FDA Lays Out Plan To Loosen Regulation Of Medical Device Software

FDA launched a pre-certification pilot program Thursday (July 27) that will allow technology and software development companies to get pre-certified with the agency, eventually allowing them to “submit less information [to FDA] than is currently required before marketing a new digital health tool,” FDA Commissioner Scott Gottlieb says. The program is part of FDA's Digital Health Innovation Action Plan, also published Thursday. The plan details how FDA's device center will implement digital health-related 21st Century Cures provisions and issue draft...