This chapter may be cited as the Federal Food, Drug, and Cosmetic Act. 21 U.S.C. § 301 June 25, 1938, ch. 675, §1, 52 Stat. 1040. STATUTORY NOTES AND RELATED SUBSIDIARIES EFFECTIVE DATE; POSTPONEMENT IN CERTAIN CASES Act June 23, 1939, ch. 242, §§1, 2, 53 Stat. 853, 854, provided that:"[SEC. 1] (a) The effective date of the following provisions of the Federal Food, Drug, and Cosmetic Act is hereby postponed until January 1, 1940: Sections 402(c) [342(c) of this title]; 403(e)(1) [343(e)(1) of this
(a) A decision of an FDA employee, other than the Commissioner, on a matter, is subject to review by the employee's supervisor under the following circumstances: (1) At the request of the employee. (2) On the initiative of the supervisor. (3) At the request of an interested person outside the agency. (4) As required by delegations of authority. (b) (1) The review will be made by consultation between the employee and the supervisor or by review of the administrative file on the matter, or both. The
(a) To designate the agency component with primary jurisdiction for the premarket review and regulation of a combination product, the agency shall determine the primary mode of action of the product. Where the primary mode of action is that of: (1) A drug (other than a biological product), the agency component charged with premarket review of drugs shall have primary jurisdiction; (2) A device, the agency component charged with premarket review of devices shall have primary jurisdiction; (3) A biological
(a) Who should file: the sponsor of: (1) Any combination product the sponsor believes is not covered by an intercenter agreement; or (2) Any product where the agency component with primary jurisdiction is unclear or in dispute. (b) When to file: a sponsor should file a request for designation before filing any application for premarket review, whether an application for marketing approval or a required investigational notice. Sponsors are encouraged to file a request for designation as soon as there
(a) (1) The Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health, and the Center for Drug Evaluation and Research have entered into agreements clarifying product jurisdictional issues. These guidance documents are on display in the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and are entitled "Intercenter Agreement Between the Center for Drug Evaluation and Research and the Center for Devices