of the vessel,
aircraft or other entity or
(ii) At any other location provided that the name, address,
registration number and expiration date as they appear on his
Certificate of Registration (DEA Form 223) for this location are
maintained for inspection at said principal office in a readily
retrievable manner.
(c) A registered medical officer may serve as medical officer for
more than one vessel, aircraft, or other entity under a single
registration, unless he serves as medical officer for more than one
owner or operator, in which case he shall either maintain a separate
registration at the location of the principal office of each such owner
or operator or utilize one or more registrations pursuant to paragraph
(b)(3)(ii) of this section.
(d) If no medical officer is employed by the owner or operator of a
vessel, or in the event such medical officer is not accessible and the
acquisition of controlled substances is required, the master or first
officer of the vessel, who shall not be registered under the Act, may
purchase controlled substances from a registered manufacturer of
distributor, or from an authorized pharmacy as described in paragraph
(f) of this section, by following the procedure outlined below:
(1) The master or first officer of the vessel must personally appear
at the vendor's place of business, present proper identification (e.g.,
Seaman's photographic identification card) and a written requisition for
the controlled substances.
(2) The written requisition must be on the vessel's official
stationery or purchase order form and must include the name and address
of the vendor, the name of the controlled substance, description of the
controlled substance (dosage form, strength and number or volume per
container) number of containers ordered, the name of the vessel, the
vessel's official number and country of registry, the owner or operator
of the vessel, the port at which the vessel is located, signature of the
vessel's officer who is ordering the controlled substances and the date
of the requisition.
(3) The vendor may, after verifying the identification of the
vessel's officer requisitioning the controlled substances, deliver the
control substances to that officer. The transaction shall be
documented, in triplicate, on a record of sale in a format similar to
that outlined in paragraph (d)(4) of this section. The vessel's
requisition shall be attached to copy 1 of the record of sale and filed
with the controlled substances records of the vendor, copy 2 of the
record of sale shall be furnished to the officer of the vessel and
retained aboard the vessel, copy 3 of the record of sale shall be
forwarded to the nearest DEA Division Office within 15 days after the
end of the month in which the sale is made.
(4) The vendor's record of sale should be similar to, and must
include all the information contained in, the below listed format.
(Name of registrant)
(Address of registrant)
(DEA registration number)
Number of lines completed
Name of vessel
Vessel's official number
Vessel's country of registry
Owner or operator of the vessel
Name and title of vessel's officer who presented the requisition
Signature of vessel's officer who presented the requisition
(e) Any medical officer described in paragraph (b) of this section
shall, in addition to complying with all requirements and duties
prescribed for registrants generally, prepare an annual report as of the
date on which his registration expires, which shall give in detail an
accounting for each vessel, aircraft, or other entity, and a summary
accounting for all vessels, aircraft, or other entities under his
supervision for all controlled substances purchased, dispensed or
disposed of during the year. The medical officer shall maintain this
report with other records required to be kept under the Act and, upon
request, deliver a copy of the report to the Administration. The
medical officer need not be present when controlled substances are
dispensed, if the person who actually dispensed the controlled
substances is responsible to the medical officer to justify his actions.
(f) Any registered pharmacy which wishes to distribute controlled
substances pursuant to this section shall be authorized to do so,
provided that:
(1) The registered pharmacy notifies the nearest Division Office of
the Administration of its intention to so distribute controlled
substances prior to the initiation of such activity. This notification
shall be by registered mail and shall contain the name, address, and
registration number of the pharmacy as well as the date upon which such
activity will commence; and
(2) Such activity is authorized by state law; and
(3) The total number of dosage units of all controlled substances
distributed by the pharmacy during any calendar year in which the
pharmacy is registered to dispense does not exceed the limitations
imposed upon such distribution by 1307.11(a)(4) and (b) of this
chapter.
(g) Owners or operators of vessels, aircraft, or other entities
described in this section shall not be deemed to possess or dispense any
controlled substance acquired, stored and dispensed in accordance with
this section.
(h) The Master of a vessel shall prepare a report for each calendar
year which shall give in detail an accounting for all controlled
substances purchased, dispensed, or disposed of during the year. The
Master shall file this report with the medical officer employed by the
owner or operator of his vessel, if any, or, if not, he shall maintain
this report with other records required to be kept under the Act and,
upon request, deliver a copy of the report to the Administration.
(i) Controlled substances acquired and possessed in accordance with
this section shall not be distributed to persons not under the general
supervision of the medical officer employed by the owner or operator of
the vessel, aircraft, or other entity, except in accordance with
1307.21 of this chapter.
(37 FR 15918, Aug. 8, 1972, as amended at 38 FR 756, Jan. 4, 1973.
Redesignated at 38 FR 26609, Sept. 24, l973, and amended at 41 FR 9546,
Mar. 5, 1976; 50 FR 31589, Aug. 5, 1985)
21 CFR 1301.29 Provisional registration of narcotic treatment programs;
compounders.
(a) All persons currently approved by the Food and Drug
Administration under 310.505 (formerly 130.44) of this title to
conduct a methadone treatment program and who are registered by the Drug
Enforcement Administration under this section will be granted a
Provisional Narcotic Treatment Program Registration.
(b) The provisions of 1301.45-1301.57 relating to revocation and
suspension of registration, shall apply to a provisional registration.
(c) Unless sooner revoked or suspended under paragraph (b) of this
section, a provisional registration shall remain in effect until (1) the
date on which such person has registered under this section or has had
his registration denied, or (2) such date as may be prescribed by
written notification to the person from the Drug Enforcement
Administration for the person to become registered to conduct a narcotic
treatment program, whichever occurs first.
(39 FR 37984, Oct. 25, 1974)
21 CFR 1301.29 Applications for Registration
21 CFR 1301.31 Time for application for registration; expiration date.
(a) Any person who is required to be registered and who is not so
registered may apply for registration at any time. No person required
to be registered shall engage in any activity for which registration is
required until the application for registration is granted and a
Certificate of Registration is issued by the Administrator to such
person.
(b) Any person who is registered may apply to be reregistered not
more than 60 days before the expiration date of his registration.
(c) At the time a manufacturer, distributor, researcher, analytical
lab, importer, exporter or narcotic treatment program is first
registered, that business activity shall be assigned to one of twelve
groups, which shall correspond to the months of the year. The
expiration date of the registrations of all registrants within any group
will be the last date of the month designated for that group. In
assigning any of the above business activities to a group, the
Administration may select a group the expiration date of which is less
than one year from the date such business activity was registered. If
the business activity is assigned to a group which has an expiration
date less than three months from the date of which the business activity
is registered, the registration shall not expire until one year from
that expiration date; in all other cases, the registration shall expire
on the expiration date following the date on which the business activity
is registered.
(d) At the time a retail pharmacy, hospital/clinic, practitioner or
teaching institution is first registered, that business activity shall
be assigned to one of twelve groups, which shall correspond to the
months of the year. The expiration date of the registrations of all
registrants within any group will be the last day of the month
designated for that group. In assigning any of the above business
activities to a group, the Administration may select a group the
expiration date of which is not less than 28 months nor more than 39
months from the date such business activity was registered. After the
initial registration period, the registration shall expire 36 months
from the initial expiration date.
(36 FR 7778, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971.
Redesignated at 38 FR 26609, Sept. 24, l973, and amended at 52 FR 20599,
June 2, 1987)
21 CFR 1301.32 Application forms; contents; signature.
(a) If any person is required to be registered, and is not so
registered and is applying for registration:
(1) To manufacture or distribute controlled substances, he shall
apply on DEA Form 225;
(2) To dispense controlled substances listed in Schedules II through
V, he shall apply on DEA Form 224;
(3) To conduct instructional activities with controlled substances
listed in Schedules II through V, he shall apply on DEA Form 224;
(4) To conduct research with controlled substances listed in
Schedules II through V (other than research described in
1301.22(a)(6), he shall apply on DEA Form 225;
(5) To conduct research with narcotic drugs listed in Schedules II
through V, as described in 1301.22(a)(6), he shall apply on DEA Form
225;
(6) To conduct research with controlled substances listed in Schedule
I, he shall apply on DEA Form 225, with three copies of a research
protocol as described in 301.33(a) attached to the form, or, in the
case of a clinical investigation, with three copies of a certificate of
submission of an IND as described in 1301.33(b) attached to the form
(the researcher also submitting to the Food and Drug Administration
three copies of a Notice of Claimed Investigational Exemption for a New
Drug as required in 1301.33(b));
(7) To conduct instructional activities with controlled substances
listed in Schedule I, he shall apply as a researcher on DEA Form 225
with two copies of a statement describing the nature, extent, and
duration of such instructional activities attached to the form;
(8) To conduct chemical analysis with controlled substances listed in
any Schedule, he shall apply on DEA Form 225; and
(9) To conduct a narcotic treatment program, including a compounder,
shall apply on DEA Form 363.
(b) If any person is registered and is applying for reregistration:
(1) To manufacture or distribute controlled substances, he shall
apply on DEA Form 225a;
(2) To dispense controlled substances listed in Schedules II through
V, he shall apply on DEA Form 224a;
(3) To conduct instructional activities with controlled substances
listed i Schedules II through V, he shall apply on DEA Form 224a;
(4) To conduct research with controlled substances listed in
Schedules II through V (other than research described in 1301.22(a)
(6), he shall apply on DEA Form 225a;
(5) To conduct research with narcotic drugs listed in Schedules II
through V, as described in 1301.22(a) (6), he shall apply on DEA Form
225a;
(6) To continue to conduct research with controlled substances listed
in Schedule I under one or more approved research protocols, he shall
apply on DEA Form 225a;
(7) To continue to conduct instructional activities with controlled
substances listed in Schedule I under one or more approved instructional
statements, he shall apply as a researcher on DEA Form 225a;
(8) To conduct chemical analysis with controlled substances listed in
any Schedule, he shall apply on DEA Form 225a; and
(9) To conduct a narcotic treatment program, including a compounder,
shall apply on DEA Form 363a (Renewal Form).
(c) DEA (or BND) Forms 224 and 225 may be obtained at any regional
office of the Administration or by writing to the Registration Unit,
Drug Enforcement Administration, Department of Justice, Post Office Box
28083, Central Station, Washington, DC 20005. DEA Forms 224a, 225a and
363a will be mailed, as applicable, to each registered person
approximately 60 days before the expiration date of his registration;
if any registered person does not receive such forms within 45 days
before the expiration date of his registration, he must promptly give
notice of such fact and request such forms by writing to the
Registration Unit of the Administration at the foregoing address.
(d) Each application for registration to handle any basic class of
controlled substance listed in Schedule I (except to conduct chemical
analysis with such classes) and each application for registration to
manufacture a basic class of controlled substance listed in Schedule II
shall include the Administration Controlled Substances Code Number, as
set forth in part 1308 of this chapter, for each basic class to be
covered by such registration.
(e) Each application for registration to conduct research with any
basic class of controlled substance listed in Schedule II shall include
the Administration Controlled Substances Code Number, as set forth in
part 1308 of this chapter, for each such basic class to be manufactured
or imported as a coincident activity of that registration. A statement
listing the quantity of each such basic class or controlled substance to
be imported or manufactured during the registration period for which
application is being made shall be included with each such application.
For purposes of this paragraph only, manufacturing is defined as the
production of a controlled substance by synthesis, extraction or by
agricultural/horticultural means.
(f) Each application shall include all information called for in the
form, unless the item is not applicable, in which case this fact shall
be indicated.
(g) Each application, attachment, or other document filed as part of
an application, shall be signed by the applicant, if an individual; by
a partner of the applicant, if a partnership; or by an officer of the
applicant, if a corporation, corporate division, association, trust or
other entity. An applicant may authorize one or more individuals, who
would not otherwise be authorized to do so, to sign applications for the
applicant by filing with the Registration Unit of the Administration a
power of attorney for each such individual. The power of attorney shall
be signed by a person who is authorized to sign applications under this
paragraph and shall contain the signature of the individual being
authorized to sign applications. The power of attorney shall be valid
until revoked by the applicant.
(36 FR 7778, Apr. 24, 1971, as amended at 36 FR 18729, Sept. 21,
1971; 37 FR 15918, Aug. 8, 1972; 37 FR 28712, Dec. 29, 1972.
Redesignated at 38 FR 26609, Sept. 24, l973)
Editorial Note: For FR citations affecting 1301.32, see the List of
CFR Sections Affected in the Finding Aids section of this volume.
21 CFR 1301.33 Research protocols.
(a) A protocol to conduct research with controlled substances listed
in Schedule I shall be in the following form and contain the following
information where applicable:
(1) Investigator:
(i) Name, address, and DEA registration number; if any.
(ii) Institutional affiliation.
(iii) Qualifications, including a curriculum vitae and an appropriate
bibliography (list of publications).
(2) Research project:
(i) Title of project.
(ii) Statement of the purpose.
(iii) Name of the controlled substances or substances involved and
the amount of each needed.
(iv) Description of the research to be conducted, including the
number and species of research subjects, the dosage to be administered,
the route and method of administration, and the duration of the project.
(v) Location where the research will be conducted.
(vi) Statement of the security provisions for storing the controlled
substances (in accordance with 1301.75) and for dispensing the
controlled substances in order to prevent diversion.
(vii) If the investigator desires to manufacture or import any
controlled substance listed in paragraph (a)(2)(iii) of this section, a
statement of the quantity to be manufactured or imported and the sources
of the chemicals to be used or the substance to be imported.
(3) Authority:
(i) Institutional approval.
(ii) Approval of a Human Research Committee for human studies.
(iii) Indication of an approved active Notice of Claimed
Investigational Exemption for a New Drug (number).
(iv) Indication of an approved funded grant (number), if any.
(b) In the case of a clinical investigation with controlled
substances listed in Schedule I, the applicant shall submit three copies
of a Notice of Claimed Investigational Exemption for a New Drug (IND)
together with a statement of the security provisions (as prescribed in
paragraph (a)(2)(v) of this section for a research protocol) to, and
have such submission approved by, the Food and Drug Administration as
required in 21 U.S.C. 355(i) and 130.3 of this title. Submission of
this Notice and statement to the Food and Drug Administration shall be
in lieu of a research protocol to the Administration as required in
paragraph (a) of this section. The applicant, when applying for
registration with the Administration, shall indicate that such notice
has been submitted to the Food and Drug Administration by submitting to
the Administration with his DEA (or BND) Form 225 three copies of the
following certificate:
I hereby certify that on -------- (Date), pursuant to 21 U.S.C.
355(i) and 21 CFR 130.3, I, ------------------------------ (Name and
Address of IND Sponsor) submitted a Notice of Claimed Investigational
Exemption for a New Drug (IND) to the Food and Drug Administration for:
------------------------------ (Name of Investigational Drug).
------------ (Date) ------------------------------ (Signature of
Applicant).
(c) In the event that the registrant desires to increase the quantity
of a controlled substance used for an approved research project, he
shall submit a request to the Registration Unit, Drug Enforcement
Administration, Post Office Box 28083, Central Station, Washington, DC
20005, by registered mail, return receipt requested. The request shall
contain the following information: DEA registration number; name of
the controlled substance or substances and the quantity of each
authorized in the approved protocol; and the additional quantity of
each desired. Upon return of the receipt, the registrant shall be
authorized to purchase the additional quantity of the controlled
substance or substances specified in the request. The Administration
shall review the letter and forward it to the Food and Drug
Administration together with the Administration comments. The Food and
Drug Administration shall approve or deny the request as an amendment to
the protocol and so notify the registrant. Approval of the letter by
the Food and Drug Administration shall authorize the registrant to use
the additional quantity of the controlled substance in the research
project.
(d) In the event the registrant desires to conduct research beyond
the variations provided in the registrant's approved protocol (excluding
any increase in the quantity of the controlled substance requested for
his research project as outlined in paragraph (c) of this section), he
shall submit three copies of a supplemental protocol in accordance with
paragraph (a) of this section describing the new research and omitting
information in the supplemental protocol which has been stated in the
original protocol. Supplemental protocols shall be processed and
approved or denied in the same manner as original research protocols.
(37 FR 28712, Dec. 29, 1972. Redesignated at 38 FR 26609, Sept. 24,
l973, and amended at 51 FR 5319, Feb. 13, 1986)
21 CFR 1301.34 Filing of application; joint filings.
(a) All applications for registration shall be submitted for filing
to the Registration Unit, Drug Enforcement Administration, Department of
Justice, Post Office Box 28083, Central Station, Washington, DC 20005.
The appropriate registration fee and any required attachments must
accompany the application.
(b) Any person required to obtain more than one registration may
submit all applications in one package. Each application must be
complete and should not refer to any accompanying application for
required information.
(36 FR 7778, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24,
1973, and amended at 51 FR 5319, Feb. 13, 1986)
21 CFR 1301.35 Acceptance for filing; defective applications.
(a) Applications submitted for filing are dated upon receipt. If
found to be complete, the application will be accepted for filing.
Applications failing to comply with the requirements of this part will
not generally be accepted for filing. In the case of minor defects as
to completeness, the Administrator may accept the application for filing
with a request to the applicant for additional information. A defective
application will be returned to the applicant within 10 days following
its receipt with a statement of the reason for not accepting the
application for filing. A defective application may be corrected and
resubmitted for filing at any time; the Administrator shall accept for
filing any application upon resubmission by the applicant, whether
complete or not.
(b) Accepting an application for filing does not preclude any
subsequent request for additional information pursuant to 1301.36 and
has no bearing on whether the application will be granted.
21 CFR 1301.36 Additional information.
The Administrator may require an applicant to submit such documents
or written statements of fact relevant to the application as he deems
necessary to determine whether the application should be granted. The
failure of the applicant to provide such documents or statements within
a reasonable time after being requested to do so shall be deemed to be a
waiver by the applicant of an opportunity to present such documents or
facts for consideration by the Administrator in granting or denying the
application.
21 CFR 1301.37 Amendments to and withdrawal of applications.
(a) An application may be amended or withdrawn without permission of
the Administrator at any time before the date on which the applicant
receives an order to show cause pursuant to 1301.48, or before the date
on which a notice of hearing on the application is published pursuant to
1301.43, whichever is sooner. An application may be amended or
withdrawn with permission of the Administrator at any time where good
cause is shown by the applicant or where the amendment or withdrawal is
in the public interest.
(b) After an application has been accepted for filing, the request by
the applicant that it be returned or the failure of the applicant to
respond to official correspondence regarding the application, when sent
by registered or certified mail, return receipt requested, shall be
deemed to be a withdrawal of the application.
21 CFR 1301.38 Special procedures for certain applications.
(a) If, at the time of application for registration of a new
pharmacy, the pharmacy has been issued a license from the appropriate
State licensing agency, the applicant may include with his application
an affidavit as to the existence of the State license in the following
form:
I, ---------- , the ------------------------ (Title of officer,
official, partner, or other position) of ------------------------
(Corporation, partnership, or sole proprietor), doing business as
---------------- (Store name) at ---------------- (Number and Street),
---------------- (City) ---------------- (State) ---------------- (Zip
code), hereby certify that said store was issued a pharmacy permit No.
-------- by the ------------------------ (Board of Pharmacy or Licensing
Agency) of the State of -------------------- on ------------ (Date).
This statement is submitted in order to obtain a Drug Enforcement
Administration registration number. I understand that if any
information is false, the Administration may immediately suspend the
registration for this store and commence proceedings to revoke under 21
U.S.C. 824(a) because of the danger to public health and safety. I
further understand that any false information contained in this
affidavit may subject me personally and the above-named
corporation/partnership/business to prosecution under 21 U.S.C. 843, the
penalties for conviction of which include imprisonment for up to 4
years, a fine of not more than $30,000 or both.
Signature (Person who signs Application for Registration)
State of ------------
County of --------------
Subscribed to and sworn before me this ---------- day of
-------------- , 19 ---- .
Notary Public
(b) Whenever the ownership of a pharmacy is being transferred from
one person to another, if the transferee owns at least one other
pharmacy licensed in the same State as the one the ownership of which is
being transferred, the transferee may apply for registration prior to
the date of transfer. The Administrator may register the applicant and
authorize him to obtain controlled substances at the time of transfer.
Such registration shall not authorize the transferee to dispense
controlled substances until the pharmacy has been issued a valid State
license. The transferee shall include with his application the
following affidavit:
I, ---------------- , the ------------------------ (Title of officer,
official, partner or other position) of ------------------------
(Corporation, partnership, or sole proprietor), doing business as
---------------- (Store name) hereby certify:
(1) That said company was issued a pharmacy permit No. -------- by
the ------------------------ (Board of Pharmacy of Licensing Agency) of
the State of ---------------- and a DEA Registration Number ----------
for a pharmacy located at -------------------- (Number and Street)
---------------- (City) ------------------ (State) ---------------- (Zip
Code); and
(2) That said company is acquiring the pharmacy business of
---------------- (Name of Seller) doing business as ----------------
with DEA Registration Number ---------- on or about ----------------
(Date of Transfer) and that said company has applied (or will apply on
---------------- (Date) for a pharmacy permit from the board of pharmacy
(or licensing agency) of the State of ---------------- to do business as
---------------- (Store name) at ---------------- (Number and Street)
---------------- (City) ---------------- (State) ---------------- (Zip
Code).
This statement is submitted in order to obtain a Drug Enforcement
Administration registration number.
I understand that if a DEA registration number is issued, the
pharmacy may acquire controlled substances but may not dispense them
until a pharmacy permit or license is issued by the State board of
pharmacy or licensing agency.
I understand that if any information is false, the Administration may
immediately suspend the registration for this store and commence
proceedings to revoke under 21 U.S.C. 824(a) because of the danger to
public health and safety. I further understand that any false
information contained in this affidavit may subject me personally to
prosecution under 21 U.S.C. 843, the penalties for conviction of which
include imprisonment for up to 4 years, a fine of not more than $30,000
or both.
Signature (Person who signs Application for Registration)
State of ------------
County of --------------
Subscribed to and sworn before me this ------------ day of
---------------- , 19 ---- .
Notary Public
(c) The Administrator shall follow the normal procedures for
approving an application to verify the statements in the affidavit. If
the statements prove to be false, the Administrator may revoke the
registration on the basis of section 1304(a)(1) of the Act (21 U.S.C.
824(a)(1)) and suspend the registration immediately by pending
revocation on the basis of section 1304(d) of the Act (21 U.S.C.
824(d)). At the same time, the Administrator may seize and place under
seal all controlled substances possessed by the applicant under section
1304(f) of the Act (21 U.S.C. 824(f)). International misuse of the
affidavit procedure may subject the applicant to prosecution for fraud
under section 403(a)(4) of the Act (21 U.S.C. 843(a)(4)), and obtaining
controlled substances under a registration fraudulently gotten may
subject the applicant to prosecution under section 403(a)(3) of the Act
(21 U.S.C. 843(a)(3)). The penalties for conviction of either offense
include imprisonment for up to 4 years, a fine not exceeding $30,000 or
both.
(38 FR 756, Jan. 4, 1973. Redesignated at 38 FR 26609, Sept. 24,
l973)
21 CFR 1301.38 Action on Applications for Registration: Revocation or Suspension of Registration
21 CFR 1301.41 Administrative review generally.
The Administrator may inspect, or cause to be inspected, the
establishment of an applicant or registrant, pursuant to subpart A of
part 1316 of this chapter. The Administrator shall review, the
application for registration and other information gathered by the
Administrator regarding an applicant in order to determine whether the
applicable standards of section 1303 of the Act (21 U.S.C. 823) have
been met by the applicant.
21 CFR 1301.42 Action on applications for research in Schedule I
substances.
(a) In the case of an application for registration to conduct
research with controlled substances listed in Schedule I, the
Administrator shall process the application and protocol and forward a
copy of each to the Secretary within 7 days after receipt. The
Secretary shall determine the qualifications and competency of the
applicant, as well as the merits of the protocol (and shall notify the
Administrator of his determination) within 21 days after receipt of the
application and complete protocol, except that in the case of a clinical
investigation, the Secretary shall have 30 days to make such
determination and notify the Administrator. The Secretary, in
determining the merits of the protocol, shall consult with the
Administrator as to effective procedures to safeguard adequately against
diversion of such controlled substances from legitimate medical or
scientific use.
(b) An applicant whose protocol is defective shall be notified by the
Secretary within 21 days after receipt of such protocol from the
Administrator (or in the case of a clinical investigation within 30
days), and he shall be requested to correct the existing defects before
consideration shall be given to his submission.
(c) If the Secretary determines the applicant qualified and competent
and the research protocol meritorious, he shall notify the Administrator
in writing of such determination. The Administrator shall issue a
certificate of registration within 10 days after receipt of this notice,
unless he determines that the certificate of registration should be
denied on a ground specified in section 304(a) of the Act (21 U.S.C.
824(a)). In the case of a supplemental protocol, a replacement
certificate of registration shall be issued by the Administrator.
(d) If the Secretary determines that the protocol is not meritorious
and/or the applicant is not qualified or competent, he shall notify the
Administrator in writing setting forth the reasons for such
determination. If the Administrator determines that grounds exist for
the denial of the application, he shall within 10 days issue an order to
show cause pursuant to 1301.48 and, if requested by the applicant, hold
a hearing on the application pursuant to 1301.51. If the grounds for
denial of the application include a determination by the Secretary, the
Secretary or his duly authorized agent shall furnish testimony and
documents pertaining to his determination at such hearing.
(e) Supplemental protocols will be processed in the same manner as
original research protocols. If the processing of an application or
research protocol is delayed beyond the time limits imposed by this
section, the applicant shall be so notified in writing.
(37 FR 28712, Dec. 29, 1972. Redesignated at 38 FR 26609, Sept. 24,
l973)
21 CFR 1301.43 Application for bulk manufacture of Schedule I and II
substances.
(a) In the case of an application for registration or reregistration
to manufacture in bulk a basic class of controlled substance listed in
Schedule I or II, the Administrator shall, upon the filing of such
application, publish in the Federal Register a notice naming the
applicant and stating that such applicant has applied to be registered
as a bulk manufacturer of a basic class of narcotic or nonnarcotic
controlled substance, which class shall be identified. A copy of said
notice shall be mailed simultaneously to each person registered as a
bulk manufacturer of that basic class and to any other applicant
therefor. Any such person may, within 30 days from the date of
publication of the notice in the Federal Register, file with the
Administrator written comments on or objections to the issuance of the
proposed registration, and may, at the same time, file a written request
for a hearing on the application in accordance with 1301.54. If a
hearing is requested, the Administrator shall hold a hearing on the
application pursuant to 1301.51. Any such person may participate in the
hearing by filing a notice of appearance in accordance with 1301.54.
Notice of the hearing shall be published in the Federal Register and
shall be mailed simultaneously to the applicant and to all persons to
whom notice of the application was mailed. Notice of the hearing shall
contain a summary of all comments and objections filed regarding the
application and shall state the time and place for the hearing, which
shall not be less than 30 days after the date of publication of such
notice in the Federal Register. A hearing pursuant to this section may
be consolidated with a hearing held pursuant to 1301.44 or 1301.45.
(b) In order to provide adequate competition, the Administrator shall
not be required to limit the number of manufacturers in any basic class
to a number less than that consistent with maintenance of effective
controls against diversion solely because a smaller number is capable of
producing an adequate and uninterrupted supply.
(c) This section shall not apply to the manufacture of basic classes
of controlled substances listed in Schedules I or II as an incident to
research or chemical analysis as authorized in 1301.22 (b).
(36 FR 7778, Apr. 24, 1971, as amended at 36 FR 18729, Sept. 21,
1971. Redesignated at 38 FR 26609, Sept. 24, l973)
21 CFR 1301.44 Certificate of registration; denial of registration.
(a) The Administrator shall issue a Certificate of Registration (DEA
Form 223) to an applicant if the issuance of registration or
reregistration is required under the applicable provisions of section
303 of the Act (21 U.S.C. 823). In the event that the issuance of
registration or reregistration is not required, the Administrator shall
deny the application. Before denying any application, the Administrator
shall issue an order to show cause pursuant to 1301.48 and, if
requested by the applicant, shall hold a hearing on the application
pursuant to 1301.51.
(b) The Certificate of Registration (DEA Form 223) shall contain the
name, address, and registration number of the registrant, the activity
authorized by the registration, the schedules and/or Administration
Controlled Substances Code Number (as set forth in part 1308 of this
chapter) of the controlled substances which the registrant is authorized
to handle, the amount of fee paid (or exemption), and the expiration
date of the registration. The registrant shall maintain the certificate
of registration at the registered location in a readily retrievable
manner and shall permit inspection of the certificate by any official,
agent or employee of the Administration or of any Federal, State, or
local agency engaged in enforcement of laws relating to controlled
substances.
(36 FR 7778, Apr. 24, 1971, as amended at 37 FR 15918, Aug. 8, 1972.
Redesignated at 38 FR 26609, Sept. 24, l973 and amended at 53 FR 4963,
Feb. 19, 1988)
21 CFR 1301.45 Suspension or revocation of registration.
(a) The Administrator may suspend any registration pursuant to
section 304 (a) of the Act (21 U.S.C. 824(a)) for any period of time he
determines.
(b) The Administrator may revoke any registration pursuant to section
304 (a) of the Act (21 U.S.C. 824(a)).
(c) Before revoking or suspending any registration, the Administrator
shall issue an order to show cause pursuant to 1301.48 and, if
requested by the registrant, shall hold a hearing pursuant to 1301.51.
Notwithstanding the requirements of this section, however, the
Administrator may suspend any registration pending a final order
pursuant to 1301.46.
(d) Upon service of the order of the Administrator suspending or
revoking registration, the registrant shall immediately deliver his
Certificate of Registration and any order forms in his possession to the
nearest office of the Administration. The suspension or revocation of a
registration shall suspend or revoke any individual manufacturing or
procurement quota fixed for the registrant pursuant to part 303 of this
chapter. Also, upon service of the order of the Administrator revoking
or suspending registration, the registrant shall, as instructed by the
Administrator:
(1) Deliver all controlled substances in his possession to the
nearest office of the Administrator or to authorized agents of the
Administrator; or
(2) Place all controlled substances in his possession under seal as
described in section 304(f) of the Act (21 U.S.C. 824(f)).
(e) In the event that revocation or suspension is limited to a
particular controlled substance or substances, the registrant shall be
given a new Certificate of Registration for all substances not affected
by such revocation or suspension; no fee shall be required to be paid
for the new Certificate of Registration. The registrant shall deliver
the old Certificate of Registration and, if appropriate, any order forms
in his possession to the nearest office of the Administration. The
suspension or revocation of a registration, when limited to a particular
basic class or classes of controlled substances, shall suspend or revoke
any individual manufacturing or procurement quota fixed for the
registrant for such class or classes pursuant to part 303 of this
chapter. Also, upon service of the order of the Administrator revoking
or suspending registration, the registrant shall, as instructed by the
Administrator:
(1) Deliver to the nearest office of the Administration or to
authorized agents of the Administration all of the particular controlled
substance or substances affected by the revocation or suspension which
are in his possession; or
(2) Place all of such substances under seal as described in section
304(f) of the Act (21 U.S.C. 824(f)).
(36 FR 7778, Apr. 24, 1971, as amended at 37 FR 15919, Aug. 8, 1972.
Redesignated at 38 FR 26609, Sept. 24, l973)
21 CFR 1301.46 Suspension of registration pending final order.
(a) The Administrator may suspend any registration simultaneously
with or at any time subsequent to the service upon the registrant of an
order to show cause why such registration should not be revoked or
suspended, in any case where he finds that there is an imminent danger
to the public health or safety. If the Administrator so suspends, he
shall serve with the order to show cause pursuant to 1301.48 an order
of immediate suspension which shall contain a statement of his findings
regarding the danger to public health or safety.
(b) Upon service of the order of immediate suspension, the registrant
shall promptly return his Certificate of Registration and any order
forms in his possession to the nearest office of the Administration.
The suspension of any registration under this section shall suspend any
quota fixed for the registrant pursuant to part 1303 of this chapter.
Also, upon service of the order of the Administrator immediately
suspending registration, the registrant shall, as instructed by the
Administrator:
(1) Deliver all affected controlled substances in his possession to
the nearest office of the Administration or to authorized agents of the
Administration; or
(2) Place all of such substances under seal as described in section
304(f) of the Act (21 U.S.C. 824(f)).
(c) Any suspension shall continue in effect until the conclusion of
all proceedings upon the revocation or suspension, including any
judicial review thereof, unless sooner withdrawn by the Administrator or
dissolved by a court of competent jurisdiction. Any registrant whose
registration is suspended under this section may request a hearing on
the revocation or suspension of his registration at a time earlier than
specified in the order to show cause pursuant to 1301.48, which request
shall be granted by the Administrator, who shall fix a date for such
hearing as early as reasonably possible.
21 CFR 1301.47 Extension of registration pending final order.
In the event that an applicant for reregistration (who is doing
business under a registration previously granted and not revoked or
suspended) has applied for reregistration at least 45 days before the
date on which the existing registration is due to expire, and the
Administrator has issued no order on the application on the date on
which the existing registration is due to expire, the existing
registration of the applicant shall automatically be extended and
continue in effect until the date on which the Administrator so issues
his order. The Administrator may extend any other existing registration
under the circumstances contemplated in this section even though the
registrant failed to apply for reregistration at least 45 days before
expiration of the existing registration, with or without request by the
registrant, if the Administrator finds that such extension is not
inconsistent with the public health and safety.
21 CFR 1301.48 Order to show cause.
(a) If, upon examination of the application for registration from any
applicant and other information gathered by the Administration regarding
the applicant, the Administrator is unable to make the determinations
required by the applicable provisions of section 303 of the Act (21
U.S.C. 823) to register the applicant, the Administrator shall serve
upon the applicant an order to show cause why the registration should
not be denied.
(b) If, upon information gathered by the Administration regarding any
registrant, the Administrator determines that the registration of such
registrant is subject to suspension or revocation pursuant to section
304 of the Act (21 U.S.C. 824), the Administrator shall serve upon the
registrant an order to show cause why the registration should not be
revoked or suspended.
(c) The order to show cause shall call upon the applicant or
registrant to appear before the Administrator at a time and place stated
in the order, which shall not be less than 30 days after the date of
receipt of the order. The order to show cause shall also contain a
statement of the legal basis for such hearing and for the denial,
revocation, or suspension of registration and a summary of the matters
of fact and law asserted.
(d) Upon receipt of an order to show cause, the applicant or
registrant must, if he desires a hearing, file a request for a hearing
pursuant to 1301.54. If a hearing is requested, the Administrator shall
hold a hearing at the time and place stated in the order, pursuant to
1301.51.
(e) When authorized by the Administrator, any agent of the
Administration may serve the order to show cause.
(36 FR 7778, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971.
Redesignated at 38 FR 26609, Sept. 24, l973)
21 CFR 1301.48 Hearings
21 CFR 1301.51 Hearings generally.
(a) In any case where the Administrator shall hold a hearing on any
registration or application therefor, the procedures for such hearing
shall be governed generally by the adjudication procedures set forth in
the Administrative Procedure Act (5 U.S.C. 551-559) and specifically by
sections 303 and 304 of the Act (21 U.S.C. 823-824), by
1301.52-1301.57, and by the procedures for administrative hearings under
the Act set forth in 1316.41-1316.67 of this chapter.
(b) Any hearing under this part shall be independent of, and not in
lieu of, criminal prosecutions or other proceedings under the Act or any
other law of the United States.
21 CFR 1301.52 Purpose of hearing.
If requested by a person entitled to a hearing, the Administrator
shall hold a hearing for the purpose of receiving factual evidence
regarding the issues involved in the denial, revocation, or suspension
of any registration, and the granting of any application for
registration to manufacture in bulk a basic class of controlled
substance listed in Schedule I or II. Extensive argument should not be
offered into evidence but rather presented in opening or closing
statements of counsel or in memoranda or proposed findings of fact and
conclusions of law.
21 CFR 1301.53 Waiver or modification of rules.
The Administrator or the presiding officer (with respect to matters
pending before him) may modify or waive any rule in this part by notice
in advance of the hearing, if he determines that no party in the hearing
will be unduly prejudiced and the ends of justice will thereby be
served. Such notice of modification or waiver shall be made a part of
the record of the hearing.
21 CFR 1301.54 Request for hearing or appearance; waiver.
(a) Any person entitled to a hearing pursuant to 1301.42-1301.45
and desiring a hearing shall, within 30 days after the date of receipt
of the order to show cause (or the date of publication of notice of the
application for registration in the Federal Register in the case of
1301.43), file with the Administrator a written request for a hearing in
the form prescribed in 1316.47 of this chapter.
(b) Any person entitled to participate in a hearing pursuant to
1301.43 and desiring to do so shall, within 30 days of the date of
publication of notice of the hearing in the Federal Register, file with
the Administrator a written notice of his intention to participate in
such hearing in the form prescribed in 1316.48 of this chapter. Any
person filing a request for a hearing need not also file a notice of
appearance.
(c) Any person entitled to a hearing or to participate in a hearing
pursuant to 1301.42-1301.45 may, within the period permitted for
filing a request for a hearing or a notice of appearance, file with the
Administrator a waiver of an opportunity for a hearing or to participate
in a hearing, together with a written statement regarding his position
on the matters of fact and law involved in such hearing. Such
statement, if admissible, shall be made a part of the record and shall
be considered in light of the lack of opportunity for cross-examination
in determining the weight to be attached to matters of fact asserted
therein.
(d) If any person entitled to a hearing or to participate in a
hearing pursuant to 1301.42-1301.45 fails to file a request for a
hearing or a notice of appearance, or if he so files and fails to appear
at the hearing, he shall be deemed to have waived his opportunity for
the hearing or to participate in the hearing, unless he shows good cause
for such failure.
(e) If all persons entitled to a hearing or to participate in a
hearing waive or are deemed to waive their opportunity for the hearing
or to participate in the hearing, the Administrator may cancel the
hearing, if scheduled, and issue his final order pursuant to 1301.57
without a hearing.
(36 FR 7778, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971.
Redesignated at 38 FR 26609, Sept. 24, l973)
21 CFR 1301.55 Burden of proof.
(a) At any hearing on an application to manufacture any controlled
substance listed in Schedule I or II, the applicant shall have the
burden of proving that the requirements for such registration pursuant
to section 303(a) of the Act (21 U.S.C. 823(a)) are satisfied. Any
other person participating in the hearing pursuant to 1301.43 shall
have the burden of proving any propositions of fact or law asserted by
him in the hearing.
(b) At any hearing on the granting or denial of an applicant to be
registered to conduct a narcotic treatment program or as a compounder,
the applicant shall have the burden of proving that the requirements for
each registration pursuant to section 303(g) of the Act (21 U.S.C.
823(g)) are satisfied.
(c) At any other hearing for the denial of a registration, the
Administration shall have the burden of proving that the requirements
for such registration pursuant to section 303 of the Act (21 U.S.C.
823) are not satisfied.
(d) At any hearing for the revocation or suspension of a
registration, the Administration shall have the burden of proving that
the requirements for such revocation or suspension to section 304 (a) of
the Act (21 U.S.C. 824(a)) are satisfied.
(36 FR 7778, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24,
1973, and amended at 41 FR 21448, May 26, 1976)
21 CFR 1301.56 Time and place of hearing.
The hearing will commence at the place and time designated in the
order to show cause or notice of hearing published in the Federal
Register (unless expedited pursuant to 1301.46(c)) but thereafter it
may be moved to a different place and may be continued from day to day
or recessed to a later day without notice other than announcement
thereof by the presiding officer at the hearing.
21 CFR 1301.57 Final order.
As soon as practicable after the presiding officer has certified the
record to the Administrator, the Administrator shall issue his order on
the granting, denial, revocation, or suspension of registration. In the
event that an application for registration to manufacture in bulk a
basic class of any controlled substance listed in Schedule I or II is
granted, or any application for registration is denied, or any
registration is revoked or suspended, the order shall include the
findings of fact and conclusions of law upon which the order is based.
The order shall specify the date on which it shall take effect. The
Administrator shall serve one copy of his order upon each party in the
hearing.
21 CFR 1301.57 Modification, Transfer and Termination of Registration
21 CFR 1301.61 Modification in registration.
Any registrant may apply to modify his registration to authorize the
handling of additional controlled substances or to change his name or
address, by submitting a letter of request to the Registration Unit,
Drug Enforcement Administration, Department of Justice, Post Office Box
28083, Central Station, Washington, DC 20005. The letter shall contain
the registrant's name, address, and registration number as printud on
the certificate of registration, and the substances and/or schedules to
be added to his registration or the new name or address and shall be
signed in accordance with 1301.32(f). If the registrant is seeking to
handle additional controlled substances listed in Schedule I for the
purpose of research or instructional activities, he shall attach three
copies of a research protocol describing each research project involving
the additional substances, or two copies of a statement describing the
nature, extent, and duration of such instructional activities, as
appropriate. No fee shall be required to be paid for the modification.
The request for modification shall be handled in the same manner as an
application for registration. If the modification in registration is
approved, the Administrator shall issue a new certificate of
registration (DEA Form 223) to the registrant, who shall maintain it
with the old certificate of registration until expiration.
(36 FR 18729, Sept. 21, 1971, as amended at 37 FR 15919, Aug. 8,
1972. Redesignated at 38 FR 26609, Sept. 24, l973, and amended at 51 FR
5319, Feb. 13, 1986; 53 FR 4963, Feb. 19, 1988)
21 CFR 1301.62 Termination of registration.
The registration of any person shall terminate if and when such
person dies, ceases legal existence, or discontinues business or
professional practice. Any registrant who ceases legal existence or
discontinues business or professional practice shall notify the
Administrator promptly of such fact.
(37 FR 15919, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24,
l973)
21 CFR 1301.63 Transfer of registration.
No registration or any authority conferred thereby shall be assigned
or otherwise transferred except upon such conditions as the
Administrator may specifically designate and then only pursuant to his
written consent.
21 CFR 1301.63 Security Requirements
21 CFR 1301.71 Security requirements generally.
(a) All applicants and registrants shall provide effective controls
and procedures to guard against theft and diversion of controlled
substances. In order to determine whether a registrant has provided
effective controls against diversion, the Administrator shall use the
security requirements set forth in 1301.72-1301.76 as standards for
the physical security controls and operating procedures necessary to
prevent diversion. Materials and construction which will provide a
structural equivalent to the physical security controls set forth in
1301.72, 1301.73 and 1301.75 may be used in lieu of the materials and
construction described in those sections.
(b) Substantial compliance with the standards set forth in
1301.72-1301.76 may be deemed sufficient by the Administrator after
evaluation of the overall security system and needs of the applicant or
registrant. In evaluating the overall security system of a registrant
or applicant, the Administrator may consider any of the following
factors as he may deem relevant to the need for strict compliance with
security requirements:
(1) The type of activity conducted (e.g., processing of bulk
chemicals, preparing dosage forms, packaging, labeling, cooperative
buying, etc.);
(2) The type and form of controlled substances handled (e.g., bulk
liquids or dosage units, usable powders or nonusable powders);
(3) The quantity of controlled substances handled;
(4) The location of the premises and the relationship such location
bears on security needs;
(5) The type of building construction comprising the facility and the
general characteristics of the building or buildings;
(6) The type of vault, safe, and secure enclosures or other storage
system (e.g., automatic storage and retrieval system) used;
(7) The type of closures on vaults, safes, and secure enclosures;
(8) The adequacy of key control systems and/or combination lock
control systems;
(9) The adequacy of electric detection and alarm systems, if any
including use of supervised transmittal lines and standby power sources;
(10) The extent of unsupervised public access to the facility,
including the presence and characteristics of perimeter fencing, if any;
(11) The adequacy of supervision over employees having access to
manufacturing and storage areas;
(12) The procedures for handling business guests, visitors,
maintenance personnel, and nonemployee service personnel;
(13) The availability of local police protection or of the
registrant's or applicant's security personnel, and;
(14) The adequacy of the registrant's or applicant's system for
monitoring the receipt, manufacture, distribution, and disposition of
controlled substances in its operations.
(c) When physical security controls become inadequate as a result of
a controlled substance being transferred to a different schedule, or as
a result of a noncontrolled substance being listed on any schedule, or
as a result of a significant increase in the quantity of controlled
substances in the possession of the registrant during normal business
operations, the physical security controls shall be expanded and
extended accordingly. A registrant may adjust physical security
controls within the requirements set forth in 1301.72-1301.76 when the
need for such controls decreases as a result of a controlled substance
being transferred to a different schedule, or a result of a controlled
substance being removed from control, or as a result of a significant
decrease in the quantity of controlled substances in the possession of
the registrant during normal business operations.
(d) Any registrant or applicant desiring to determine whether a
proposed security system substantially complies with, or is the
structural equivalent of, the requirements set forth in
1301.72-1301.76 may submit any plans, blueprints, sketches or other
materials regarding the proposed security system either to the Special
Agent in Charge in the region in which the system will be used, or to
the Diversion Operations Section, Drug Enforcement Administration,
Department of Justice, Washington, DC 20537.
(e) Physical security controls of locations registered under the
Harrison Narcotic Act or the Narcotics Manufacturing Act of 1960 on
April 30, 1971, shall be deemed to comply substantially with the
standards set forth in 1301.72, 1301.73 and 1301.75. Any new
facilities or work or storage areas constructed or utilized for
controlled substances, which facilities or work or storage areas have
not been previously approved by the Administration, shall not
necessarily be deemed to comply substantially with the standards set
forth in 1301.72, 1301.73 and 1301.75, notwithstanding that such
facilities or work or storage areas have physical security controls
similar to those previously approved by the Administration.
(36 FR 18729, Sept. 21, 1971. Redesignated at 38 FR 26609, Sept. 24,
l973, and amended at 46 FR 28841, May 29, 1981; 47 FR 41735, Sept. 22,
1982; 51 FR 5319, Feb. 13, 1986)
21 CFR 1301.72 Physical security controls for non-practitioners;
narcotic treatment programs and compounders for narcotic treatment
programs; storage areas.
(a) Schedules I and II. Raw materials, bulk materials awaiting
further processing, and finished products which are controlled
substances listed in Schedule I or II shall be stored in one of the
following secure storage areas:
(1) Where small quantities permit, a safe or steel cabinet;
(i) Which safe or steel cabinet shall have the following
specifications or the equivalent: 30 man-minutes against surreptitious
entry, 10 man-minutes against forced entry, 20 man-hours against lock
manipulation, and 20 man-hours against radiological techniques;
(ii) Which safe or steel cabinet, if it weighs less than 750 pounds,
is bolted or cemented to the floor or wall in such a way that it cannot
be readily removed; and
(iii) Which safe or steel cabinet, if necessary, depending upon the
quantities and type of controlled substances stored, is equipped with an
alarm system which, upon attempted unauthorized entry, shall transmit a
signal directly to a central protection company or a local or State
police agency which has a legal duty to respond, or a 24-hour control
station operated by the registrant, or such other protection as the
Administrator may approve.
(2) A vault constructed before, or under construction on, September
1, 1971, which is of substantial construction with a steel door,
combination or key lock, and an alarm system; or
(3) A vault constructed after September 1, 1971:
(i) The walls, floors, and ceilings of which vault are constructed of
at least 8 inches of reinforced concrete or other substantial masonry,
reinforced vertically and horizontally with 1/2-inch steel rods tied 6
inches on center, or the structural equivalent to such reinforced walls,
floors, and ceilings;
(ii) The door and frame unit of which vault shall conform to the
following specifications or the equivalent: 30 man-minutes against
surreptitious entry, 10 man-minutes against forced entry, 20 man-hours
against lock manipulation, and 20 man-hours against radiological
techniques;
(iii) Which vault, if operations require it to remain open for
frequent access, is equipped with a ''day-gate'' which is self-closing
and self-locking, or the equivalent, for use during the hours of
operation in which the vault door is open;
(iv) The walls or perimeter of which vault are equipped with an
alarm, which upon unauthorized entry shall transmit a signal directly to
a central station protection company, or a local or State police agency
which has a legal duty to respond, or a 24-hour control station operated
by the registrant, or such other protection as the Administrator may
approve, and, if necessary, holdup buttons at strategic points of entry
to the perimeter area of the vault;
(v) The door of which vault is equipped with contact switches; and
(vi) Which vault has one of the following: Complete electrical
lacing of the walls, floor and ceilings; sensitive ultrasonic equipment
within the vault; a sensitive sound accumulator system; or such other
device designed to detect illegal entry as may be approved by the
Administration.
(b) Schedules III, IV and V. Raw materials, bulk materials awaiting
further processing, and finished products which are controlled
substances listed in Schedules III, IV and V shall be stored in the
following secure storage areas:
(1) A safe or steel cabinet as described in paragraph (a)(1) of this
section;
(2) A vault as described in paragraph (a)(2) or (3) of this section
equipped with an alarm system as described in paragraph (b)(4)(v) of
this section;
(3) A building used for storage of Schedules III through V controlled
substances with perimeter security which limits access during working
hours and provides security after working hours and meets the following
specifications:
(i) Has an electronic alarm system as described in paragraph
(b)(4)(v) of this section,
(ii) Is equipped with self-closing, self-locking doors constructed of
substantial material commensurate with the type of building
construction, provided, however, a door which is kept closed and locked
at all times when not in use and when in use is kept under direct
observation of a responsible employee or agent of the registrant is
permitted in lieu of a self-closing, self-locking door. Doors may be
sliding or hinged. Regarding hinged doors, where hinges are mounted on
the outside, such hinges shall be sealed, welded or otherwise
constructed to inhibit removal. Locking devices for such doors shall be
either of the multiple-position combination or key lock type and:
(a) In the case of key locks, shall require key control which limits
access to a limited number of employees, or;
(b) In the case of combination locks, the combination shall be
limited to a minimum number of employees and can be changed upon
termination of employment of an employee having knowledge of the
combination;
(4) A cage, located within a building on the premises, meeting the
following specifications:
(i) Having walls constructed of not less than No. 10 gauge steel
fabric mounted on steel posts, which posts are:
(a) At least one inch in diameter;
(b) Set in concrete or installed with lay bolts that are pinned or
brazed; and
(c) Which are placed no more than ten feet apart with horizontal one
and one-half inch reinforcements every sixty inches;
(ii) Having a mesh construction with openings of not more than two
and one-half inches across the square,
(iii) Having a ceiling constructed of the same material, or in the
alternative, a cage shall be erected which reaches and is securely
attached to the structural ceiling of the building. A lighter gauge
mesh may be used for the ceilings of large enclosed areas if walls are
at least 14 feet in height,
(iv) Is equipped with a door constructed of No. 10 gauge steel
fabric on a metal door frame in a metal door flange, and in all other
respects conforms to all the requirements of 21 CFR 1301.72(b)(3)(ii),
and
(v) Is equipped with an alarm system which upon unauthorized entry
shall transmit a signal directly to a central station protection agency
or a local or state police agency, each having a legal duty to respond,
or to a 24-hour control station operated by the registrant, or to such
other source of protection as the Administrator may approve;
(5) An enclosure of masonry or other material, approved in writing by
the Administrator as providing security comparable to a cage;
(6) A building or enclosure within a building which has been
inspected and approved by DEA or its predecessor agency, BNDD, and
continues to provide adequate security against the diversion of Schedule
III through V controlled substances, of which fact written
acknowledgment has been made by the Special Agent in Charge of DEA for
the area in which such building or enclosure is situated;
(7) Such other secure storage areas as may be approved by the
Administrator after considering the factors listed in 1301.71(b), (1)
through (14);
(8) (i) Schedule III through V controlled substances may be stored
with Schedules I and II controlled substances under security measures
provided by 21 CFR 1301.72(a);
(ii) Non-controlled drugs, substances and other materials may be
stored with Schedule III through V controlled substances in any of the
secure storage areas required by 21 CFR 1301.72(b), provided that
permission for such storage of non-controlled items is obtained in
advance, in writing, from the Special Agent in Charge of DEA for the
area in which such storage area is situated. Any such permission
tendered must be upon the Special Agent in Charge's written
determination that such non-segregated storage does not diminish
security effectiveness for Schedules III through V controlled
substances.
(c) Multiple storage areas. Where several types or classes of
controlled substances are handled separately by the registrant or
applicant for different purposes (e.g., returned goods, or goods in
process), the controlled substances may be stored separately, provided
that each storage area complies with the requirements set forth in this
section.
(d) Accessibility to storage areas. The controlled substances
storage areas shall be accessible only to an absolute minimum number of
specifically authorized employees. When it is necessary for employee
maintenance personnel, nonemployee maintenance personnel, business
guests, or visitors to be present in or pass through controlled
substances storage areas, the registrant shall provide for adequate
observation of the area by an employee specifically authorized in
writing.
(36 FR 18730, Sept. 21, 1971, as amended at 37 FR 15919, Aug. 8,
1972. Redesignated at 38 FR 26609, Sept. 24, l973)
Editorial Note: For Federal Register citations affecting 1301.72,
see the List of CFR Sections Affected in the Finding Aids section of
this volume.
21 CFR 1301.73 Physical security controls for non-practitioners;
compounders for narcotic treatment programs; manufacturing and
compounding areas.
All manufacturing activities (including processing, packaging and
labeling) involving controlled substances listed in any schedule and all
activities of compounders shall be conducted in accordance with the
following:
(a) All in-process substances shall be returned to the controlled
substances storage area at the termination of the process. If the
process is not terminated at the end of a workday (except where a
continuous process or other normal manufacturing operation should not be
interrupted), the processing area or tanks, vessels, bins or bulk
containers containing such substances shall be securely locked, with
adequate security for the area or building. If such security requires
an alarm, such alarm, upon unauthorized entry, shall transmit a signal
directly to a central station protection company, or local or state
police agency which has a legal duty to respond, or a 24-hour control
station operated by the registrant.
(b) Manufacturing activities with controlled substances shall be
conducted in an area or areas of clearly defined limited access which is
under surveillance by an employee or employees designated in writing as
responsible for the area. ''Limited access'' may be provided, in the
absence of physical dividers such as walls or partitions, by traffic
control lines or restricted space designation. The employee designated
as responsible for the area may be engaged in the particular
manufacturing operation being conducted: Provided, That he is able to
provide continuous surveillance of the area in order that unauthorized
persons may not enter or leave the area without his knowledge.
(c) During the production of controlled substances, the manufacturing
areas shall be accessible to only those employees required for efficient
operation. When it is necessary for employee maintenance personnel,
nonemployee maintenance personnel, business guests, or visitors to be
present in or pass through manufacturing areas during production of
controlled substances, the registrant shall provide for adequate
observation of the area by an employee specifically authorized in
writing.
(36 FR 18731, Sept. 21, 1971. Redesignated at 38 FR 26609, Sept. 24,
l973 and amended at 39 FR 37984, Oct. 25, 1974)
21 CFR 1301.74 Other security controls for non-practitioners; narcotic
treatment programs and compounders for narcotic treatment programs.
(a) Before distributing a controlled substance to any person who the
registrant does not know to be registered to possess the controlled
substance, the registrant shall make a good faith inquiry either with
the Administration or with the appropriate State controlled substances
registration agency, if any, to determine that the person is registered
to possess the controlled substance.
(b) The registrant shall design and operate a system to disclose to
the registrant suspicious orders of controlled substances. The
registrant shall inform the Field Division Office of the Administration
in his area of suspicious orders when discovered by the registrant.
Suspicious orders include orders of unusual size, orders deviating
substantially from a normal pattern, and orders of unusual frequency.
(c) The registrant shall notify the Field Division Office of the
Administration in his area of any theft or significant loss of any
controlled substances upon discovery of such theft or loss. The
supplier shall be responsible for reporting in-transit losses of
controlled substances by the common or contract carrier selected
pursuant to 1301.74(e), upon discovery of such theft or loss. The
registrant shall also complete DEA Form 106 regarding such theft or
loss. Thefts must be reported whether or not the controlled substances
are subsequently recovered and/or the responsible parties are identified
and action taken against them.
(d) The registrant shall not distribute any controlled substance
listed in Schedules II through V as a complimentary sample to any
potential or current customer (1) without the prior written request of
the customer, (2) to be used only for satisfying the legitimate medical
needs of patients of the customer, and (3) only in reasonable
quantities. Such request must contain the name, address, and
registration number of the customer and the name and quantity of the
specific controlled substance desired. The request shall be preserved
by the registrant with other records of distribution of controlled
substances. In addition, the requirements of part 1305 of the chapter
shall be complied with for any distribution of a controlled substance
listed in Schedule II. For purposes of this paragraph, the term
''customer'' includes a person to whom a complimentary sample of a
substance is given in order to encourage the prescribing or recommending
of the substance by the person.
(e) When shipping controlled substances, a registrant is responsible
for selecting common or contract carriers which provide adequate
security to guard against in-transit losses. When storing controlled
substances in a public warehouse, a registrant is responsible for
selecting a warehouseman which will provide adequate security to guard
against storage losses; wherever possible, the registrant shall store
controlled substances in a public warehouse which complies with the
requirements set forth in 1301.72. In addition, the registrant shall
employ precautions (e.g., assuring that shipping containers do not
indicate that contents are controlled substances) to guard against
storage or in-transit losses.
(f) When distributing controlled substances through agents (e.g.,
detailmen), a registrant is responsible for providing and requiring
adequate security to guard against theft and diversion while the
substances are being stored or handled by the agent or agents.
(g) Before the initial distribution of carfentanil etorphine
hydrochloride and/or diprenorphine to any person, the registrant must
verify that the person is authorized to handle the substances(s) by
contacting the Drug Enforcement Administration.
(h) The acceptance of delivery of narcotic substances by a narcotic
treatment program shall be made only by a licensed practitioner employed
at the facility or other authorized individuals designated in writing.
At the time of delivery, the licensed practitioner or other authorized
individual designated in writing (excluding persons currently or
previously dependent on narcotic drugs), shall sign for the narcotics
and place his specific title (if any) on any invoice. Copies of these
signed invoices shall be kept by the distributor.
(i) Narcotics dispensed or administered at a narcotic treatment
program will be dispensed or administered directly to the patient by
either (1) the licensed practitioner, (2) a registered nurse under the
direction of the licensed practitioner, (3) a licensed practical nurse
under the direction of the licensed practitioner, or (4) a pharmacist
under the direction of the licensed practitioner.
(j) Persons enrolled in a narcotic treatment program will be required
to wait in an area physically separated from the narcotic storage and
dispensing area. This requirement will be enforced by the program
physician and employees.
(k) All narcotic treatment programs must comply with standards
established by the Secretary of Health and Human Services (after
consultation with the Administration) respecting the quantities of
narcotic drugs which may be provided to persons enrolled in a narcotic
treatment program for unsupervised use.
(l) DEA may exercise discretion regarding the degree of security
required in narcotic treatment programs based on such factors as the
location of a program, the number of patients enrolled in a program and
the number of physicians, staff members and security guards. Similarly,
such factors will be taken into consideration when evaluating existing
security or requiring new security at a narcotic treatment program.
(36 FR 7778, Apr. 24, 1971; 36 FR 13386, July 21, 1971, as amended
at 36 FR 18731, Sept. 21, 1971. Redesignated at 38 FR 26609, Sept. 24,
l973)
Editorial Note: For Federal Register citations affecting 1301.74,
see the List of CFR Sections Affected in the Finding Aids section of
this volume.
21 CFR 1301.75 Physical security controls for practitioners.
(a) Controlled substances listed in Schedule I shall be stored in a
securely locked, substantially constructed cabinet.
(b) Controlled substances listed in Schedules II, III, IV, and V
shall be stored in a securely locked, substantially constructed cabinet.
However, pharmacies and institutional practitioners (as defined in
1304.02(e) of this chapter) may disperse such substances throughout the
stock of noncontrolled substances in such a manner as to obstruct the
theft or diversion of the controlled substances.
(c) This section shall also apply to nonpractitioners authorized to
conduct research or chemical analysis under another registration.
(d) Carfentanil etorphine hydrochloride and diprenorphine shall be
stored in a safe or steel cabinet equivalent to a U.S. Government Class
V security container.
(39 FR 3674, Jan. 29, 1974, as amended at 39 FR 17838, May 21, 1974;
54 FR 33674, Aug. 16, 1989)
21 CFR 1301.76 Other security controls for practitioners.
(a) The registrant shall not employ, as an agent or employee who has
access to controlled substances, any person who has been convicted of a
felony offense relating to controlled substances or who, at any time,
had an application for registration with the DEA denied, had a DEA
registration revoked or has surrendered a DEA registration for cause.
For purposes of this subsection, the term ''for cause'' means a
surrender in lieu of, or as a consequence of, any federal or state
administrative, civil or criminal action resulting from an investigation
of the individual's handling of controlled substances.
(b) The registrant shall notify the Field Division Office of the
Administration in his area of the theft or significant loss of any
controlled substances upon discovery of such loss or theft. The
registrant shall also complete DEA (or BND) Form 106 regarding such loss
or theft.
(c) Whenever the registrant distributes a controlled substance
(without being registered as a distributor, as permitted in 1301.22(b)
and/or 1307.11-1307.14), he shall comply with the requirements imposed
on nonpractitioners in 1301.74 (a), (b), and (e).
(36 FR 7778, Apr. 24, 1971, as amended at 36 FR 18731, Sept. 21,
1971; 37 FR 15919, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept.
24, l973; 47 FR 41735, Sept. 22, 1982; 56 FR 36728, Aug. 1, 1991)
21 CFR 1301.76 Employee Screening -- Non- Practitioners
21 CFR 1301.90 Employee screening procedures.
It is the position of DEA that the obtaining of certain information
by non-practitioners is vital to fairly assess the likelihood of an
employee committing a drug security breach. The need to know this
information is a matter of business necessity, essential to overall
controlled substances security. In this regard, it is believed that
conviction of crimes and unauthorized use of controlled substances are
activities that are proper subjects for inquiry. It is, therefore,
assumed that the following questions will become a part of an employer's
comprehensive employee screening program:
Question. Within the past five years, have you been convicted of a
felony, or within the past two years, of any misdemeanor or are you
presently formally charged with committing a criminal offense? (Do not
include any traffic violations, juvenile offenses or military
convictions, except by general court-martial.) If the answer is yes,
furnish details of conviction, offense, location, date and sentence.
Question. In the past three years, have you ever knowingly used any
narcotics, amphetamines or barbiturates, other than those prescribed to
you by a physician? If the answer is yes, furnish details.
Advice. An authorization, in writing, that allows inquiries to be
made of courts and law enforcement agencies for possible pending charges
or convictions must be executed by a person who is allowed to work in an
area where access to controlled substances clearly exists. A person
must be advised that any false information or omission of information
will jeopardize his or her position with respect to employment. The
application for employment should inform a person that information
furnished or recovered as a result of any inquiry will not necessarily
preclude employment, but will be considered as part of an overall
evaluation of the person's qualifications. The maintaining of fair
employment practices, the protection of the person's right of privacy,
and the assurance that the results of such inquiries will be treated by
the employer in confidence will be explained to the employee.
(40 FR 17143, Apr. 17, 1975)
21 CFR 1301.91 Employee responsibility to report drug diversion.
Reports of drug diversion by fellow employees is not only a necessary
part of an overall employee security program but also serves the public
interest at large. It is, therefore, the position of DEA that an
employee who has knowledge of drug diversion from his employer by a
fellow employee has an obligation to report such information to a
responsible security official of the employer. The employer shall treat
such information as confidential and shall take all reasonable steps to
protect the confidentiality of the information and the identity of the
employee furnishing information. A failure to report information of
drug diversion will be considered in determining the feasibility of
continuing to allow an employee to work in a drug security area. The
employer shall inform all employees concerning this policy.
(40 FR 17143, Apr. 17, 1975)
21 CFR 1301.92 Illicit activities by employees.
It is the position of DEA that employees who possess, sell, use or
divert controlled substances will subject themselves not only to State
or Federal prosecution for any illicit activity, but shall also
immediately become the subject of independent action regarding their
continued employment. The employer will assess the seriousness of the
employee's violation, the position of responsibility held by the
employee, past record of employment, etc., in determining whether to
suspend, transfer, terminate or take other action against the employee.
(40 FR 17143, Apr. 17, 1975)
21 CFR 1301.93 Sources of information for employee checks.
DEA recommends that inquiries concerning employees' criminal records
be made as follows:
Local inquiries. Inquiries should be made by name, date and place of
birth, and other identifying information, to local courts and law
enforcement agencies for records of pending charges and convictions.
Local practice may require such inquiries to be made in person, rather
than by mail, and a copy of an authorization from the employee may be
required by certain law enforcement agencies.
DEA inquiries. Inquiries supplying identifying information should
also be furnished to DEA Field Division Offices along with written
consent from the concerned individual for a check of DEA files for
records of convictions. The Regional check will result in a national
check being made by the Field Division Office.
(40 FR 17143, Apr. 17, 1975, as amended at 47 FR 41735, Sept. 22,
1982)
21 CFR 1301.93 PART 1302 -- LABELING AND PACKAGING REQUIREMENTS FOR
CONTROLLED SUBSTANCES
Sec.
1302.01 Scope of Part 1302.
1302.02 Definitions.
1302.03 Symbol required; exceptions.
1302.04 Location and size of symbol on label.
1302.05 Location and size of symbol on labeling.
1302.06 Effective dates of labeling requirements.
1302.07 Sealing of controlled substances.
1302.08 Labeling and packaging requirements for imported and exported
substances.
Authority: 21 U.S.C. 821, 825, 871(b), 958(e).
Source: 36 FR 7785, Apr. 24, 1971, unless otherwise noted.
Redesignated at 38 FR 26609, Sept. 24, 1973.
21 CFR 1302.01 Scope of Part 1302.
Requirements governing the labeling and packaging of controlled
substances pursuant to sections 1305 and 1008(d) of the Act (21 U.S.C.
825 and 958(d)) are set forth generally by those sections and
specifically by the sections of this part.
(36 FR 13386, July 21, 1971. Redesignated at 38 FR 26609, Sept. 24,
l973)
21 CFR 1302.02 Definitions.
As used in this part, the following terms shall have the meanings
specified:
(a) The term commercial container means any bottle, jar, tube,
ampule, or other receptacle in which a substance is held for
distribution or dispensing to an ultimate user, and in addition, any box
or package in which the receptacle is held for distribution or
dispensing to an ultimate user. The term commercial container does not
include any package liner, package insert or other material kept with or
within a commercial container, nor any carton, crate, drum, or other
package in which commercial containers are stored or are used for
shipment of controlled substances.
(b) The term label means any display of written, printed, or graphic
matter placed upon the commercial container of any controlled substance
by any manufacturer of such substance.
(c) The term labeling means all labels and other written, printed, or
graphic matter (1) upon any controlled substance or any of its
commercial containers or wrappers, or (2) accompanying such controlled
substance.
(d) The term manufacture means the producing, preparation,
propagation, compounding, or processing of a drug or other substance or
the packaging or repackaging of such substance, or the labeling or
relabeling of the commercial container of such substance, but does not
include the activities of a practitioner who, as an incident to his
administration or dispensing such substance in the course of his
professional practice, prepares, compounds, packages or labels such
substance. The term manufacturer means a person who manufactures a drug
or other substance, whether under a registration as a manufacturer or
under authority of registration as a researcher or chemical analyst.
(e) Any term not defined in this section shall have the definition
set forth in section 102 of the Act (21 U.S.C. 802) or 1301.02 of this
chapter.
(36 FR 7785, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971.
Redesignated at 38 FR 26609, Sept. 24, 1973)
21 CFR 1302.03 Symbol required; exceptions.
(a) Each commercial container of a controlled substance (except for a
controlled substance excepted by the Administrator pursuant to 1308.31
of this chapter) shall have printed on the label the symbol designating
the schedule in which such controlled substance is listed. Each such
commercial container, if it otherwise has no label, must bear a label
complying with the requirement of this part.
(b) Each manufacturer shall print upon the labeling of each
controlled substance distributed by him the symbol designating the
schedule in which such controlled substance is listed.
(c) The following symbols shall designate the schedule corresponding
thereto:
The word ''schedule'' need not be used. No distinction need be made
between narcotic and nonnarcotic substances.
(d) The symbol is not required on a carton or wrapper in which a
commercial container is held if the symbol is easily legible through
such carton or wrapper.
(e) The symbol is not required on a commercial container too small or
otherwise unable to accommodate a label, if the symbol is printed on the
box or package from which the commercial container is removed upon
dispensing to an ultimate user.
(f) The symbol is not required on a commercial container containing,
or on the labeling of, a controlled substance being utilized in clinical
research involving blind and double blind studies.
(36 FR 7785, Apr. 24, 1971, as amended at 36 FR 18731, Sept. 21,
1971. Redesignated at 38 FR 26609, Sept. 24, 1973)
21 CFR 1302.04 Location and size of symbol on label.
(a) The symbol shall be prominently located on the right upper corner
of the principal panel of the label of the commercial container and/or
the panel of the commercial container normally displayed to dispensers
of any controlled substance listed in Schedules I through V. The symbol
must be at least two times as large as the largest type otherwise
printed on the label.
(b) In lieu of locating the symbol in the corner of the label, as
prescribed in paragraph (a) of this section, the symbol may be
overprinted on the label, in which case the symbol must be printed at
least one-half the height of the label and in a contrasting color
providing clear visibility against the background color of the label.
(c) In all cases the symbol shall be clear and large enough to afford
easy identification of the schedule of the controlled substance upon
inspection without removal from the dispenser's shelf.
21 CFR 1302.05 Location and size of symbol on labeling.
The symbol shall be prominently located on all labeling other than
labels covered by 1302.04. In all cases the symbol shall be clear and
large enough to afford prompt identification of the controlled substance
upon inspection of the labeling.
21 CFR 1302.06 Effective dates of labeling requirements.
(a) All labels on commercial containers of, and all labeling of, a
controlled substance which is listed in any schedule on May 1, 1971, and
which is packaged after December 1, 1971, shall comply with the
requirements of 1302.03.
(b) All labels on commercial containers of, and all labeling of, a
controlled substance which either is listed in any schedule on May 1,
1971, and thereafter transferred to another schedule or is added to any
schedule after May 1, 1971, and which is packaged more than 180 days
following the date on which the transfer or addition becomes effective,
shall comply with the requirements of 1302.03.
(c) The Administrator may, in the case of any controlled substance,
require compliance with the requirements of 1302.03 within a period of
time shorter than required by this section if he finds that public
health or safety necessitate an earlier effective date.
(d) Until compliance is required under this section, the label on
commercial container containing, and the labeling of, any controlled
substance shall comply with any requirements under Federal law as to
labels of such containers and as to labeling of such substances existing
prior to the effective date prescribed in this section.
21 CFR 1302.07 Sealing of controlled substances.
(a) On each bottle, multiple dose vial, or other commercial container
of any controlled substance listed in Schedules I or II or of any
narcotic controlled substance listed in Schedule III or IV, there shall
be securely affixed to the stopper, cap, lid, covering, or wrapper or
such container a seal to disclose upon inspection any tampering or
opening of the container.
(b) Any seal accepted for use under Federal law prior to May 1, 1971,
shall be deemed acceptable for use under this section.
(36 FR 7785, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971.
Redesignated at 38 FR 26609, Sept. 24, 1973)
21 CFR 1302.08 Labeling and packaging requirements for imported and
exported substances.
(a) The symbol requirements of 1302.03-1302.06 apply to every
commercial container containing, and to all labeling of, controlled
substances imported into the jurisdiction of and/or the customs
territory of the United States, as defined in 1311.02 of this chapter.
(b) The symbol requirements of 1302.03-1302.06 do not apply to any
commercial containers containing, or any labeling of, a controlled
substance intended for export from the jurisdiction of the United
States, as defined in 1311.02 of this chapter.
(c) The sealing requirements of 1302.07 apply to every bottle,
multiple dose vial, or other commercial container of any controlled
substance listed in schedule I or II, or of any narcotic controlled
substance listed in schedule III or IV, imported into, exported from, or
intended for export from, the jurisdiction of and/or the customs
territory of the United States, as defined in 1311.02 of this chapter.
(36 FR 18731, Sept. 21, 1971. Redesignated at 38 FR 26609, Sept. 24,
1973)
21 CFR 1302.08 PART 1303 -- QUOTAS
Sec.
1303.01 Scope of Part 1303.
1303.02 Definitions.
1303.11 Aggregate production quotas.
1303.12 Procurement quotas.
1303.13 Adjustments of aggregate production quotas.
1303.21 Individual manufacturing quotas.
1303.22 Procedure for applying for individual manufacturing quotas.
1303.23 Procedure for fixing individual manufacturing quotas.
1303.24 Inventory allowance.
1303.25 Increase in individual manufacturing quotas.
1303.26 Reduction in individual manufacturing quotas.
1303.27 Abandonment of quota.
1303.31 Hearings generally.
1303.32 Purpose of hearing.
1303.33 Waiver or modification of rules.
1303.34 Request for hearing or appearance; waiver.
1303.35 Burden of proof.
1303.36 Time and place of hearing.
1303.37 Final order.
Authority: 21 U.S.C. 821, 826, 871(b).
21 CFR 1302.08 General Information
21 CFR 1303.01 Scope of Part 1303.
Procedures governing the establishment of production and
manufacturing quotas on basic classes of controlled substances listed in
schedules I and II pursuant to section 306 of the Act (21 U.S.C. 826)
are governed generally by that section and specifically by the sections
of this part.
(36 FR 7786, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24,
1973)
21 CFR 1303.02 Definitions.
As used in this part, the following terms shall have the meanings
specified:
(a) The term hearing means any hearing held pursuant to this part
regarding the determination of aggregate production quota or the
issuance, adjustment, suspension, or denial of a procurement quota or an
individual manufacturing quota.
(b) The term inventory means all factory and branch stocks in
finished form of a basic class of controlled substance manufactured or
otherwise acquired by a registrant, whether in bulk, commercial
containers, or contained in pharmaceutical preparations in the
possession of the registrant (including stocks held by the registrant
under separate registration as a manufacturer, importer, exporter, or
distributor).
(c) The term net disposal means, for a stated period, the quantity of
a basic class of controlled substance distributed by the registrant to
another person, plus the quantity of that basic class used by the
registrant in the production of (or converted by the registrant into)
another basic class of controlled substance or a noncontrolled
substance, plus the quantity of that basic class otherwise disposed of
by the registrant, less the quantity of that basic class returned to the
registrant by any purchaser, and less the quantity of that basic class
distributed by the registrant to another registered manufacturer of that
basic class for purposes other than use in the production of, or
conversion into, another basic class of controlled substance or a
noncontrolled substance or in the manufacture of dosage forms of that
basic class.
(d) The term registrant means any person registered pursuant to
section 303 of the Act (21 U.S.C. 823).
(e) Any term not defined in this section shall have the definition
set forth in section 102 of the Act (21 U.S.C. 802) and 1301.02 of this
chapter.
(36 FR 7786, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971;
37 FR 15919, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24,
1973)
Editorial Note: For an interpretation document clarifying
1303.02(b), see 40 FR 52844, Nov. 13, 1975.
21 CFR 1303.02 Aggregate Production and Procurement Quotas
21 CFR 1303.11 Aggregate production quotas.
(a) The Administrator shall determine the total quantity of each
basic class of controlled substance listed in Schedule I or II necessary
to be manufactured during the following calendar year to provide for the
estimated medical, scientific, research and industrial needs of the
United States, for lawful export requirements, and for the establishment
and maintenance of reserve stocks.
(b) In making his determinations, the Administrator shall consider
the following factors:
(1) Total net disposal of the class by all manufacturers during the
current and 2 preceding years;
(2) Trends in the national rate of net disposal of the class;
(3) Total actual (or estimated) inventories of the class and of all
substances manufactured from the class, and trends in inventory
accumulation;
(4) Projected demand for such class as indicated by procurement
quotas requested pursuant to 1303.12; and
(5) Other factors affecting medical, scientific, research, and
industrial needs in the United States and lawful export requirements, as
the Administrator finds relevant, including changes in the currently
accepted medical use in treatment with the class or the substances which
are manufactured from it, the economic and physical availability of raw
materials for use in manufacturing and for inventory purposes, yield and
stability problems, potential disruptions to production (including
possible labor strikes), and recent unforeseen emergencies such as
floods and fires.
(c) The Administrator shall, on or before May 1 of each year, publish
in the Federal Register, general notice of an aggregate production quota
for any basic class determined by him under this section. A copy of
said notice shall be mailed simultaneously to each person registered as
a bulk manufacturer of the basic class. The Administrator shall permit
any interested person to file written comments on or objections to the
proposal and shall designate in the notice the time during which such
filings may be made. The Administrator may, but shall not be required
to, hold a public hearing on one or more issues raised by the comments
and objections filed with him. In the event the Administrator decides
to hold such a hearing, he shall publish notice of the hearing in the
Federal Register, which notice shall summarize the issues to be heard
and shall set the time for the hearing which shall not be less than 30
days after the date of publication of the notice. After consideration
of any comments or objections, or after a hearing if one is ordered by
the Administrator, the Administrator shall issue and publish in the
Federal Register his final order determining the aggregate production
quota for the basic class of controlled substance. The order shall
include the findings of fact and conclusions of law upon which the order
is based. The order shall specify the date on which it shall take
effect. A copy of said order shall be mailed simultaneously to each
person registered as a bulk manufacturer of the basic class.
(36 FR 7786, Apr. 24, 1971, as amended at 37 FR 15919, Aug. 8, 1972.
Redesignated at 38 FR 26609, Sept. 24, 1973)
21 CFR 1303.12 Procurement quotas.
(a) In order to determine the estimated needs for, and to insure an
adequate and uninterrupted supply of, basic classes of controlled
substances listed in Schedules I and II (except raw opium being imported
by the registrant pursuant to an import permit) the Administrator shall
issue procurement quotas authorizing persons to procure and use
quantities of each basic class of such substances for the purpose of
manufacturing such class into dosage forms or into other substances.
(b) Any person who is registered to manufacture controlled substances
listed in any schedule and who desires to use during the next calendar
year any basic class of controlled substances listed in Schedule I or II
(except raw opium being imported by the registrant pursuant to an import
permit) for purposes of manufacturing, shall apply on DEA (or BND) Form
250 for a procurement quota for such basic class. A separate
application must be made for each basic class desired to be procured or
used. The applicant shall state whether he intends to manufacture the
basic class himself or purchase it from another manufacturer. The
applicant shall state separately each purpose for which the basic class
is desired, the quantity desired for that purpose during the next
calendar year, and the quantities used and estimated to be used, if any,
for that purpose during the current and preceding 2 calendar years. If
the purpose is to manufacture the basic class into dosage form, the
applicant shall state the official name, common or usual name, chemical
name, or brand name of that form. If the purpose is to manufacture
another substance, the applicant shall state the official name, common
or usual name, chemical name, or brand name of the substance, and, if a
controlled substance listed in any schedule, the schedule number and
Administration Controlled Substances Code Number, as set forth in part
1308 of this chapter, of the substance. If the purpose is to
manufacture another basic class of controlled substance listed in
Schedule I or II, the applicant shall also state the quantity of the
other basic class which the applicant has applied to manufacture
pursuant to 1303.22 and the quantity of the first basic class necessary
to manufacture a specified unit of the second basic class. DEA (or BND)
Form 250 shall be filed on or before April 1 of the year preceding the
calendar year for which the procurement quota is being applied. Copies
of DEA (or BND) Form 250 may be obtained from, and shall be filed with,
the Drug Control Section, Drug Enforcement Administration, Department of
Justice, Washington, DC 20537.
(c) The Administrator shall, on or before July 1 of the year
preceding the calendar year during which the quota shall be effective,
issue to each qualified applicant a procurement quota authorizing him to
procure and use:
(1) All quantities of such class necessary to manufacture all
quantities of other basic classes of controlled substances listed in
Schedules I and II which the applicant is authorized to manufacture
pursuant to 1303.23; and
(2) Such other quantities of such class as the applicant has applied
to procure and use and are consistent with his past use, his estimated
needs, and the total quantity of such class that will be produced.
(d) Any person to whom a procurement quota has been issued may at any
time request an adjustment in the quota by applying to the Administrator
with a statement showing the need for the adjustment. Such application
shall be filed with the Drug Control Section, Drug Enforcement
Administration, Department of Justice, Washington, DC 20537. The
Administrator shall increase or decrease the procurement quota of such
person if and to the extent that he finds, after considering the factors
enumerated in paragraph (c) of this section and any occurrences since
the issuance of the procurement quota, that the need justifies an
adjustment.
(e) The following persons need not obtain a procurement quota:
(1) Any person who is registered to manufacture a basic class of
controlled substance listed in Schedule I or II and who uses all of the
quantity he manufactures in the manufacture of a subsance not controlled
under the Act;
(2) Any person who is registered or authorized to conduct chemical
analysis with controlled substances (for controlled substances to be
used in such analysis only); and
(3) Any person who is registered to conduct research with a basic
class of controlled substance listed in Schedule I or II and who is
authorized to manufacture a quantity of such class pursuant to
1301.22(b) of this chapter.
(f) Any person to whom a procurement quota has been issued,
authorizing that person to procure and use a quantity of a basic class
of controlled substances listed in Schedules I or II during the current
calendar year, shall, at or before the time of giving an order to
another manufacturer requiring the distribution of a quantity of such
basic class, certify in writing to such other manufacturer that the
quantity of such basic class ordered does not exceed the person's unused
and available procurement quota of such basic class for the current
calendar year. The written certification shall be executed by the same
individual who signed the DEA Form 222 transmitting the order.
Manufacturers shall not fill an order from persons required to apply for
a procurement quota under paragraph (b) of this section unless the order
is accompanied by a certification as required under this section. The
certification required by this section shall contain the following: The
date of the certification; the name and address of the bulk
manufacturer to whom the certification is directed; a reference to the
number of the DEA Form 222 to which the certification applies; the name
of the person giving the order to which the certification applies; the
name of the basic class specified in the DEA Form 222 to which the
certification applies; the appropriate schedule within which is listed
the basic class specified in the DEA Form 222 to which the certification
applies; a statement that the quantity (expressed in grams) of the
basic class specified in the DEA Form 222 to which the certification
applies does not exceed the unused and available procurement quota of
such basic class, issued to the person giving the order, for the current
calendar year; and the signature of the individual who signed the DEA
Form 222 to which the certification applies.
(36 FR 7786, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971;
36 FR 18731, Sept. 21, 1971; 37 FR 15919, Aug. 8, 1972. Redesignated
at 38 FR 26609, Sept. 24, 1973)
Editorial Note: For FR citations affecting 1303.12, see the List of
CFR Sections Affected in the Finding Aids section of this volume.
21 CFR 1303.13 Adjustments of aggregate production quotas.
(a) The Administrator may at any time increase or reduce the
aggregate production quota for a basic class of controlled substance
listed in Schedule I or II which he has previously fixed pursuant to
1303.11.
(b) In determining to adjust the aggregate production quota, the
Administrator shall consider the following factors:
(1) Changes in the demand for that class, changes in the national
rate of net disposal of the class, and changes in the rate of net
disposal of the class by registrants holding individual manufacturing
quotas for that class;
(2) Whether any increased demand for that class, the national and/or
individual rates of net disposal of that class are temporary, short
term, or long term;
(3) Whether any increased demand for that class can be met through
existing inventories, increased individual manufacturing quotas, or
increased importation, without increasing the aggregate production
quota, taking into account production delays and the probability that
other individual manufacturing quotas may be suspended pursuant to
1303.24(b);
(4) Whether any decreased demand for that class will result in
excessive inventory accumulation by all persons registered to handle
that class (including manufacturers, distributors, practitioners,
importers, and exporters), notwithstanding the possibility that
individual manufacturing quotas may be suspended pursuant to 1303.24(b)
or abandoned pursuant to 1303.27;
(5) Other factors affecting medical, scientific, research, and
industrial needs in the United States and lawful export requirements, as
the Administrator finds relevant, including changes in the currently
accepted medical use in treatment with the class or the substances which
are manufactured from it, the economic and physical availability of raw
materials for use in manufacturing and for inventory purposes, yield and
stability problems, potential disruptions to production (including
possible labor strikes), and recent unforeseen emergencies such as
floods and fires.
(c) The Administrator in the event he determines to increase or
reduce the aggregate production quota for a basic class of controlled
substance, shall publish in the Federal Register general notice of an
adjustment in the aggregate production quota for that class determined
by him under this section. A copy of said notice shall be mailed
simultaneously to each person registered as a bulk manufacturer of the
basic class. The Administrator shall permit any interested person to
file written comments on or objections to the proposal and shall
designate in the notice the time during which such filings may be made.
The Administrator may, but shall not be required to, hold a public
hearing on one or more issues raised by the comments and objections
filed with him. In the event the Administrator decides to hold such a
hearing, he shall publish notice of the hearing in the Federal Register,
which notice shall summarize the issues to be heard and shall set the
time for the hearing, which shall not be less than 10 days after the
date of publication of the notice. After consideration of any comments
or objections, or after a hearing if one is ordered by the
Administrator, the Administrator shall issue and publish in the Federal
Register his final order determining the aggregate production for the
basic class of controlled substance. The order shall include the
findings of fact and conclusions of law upon which the order is based.
The order shall specify the date on which it shall take effect. A copy
of said order shall be mailed simultaneously to each person registered
as a bulk manufacturer of the basic class.
(37 FR 15919, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24,
1973)
21 CFR 1303.13 Individual Manufacturing Quotas
21 CFR 1303.21 Individual manufacturing quotas.
(a) The Administrator shall, on or before July 1 of each year, fix
for and issue to each person who is registered to manufacture a basic
class of controlled substance listed in Schedule I or II, and who
applies for a manufacturing quota, an individual manufacturing quota
authorizing that person to manufacture during the next calendar year a
quantity of that basic class. Any manufacturing quota fixed and issued
by the Administrator shall be subject to his authority to reduce or
limit it at a later date pursuant to 1303.26 and to his authority to
revoke or suspend it at any time pursuant to 1301.45 and 1301.46 of
this chapter.
(b) No individual manufacturing quota shall be required for
registrants listed in 1303.12(e).
(36 FR 7786, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24,
1973)
21 CFR 1303.22 Procedure for applying for individual manufacturing
quotas.
Any person who is registered to manufacture any basic class of
controlled substance listed in Schedule I or II and who desires to
manufacture a quantity of such class shall apply on DEA (or BND) Form
189 for a manufacturing quota for such quantity of such class. Copies
of DEA (or BND) Form 189 may be obtained from, and shall be filed (on or
before May 1 of the year preceding the calendar year for which the
manufacturing quota is being applied) with, the Drug Control Section,
Drug Enforcement Administration, Department of Justice, Washington, D.C.
20537. A separate application must be made for each basic class desired
to be manufactured. The applicant shall state:
(a) The name and Administration Controlled Substances Code Number, as
set forth in part 1308 of this chapter, of the basic class.
(b) For the basic class in each of the current and preceding 2
calendar years,
(1) The authorized individual manufacturing quota, if any;
(2) The actual or estimated quantity manufactured;
(3) The actual or estimated net disposal;
(4) The actual or estimated inventory allowance pursuant to 1303.24;
and
(5) The actual or estimated inventory as of December 31;
(c) For the basic class in the next calendar year,
(1) The desired individual manufacturing quota; and
(2) Any additional factors which the applicant finds relevant to the
fixing of his individual manufacturing quota, including the trend of
(and recent changes in) his and the national rates of net disposal, his
production cycle and current inventory position, the economic and
physical availability of raw materials for use in manufacturing and for
inventory purposes, yield and stability problems, potential disruptions
to production (including possible labor strikes) and recent unforeseen
emergencies such as floods and fires.
(36 FR 7786, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971;
37 FR 15920, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24,
1973, and amended at 46 FR 28841, May 29, 1981; 51 FR 5319, Feb. 13,
1986)
21 CFR 1303.23 Procedure for fixing individual manufacturing quotas.
(a) In fixing individual manufacturing quotas for a basic class of
controlled substance listed in Schedule I or II, the Administrator shall
allocate to each applicant who is currently manufacturing such class a
quota equal to 100 percent of the estimated net disposal of that
applicant for the next calendar year, adjusted --
(1) By the amount necessary to increase or reduce the estimated
inventory of the applicant on December 31 of the current year to his
estimated inventory allowance for the next calendar year, pursuant to
1303.24, and
(2) By any other factors which the Administrator deems relevant to
the fixing of the individual manufacturing quota of the applicant,
including the trend of (and recent changes in) his and the national
rates of net disposal, his production cycle and current inventory
position, the economic and physical availability of raw materials for
use in manufacturing and for inventory purposes, yield and stability
problems, potential disruptions to production (including possible labor
strikes), and recent unforeseen emergencies such as floods and fires.
(b) In fixing individual manufacturing quotas for a basic class of
controlled substance listed in Schedule I or II, the Administrator shall
allocate to each applicant who is not currently manufacturing such class
a quota equal to 100 percent of the reasonably estimated net disposal of
that applicant for the next calendar year, as determined by the
Administrator, adjusted --
(1) By the amount necessary to provide the applicant his estimated
inventory allowance for the next calendar year, pursuant to 1303.24,
and
(2) By any other factors which the Administrator deems relevant to
the fixing of the individual manufacturing quota of the applicant,
including the trend of (and recent changes in) the national rate of net
disposal, his production cycle and current inventory position, the
economic and physical availability of raw materials for use in
manufacturing and for inventory purposes, yield and stability problems,
potential disruptions to production (including possible labor strikes),
and recent unforeseen emergencies such as floods and fires.
(c) The Administrator shall, on or before March 1 of each year,
adjust the individual manufacturing quota allocated for that year to
each applicant in paragraph (a) of this section by the amount necessary
to increase or reduce the actual inventory of the applicant to December
31 of the preceding year to his estimated inventory allowance for the
current calendar year, pursuant to 1303.24.
(36 FR 7786, Apr. 24, 1971, as amended at 37 FR 15920, Aug. 8, 1972.
Redesignated at 38 FR 26609, Sept. 24, 1973)
21 CFR 1303.24 Inventory allowance.
(a) For the purpose of determining individual manufacturing quotas
pursuant to 1303.23, each registered manufacturer shall be allowed as a
part of such quota an amount sufficient to maintain an inventory equal
to,
(1) For current manufacturers, 50 percent of his average estimated
net disposal for the current calendar year and the last preceding
calendar year; or
(2) For new manufacturers, 50 percent of his reasonably estimated net
disposal for the next calendar year as determined by the Administrator.
(b) During each calendar year each registered manufacturer shall be
allowed to maintain an inventory of a basic class not exceeding 65
percent of his estimated net disposal of that class for that year, as
determined at the time his quota for that year was determined. At any
time the inventory of a basic class held by a manufacturer exceeds 65
percent of his estimated net disposal, his quota for that class is
automatically suspended and shall remain suspended until his inventory
is less than 60 percent of his estimated net disposal. The
Administrator may, upon application and for good cause shown, permit a
manufacturer whose quota is, or is likely to be, suspended pursuant to
this paragraph to continue manufacturing and to accumulate an inventory
in excess of 65 percent of his estimated net disposal, upon such
conditions and within such limitations as the Administrator may find
necessary or desirable.
(c) If, during a calendar year, a registrant has manufactured the
entire quantity of a basic class allocated to him under an individual
manufacturing quota, and his inventory of that class is less than 40
percent of his estimated net disposal of that class for that year, the
Administrator may, upon application pursuant to 1303.25, increase the
quota of such registrant sufficiently to allow restoration of the
inventory to 50 percent of the estimated net disposal for that year.
(36 FR 7786, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971.
Redesignated at 38 FR 26609, Sept. 24, 1973)
21 CFR 1303.25 Increase in individual manufacturing quotas.
(a) Any registrant who holds an individual manufacturing quota for a
basic class of controlled substance listed in Schedule I or II may file
with the Administrator an application on Administration Form 189 for an
increase in such quota in order for him to meet his estimated net
disposal, inventory and other requirements during the remainder of such
calendar year.
(b) The Administrator, in passing upon a registrant's application for
an increase in his individual manufacturing quota, shall take into
consideration any occurrences since the filing of such registrant's
initial quota application that may require an increased manufacturing
rate by such registrant during the balance of the calendar year. In
passing upon such application the Administrator may also take into
consideration the amount, if any, by which his determination of the
total quantity for the basic class of controlled substance to be
manufactured under 1303.11 exceeds the aggregate of all the individual
manufacturing quotas for the basic class of controlled substance, and
the equitable distribution of such excess among other registrants.
(36 FR 7786, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971.
Redesignated at 38 FR 26609, Sept. 24, 1973)
21 CFR 1303.26 Reduction in individual manufacturing quotas.
The Administrator may at any time reduce an individual manufacturing
quota for a basic class of controlled substance listed in Schedule I or
II which he has previously fixed in order to prevent the aggregate of
the individual manufacturing quotas and import permits outstanding or to
be granted from exceeding the aggregate production quota which has been
established for that class pursuant of 1303.11, as adjusted pursuant to
1303.13. If a quota assigned to a new manufacturer pursuant to
1303.23(b), or if a quota assigned to any manufacturer is increased
pursuant to 1303.24(c), or if an import permit issued to an importer
pursuant to part 1312 of this chapter, causes the total quantity of a
basic class to be manufactured and imported during the year to exceed
the aggregate production quota which has been established for that class
pursuant to 1303.11, as adjusted pursuant to 1303.13, the
Administrator may proportionately reduce the individual manufacturing
quotas and import permits of all other registrants to keep the aggregate
production quota within the limits originally established, or,
alternatively, the Administrator may reduce the individual manufacturing
quota of any registrant whose quota is suspended pursuant to 1303.24(b)
or 1301.45 or 1301.46 of this chapter, or is abandoned pursuant to
1303.27.
(36 FR 7786, Apr. 24, 1971, as amended at 37 FR 15920, Aug. 8, 1972.
Redesignated at 38 FR 26609, Sept. 24, 1973)
21 CFR 1303.27 Abandonment of quota.
Any manufacturer assigned an individual manufacturing quota for any
basic class pursuant to 1303.23 may at any time abandon his right to
manufacture all or any part of such quota by filing with the Drug
Control Section a written notice of such abandonment, stating the name
and Administration Controlled Substances Code Number, as set forth in
part 1308 of this chapter, of the substance and the amount which he has
chosen not to manufacture. The Administrator may, in his discretion,
allocate such amount among the other manufacturers in proportion to
their respective quotas.
(36 FR 7786, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971.
Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 46 FR 28841,
May 29, 1981; 51 FR 5319, Feb. 13, 1986)
21 CFR 1303.27 Hearings
21 CFR 1303.31 Hearings generally.
(a) In any case where the Administrator shall hold a hearing
regarding the determination of an aggregate production quota pursuant to
1303.11(c), or regarding the adjustment of an aggregate production
quota pursuant to 1303.13(c), the procedures for such hearing shall be
governed generally by the rule making procedures set forth in the
Administrative Procedure Act (5 U.S.C. 551-559) and specifically by
section 306 of the Act (21 U.S.C. 826), by 1303.32-1303.37, and by the
procedures for administrative hearings under the Act set forth in
1316.41-1316.67 of this chapter.
(b) In any case where the Administrator shall hold a hearing
regarding the issuance, adjustment, suspension, or denial of a
procurement quota pursuant to 1303.12, or the issuance, adjustment,
suspension, or denial of an individual manufacturing quota pursuant to
1303.21-1303.27, the procedures for such hearing shall be governed
generally by the adjudication procedures set forth in the Administrative
Procedures Act (5 U.S.C. 551-559) and specifically by section 306 of the
Act (21 U.S.C. 826), by 1303.32-1303.37, and by the procedures for
administrative hearings under the Act set forth in 1316.41-1316.67 of
this chapter.
(36 FR 7786, Apr. 24, 1971, as amended at 37 FR 15920, Aug. 8, 1972.
Redesignated at 38 FR 26609, Sept. 24, 1973)
21 CFR 1303.32 Purpose of hearing.
(a) The Administrator may, in his sole discretion, hold a hearing for
the purpose of receiving factual evidence regarding any one or more
issues (to be specified by him) involved in the determination or
adjustment of any aggregate production quota.
(b) If requested by a person applying for or holding a procurement
quota or an individual manufacturing quota, the Administrator shall hold
a hearing for the purpose of receiving factual evidence regarding the
issues involved in the issuance, adjustment, suspension, or denial of
such quota to such person, but the Administrator need not hold a hearing
on the suspension of a quota pursuant to 1301.45 or 1301.46 of this
chapter separate from a hearing on the suspension of registration
pursuant to those sections.
(c) Extensive argument should not be offered into evidence but rather
presented in opening or closing statements of counsel or in memoranda or
proposed findings of fact and conclusions of law.
(36 FR 7786, Apr. 24, 1971, as amended at 37 FR 15920, Aug. 8, 1972.
Redesignated at 38 FR 26609, Sept. 24, 1973)
21 CFR 1303.33 Waiver or modification of rules.
The Administrator or the presiding officer (with respect to matters
pending before him) may modify or waive any rule in this part by notice
in advance of the hearing, if he determines that no party in the hearing
will be unduly prejudiced and the ends of justice will thereby be
served. Such notice of modification or waiver shall be made a part of
the record of the hearing.
(36 FR 7786, Apr. 24,1971. Redesignated at 38 FR 26609, Sept. 24,
1973)
21 CFR 1303.34 Request for hearing or appearance; waiver.
(a) Any applicant or registrant who desires a hearing on the
issuance, adjustment, suspension, or denial of his procurement and/or
individual manufacturing quota shall, within 30 days after the date of
receipt of the issuance, adjustment, suspension, or denial of such
quota, file with the Administrator a written request for a hearing in
the form prescribed in 1316.47 of this chapter. Any interested person
who desires a hearing on the determination of an aggregate production
quota shall, within the time prescribed in 1303.11(c), file with the
Administrator a written request for a hearing in the form prescribed in
1316.47 of this chapter, including in the request a statement of the
grounds for a hearing.
(b) Any interested person who desires to participate in a hearing on
the determination or adjustment of an aggregate production quota, which
hearing is ordered by the Administrator pursuant to 1303.11(c) or
1303.13(c) may do so by filing with the Administrator, within 30 days of
the date of publication of notice of the hearing in the Federal
Register, a written notice of his intention to participate in such
hearing in the form prescribed in 1316.48 of this chapter.
(c) Any person entitled to a hearing or to participate in a hearing
pursuant to paragraph (b) of this section, may, within the period
permitted for filing a request for a hearing of notice of appearance,
file with the Administrator a waiver of an opportunity for a hearing or
to participate in a hearing, together with a written statement regarding
his position on the matters of fact and law involved in such hearing.
Such statement, if admissible, shall be made a part of the record and
shall be considered in light of the lack of opportunity for
cross-examination in determining the weight to be attached to matters of
fact asserted therein.
(d) If any person entitled to a hearing or to participate in a
hearing pursuant to paragraph (b) of this section, fails to file a
request for a hearing or notice of appearance, or if he so files and
fails to appear at the hearing, he shall be deemed to have waived his
opportunity for the hearing or to participate in the hearing, unless he
shows good cause for such failure.
(e) If all persons entitled to a hearing or to participate in a
hearing waive or are deemed to waive their opportunity for the hearing
or to participate in the hearing, the Administrator may cancel the
hearing, if scheduled, and issue his final order pursuant to 1303.37
without a hearing.
(36 FR 7786, Apr. 24, 1971, as amended at 36 FR 18731, Sept. 21,
1971; 37 FR 15920, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept.
24, 1973)
21 CFR 1303.35 Burden of proof.
(a) At any hearing regarding the determination or adjustment of an
aggregrate production quota, each interested person participating in the
hearing shall have the burden of proving any propositions of fact or law
asserted by him in the hearing.
(b) At any hearing regarding the issuance, adjustment, suspension, or
denial of a procurement or individual manufacturing quota, the
Administration shall have the burden of proving that the requirements of
this part for such issuance, adjustment, suspension, or denial are
satisfied.
(36 FR 7786, Apr. 24, 1971, as amended at 37 FR 15920, Aug. 8, 1972.
Redesignated at 38 FR 26609, Sept. 24, 1973)
21 CFR 1303.36 Time and place of hearing.
(a) If any applicant or registrant requests a hearing on the
issuance, adjustment, suspension, or denial of his procurement and/or
individual manufacturing quota pursuant to 1303.34, the Administrator
shall hold such hearing. Notice of the hearing shall be given to the
applicant or registrant of the time and place at least 30 days prior to
the hearing, unless the applicant or registrant waives such notice and
requests the hearing be held at an earlier time, in which case the
Administrator shall fix a date for such hearing as early as reasonably
possible.
(b) The hearing will commence at the place and time designated in the
notice given pursuant to paragraph (a) of this section or in the notice
of hearing published in the Federal Register pursuant to 1303.11(c) or
1303.13 (c), but thereafter it may be moved to a different place and may
be continued from day to day or recessed to a later day without notice
other than announcement thereof by the presiding officer at the hearing.
(36 FR 7786, Apr. 24, 1971, as amended at 37 FR 15920, Aug. 8, 1972.
Redesignated at 38 FR 26609, Sept. 24, 1973)
21 CFR 1303.37 Final order.
As soon as practicable after the presiding officer has certified the
record to the Administrator, the Administrator shall issue his order on
the determination or adjustment of the aggregate production quota or on
the issuance, adjustment, suspension, or denial of the procurement quota
or individual manufacturing quota, as case may be. The order shall
include the findings of fact and conclusions of law upon which the order
is based. The order shall specify the date on which it shall take
effect. The Administrator shall serve one copy of his order upon each
party in the hearing.
(36 FR 7786, Apr. 24, 1971, as amended at 37 FR 15920, Aug. 8, 1972.
Redesignated at 38 FR 26609, Sept. 24, 1973)
21 CFR 1303.37 PART 1304 -- RECORDS AND REPORTS OF REGISTRANTS
Sec.
1304.01 Scope of Part 1304.
1304.02 Definitions.
1304.03 Persons required to keep records and file reports.
1304.04 Maintenance of records and inventories.
1304.11 General requirements for inventories.
1304.12 Initial inventory date.
1304.13 Biennial inventory date.
1304.14 Inventory date for newly controlled substances.
1304.15 Inventories of manufacturers.
1304.16 Inventories of distributors.
1304.17 Inventories of dispensers and researchers.
1304.18 Inventories of importers and exporters.
1304.19 Inventories of chemical analysts.
1304.21 General requirements for continuing records.
1304.22 Records for manufacturers.
1304.23 Records for distributors.
1304.24 Records for dispensers and researchers.
1304.25 Records for importers.
1304.26 Records for exporters.
1304.27 Records for chemical analysts.
1304.28 Records for maintenance treatment programs and detoxification
treatment programs.
1304.29 Records for treatment programs which compound narcotics for
treatment programs and other locations.
1304.31 Reports from manufacturers importing opium.
1304.32 Reports of manufacturers importing medicinal coca leaves.
1304.33 Reports from manufacturers importing special coca leaves.
1304.34 Reports generally.
1304.35 Reports from manufacturers of bulk materials or dosage units.
1304.36 Reports from packagers and labelers.
1304.37 Reports from distributors.
1304.38 Reports from manufacturers importing poppy straw or
concentrate of poppy straw.
Authority: 21 U.S.C. 821, 827, 871(b), 958(d), 965, unless otherwise
noted.
21 CFR 1303.37 General Information
21 CFR 1304.01 Scope of Part 1304.
Inventory and other records and reports required under section 307 or
section 1008(d) of the Act (21 U.S.C. 827 and 958(d)) shall be in
accordance with, and contain the information required by, those sections
and by the sections of this part.
(36 FR 7789, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24,
1973)
21 CFR 1304.02 Definitions.
As used in this part, the following terms shall have the meanings
specified:
(a) The term Act means the Controlled Substances Act (84 Stat. 1242;
21 U.S.C. 801) and/or the Controlled Substances Import and Export Act
(84 Stat. 1285; 21 U.S.C. 951).
(b) The term commercial container means any bottle, jar, tube,
ampule, or other receptacle in which a substance is held for
distribution or dispensing to an ultimate user, and in addition, any box
or package in which the receptacle is held for distribution or
dispensing to an ultimate user. The term commercial container does not
include any package liner, package insert of other material kept with or
within a commercial container, nor any carton, crate, drum, or other
package in which commercial containers are stored or are used for
shipment of controlled substances.
(c) The term dispenser means an individual practitioner,
institutional practitioner, pharmacy or pharmacist who dispenses a
controlled substance.
(d) The term individual practitioner means a physician, dentist,
veterinarian, or other individual licensed, registered, or otherwise
permitted, by the United States or the jurisdiction in which he
practices, to dispense a controlled substance in the course of
professional practice, but does not include a pharmacist, a pharmacy, or
an institutional practitioner.
(e) The term institutional practitioner means a hospital or other
person (other than an individual) licensed, registered, or otherwise
permitted, by the United States or the jurisdiction in which it
practices, to dispense a controlled substance in the course of
professional practice, but does not include a pharmacy.
(f) The term name means the official name, common or usual name,
chemical name, or brand name of a substance.
(g) The term pharmacist means any pharmacist licensed by a State to
dispense controlled substances, and shall include any other person
(e.g., pharmacist intern) authorized by a State to dispense controlled
substances under the supervision of a pharmacist licensed by such State.
(h) The term readily retrievable means that certain records are kept
by automatic data processing systems or other electronic or mechanized
recordkeeping systems in such a manner that they can be separated out
from all other records in a reasonable time and/or records are kept on
which certain items are asterisked, redlined, or in some other manner
visually identifiable apart from other items appearing on the records.
(i) Any term not defined in this section shall have the definition
set forth in sections 102 and 1001 of the Act (21 U.S.C. 802 and 951)
and in 1301.02 and 1311.02 of this chapter.
(36 FR 7789, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971.
Redesignated at 38 FR 26609, Sept. 24, 1973)
21 CFR 1304.03 Persons required to keep records and file reports.
(a) Each registrant shall maintain the records and inventories and
shall file the reports required by this part, except as exempted by this
section. Any registrant who is authorized to conduct other activities
without being registered to conduct those activities, either pursuant to
1301.22(b) of this chapter or pursuant to 1307.11-1307.15 of this
chapter, shall maintain the records and inventories and shall file the
reports required by this part for persons registered to conduct such
activities. This latter requirement should not be construed as
requiring stocks of controlled substances being used in various
activities under one registration to be stored separately, nor that
separate records are required for each activity. The intent of the
Administration is to permit the registrant to keep one set of records
which are adapted by the registrant to account for controlled substances
used in any activity. Also, the Administration does not wish to acquire
separate stocks of the same substance to be purchased and stored for
separate activities. Otherwise, there is no advantage gained by
permitting several activities under one registration. Thus, when a
researcher manufactures a controlled item, he must keep a record of the
quantity manufactured; when he distributes a quantity of the item, he
must use and keep invoices or order forms to document the transfer;
when he imports a substance, he keeps as part of his records the
documentation required of an importer; and when substances are used in
chemical analysis, he need not keep a record of this because such a
record would not be required of him under a registration to do chemical
analysis. All of these records may be maintained in one consolidated
record system. Similarly, the researcher may store all of his
controlled items in one place, and every two years take inventory of all
items on hand, regardless of whether the substances were manufactured by
him, imported by him, or purchased domestically by him, of whether the
substances will be administered to subjects, distributed to other
researchers, or destroyed during chemical analysis.
(b) A registered individual practitioner is required to keep records,
as described in 1304.04, of controlled substances in Schedules II, III,
IV, and V which are dispensed, other than by prescribing or
administering in the lawful course of professional practice.
(c) A registered individual practitioner is not required to keep
records of controlled substances in Schedules II, III, IV, and V which
are prescribed in the lawful course of professional practice, unless
such substances are prescribed in the course of maintenance or
detoxification treatment of an individual.
(d) A registered individual practitioner is not required to keep
records of controlled substances listed in Schedules II, III, IV and V
which are administered in the lawful course of professional practice
unless the practitioner regularly engages in the dispensing or
administering of controlled substances and charges patients, either
separately or together with charges for other professional services, for
substances so dispensed or administered. Records are required to be
kept for controlled substances administered in the course of maintenance
or detoxification treatment of an individual.
(e) A registered person using any controlled substance in research
conducted in conformity with an exemption granted under section 505(i)
or 512(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)
or 360b(j)) at a registered establishment which maintains records in
accordance with either of those sections is not required to keep records
if he notifies the Administration of the name, address, and registration
number of the establishment maintaining such records.
(f) A registered person using any controlled substance in preclinical
research or in teaching at a registered establishment which maintains
records with respect to such substances is not required to keep records
if he notifies the Administration of the name, address, and registration
number of the establishment maintaining such records.
(g) Notice required by paragraphs (e) and (f) of this section shall
be given at the time the person applies for registration or
reregistration and shall be made in the form of an attachment to the
application, which shall be filed with the application.
(36 FR 7790, Apr. 24, 1971, as amended at 36 FR 18731, Sept. 21,
1971; 37 FR 15920, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept.
24, 1973, and amended at 50 FR 40523, Oct. 4, 1985; 51 FR 5320, Feb.
13, 1986; 51 FR 26154, July 21, 1986)
21 CFR 1304.04 Maintenance of records and inventories.
(a) Every inventory and other records required to be kept under this
part shall be kept by the registrant and be available, for at least 2
years from the date of such inventory or records, for inspection and
copying by authorized employees of the Administration, except that
financial and shipping records (such as invoices and packing slips but
not excuted order forms subject to 1305.13 of this chapter) may be kept
at a central location, rather than at the registered location, if the
registrant has notified the Administration of his intention to keep
central records. Written notification must be submitted by registered
or certified mail, return receipt requested, in triplicate, to the
Special Agent in Charge of the Administration in the area in which the
registrant is located. Unless the registrant is informed by the Special
Agent in Charge that permission to keep central records is denied, the
registrant may maintain central records commencing 14 days after receipt
of his notification by the Special Agent in Charge.
All notifications must include:
(1) The nature of the records to be kept centrally.
(2) The exact location where the records will be kept.
(3) The name, address, DEA registration number and type of DEA
registration of the registrant whose records are being maintained
centrally.
(4) Whether central records will be maintained in a manual, or
computer readable form.
(b) All registrants that are authorized to maintain a central
recordkeeping system shall be subject to the following conditions:
(1) The records to be maintained at the central record location shall
not include executed order forms, prescriptions and/or inventories which
shall be maintained at each registered location.
(2) If the records are kept on microfilm, computer media or in any
form requiring special equipment to render the records easily readable,
the registrant shall provide access to such equipment with the records.
If any code system is used (other than pricing information), a key to
the code shall be provided to make the records understandable.
(3) The registrant agrees to deliver all or any part of such records
to the registered location within two business days upon receipt of a
written request from the Administration for such records, and if the
Administration chooses to do so in lieu of requiring delivery of such
records to the registered location, to allow authorized employees of the
Administration to inspect such records at the central location upon
request by such employees without a warrant of any kind.
(4) In the event that a registrant fails to comply with these
conditions, the Special Agent in Charge may cancel such central
recordkeeping authorization, and all other central recordkeeping
authorizations held by the registrant without a hearing or other
procedures. In the event of a cancellation of central recordkeeping
authorizations under this paragraph the registrant shall, within the
time specified by the Special Agent in Charge, comply with the
requirements of this section that all records be kept at the registered
location.
(c) Registrants need not notify the Special Agent in Charge or obtain
central recordkeeping approval in order to maintain records on an
in-house computer system.
(d) ARCOS participants who desire authorization to report from other
than their registered locations must obtain a separate central reporting
identifier. Request for central reporting identifiers will be submitted
to: ARCOS Unit, P.O. Box 28293, Central Station, Washington, DC 20005.
(e) All central recordkeeping permits previously issued by the
Administration will expire on September 30, 1980. Registrants who
desire to continue maintaining central records will make notification to
the local Special Agent in Charge as provided in paragraph (a) of this
section.
(f) Each registered manufacturer, distributor, importer, exporter,
narcotic treatment program and compounder for narcotic treatment program
shall maintain inventories and records of controlled substances as
follows:
(1) Inventories and records of controlled substances listed in
Schedules I and II shall be maintained separately from all of the
records of the registrant; and
(2) Inventories and records of controlled substances listed in
Schedules III, IV, and V shall be maintained either separately from all
other records of the registrant or in such form that the information
required is readily retrievable from the ordinary business records of
the registrant.
(g) Each registered individual practitioner required to keep records
and institutional practitioner shall maintain inventories and records of
controlled substances in the manner prescribed in paragraph (f) of this
section.
(h) Each registered pharmacy shall maintain the inventories and
records of controlled substances as follows:
(1) Inventories and records of all controlled substances listed in
Schedules I and II shall be maintained separately from all other records
of the pharmacy, and prescriptions for such substances shall be
maintained in a separate prescription file; and
(2) Inventories and records of controlled substances listed in
Schedules III, IV, and V shall be maintained either separately from all
other records of the pharmacy or in such form that the information
required is readily retrievable from ordinary business records of the
pharmacy, and prescriptions for such substances shall be maintained
either in separate prescription file for controlled substances listed in
Schedules III, IV, and V only or in such form that they are readily
retrievable from the other prescription records of the pharmacy.
Prescriptions will be deemed readily retrievable if, at the time they
are initially filed, the face of the prescription is stamped in red ink
in the lower right corner with the letter ''C'' no less than 1-inch high
and filed either in the prescription file for controlled substances
listed in Schedules I and II or in the usual consecutively numbered
prescription file for non-controlled substances.
(21 U.S.C. 821 and 871(b); 28 CFR 0.100)
(36 FR 7790, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971.
Redesignated at 38 FR 26609, Sept. 24, l973, and amended at 39 FR 37985,
Oct. 25, 1974; 45 FR 44266, July 1, 1980; 47 FR 41735, Sept. 22, 1982;
51 FR 5320, Feb. 13, 1986)
21 CFR 1304.04 Inventory Requirements
21 CFR 1304.11 General requirements for inventories.
(a) Each inventory shall contain a complete and accurate record of
all controlled substances on hand on the date the inventory is taken.
Controlled substances shall be deemed to be ''on hand'' if they are in
the possession of or under the control of the registrant, including
substances returned by a customer, substances ordered by a customer but
not yet invoiced, substances stored in a warehouse on behalf of the
registrant, and substances in the possession of employees of the
registrant and intended for distribution as complimentary samples.
(b) A separate inventory shall be made by a registrant for each
registered location. In the event controlled substances in the
possession or under the control of the registrant at a location for
which he is not registered, the substances shall be included in the
inventory of the registered location to which they are subject to
control or to which the person possessing the substance is responsible.
Each inventory for a registered location shall be kept at the registered
location.
(c) A separate inventory shall be made by a registrant for each
independent activity for which he is registered, except as provided in
1304.18.
(d) A registrant may take an inventory on a date that is within 4
days of his biennial inventory date pursuant to 1304.13 if he notifies
in advance the Special Agent in Charge of the Administration in his area
of the date on which he will take the inventory. A registrant may take
an inventory either as of the opening of business or as of the close of
business on the inventory date. The registrant shall indicate on the
inventory records whether the inventory is taken as of the opening or as
of the close of business and the date the inventory is taken.
(e) An inventory must be maintained in a written, typewritten or
printed form. An inventory taken by use of an oral recording device
must be promptly transcribed.
(36 FR 7790, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24,
l973, and amended at 47 FR 41735, Sept. 22, 1982)
21 CFR 1304.12 Initial inventory date.
(a) Every person required to keep records who is provisionally
registered on May 1, 1971, shall take an inventory of all stocks of
controlled substances on hand on that date in accordance with
1304.15-1304.19, as applicable.
(b) Every person required to keep records who is registered after May
1, 1971, and who was not provisionally registered on that date, shall
take an inventory of all stocks of controlled substances on hand on the
date he first engages in the manufacture, distribution, or dispensing of
controlled substances, in accordance with 1304.15-1304.19, as
applicable. In the event a person commences business with no controlled
substances on hand, he shall record this fact as his initial inventory.
(36 FR 7791, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971;
37 FR 15920, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24,
1973)
21 CFR 1304.13 Biennial inventory date.
Every 2 years following the date on which the initial inventory is
taken by a registrant pursuant to 1304.12, the registrant shall take a
new inventory of all stocks of controlled substances on hand. The
biennial inventory may be taken (a) on the day of the year on which the
initial inventory was taken or (b) on the registrant's regular general
physical inventory date, if any, which is nearest to and does not vary
by more than 6 months from the biennial date that would otherwise apply
or (c) on any other fixed date which does not vary by more than 6 months
from the biennial date that would otherwise apply. If the registrant
elects to take the biennial inventory on his regular general physical
inventory date or another fixed date, he shall notify the Administration
of this election and of the date on which the biennial inventory will be
taken.
(36 FR 7791, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24,
1973)
21 CFR 1304.14 Inventory date for newly controlled substances.
On the effective date of a rule by the Administrator pursuant to
1308.48-1308.49, or 1308.50 of this chapter adding a substance to any
schedule of controlled substances, which substance was, immediately
prior to that date, not listed on any such schedule, every registrant
required to keep records who possesses that substance shall take an
inventory of all stocks of the substance on hand. Thereafter such
substance shall be included in each inventory made by the registrant
pursuant to 1304.13.
(36 FR 7791, Apr. 24, 1971, as amended at 36 FR 18732, Sept. 21,
1971. Redesignated at 38 FR 26609, Sept. 24, 1973)
21 CFR 1304.15 Inventories of manufacturers.
Each person registered or authorized (by 1301.22(b), 1307.12, or
1307.15 of this chapter) to manufacture controlled substances shall
include the following information in his inventory:
(a) For each controlled substance in bulk form to be used in (or
capable of use in) the manufacture of the same or other controlled or
non-controlled substances in finished form:
(1) The name of the substance; and
(2) The total quantity of the substance to the nearest metric unit
weight consistent with unit size (except that for inventories made in
1971, avoirdupois weights may be utilized where metric weights are not
readily available).
(b) For each controlled substance in the process of manufacture on
the inventory date:
(1) The name of the substance;
(2) The quantity of the substance in each batch and/or stage of
manufacture, identified by the batch number or other appropriate
identifying number;
(3) The physical form which the substance is to take upon completion
of the manufacturing process (e.g., granulations, tablets, capsules, or
solutions), identified by the batch number or other appropriate
identifying number, and if possible the finished form of the substance
(e.g., 10-milligram tablet or 10-milligram concentration per fluid ounce
or milliliter) and the number or volume thereof; and
(c) For each controlled substance in finished form:
(1) The name of the substance;
(2) Each finished form of the substance (e.g., 10-milligram tablet or
10-milligram concentration per fluid ounce or milliliter);
(3) The number of units or volume of each finished form in each
commercial container (e.g., 100-tablet bottle or 3-milliliter vial);
and
(4) The number of commercial containers of each such finished form
(e.g. four 100-tablet bottles or six 3-milliliter vials).
(d) For each controlled substance not included in paragraphs (a), (b)
or (c) of this section (e.g., damaged, defective or impure substances
awaiting disposal, substances held for quality control purposes, or
substances maintained for extemporaneous compoundings):
(1) The name of the substance;
(2) The total quantity of the substance to the nearest metric unit
weight or the total number of units of finished form; and
(3) The reason for the substance being maintained by the registrant
and whether such substance is capable of use in the manufacture of any
controlled substance in finished form.
(36 FR 7791, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971;
36 FR 18732, Sept. 21, 1971. Redesignated at 38 FR 26609, Sept. 24,
1973)
21 CFR 1304.16 Inventories of distributors.
Each person registered or authorized (by 1301.22(b) or
1307.11-1307.14 of this chapter) to distribute controlled substances
shall include in his inventory the same information required of
manufacturers pursuant to 1304.15 (c) and (d).
(36 FR 7791, Apr. 24, 1971, as amended at 36 FR 18732, Sept. 21,
1971. Redesignated at 38 FR 26609, Sept. 24, 1973)
21 CFR 1304.17 Inventories of dispensers and researchers.
Each person registered or authorized (by 1301.22(b) of this chapter)
to dispense or conduct research with controlled substances and required
to keep records pursuant to 1304.03 shall include in his inventory the
same information required of manufacturers pursuant to 1304.15 (c) and
(d). In determining the number of units of each finished form of a
controlled substance in a commercial container which has been opened,
the dispenser shall do as follows:
(a) If the substance is listed in Schedule I or II, he shall make an
exact count or measure of the contents; and
(b) If the substance is listed in Schedule III, IV, or V, he shall
make an estimated count or measure of the contents, unless the container
holds more than 1,000 tablets or capsules in which case he must make an
exact count of the contents.
(36 FR 7791, Apr. 24, 1971, as amended at 36 FR 18732, Sept. 21,
1971. Redesignated at 38 FR 26609, Sept. 24, 1973)
21 CFR 1304.18 Inventories of importers and exporters.
Each person registered or authorized (by 1301.22(b) of this chapter)
to import or export controlled substances shall include in his inventory
the same information required of manufacturers pursuant to 1304.15 (a),
(c), and (d). Each such person who is also registered as a manufacturer
or as a distributor shall include in his inventory as an importer or
exporter only those stocks of controlled substances that are actually
separated from his stocks as a manufacturer or as a distributor (e.g.,
in transit or in storage for shipment).
(36 FR 7791, Apr. 24, 1971, as amended at 36 FR 18732, Sept. 21,
1971. Redesignated at 38 FR 26609, Sept. 24, 1973)
21 CFR 1304.19 Inventories of chemical analysts.
Each person registered or authorized (by 1301.22(b) of this chapter)
to conduct chemical analysis with controlled substances shall include in
his inventory the same information required of manufacturers pursuant to
1305.15 (a), (c), and (d) as to substances which have been
manufactured, imported, or received by such person. If less than 1
kilogram of any controlled substance (other than a hallucinogenic
controlled substance listed in Schedule I), or less than 20 grams of a
hallucinogenic substance listed in Schedule I (other than lysergic acid
diethylamide), or less than 0.5 gram of lysergic acid diethylamide, is
on hand at the time of inventory, that substance need not be included in
the inventory. Laboratories of the Administrator may possess up to 150
grams of any hallucinogenic substance in Schedule I without regard to a
need for an inventory of those substances. No inventory is required of
known or suspected controlled substances received as evidentiary
materials for analysis.
(36 FR 7791, Apr. 24, 1971, as amended at 36 FR 18732, Sept. 21,
1971. Redesignated at 38 FR 26609, Sept. 24, 1973)
21 CFR 1304.19 Continuing Records
21 CFR 1304.21 General requirements for continuing records.
(a) On and after May 1, 1971, every registrant required to keep
records pursuant to 1304.03 shall maintain on a current basis a
complete and accurate record of each such substance manufactured,
imported, received, sold, delivered, exported, or otherwise disposed of
by him, except that no registrant shall be required to maintain a
perpetual inventory.
(b) Separate records shall be maintained by a registrant for each
registered location except as provided in 1304.04 (a). In the event
controlled substances are in the possession or under the control of a
registrant at a location for which he is not registered, the substances
shall be included in the records of the registered location to which
they are subject to control or to which the person possessing the
substance is responsible.
(c) Separate records shall be maintained by a registrant for each
independent activity for which he is registered, except as provided in
1304.25 and 1304.26.
(d) In recording dates of receipt, importation, distribution,
exportation, or other transfers, the date on which the controlled
substances are actually received, imported, distributed, exported, or
otherwise transferred shall be used as the date of receipt or
distribution of any documents of transfer (e.g., invoices or packing
slips).
(36 FR 7792, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971.
Redesignated at 38 FR 26609, Sept. 24, 1973)
21 CFR 1304.22 Records for manufacturers.
Each person registered or authorized (by 1301.22(b) or 1307.15 of
this chapter) to manufacture controlled substances shall maintain
records with the following information:
(a) For each controlled substance in bulk form to be used in, or
capable of use in, or being used in, the manufacture of the same or
other controlled or noncontrolled substances in finished form,
(1) The name of the substance;
(2) The quantity manufactured in bulk form by the registrant,
including the date, quantity and batch or other identifying number of
each batch manufactured;
(3) The quantity received from other persons, including the date and
quantity of each receipt and the name, address, and registration number
of the other person from whom the substance was received;
(4) The quantity imported directly by the registrant (under a
registration as an importer) for use in manufacture by him, including
the date, quantity, and import permit or declaration number for each
importation;
(5) The quantity used to manufacture the same substance in finished
form, including:
(i) The date and batch or other identifying number of each
manufacture;
(ii) The quantity used in the manufacture;
(iii) The finished form (e.g., 10-milligram tablets or 10-milligram
concentration per fluid ounce or milliliter);
(iv) The number of units of finished form manufactured;
(v) The quantity used in quality control;
(vi) The quantity lost during manufacturing and the causes therefor,
if known;
(vii) The total quantity of the substance contained in the finished
form;
(viii) The theoretical and actual yields; and
(ix) Such other information as is necessary to account for all
controlled substances used in the manufacturing process;
(6) The quantity used to manufacture other controlled and
noncontrolled substances, including the name of each substance
manufactured and the information required in paragraph (a)(5) of this
section;
(7) The quantity distributed in bulk form to other persons, including
the date and quantity of each distribution and the name, address, and
registration number of each person to whom a distribution was made;
(8) The quantity exported directly by the registrant (under a
registration as an exporter), including the date, quantity, and export
permit or declaration number of each exportation;
(9) The quantity distributed or disposed of in any other manner by
the registrant (e.g., by distribution of complimentary samples or by
destruction), including the date and manner of distribution or disposal,
the name, address, and registration number of the person to whom
distributed, and the quantity distributed or disposed;
(10) The originals of all written certifications of available
procurement quotas submitted by other persons (as required by
1303.12(f) of this chapter) relating to each order requiring the
distribution of a basic class of controlled substance listed in Schedule
I or II.
(b) For each controlled substance in finished form,
(1) The name of the substance;
(2) Each finished form (e.g., 10-milligram tablet or 10-milligram
concentration per fluid ounce or milliliter) and the number of units or
volume of finished form in each commercial container (e.g., 100-tablet
bottle or 3-milliliter vial);
(3) The number of containers of each such commercial finished form
manufactured from bulk form by the registrant, including the information
required pursuant to paragraph (a)(5) of this section;
(4) The number of units of finished forms and/or commercial
containers received from other persons, including the date of and number
of units and/or commercial containers in each receipt and the name,
address, and registration number of the person from whom the units were
received;
(5) The number of units of finished forms and/or commercial
containers imported directly by the person (under a registration or
authorization to import), including the date of, the number of units
and/or commercial containers in, and the import permit or declaration
number for, each importation;
(6) The number of units and/or commercial containers manufactured by
the registrant from units in finished form received from others or
imported, including:
(i) The date and batch or other identifying number of each
manufacture;
(ii) The operation performed (e.g., repackaging or relabeling);
(iii) The number of units of finished form used in the manufacture,
the number manufactured and the number lost during manufacture, with the
causes for such losses, if known; and
(iv) Such other information as is necessary to account for all
controlled substances used in the manufacturing process;
(7) The number of commercial containers distributed to other persons,
including the date of and number of containers in each distribution, and
the name, address, and registration number of the person to whom the
containers were distributed;
(8) The number of commercial containers exported directly by the
registrant (under a registration as an exporter), including the date,
number of containers and export permit or declaration number for each
exportation; and
(9) The number of units of finished forms and/or commercial
containers distributed or disposed of in any other manner by the
registrant (e.g., by distribution of complimentary samples or by
destruction), including the date and manner of distribution or disposal,
the name, address, and registration number of the person to whom
distributed, and the quantity in finished form distributed or disposed.
(36 FR 7792, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971;
36 FR 18732, Sept. 21, 1971; 37 FR 15920, Aug. 8, 1972. Redesignated
at 38 FR 26609, Sept. 24, 1973)
Editorial Note: For FR citations affecting 1304.22, see the List of
CFR Sections Affected in the Finding Aids section of this volume.
21 CFR 1304.23 Records for distributors.
Each person registered or authorized (by 1301.22(b) or
1307.11-1307.14 of this chapter) to distribute controlled substances
shall maintain records with the following information for each
controlled substance:
(a) The name of the substance;
(b) Each finished form (e.g., 10-milligram tablet or 10-milligram
concentration per fluid ounce or milliliter) and the number of units or
volume of finished form in each commercial container (e.g., 100-tablet
bottle or 3-milliliter vial);
(c) The number of commercial containers of each such finished form
received from other persons, including the date of and number of
containers in each receipt and the name, address, and registration
number of the person from whom the containers were received;
(d) The number of commercial containers or each such finished form
imported directly by the person (under a registration or authorization
to import), including the date of, the number of commercial containers
in, and the import permit or declaration number for, each importation;
(e) The number of commercial containers of each such finished form
distributed to other persons, including the date of and number of
containers in each distribution and the name, address, and registration
number of the person to whom the containers were distributed;
(f) The number of commercial containers of each such finished form
exported directly by the person (under a registration or authorization
to export), including the date of, the number of commercial containers
in, and the export permit or declaration number for, each exportation;
and
(g) The number of units or volume of finished forms and/or commercial
containers distributed or disposed of in any other manner by the person
(e.g., by distribution as complimentary samples or by destruction)
including the date and manner of distribution or disposal, the name,
address, and registration number of the person to whom distributed, and
the quantity of the substance in finished form distributed or disposed.
(36 FR 7792, Apr. 24, 1971, as amended at 36 FR 18732, Sept. 21,
1971. Redesignated at 38 FR 26609, Sept. 24, 1973)
21 CFR 1304.24 Records for dispensers and researchers.
Each person registered or authorized (by 1301.22(b) of this chapter)
to dispense or conduct research with controlled substances and required
to keep records pursuant to 1304.03 shall maintain records with the
following information for each controlled substance:
(a) The name of the substance;
(b) Each finished form (e.g., 10-milligram tablet or 10-milligram
concentration per fluid ounce or milliliter) and the number of units or
volume of finished form in each commercial container (e.g., 100-tablet
bottle or 3-milliliter vial);
(c) The number of commercial containers of each such finished form
received from other persons, including the date of and number of
containers in each receipt and the name, address, and registration
number of the person from whom the containers were received;
(d) The number of units or volume of such finished form dispensed,
including the name and address of the person to whom it was dispensed,
the date of dispensing, the number of units or volume dispensed, and the
written or typewritten name or initials of the individual who dispensed
or administered the substance on behalf of the dispenser; and
(e) The number of units or volume of such finished forms and/or
commercial containers disposed of in any other manner by the registrant,
including the date and manner of disposal and the quantity of the
substance in finished form disposed.
(36 FR 7793, Apr. 24, 1971, as amended at 36 FR 18732, Sept. 21,
1971. Redesignated at 38 FR 26609, Sept. 24, 1973)
21 CFR 1304.25 Records for importers.
Each person registered or authorized (by 1301.22(b) of this chapter)
to import controlled substances shall maintain records with the
following information for each controlled substance:
(a) The name of the substance;
(b) The quantity (or number of units or volume in finished form)
imported, including the date, quantity (or number of units or volume),
and import permit or declaration number for each importation;
(c) The quantity (or number of units or volume in finished form)
distributed to other persons, including the date and quantity (or number
of units or volume) of each distribution and the name, address, and
registration number of each person to whom a distribution was made; and
(d) The quantity disposed of in any other manner by the registrant
(except quantities used in manufacturing by an importer under a
registration as a manufacturer, which quantities are to be recorded
pursuant to 1304.22(a) (4) or (b) (5)), including the date and manner
of disposal and the quantity disposed.
(36 FR 7793, Apr. 24, 1971, as amended at 36 FR 18732, Sept. 21,
1971. Redesignated at 38 FR 26609, Sept. 24, 1973)
21 CFR 1304.26 Records for exporters.
Each person registered or authorized (by 1301.22(b) of this chapter)
to export controlled substances shall maintain records with the
following information for each controlled substance:
(a) The name of the substance;
(b) The quantity (or number of units or volume in finished form)
received from other persons, including the date and quantity (or number
of units or volume) of each receipt and the name, address, and
registration number of each person from whom the substance was received;
(c) The quantity (or number of units or volume in finished form)
exported, including the date, quantity (or number of units or volume),
and the export permit or declaration number for each exportation, but
excluding all quantities (and numbers of units and volumes) manufactured
by an exporter under a registration as a manufacturer, which quantities
(and numbers of units and volumes) are to be recorded pursuant to
1304.22 (a) (8) or (b) (8); and
(d) The quantity disposed of in any other manner by the registrant,
including the date and manner of disposal and the quantity disposed.
(36 FR 7793, Apr. 24, 1971, as amended at 36 FR 18732, Sept. 21,
1971. Redesignated at 38 FR 26609, Sept. 24, 1973)
21 CFR 1304.27 Records for chemical analysts.
(a) Each person registered or authorized (by 1301.22(b) of this
chapter) to conduct chemical analysis with controlled substances shall
maintain records with the following information (to the extent known and
reasonably ascertainable by him) for each controlled substance:
(1) The name of the substance;
(2) The form or forms in which the substance is received, imported,
or manufactured by the registrant (e.g., powder, granulation, tablet,
capsule, or solution) and the concentration of the substance in such
form (e.g., C.P., U.S.P., N.F., 10-milligram tablet or 10-milligram
concentration per milliliter);
(3) The total number of the forms received, imported or manufactured
(e.g., 100 tablets, thirty 1-milliliter vials, or 10 grams of powder),
including the date and quantity of each receipt, importation, or
manufacture and the name, address, and registration number, if any, of
the person from whom the substance was received;
(4) The quantity distributed, exported, or destroyed in any manner by
the registrant (except quantities used in chemical analysis or other
laboratory work), including the date and manner of distribution,
exportation, or destruction, and the name, address, and registration
number, if any, of each person to whom the substance was distributed or
exported.
(b) Records of controlled substances used in chemical analysis or
other laboratory work are not required.
(c) Records relating to known or suspected controlled substances
received as evidentiary material for analysis are not required under
paragraph (a) of this section.
(36 FR 7793, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971;
36 FR 18732, Sept. 21, 1971. Redesignated at 38 FR 26609, Sept. 24,
1973)
21 CFR 1304.28 Records for maintenance treatment programs and
detoxification treatment programs.
(a) Each person registered or authorized (by 1301.22 of this
chapter) to maintain and/or detoxify controlled substance users in a
narcotic treatment program shall maintain records with the following
information for each narcotic controlled substance:
(1) Name of substance;
(2) Strength of substance;
(3) Dosage form;
(4) Date dispensed;
(5) Adequate identification of patient (consumer);
(6) Amount consumed;
(7) Amount and dosage form taken home by patient; and
(8) Dispenser's initials.
(b) The records required by paragraph (a) of this section will be
maintained in a dispensing log at the narcotic treatment program site
and will be maintained in compliance with 1304.24 without reference to
1304.03.
(c) All sites which compound a bulk narcotic solution from bulk
narcotic powder to liquid for on-site use must keep a separate batch
record of the compounding.
(d) Records of identity, diagnosis, prognosis, or treatment of any
patients which are maintained in connection with the performance of a
narcotic treatment program shall be confidential, except that such
records may be disclosed for purposes and under the circumstances
authorized by part 310 and part 1401 of this title.
(39 FR 37985, Oct. 25, 1974)
21 CFR 1304.29 Records for treatment programs which compound narcotics
for treatment programs and other locations.
Each person registered or authorized by 1301.22 of this chapter to
compound narcotic drugs for off-site use in a narcotic treatment program
shall maintain records which include the following information for each
narcotic drug:
(a) For each narcotic controlled substance in bulk form to be used
in, or capable of use in, or being used in, the compounding of the same
or other noncontrolled substances in finished form:
(1) The name of the substance;
(2) The quantity compounded in bulk form by the registrant, including
the date, quantity and batch or other identifying number of each batch
compounded;
(3) The quantity received from other persons, including the date and
quantity of each receipt and the name, address and registration number
of the other person from whom the substance was received;
(4) The quantity imported directly by the registrant (under a
registration as an importer) for use in compounding by him, including
the date, quantity and import permit or declaration number of each
importation;
(5) The quantity used to compound the same substance in finished
form, including:
(i) The date and batch or other identifying number of each
compounding;
(ii) The quantity used in the compound;
(iii) The finished form (e.g., 10-milligram tablets or 10-milligram
concentration per fluid ounce or milliliter;
(iv) The number of units of finished form compounded;
(v) The quantity used in quality control;
(vi) The quantity lost during compounding and the causes therefore,
if known;
(vii) The total quantity of the substance contained in the finished
form;
(viii) The theoretical and actual yields; and
(ix) Such other information as is necessary to account for all
controlled substances used in the compounding process;
(6) The quantity used to manufacture other controlled and
non-controlled substances; including the name of each substance
manufactured and the information required in paragraph (a)(5) of this
section;
(7) The quantity distributed in bulk form to other programs,
including the date and quantity of each distribution and the name,
address and registration number of each program to whom a distribution
was made;
(8) The quantity exported directly by the registrant (under a
registration as an exporter), including the date, quantity, and export
permit or declaration number of each exploration; and
(9) The quantity disposed of by destruction, including the reason,
date and manner of destruction. All other destruction of narcotic
controlled substances will comply with 1307.22.
(b) For each narcotic controlled substance in finished form:
(1) The name of the substance;
(2) Each finished form (e.g., 10-milligram tablet or 10 milligram
concentration per fluid ounce or milliliter) and the number of units or
volume or finished form in each commercial container (e.g., 100-tablet
bottle or 3-milliliter vial);
(3) The number of containers of each such commercial finished form
compounded from bulk form by the registrant, including the information
required pursuant to paragraph (a)(5) of this section;
(4) The number of units of finished forms and/or commercial
containers received from other persons, including the date of and number
of units and/or commercial containers in each receipt and the name,
address and registration number of the person from whom the units were
received;
(5) The number of units of finished forms and/or commercial
containers imported directly by the person (under a registration or
authorization to import), including the date of, the number of units
and/or commercial containers in, and the import permit or declaration
number for, each importation;
(6) The number of units and/or commercial containers compounded by
the registrant from units in finished form received from others or
imported, including:
(i) The date and batch or other identifying number of each
compounding;
(ii) The operation performed (e.g., repackaging or relabeling);
(iii) The number of units of finished form used in the compound, the
number compounded and the number lost during compounding, with the
causes for such losses, if known; and
(iv) Such other information as is necessary to account for all
controlled substances used in the compounding process;
(7) The number of containers distributed to other programs, including
the date, the number of containers in each distribution, and the name,
address and registration number of the program to whom the containers
were distributed;
(8) The number of commercial containers exported directly by the
registrant (under a registration as an exporter), including the date,
number of containers and export permit or declaration number for each
exportation; and
(9) The number of units of finished forms and/or commercial
containers destroyed in any manner by the registrant, including the
reason, the date and manner of destruction. All other destruction of
narcotic controlled substances will comply with 1307.22.
(39 FR 37985, Oct. 25, 1974)
21 CFR 1304.29 Reports
21 CFR 1304.31 Reports from manufacturers importing opium.
(a) Every manufacturer importing crude opium shall submit, in
addition to the report on DEA (or BND) Form 234 and its supplements, DEA
(or BND) Form 247 and its supplements, 247a and 247b, accounting for the
importation and for all manufacturing operations performed between
importation and the production in bulk of finished marketable products,
standardized in accordance with the U.S. Pharmacopeia, National
Formulary, or other recognized medical standards. Subsequent
manufacture from such products, including bottling or packaging
operations, shall be accounted for in the quarterly returns on DEA (or
BND) Form 234 and its supplements. DEA (or BND) Form 247 and its
supplements shall be submitted quarterly to the Drug Control Section,
Drug Enforcement Administration, Department of Justice, Washington, DC
20537, on or before the 15th day of the month immediately following the
period for which it is submitted.
(b) The report of manufacture from crude opium shall consist of
summaries (DEA (or BND) Forms 247 and 247a) with supporting detail
sheets (on DEA (or BND) Form 247b) accounting for original manufacture
from crude opium, production from morphine for further manufacture and
production from manufacturing opium, and also accounting for stocks of
crude opium, manufacturing opium, morphine for further manufacture and
other crude alkaloids.
(c) The detail sheets (DEA (or BND) Form 247b) supporting the summary
of original manufacture from crude opium shall show separately the crude
opium used for the manufacture of opium tinctures and extracts, crude
opium used for the extraction of alkaloids, crude opium used for the
manufacture of controlled substances listed in Schedule V, and crude
opium used for the production of manufacturing opium; and shall show
separately the medicinal opium, alkaloids and salts, opium tinctures and
extracts, controlled substances listed in Schedule V, and manufacturing
opium produced.
(d) Importation of opium shall be reported in summarized entries in
the debit summary of the quarterly report (DEA (or BND) Form 234) and
shall be immediately reported by similar summarized entries in the
credit summary of the quarterly report (DEA (or BND) Form 234) as
transferred to importing manufacturer's report. Such importations shall
further be reported in summary (DEA (or BND) Form 247) and supporting
detail sheets (DEA (or BND) Form 247b). Products manufactured therefrom
shall be reported as produced in accordance with paragraphs (b) and (c)
of this section and, with the exception of manufacturing opium, morphine
for further manufacture, and other crude or unfinished alkaloids, shall
be transferred to the quarterly report (DEA (or BND) Form 234) when
reported produced.
(e) Upon importation of crude opium, samples will be selected and
assays made by the importing manufacturer in the manner and according to
the method specified in the U.S. Pharmacopoeia. These assays shall be
accounted for in terms of its anhydrous morphine alkaloid content.
Where final assay data is not determined at the time of rendering
report, the report shall be made on the basis of the best data
available, subject to adjustment, and the necessary adjusting entries
shall be made on the next report.
(f) Upon withdrawal of crude opium from customs custody, the
importing manufacturer shall assign to each container an identification
mark or number by which the opium will be associated with the lot assay
and identified in reports.
(g) Where factory procedure is such that partial withdrawals of opium
are made from individual containers, there shall be attached to each
container a stock record card on which shall be kept a complete record
of all withdrawals therefrom.
(h) Opium products and derivatives which are produced for exclusive
use in further manufacturing purposes shall be reported produced when
they come into existence in that form in which they are to be so used.
Medicinal opium, morphine and its salts, or other alkaloids or
derivatives produced exclusively for distribution shall be reported as
produced when manufacture has actually been completed and the finished
marketable product ready for packaging and distribution. Such products
shall be regarded as ready for packaging and distribution as soon as all
processing other than mere packaging has been completed. Medicinal
opium, tinctures, extracts, or other products manufactured partly for
distribution and partly for use in further manufacture will be reported
produced as soon as manufacture is complete and they are ready either
for use in further manufacture or for packaging for distribution.
(i) Subject to 1303.24(c) of this chapter, no accumulations of
morphine or other narcotic controlled substances in their pure or
near-pure states shall be permitted to remain inactively in process for
an unreasonable time in light of efficient industrial practices. All
such products nearing completion of their respective processes and
approaching a condition of purity shall be carefully protected, promptly
completed, and immediately transferred to finished stocks, and reported
as produced.
(j) In making conversions of opium alkaloids and their salts to
anhydrous morphine the quantity of the particular alkaloid or salt in
avoirdupois ounces shall be multipled by a conversion factor arrived at
by ascertaining the ratio, carried to the fourth decimal place, between
the respective molecular weight of such alkaloid or salt and the
molecular weight of anhydrous morphine (285.16), such weights being
computed to the third decimal place from the chemical formulae of the
substances and the atomic weights of elements, as adopted by the
International Committee on Chemical Elements and published in the latest
edition of the U.S. Pharmacopoeia.
(36 FR 7794, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24,
1973. Redesignated and amended at 51 FR 5319, 5320, Feb. 13, 1986)
21 CFR 1304.32 Reports of manufacturers importing medicinal coca
leaves.
(a) Every manufacturer importing raw coca leaves for the manufacture
of medicinal products shall submit, in addition to the report on DEA (or
BND) Form 234 and its supplements, DEA (or BND) Form 168 and its
supplements, 168a and 168b, accounting for the importation and for all
manufacturing operations performed between the importation and the
manufacture of bulk or finished products standardized in accordance with
U.S. Pharmacopoeia, National Formulary, or other recognized standards.
Subsequent manufacture from such products, including bottling or
packaging operations, shall be accounted for in quarterly reports on DEA
(or BND) Form 234 and its supplements. Reports on Form 168 and its
supplements shall be submitted quarterly to the Drug Control Section,
Drug Enforcement Administration, Department of Justice, Washington, DC
20537, on or before the 15th day of the month immediately following the
period for which it is submitted.
(b) The report of manufacture from medicinal coca leaves shall
consist of summaries (DEA (or BND) Forms 168 and 168a) with supporting
detail sheets (DEA (or BND) Form 168b) accounting for original
manufacture from such leaves, conversions or production from
manufacturing coca extracts, and also accounting for stocks of raw coca
leaves, manufacturing coca extracts, and other crude coca alkaloids.
(c) The detail sheets (DEA (or BND) Form 168b) supporting the summary
of original manufacture from medicinal coca leaves, shall show
separately the coca leaves used for the manufacture of manufacturing
coca extracts, coca leaves used for the direct manufacture of marketable
coca tinctures and extracts, and coca leaves used for the extraction of
alkaloids, and shall show separately the coca alkaloids and salts, coca
tinctures and extracts, and manufacturing coca extracts produced.
(d) Importations of medicinal coca leaves shall be reported in
summarized entries in the debit summary of the quarterly report (DEA (or
BND) Form 234) and shall be immediately reported by similar summarized
entries in the credit summary of the quarterly report (DEA (or BND) Form
234) as transferred to importing manufacturer's report. Such
importations shall further be reported in summary (DEA (or BND) Form
168) and supporting detail sheets (DEA (or BND) Form 168b). Products
manufactured therefrom shall be reported as produced in accordance with
paragraph (h) of this section and, with the exception of manufacturing
coca extracts, residues or bases for further manufacture, and other
crude or unfinished alkaloids, shall be transferred to the quarterly
report (DEA (or BND) Form 234) when reported produced.
(e) Upon importation of medicinal coca leaves, samples will be
selected and assays made by the importing manufacturer in accordance
with recognized chemical procedures. These assays shall form the basis
of accounting for such coca leaves, which shall be accounted for in
terms of their cocaine alkaloid content or equivalency or their total
anhydrous coca alkaloid content. Where final assay data is not
determined at the time of submitting the report, the report shall be
made on the basis of the best data available, subject to adjustment, and
the necessary adjusting entries shall be made on the next report.
(f) Upon withdrawal of medicinal coca leaves from customs custody,
the importing manufacturer shall assign to each bale or container an
identification mark or number by which the coca leaves will be
associated with the lot assay and identified in reports.
(g) Where factory procedure is such that partial withdrawals of
medicinal coca leaves are made from individual containers, there shall
be attached to the container a stock record card on which shall be kept
a complete record of withdrawals therefrom.
(h) Manufacturing coca extracts shall be reported as produced when
they come into existence in that form in which they are intended for
exclusive use in further manufacture. Cocaine and its salts, ecgonine
and its salts, or other alkaloids or derivatives produced exclusively
for distribution shall be reported as produced when manufacture has
actually been completed and the finished marketable product is ready for
packaging and distribution. Such products shall be regarded as ready
for packaging and distribution as soon as all processing other than mere
packaging has been completed. Tinctures, extracts, or other products
manufactured partly for distribution and partly for use in further
manufacture shall be reported produced as soon as manufacture is
complete and they are ready either for use in further manufacture or for
packaging for distribution.
(i) No accumulations of cocaine or ecgonine or other narcotic
controlled substances in their pure or near-pure states shall be
permitted to remain inactively in process. All such products nearing
completion of their respective processes and approaching a condition of
purity shall be carefully protected, promptly completed, and immediately
transferred to finished stocks and reported as produced.
(j) In making conversions of coca alkaloids and their salts to
cocaine alkaloid and to anhydrous ecgonine alkaloid, the quantity of the
particular alkaloid or salt in avoirdupois ounces shall be multiplied by
a conversion factor arrived at by ascertaining the ratio, carried to the
fourth decimal place, between the molecular weight of such alkaloid or
salt and the molecular weight of cocaine alkaloid (303.172) or anhydrous
ecgonine alkaloid (185.125), as the case may be, such weights being
computed to the third decimal place from the chemical formulae of the
substances and the atomic weights of elements, as adopted by the
International Committee on Chemical Elements and published in the latest
edition of the U.S. Pharmacopoeia.
(36 FR 7795, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24,
1973. Redesignated and amended at 51 FR 5319, 5320, Feb. 13, 1986)
21 CFR 1304.33 Reports from manufacturers importing special coca
leaves.
(a) Every manufacturer using special coca leaves imported into the
United States shall submit a quarterly report (DEA (or BND) Form 249)
accounting for all transactions involving such leaves or substances
derived therefrom which contain cocaine or ecgonine, or any salts,
derivatives, or preparations from which cocaine or ecgonine may be
synthesized or made. This report shall be submitted to the Drug Control
Section, Drug Enforcement Administration, Department of Justice,
Washington, DC 20537, on or before the 15th day of the month following
the period for which the report is made. Such report shall include a
report of all importations of special coca leaves (DEA (or BND) Form
249a), a report of all materials entered into the processes of
manufacture (DEA (or BND) Form 249b), a report of the various substances
produced therefrom (DEA (or BND) Forms 249c, 249d, and 249e), a report
of all such substances destroyed (DEA (or BND) Form 249f), and a summary
of operations (DEA (or BND) Form 249g).
(b) The report of importations shall provide in appropriate columns
the following data as to each importation:
(1) The date of the import permit;
(2) The serial number of the import permit;
(3) The name of the foreign consignor;
(4) The address of the foreign consignor;
(5) The foreign port of export;
(6) The number of bales imported;
(7) The serial numbers of the bales imported; and
(8) The quantity imported in avoirdupois pounds.
(c) The report of materials entered into the process of manufacture
shall provide in appropriate columns the following information as to
each lot of leaves dumped:
(1) The lot number of specification, a specification to be assigned
to each dump for identification purposes in order to avoid repeating the
serial numbers of the bales when the lot is subsequently referred to;
(2) The date the leaves entered into the process of manufacture;
(3) The number of bales dumped;
(4) The serial numbers of the bales;
(5) The quantity of leaves entered into the process of manufacture,
stated in avoirdupois pounds;
(6) The quantity of alcohol used for each extraction or wash of the
leaves;
(7) The quantity of water used for each water extraction or dilution;
(8) The quantity of any other or additional substance introduced at
any stage into the process of manufacture; and
(9) The dry weight of any filter cloth or other absorbent material to
be later removed from the process after saturation.
(d) The reports of substances produced from special coca leaves shall
provide in columns the following information as to each production lot
or dump:
(1) The lot number;
(2) The quantity of ground leaves entered into process, in terms of
avoirdupois ounces and the quantity, in ounces and grains, of alkaloid
contained therein as determined by analysis;
(3) The quantity of substance in process after each distinct step in
the manufacturing process and the total alkaloid contained in each,
stated in ounces and grains;
(4) The quantity of exhausted or spent leaves and the quantity of
each residue removed from process, and the total alkaloid contained in
each, stated in ounces and grains;
(5) The weight of the used filter cloth or other absorbent material
removed after saturation; and
(6) The quantity, in gallons, of finished extract produced.
(e) The report of substances destroyed, shall provide in appropriate
columns the following data as to each lot destroyed:
(1) The lot number;
(2) The quantity of spent leaves, residues, and saturated materials
destroyed, stated separately for each; and
(3) The name of the Government officer witnessing the destruction.
(f) The summary shall include a complete accounting for all
transactions in raw leaves, leaves in process, and residues removed from
production processes.
(1) The summary of raw coca leaves shall include:
(i) The quantity of special coca leaves on hand at the beginning of
the quarter;
(ii) The quantity of special coca leaves imported during the quarter;
(iii) The quantity of special coca leaves entered into the process of
manufacture during the quarter;
(iv) The quantity of special coca leaves on hand at the end of the
quarter; and
(v) Any other transaction during the quarter which increased or
decreased the quantity of raw coca leaves on hand.
(2) The summary of coca leaves in process shall include:
(i) The quantity of special coca leaves in process at the beginning
of the quarter;
(ii) The quantity of such leaves placed in the process during the
quarter;
(iii) The quantity of such leaves represented by lots completed
during the quarter;
(iv) The quantity of such leaves represented by lots in process at
the end of the quarter; and
(v) Any other transaction during the quarter which increased or
decreased the quantity of leaves in process.
(3) The summary of residues removed from production processes shall
provide in appropriate columns, separately as to spent leaves, each
residue and saturated material, the following information:
(i) The quantity of each, on hand at the beginning of the quarter,
awaiting destruction;
(ii) The quantity of each removed from process during the quarter;
(iii) The quantity of each destroyed during the quarter;
(iv) The quantity of each on hand at the end of the quarter; and
(v) Any other transaction during the quarter affecting the quantity
of such residues on hand.
(36 FR 7795, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24,
1973, and amended at 46 FR 28841, May 29, 1981. Redesignated and amended
at 51 FR 5319, Feb. 13, 1986)
21 CFR 1304.34 Reports generally.
(a) All reports required by 1304.35 -- 1304.38 shall be filed with
the ARCOS Unit, P.O. Box 28293, Central Station, Washington, DC. 20005.
(b) Reports required by 1304.35 -- 1304.38 shall be filed on DEA
(or BND) Form 333, or on media which contains the data required by DEA
(or BND) Form 333 and which is acceptable to the ARCOS Unit.
(c) References to DEA (or BND) Form 234 in 1304.33 and 1304.34
shall be deemed to refer equally to DEA (or BND) Form 333.
(37 FR 28714, Dec. 29, 1972. Redesignated at 38 FR 26609, Sept. 24,
1973, and amended at 46 FR 28841, May 29, 1981. Redesignated and amended
at 51 FR 5319, 5320, Feb. 13, 1986)
21 CFR 1304.35 Reports from manufacturers of bulk materials or dosage
units.
Each person who is registered to manufacture controlled substances in
bulk or dosage form shall report as follows:
(a) Substance covered. Reports shall include data on each controlled
substance listed in Schedules I and II, on each narcotic controlled
substance listed in Schedules III, IV and V, and on each psychotropic
controlled substance listed in Schedules III and IV as identified below:
(1) Benzphetamine;
(2) Cyclobarbital;
(3) Glutethimide;
(4) Methylprylon; and
(5) Phendimetrazine.
(1) Barbital;
(2) Diethylproprion (Amfepramone);
(3) Ethchlovynol;
(4) Ethinamate;
(5) Lefetamine (SPA);
(6) Mazindol;
(7) Meprobamate;
(8) Methylphenobarbital;
(9) Phenobarbital;
(10) Phentermine; and
(11) Pipradrol.
Data shall be presented in such a manner as to identify the
particular form, strength, and trade name, if any, of the product
containing the controlled substance for which the report is being made.
For this purpose, persons filing reports shall utilize the National Drug
Code Number assigned to the product under the National Drug Code System
of the Food and Drug Administration.
(b) Transactions reported. Reports shall provide data on each
acquisition to inventory (identifying whether it is, e.g., by purchase
or transfer, return from a customer, recovery of waste material,
manufacture from other materials, or supplied by the Federal Government)
and each reduction from inventory (identifying whether it is, e.g., by
sale or transfer, sampling, use in production, loss through
nonrecoverable waste, theft, destruction, or seizure by Government
agencies). These reports shall be filed every month not later than the
15th day of the month succeeding the month for which it is submitted;
except that a registrant may be given permission to file more frequently
or less frequently (but not less than quarterly), depending on the
number of transactions being reported each time by that registrant.
(c) Inventories reported. Reports shall provide data on the stocks
of each reported controlled substance on hand as of the close of
business on December 31 of each year, indicating whether the substance
is in storage or in process of manufacturing. These reports shall be
filed no later than January 15 of the following year.
(d) Registrants manufacturing etorphine hydrochloride or
diprenorphine shall, on a weekly basis, forward a copy of the order
forms received for these substances to the Administration.
(Approved by the Office of Management and Budget under control number
1117-0003)
(37 FR 28714, Dec. 29, 1972. Redesignated at 38 FR 26609, Sept. 24,
1973, and amended at 39 FR 17838, May 21, 1974; 49 FR 37060, Sept. 21,
1984. Redesignated and amended at 51 FR 5320, Feb. 13, 1986)
21 CFR 1304.36 Reports from packagers and labelers.
Each person who is registered to manufacture controlled substances
and who only packages, repackages, labels, or relabels such substances
shall report as follows:
(a) Substances covered. Reports shall include data on each
controlled substance listed in Schedule I and II and on each narcotic
controlled substance listed in Schedule III (but not on any material,
compound, mixture, or preparation containing a quantity of a substance
having a stimulant effect on the central nervous system, which material,
compound, mixture, or preparation is listed in Schedule III or on any
narcotic controlled substance listed in Schedule V). Data shall be
presented in such a manner as to identify the particular form, strength,
and trade name, if any, of the product containing the controlled
substance for which the report is being made. For this purpose, persons
filing reports shall utilize the National Drug Code Number assigned to
the product under the National Drug Code System of the Food and Drug
Administration.
(b) Transactions reported. Reports shall provide data on each
acquisition to inventory (identifying whether it is, e.g., by purchase
or transfer, return from a customer, or supply by the Federal Government
and each reduction from inventory (identifying whether it is, e.g., by
sale or transfer, sampling, theft, destruction, or seizure by Government
agencies). These reports shall be filed every month not later than the
15th day of the month succeeding the month for which it is submitted;
except that a registrant may be given permission to file more frequently
or less frequently (but not less than quarterly), depending on the
number of transactions being reported each time by that registrant.
(c) Inventories reported. Reports shall provide data on the stocks
of each reported controlled substance on hand as of the close of
business on December 31 of each year. These reports shall be filed no
later than January 15 of the following year.
(d) Exceptions. A registered institutional practitioner who
repackages or relabels exclusively for distribution to and dispensing by
agents, employees, or affiliated institutional practitioners of the
registrant may be exempted from filing reports under this section by
applying to the ARCOS Unit of the Administration.
(Approved by the Office of Management and Budget under control number
1117-0003)
(37 FR 28714, Dec. 29, 1972. Redesignated at 38 FR 26609, Sept. 24,
1973, and amended at 38 FR 34998, Dec. 21, 1973; 46 FR 28841, May 29,
1981; 49 FR 37060, Sept. 21, 1984. Redesignated at 51 FR 5320, Feb. 13,
1986)
21 CFR 1304.37 Reports from distributors.
Each person who is registered to distribute controlled substances
shall report as follows:
(a) Substances covered. Reports shall include data on each
controlled substance listed in Schedules I and II and on each narcotic
controlled substance listed in Schedule III (but not on any material,
compound, mixture or preparation containing a quantity of a substance
having a stimulant effect on the central nervous system, which material,
compound, mixture or preparation is listed in Schedule III or on any
narcotic controlled substance listed in Schedule V). Data shall be
presented in such a manner as to identify the particular form, strength,
and trade name, if any, of the product containing the controlled
substance for which the report is being made. For this purpose, persons
filing reports shall utilize the National Drug Code Number assigned to
the product under the National Drug Code System of the Food and Drug
Administration.
(b) Transactions reported. Reports shall provide data on each
acquisition to inventory (identifying whether it is, e.g., by purchase
or transfer, return from a customer, or supply by the Federal
Government) and each reduction from inventory (identifying whether it
is, e.g., by sale or transfer, sampling, theft, destruction, or seizure
by Government agencies). These reports shall be filed every month not
later than the 15th day of the month succeeding the month for which it
is submitted: except that a registrant may be given permission to file
more frequently or less frequently (but not less than quarterly),
depending on the number of transactions being reported each time by that
registrant.
(c) Inventories reported. Reports shall provide data on the stocks
of each reported controlled substance on hand as of the close of
business on December 31 of each year. These reports shall be filed no
later than January 15 of the following year.
(d) Exceptions. A registered institutional practitioner which
distributes exclusively to (for dispensing by) agents, employees, or
affiliated institutional practitioners of the registrant may be exempted
from filing reports under this section by applying to the ARCOS Unit of
the Administration.
(37 FR 28714, Dec. 29, 1972. Redesignated at 38 FR 26609, Sept. 24,
1973, and amended at 38 FR 34998, Dec. 21, 1973; 46 FR 28841, May 29,
1981. Redesignated at 49 FR 37060, Sept. 21, 1984. Redesignated at 51 FR
5320, Feb. 13, 1986)
21 CFR 1304.38 Reports from manufacturers importing poppy straw or
concentrate of poppy straw.
(a) Every manufacturer importing poppy straw or concentrate of poppy
straw shall submit in addition to Form 333, Form DEA 247(c) accounting
for the importation and for all manufacturing operations performed
between importation and the production in bulk of finished marketable
products, standardized in accordance with the U.S. Pharmacopeia,
National Formulary, or other recognized medical standards. Subsequent
manufacture from such products, including bottling or packaging
operations, shall be accounted for in the returns on DEA Form 333 (
1304.38) and its supplements. DEA Form 247(c) shall be submitted
quarterly to the Drug Control Section, Drug Enforcement Administration,
Department of Justice, Washington, DC 20537, on or before the 15th day
of the month immediately following the period for which it is submitted.
(b) The report of manufacture from poppy straw or concentrate of
poppy straw shall consist of summaries with supporting detail sheets
accounting for original manufacture from poppy straw to concentrate, and
from concentrate of poppy straw, production from morphine for further
manufacture and also accounting for all stocks of poppy straw,
concentrate of poppy straw, morphine for further manufacture and other
crude alkaloids.
(c) The detail sheets (DEA 247(c)) supporting the summary of
manufacture from poppy straw or concentrate of poppy straw shall show
separately the amount of poppy straw or concentrate imported, the poppy
straw used for production of concentrate, the concentrate used for
extraction of alkaloids, subsequent manufacture from those alkaloids and
the inventory of poppy straw and concentrate of poppy straw at the close
of the reporting period.
(d) Upon importation of poppy straw or concentrate of poppy straw,
samples will be selected and assays made by the importing manufacturer
in a manner and according to a method previously approved by DEA. Where
final assay data is not determined at the time of rendering report, the
report shall be made on the basis of the best data available, subject to
adjustment, and the necessary adjusting entries shall be made on the
next report.
(e) Upon withdrawal of poppy straw or concentrate of poppy straw from
Customs custody, the importing manufacturer shall assign to each lot or
container an identification number by which the poppy straw or
concentrate will be associated with the lot assay and identified in
reports.
(f) Where factory procedure is such that partial withdrawals of poppy
straw or concentrate are made from individual containers, there shall be
attached to each container a stock record card on which shall be kept a
complete record of all withdrawals therefrom.
(g) Concentrate of poppy straw and derivatives produced for exclusive
use in further manufacturing purposes shall be reported produced when
they come into existence in that form in which they are to be so used.
Alkaloids or derivatives produced exclusively for distribution shall be
reported as produced when manufacture has actually been completed and
the finished marketable product ready for packaging and distribution.
Such products shall be regarded as ready for packaging and distribution
as soon as all processing other than mere packaging has been completed.
Products manufactured partly for distribution and partly for use in
further manufacture will be reported produced as soon as manufacture is
complete and they are ready either for use in further manufacture or for
packaging for distribution.
(h) Subject to 1303.24(c) of this chapter, no accumulations of
morphine or other narcotic controlled substances in their pure or
near-pure states shall be permitted to remain inactively in process for
an unreasonable time in light of efficient industrial practices. All
such products nearing completion of their respective processes and
approaching a condition of purity shall be carefully protected, promptly
completed, and immediately transferred to finished stocks, and reported
as produced.
(i) In making conversions of concentrate of poppy straw alkaloids and
their salts to anhydrous morphine the quantity of the particular
alkaloid or salt in avoirdupois ounces shall be multiplied by a
conversion factor arrived at by ascertaining the ratio, carried to the
fourth decimal place, between the respective molecular weight of such
alkaloid or salt and the molecular weight of anhydrous morphine
(285.16), such weights being computed to the third decimal place from
the chemical formulae of the substances and the atomic weights of
elements, as adopted by the International Committee on Chemical Elements
and published in the latest edition of the U.S. Pharmacopoeia.
(40 FR 6779, Feb. 14, 1975, as amended at 40 FR 42866, Sept. 17,
1975; 46 FR 28841, May 29, 1981. Redesignated at 49 FR 37060, Sept.
21, 1984. Redesignated and amended at 51 FR 5319, 5320, Feb. 13, 1986)
21 CFR 1304.38 PART 1305 -- ORDER FORMS
Sec.
1305.01 Scope of Part 1305.
1305.02 Definitions.
1305.03 Distributions requiring order forms.
1305.04 Persons entitled to obtain and execute order forms.
1305.05 Procedure for obtaining order forms.
1305.06 Procedure for executing order forms.
1305.07 Power of attorney.
1305.08 Persons entitled to fill order forms.
1305.09 Procedure for filling order forms.
1305.10 Procedure for endorsing order forms.
1305.11 Unaccepted and defective order forms.
1305.12 Lost and stolen order forms.
1305.13 Preservation of order forms.
1305.14 Return of unused order forms.
1305.15 Cancellation and voiding of order forms.
1305.16 Special procedure for filling certain order forms.
Authority: 21 U.S.C. 821, 828, 871(b), unless otherwise noted.
Source: 36 FR 7796, Apr. 24, 1971, unless otherwise noted.
Redesignated at 38 FR 26609, Sept. 24, 1973.
21 CFR 1305.01 Scope of Part 1305.
Procedures governing the issuance, use, and preservation of order
forms pursuant to section 1308 of the Act (21 U.S.C. 828) are set forth
generally by that section and specifically by the sections of this part.
21 CFR 1305.02 Definitions.
As used in this part, the following terms shall have the meanings
specified:
(a) The term Act means the Controlled Substances Act (84 Stat. 1242;
21 U.S.C. 801) and/or the Controlled Substances Import and Export Act
(84 Stat. 1285; 21 U.S.C. 951).
(b) The term purchaser means any registered person entitled to obtain
and execute order forms pursuant to 1305.04 and 1305.06.
(c) The term supplier means any registered person entitled to fill
order forms pursuant to 1305.08.
(d) Any term not defined in this section shall have the definition
set forth in section 102 of the Act (21 U.S.C. 802) and 1301.02 and
1302.02 of this chapter.