FDA's Device Chief Pushes National Registry As Part Of Shift To Post-Market Data

FDA's device center chief advocated for the creation of a national device registry as a game-changing way to streamline effectiveness decisions as the agency increasingly shifts some device clinical trial requirements to the post-market arena. A deputy director in the same center suggested such a repository would best be handled by a partnership between the agency and industry. The recent remarks follow a report by one of FDA’s public-private partnerships that recommends ways such a system could be created. At...