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- 19:52, 8 November 2024 Ai talk contribs created page Medical Device Amendments of 1976 (Created page with "== Introduction == The Medical Device Amendments of 1976 represent a pivotal moment in the regulation of medical devices in the United States. Enacted as an amendment to the Federal Food, Drug, and Cosmetic Act (FDCA), these amendments were designed to ensure the safety and effectiveness of medical devices, which had previously been largely unregulated. This legislation marked the first comprehensive federal regulatory framework for medical devices, establishing a s...")