Posted by Michael Wonder on 04 Aug 2021
FDA regulation and approval of medical devices: 1976-2020
3 August 2021 - US law generally requires testing of high-risk medical devices prior to approval, as well as pre-market evaluation of moderate-risk medical devices, with the goal of ensuring that the benefits of these products exceed their risks.
The US FDA attempts to balance the need for evidence generation with an approval process that facilitates access and encourages innovation.
This article reviews the development of laws and standards affecting the evaluation and oversight of medical devices by the US regulatory system and the outcomes of this system from 1976 to 2020.
