21 C.F.R. § 861.36 Effective dates.
Title 21 - Food and Drugs
(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 [45 FR 7484, Feb. 1, 1980, as amended at 57 FR 58405, Dec. 10, 1992]
Title 21: Food and Drugs
PART 861—PROCEDURES FOR PERFORMANCE STANDARDS DEVELOPMENT
Subpart B—Procedures for Performance Standards Development and Publication
§ 861.36 Effective dates.