Medical Device Regulation

Medical Device Regulation

provides the current FDA-CDRH thinking on the regulation of medical devices.

This book offers information on how devices meet criteria for being a medical device, which agencies regulate medical devices, how policies regarding regulation affect the market, rules regarding marketing, and laws and standards that govern testing.

This practical, well-structured reference tool helps medical device manufacturers both in and out of the United States with premarket application and meeting complex FDA regulatory requirements.

The book delivers a comprehensive overview of the field from an author with expertise in regulatory affairs and commercialization of medical devices.