Title 21

SECTION 861.36

861.36 Effective dates.

§ 861.36 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 date of any final action on the proposal.

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