CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 8]

[CITE: 21CFR861.24]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER H - MEDICAL DEVICES

PART 861 -- PROCEDURES FOR PERFORMANCE STANDARDS DEVELOPMENT

Subpart B - Procedures for Performance Standards Development and Publication

Sec. 861.24 Existing standard as a proposed standard.

(a) The Food and Drug Administration may accept an existing standard or a proposed or draft standard if it includes:

(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]