(1) A description of the procedures used to develop the standard and a list of the persons and organizations that participated in its development, to the extent that such information is available or reasonably obtainable;

(2) An identification of the specific portions of the existing standard that the person submitting the standard believes are appropriate for adoption as, or inclusion in, the proposed standard; and

(3) A summary of the test data, or, if requested by the Food and Drug Administration, all such data or other information supporting the specific portions of the standard identified by the person submitting the standard.

(b) The Food and Drug Administration will publish a notice in the FEDERAL REGISTER stating either that it has accepted, or accepted with modification, as a proposed standard, an existing standard or one that has been developed, or that an existing standard is not acceptable, together with the reasons therefor.

[45 FR 7484, Feb. 1, 1980, as amended at 57 FR 58405, Dec. 10, 1992]

§861.30 Development of standards.

The Food and Drug Administration (FDA), while engaged in the development of a proposed standard under this section will:

(a) Support its proposed performance standard by such test data or other documents or materials as may reasonably be required;

(b) Provide interested persons an opportunity to participate in the development of the standard by accepting comments and, where appropriate, holding public meetings on issues relating to development of the standard. Notice of the opportunity to participate in the development of the standard will be furnished in a manner reasonably calculated to reach the majority of persons interested in the development of the standard. This requirement shall be satisfied by publishing such a notice in the FEDERAL REGISTER. Whenever it is appropriate, FDA will use the FEDERAL REGISTER to make announcements about the standard development process of standard developers other than Federal agencies.

(c) Maintain records disclosing the course of development of the proposed standard, the comments and other information submitted by a person in connection with such development (including comments and information regarding the need for a standard), and such other information as may be required to evaluate the standard.

[45 FR 7484, Feb. 1, 1980, as amended at 57 FR 58405, Dec. 10, 1992]

§861.34 Amendment or revocation of a

standard.

(a) The Food and Drug Administration will provide for periodic evaluation of performance standards to determine whether such standards should be changed to reflect new medical, scientific, or other technological data.

(b) The Food and Drug Administration may, on its own initiative or upon petition of an interested party, amend 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 Į 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.

$861.36 Effective dates.

(a) A regulation establishing, amend- i ing, 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:

t

(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 date of any final action on the proposal.

[45 FR 7484, Feb. 1, 1980, as amended at 57 FR 58405, Dec. 10, 1992]

$861.38 Standards advisory committees.

(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 reason or basis for the recommendation. A copy of the report and recommendation will be publicly displayed in the office of the Dockets Management Branch, Food and Drug Administration.

(d) Where appropriate, each proposed regulation establishing a standard published in the FEDERAL REGISTER will include a call for nominations to the advisory committee for that particular standard.

[45 FR 7484, Feb. 1, 1980, as amended at 57 FR 58405, Dec. 10, 1992]

PART 862-CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES

862.1565 6-Phosphogluconate dehydrogenase test system.

862.1570 Phosphohexose isomerase test system.

862.1575 Phospholipid test system.

862.1580 Phosphorus (inorganic) test system. 862.1585 Human placental lactogen test system.

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 (nonquantitative) 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 system.

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

test

862.1820 Xylose test system.

Subpart C-Clinical Laboratory Instruments 862.2050 General purpose laboratory equipment 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 multiple chemistry analyzer for clinical use. 862.2160 Discrete photometric chemistry analyzer for clinical use.

862.2170 Micro chemistry analyzer for clinical use.

862.2230 Chromatographic separation material for clinical use.

862.2250 Gas liquid chromatography system for clinical use.

862.2260 High pressure liquid chromatography system for clinical use. 862.2270 Thin-layer chromatography system for clinical use.

862.2300 Colorimeter, photometer,

or

assay test system. 862.3650 Opiate test system. 862.3660 Phenobarbital test system. 862.3670 Phenothiazine test system. 862.3680 Primidone test system. 862.3700 Propoxyphene test system. 862.3750 Quinine test system. 862.3830 Salicylate test system. 862.3850 Sulfonamide test system. 862.3870 Cannabinoid test system. 862.3880 Theophylline test system. 862.3900 Tobramycin test system. 862.3910 Tricyclic antidepressant drugs test system.

862.3950 Vancomycin test system.

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 16122, May 1, 1987, unless otherwise noted.

Subpart A-General Provisions

§862.1 Scope.

(a) This part sets forth the classification of clinical chemistry and clinical toxicology 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 de

vice is substantially equivalent to other devices, as required in §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.

§862.2 Regulation of calibrators.

Many devices classified in this part are intended to be used with a cali-: brator. 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) manufac tured 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.

§ 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