title: Oversight overhaul: eliminating the premarket review of medical devices and implementing a provider-centered postmarket surveillance strategy.
abstract: Through its premarket regulation of medical devices, FDA aims to secure device safety and effectiveness while allowing for device innovation. However, these competing objectives have proven too difficult to reconcile. Premarket regulations not only impose a substantial burden on device manufacturers, patients, and FDA itself, they also threaten the advancement of new device technologies. This Article provides an in-depth look at the costs of FDA's current regulatory system, and suggests that these costs ultimately outweigh the system's benefits. Therefore, it proposes that the U.S. consider a new approach to device regulation--one that focuses primarily on postmarket surveillance, and allows end-users, such as health care providers and professional medical organizations, to take a more prominent role.
authors: Emory University, USA.
authors: Bonnie
authors: B
authors: Scott
mesh_terms: D003362:Cost-Benefit Analysis; D018795:Device Approval / Q000331:legislation & jurisprudence; D004869:Equipment Safety / Q000191:economics; D006801:Humans; D007883:Legislation, Medical; D062307:Medical Device Legislation / Q000191:economics; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence