Federal regulations · Through 2026-08-25 · Newer source version available

21 CFR 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.

Where this section sits in the code

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

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.

Collected 2026-08-27T02:24:47Z. Source file · JSON

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