FDA Regulation of Medical Devices

The United States Food & Drug Administration has extensive premarket and postmarket regulatory jurisdiction over medical devices that are entered into interstate commerce, and their manufacturers. FDA's authority to regulate medical devices arises out of the Federal Food, Drug, and Cosmetic Act (FDCA). As originally written, the FDCA only had very limited provisions addressing the regulation of medical devices. By the mid-1970s, it had become clear to Congress that, due to a combination of significant and rapid scientific advances and the occasional marketing of some unsafe, ineffective, and even fraudulent devices, an increase in FDA regulatory authority over medical devices was needed.

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