The Federal Regulation of Medical Devices

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Abstract
BEFORE 1976, medical devices could be marketed without review by the U.S. Food and Drug Administration (FDA). Periodic attempts to regulate some devices as drugs for which the agency did require premarketing clearance proved to be cumbersome and inadequate. Spurred by the increased technological complexity of devices and mounting disclosures of shortcomings involving pacemakers, intrauterine devices, and intraocular lenses, Congress enacted the comprehensive Medical Device Amendments of 1976 to the Federal Food, Drug, and Cosmetic Act.1 2 3 4 The primary purpose of the amendments was to ensure that new devices were safe and effective before they were marketed.In the past few . . .

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