FDA Regulation and Approval of Medical Devices: 1976-2020.

Abstract

US law generally requires testing of high-risk medical devices prior to approval, as well as premarket evaluation of moderate-risk medical devices, with the goal of ensuring that the benefits of these products exceed their risks. The US Food and Drug Administration (FDA) attempts to balance the need for evidence generation with an approval process that facilitates access and encourages innovation. To review the development of laws and standards affecting the evaluation and oversight of medical d