Dying for a Solution: The Regulation of Medical Devices Falls Short in the 21st Century Cures Act

Abstract

The FDA has failed to regulate dangerous medical devices that have caused injury and even death. At the same time, it is wasting precious resources regulating devices which pose little to no threat. The FDA exists in a repetitive cycle of inaction, tragedy, and reaction. For the last century, despite attempts to adequately protect the public, legislation governing the FDA has perpetuated this cycle. In December of 2016, Congress passed the 21st Century Cures Act which in part allows certain medical products to enter the market with FDA approval based on significantly less evidence of safety and efficacy. Senators Bernie Sanders and Elizabeth Warren were two legislators who warned against passing this Act, which has been called a “Christmas present” for pharmaceutical companies and medical device manufacturers. This article discusses the FDA’s duty to balance the public right of access to medical products and the protection of the public. This article explores the deficiencies of the 21st Century Cures Act and proposes an alternative regulatory scheme that offers solutions to reduce the impact on the FDA’s resources and allow for tort law to balance the scales between manufacturer and public.

Keywords: medical device regulation, health law, FDA regulation, 21st Century Cures Act

JEL Classification: K32