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Subpart B-Procedures for Per

formance Standards Development and Publication

(c) The manufacturing processes and quality control procedures applicable to the device;

(d) Testing of the device on either a sample or a 100-percent basis by the manufacturer, or, if it is determined that no other more practical means are available to the Food and Drug Administration to assure the conformity of the device to the standard, providing for testing by the Food and Drug Administration or a third person to ensure that the device conforms to the standard;

(e) The publication of the results of each test or of certain tests of the device to show that the device conforms to the portions of the standard for which the test or tests were required;

(f) Manufacturers' certification to purchasers or to the Food and Drug Administration that the device conforms to the applicable performance standard;

(8) Restrictions on the sale and distribution of the device, but only to the extent authorized under section 520(e) of the act;

(h) The use, and the form and content, of labeling for the proper installation, maintenance, operation, and use of the device. Among the provisions that may be required in the labeling are warnings; storage and transportation information; expiration dates; the date and place of manufacture; the results that may be expected if the device is used properly; the ranges of accuracy of diagnostic information; instructions regarding the proper care of, and the proper components, accessories, or other equipment to be used with the device; and statements concerning the appropriate patient population, for example, a statement that the device is considered safe and effective only when used by, or in the treatment of, a patient who has been tested by particular designated procedures and found to have an illness or condition for which use of the device is indicated by a person skilled in the use of the device.

$ 861.20 Summary of standards devel.

opment process. The procedure by which a performance standard for a device may be established, amended, or revoked is as follows:

(a) The Food and Drug Administration (FDA) will publish in the FEDERAL REGISTER a notice of proposed rulemaking for the establishment, amendment, or revocation of any performance standard for a device.

(1) A notice of proposed rulemaking for the establishment or amendment of a performance standard for a device will:

(1) Set forth a finding, with supporting justification, that the performance standard is appropriate and necessary to provide reasonable assurance of the safety and effectiveness of the device;

(ii) Set forth proposed findings with respect to the risk of illness or injury that the performance standard is intended to reduce or eliminate;

(iii) Invite interested persons to submit to the Food and Drug Administration, within 30 days of the publication of the notice, requests for changes in the classification of the device pursuant to $860.132 of this chapter, based on new information relevant to the classification; and

(iv) Invite interested persons to submit an existing performance standard for the device, including a draft or proposed performance standard, for consideration by the Commissioner of Food and Drugs.

(2) A notice of proposed rulemaking for the revocation of a performance standard will set forth a finding, with supporting justification, that the performance standard is no longer necessary to provide reasonable assurance of the safety and effectiveness of a device.

(b) A notice under this section will provide for a comment period of not less than 60 days.

(c) If, after publication of a notice developed, or that an existing standard under paragraph (a) of this section, is not acceptable, together with the FDA receives a request to change the reasons therefor. classification of the device, FDA will,

[45 FR 7484, Feb. 1, 1980, as amended at 57 FR within 60 days of the publication of the

58405, Dec. 10, 1992) notice and after consultation with the appropriate panel under $860.125 of this

8 861.30 Development of standards. chapter, either deny the request or give notice of its intent to initiate a change

The Food and Drug Administration in the classification under $860.130.

(FDA), while engaged in the develop(d) If FDA initiates a rulemaking

ment of a proposed standard under this proceeding under paragraph (a) of this

section will: section, FDA will:

(a) Support its proposed performance (1) Complete the proceeding and es

standard by such test data or other tablish the performance standard for

documents or materials as may reasonthe device in accordance with this part

ably be required; and $ 10.40 of this chapter; or

(b) Provide interested persons an op(2) Terminate the proceeding by pub- portunity to participate in the developlishing in the FEDERAL REGISTER a no- ment of the standard by accepting tice announcing such termination and

comments and, where appropriate, the reasons therefor and, unless the holding public meetings on issues reproceeding is terminated because the lating to development of the standard. device is a banned device, initiate a Notice of the opportunity to participroceeding in accordance with section pate in the development of the stand513(e) of the act to reclassify the de

ard will be furnished in a manner reavice; or

sonably calculated to reach the major(3) Take other appropriate action. ity of persons interested in the devel

opment of the standard. This require(57 FR 58404, Dec. 10, 1992)

ment shall be satisfied by publishing

such a notice in the FEDERAL REG8861.24 Existing standard as

a proposed standard.

ISTER. Whenever it is appropriate, FDA

will use the FEDERAL REGISTER to (a) The Food and Drug Administra

make announcements about the standtion may accept an existing standard

ard development process of standard or a proposed or draft standard if it includes:

developers other than Federal agen

cies. (1) A description of the procedures used to develop the standard and a list

(c) Maintain records disclosing the of the persons and organizations that

course of development of the proposed

standard, the comments and other inparticipated in its development, to the

formation submitted by a person in extent that such information is avail

connection with such development (inable or reasonably obtainable; (2) An identification of the specific

cluding comments and information reportions of the existing standard that

garding the need for a standard), and

such other information as may be rethe person submitting the standard be

quired to evaluate the standard. lieves are appropriate for adoption as, or inclusion in, the proposed standard; (45 FR 7484, Feb. 1, 1980, as amended at 57 FR and

58405, Dec. 10, 1992) (3) A summary of the test data, or, if requested by the Food and Drug Ad

$ 861.34 Amendment or revocation of a

standard. ministration, all such data or other information supporting the specific por- (a) The Food and Drug Administrations of the standard identified by the tion will provide for periodic evaluaperson submitting the standard.

tion of performance standards to deter(b) The Food and Drug Administra- mine whether such standards should be tion will publish a notice in the FED- changed to reflect new medical, sciERAL REGISTER stating either that it entific, or other technological data. has accepted, or accepted with modi- (b) The Food and Drug Administrafication, as a proposed standard, an ex- tion may, on its own initiative or upon isting standard or one that has been petition of an interested party, amend

date of any final action on the proposal. [45 FR 7484, Feb. 1, 1980, as amended at 57 FR 58405, Dec. 10, 1992]

or revoke by regulation a standard established under this part.

(c) Any petition to amend or revoke a standard shall:

(1) Identify the specific device and standard for which the amendment or revocation is sought; and

(2) Be submitted in accordance with the requirements of $10.30.

(d) Proceedings to amend or revoke a performance standard shall be conducted in accordance with the rulemaking procedures of $10.40. In addition, a notice of proposed rulemaking to amend or revoke a standard shall set forth proposed findings with respect to the degree of risk or illness to be eliminated or reduced and the benefit the public will derive from the proposed amendment or revocation.

8861.36 Effective dates.

(a) A regulation establishing, amending, or revoking a performance standard will set forth the date upon which it will take effect. To the extent practical, consistent with the public health and safety, such effective date will be established so as to minimize economic loss to, and disruption or dislocation of, domestic and international trade.

(b) Except as provided in paragraph (c) of this section, no regulation establishing, amending, or revoking a standard may take effect before 1 year after the date of its publication unless:

(1) The Food and Drug Administration determines that an earlier effective date is necessary to protect the public health and safety; or

(2) The standard has been established for a device that, by the effective date of the standard, has been reclassified from class III to class II.

(c) The Food and Drug Administration may declare a proposed regulation amending a standard effective on publication in the FEDERAL REGISTER if it determines that making the regulation so effective is in the public interest. A proposed amendment of a performance standard made effective upon publication may not prohibit the introduction or delivery for introduction into interstate commerce of a device that conforms to the standard without the change or changes provided in the proposed amendment until the effective

8861.38 Standards advisory commit

tees. (a) The Food and Drug Administration will establish advisory Committees to which proposed regulations may be referred, and these committees shall consider such referrals in accordance with this section and part 14 of this chapter. Such advisory Committees, which may not be classification panels, shall be considered ad hoc advisory committees. Their members shall be selected in accordance with $$ 14.82 and 14.84, except that no member may be a regular full-time FDA employee. Each advisory committee established under this section shall include as nonvoting members a representative of consumer interests and a representative of interests of the device manufacturing industry.

(b) A proposed regulation to establish, amend, or revoke a performance standard shall be referred to an advisory committee for a report and recommendation with respect to any matter involved in the proposed regulation which requires the exercise of scientific judgment if:

(1) The Food and Drug Administration determines that such referral is necessary or appropriate under the circumstances; or

(2) Requested by an interested person, in the form of a citizen petition in accordance with $10.30 of this chapter, which is made within the period provided for comment on the proposed regulation and which demonstrates good cause for referral.

(c) When a proposed regulation is referred to an advisory Committee, the Food and Drug Administration will furnish the committee with the data and information upon which the proposed regulation is based. After independently reviewing the materials furnished by the Food and Drug Administration and any other available data and information, the advisory committee shall, within 60 days of the referral, submit a report and recommendation on the proposed regulation, together with all underlying data

and information and a statement of the 862.1117 B-type natriuretic peptide test sysreason or basis for the recommenda


862.1118 Biotinidase test system. tion. A copy of the report and rec

862.1120 Blood gases (Pco2P02) and blood pH ommendation will be publicly dis

test system. played in the office of the Dockets

862.1130 Blood volume test system. Management Branch, Food and Drug

862.1135 C-peptides of proinsulin test sysAdministration.

tem. (d) Where appropriate, each proposed 862.1140 Calcitonin test system. regulation establishing a standard pub

862.1145 Calcium test system. lished in the FEDERAL REGISTER will

862.1150 Calibrator.

862.1155 Human chorionic gonadotropin include a call for nominations to the

(HCG) test system. advisory committee for that particular

862.1160 Bicarbonate/carbon dioxide test standard.


862.1166 Catecholamines (total) test system. [45 FR 7484, Feb. 1, 1980, as amended at 57 FR

862.1170 Chloride test system. 58405, Dec. 10, 1992)

862.1175 Cholesterol (total) test system.

862.1177 Cholylglycine test system. PART 862-CLINICAL CHEMISTRY 862.1180 Chymotrypsin test system.

AND CLINICAL TOXICOLOGY 862.1185 Compound S (11-deoxycortisol) test DEVICES

system. 862.1187 Conjugated sulfolithocholic acid

(SLCG) test system. Subpart A-General Provisions

862.1190 Copper test system.

862.1195 Corticoids test system. Sec.

862.1200 Corticosterone test system. 862.1 Scope.

862.1205 Cortisol (hydrocortisone and 862.2 Regulation of calibrators.

hydroxycorticosterone) test system. 862.3 Effective dates of requirement for pre

862.1210 Creatine test system. market approval.

862.1215 Creatine phosphokinase/creatine ki862.9 Limitations of exemptions from sec

nase or isoenzymes test system. tion 510(k) of the Federal Food, Drug,

862.1225 Creatinine test system. and Cosmetic Act (the act).

862.1230 Cyclic AMP test system.

862.1240 Cystine test system. Subpart B-Clinical Chemistry Test Systems

862.1245 Dehydroepiandrosterone (free and

sulfate) test system. 862.1020 Acid phosphatase (total or pros

862.1250 Desoxycorticosterone test system. tatic) test system.

862.1255 2,3-Diphosphoglyceric acid test sys862.1025 Adrenocorticotropic hormone

tem. (ACTH) test system.

862.1260 Estradiol test system. 862.1030 Alanine amino transferase (ALT/

862.1265 Estriol test system. SGPT) test system.

862.1270 Estrogens (total, in pregnancy) test 862.1035 Albumin test system.

system. 862.1040 Aldolase test system.

862.1275 Estrogens (total, nonpregnancy) 862.1045 Aldosterone test system.

test system. 862.1050 Alkaline phosphatase or isoenzymes 862.1280 Estrone test system. test system.

862.1285 Etiocholanolone test system. 862.1060 Delta-aminolevulinic acid test sys- 862.1290 Fatty acids test system. tem.

862.1295 Folic acid test system. 862.1065 Ammonia test system.

862.1300 Follicle-stimulating hormone test 862.1070 Amylase test system.

system. 862.1075 Androstenedione test system.

862.1305 Formiminoglutamic acid (FIGLU) 862.1080 Androsterone test system.

test system. 862.1085 Angiotensin I and renin test sys- 862.1310 Galactose test system. tem.

862.1315 Galactose-1-phosphate uridyl trans862.1090 Angiotensin converting enzyme

ferase test system. (A.C.E.) test system.

862.1320 Gastric acidity test system. 862.1095 Ascorbic acid test system.

862.1325 Gastrin test system. 862.1100 Aspartate amino transferase (AST/ 862.1330 Globulin test system. SGOT) test system.

862.1335 Glucagon test system. 862.1110 Bilirubin (total or direct) test sys- 862.1340 Urinary glucose (nonquantitative) tem.

test system. 862.1113 Bilirubin (total and unbound) in the 862.1345 Glucose test system. neonate test system.

862.1360 Gamma-glutamyl transpeptidase 862.1115 Urinary bilirubin and its conjugates and isoenzymes test system. (nonquantitative) test system.

862.1365 Glutathione test system.

862.1370 Human growth hormone test sys

tem. 862.1375 Histidine test system. 862.1377 Urinary homocystine (nonquantita

tive) test system. 862.1380 Hydroxybutyric dehydrogenase test

system. 862.1385 17-Hydroxycorticosteroids (17

ketogenic steroids) test system, 862.1390 5-Hydroxyindole acetic acid/sero

tonin test system. 862.1395 17-Hydroxyprogesterone test sys

tem. 862.1400 Hydroxyproline test system. 862.1405 Immunoreactive insulin test sys

tem. 862.1410 Iron (non-heme) test system. 862.1415 Iron-binding capacity test system. 862.1420 Isocitric dehydrogenase test sys

tem. 862.1430 17-ketosteroids test system. 862.1435 Ketones (nonquantitative) test sys

tem. 862.1440 Lactate dehydrogenase test system. 862.1445 Lactate dehydrogenase isoenzymes

test system. 862.1450 Lactic acid test system. 862.1455 Lecithin/sphingomyelin ratio in

amniotic fluid test system. 862.1460 Leucine aminopeptidase test sys

tem. 862.1465 Lipase test system. 862.1470 Lipid (total) test system. 862.1475 Lipoprotein test system. 862.1485 Luteinizing hormone test system. 862.1490 Lysozyme (muramidase) test sys

tem. 862.1495 Magnesium test system. 862.1500 Malic dehydrogenase test system. 862.1505 Mucopolysaccharides (nonquantita

tive) test system. 862.1509 Methylmalonic acid (nonquantita

tive) test system. 862.1510 Nitrite (nonquantitative) test sys

tem. 862.1515 Nitrogen (amino-nitrogen) test sys

862.1590 Porphobilinogen test system. 862.1595 Porphyrins test system. 862.1600 Potassium test system. 862.1605 Pregnanediol test system. 862.1610 Pregnanetriol test system. 862.1615 Pregnenolone test system. 862.1620 Progesterone test system. 862.1625 Prolactin (lactogen) test system. 862.1630 Protein (fractionation) test system. 862.1635 Total protein test system. 862.1640 Protein-bound iodine test system. 862.1645 Urinary protein or albumin (non

quantitative) test system. 862.1650 Pyruvate kinase test system. 862.1655 Pyruvic acid test system. 862.1660 Quality control material (assayed

and unassayed). 862.1665 Sodium test system. 862.1670 Sorbitol dehydrogenase test sys

tem. 862.1675 Blood specimen collection device. 862.1680 Testosterone test system. 862.1685 Thyroxine-binding globulin test

system. 862.1690 Thyroid-stimulating hormone test

system. 862.1695 Free thyroxine test system. 862.1700 Total thyroxine test system. 862.1705 Triglyceride test system. 862.1710 Total triiodothyronine test system. 862.1715 Triiodothyronine uptake test sys

tem. 862.1720 Triose phosphate isomerase test

system. 862.1725 Trypsin test system. 862.1730 Free tyrosine test system. 862.1770 Urea nitrogen test system. 862.1775 Uric acid test system. 862.1780 Urinary calculi (stones) test sys

tem. 862.1785 Urinary urobilinogen (nonquantita

tive) test system. 862.1790 Uroporphyrin test system. 862.1795 Vanilmandelic acid test system. 862.1805 Vitamin A test system. 862.1810 Vitamin B 12 test system. 862.1815 Vitamin E test system. 862.1820 Xylose test system. 862.1825 Vitamin D test system.

Subpart C-Clinical Laboratory Instruments 862.2050 General purpose laboratory equip

ment labeled or promoted for a specific

medical use. 862.2100 Calculator/data processing module

for clinical use. 862.2140 Centrifugal chemistry analyzer for

clinical use. 862.2150 Continuous flow sequential mul

tiple chemistry analyzer for clinical use. 862.2160 Discrete photometric chemistry an

alyzer for clinical use. 862.2170 Micro chemistry analyzer for clin

tem. 862.1520 5'-Nucleotidase test system. 862.1530 Plasma oncometry test system. 862.1535 Ornithine carbamyl transferase test

system. 862.1540 Osmolality test system. 862.1542 Oxalate test system. 862.1545 Parathyroid hormone test system. 862.1550 Urinary pH (nonquantitative) test

system. 862.1555 Phenylalanine test system. 862.1560 Urinary phenylketones (non

quantitative) test system. 862.1565 6-Phosphogluconate dehydrogenase

test system. 862.1570 Phosphohexose isomerase test sys

tem. 862.1575 Phospholipid test system. 862.1580 Phosphorus (inorganic) test system. 862.1585 Human placental lactogen test sys


ical use. 862.2230 Chromatographic separation mate

rial for clinical use.

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