What Federal Food, Drug, and Cosmetic Act 1938 - 21 USC 301 requires
Section 301 of title 21 of the United States Code is the short title provision of the Federal Food, Drug, and Cosmetic Act (FDCA, Public Law 75-717, enacted 25 June 1938), the principal US statute governing the safety and efficacy of food, drugs, medical devices, cosmetics, dietary supplements, tobacco products, and animal drugs. Title 21 Chapter 9 codifies the FDCA across approximately 1,200 sections covering Subchapter II Definitions (sections 321-332), Subchapter III Prohibited Acts and Penalties (sections 331-337a including the central prohibition on misbranding, adulteration, and introduction into interstate commerce), Subchapter IV Food, Subchapter V Drugs and Devices (including IND, NDA, ANDA, BLA, premarket approval, 510(k) for devices, breakthrough designation, accelerated approval, REMS), Subchapter VI Cosmetics (with the 2022 MoCRA modernisation), Subchapter VII General Authority including section 704 inspection, section 705 publicity, and section 708 confidential information. The FDA Modernization Acts (1997 FDAMA, 2007 FDAAA, 2012 FDASIA, 21st Century Cures Act 2016, MoCRA 2022, FDORA 2022) have substantially extended the FDCA. AI-enabled drug discovery, AI-as-medical-device (SaMD), AI-supported clinical decision support, and AI-driven adverse-event detection all operate within the FDCA framework, with the FDA AI/ML Action Plan and Predetermined Change Control Plan framework providing the principal regulatory pathway.
Pillar: Pharmaceuticals & Life Sciences · Authority: United States Congress (Office of the Law Revision Counsel) · Version: 1.0.0 · Last updated:
Primary source: https://www.law.cornell.edu/uscode/text/21/301
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Primary Citations — 8 traced to source
- 21 USC 301 (Short title, Federal Food, Drug, and Cosmetic Act) https://www.law.cornell.edu/uscode/text/21/301
- Federal Food, Drug, and Cosmetic Act of 1938, Public Law 75-717, enacted 25 June 1938
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