Medical Devices to Enter FDA Pilot Program Starting in 2023

Up to 15 medical devices will be enrolled next year in a new FDA pilot program that aims to boost agency engagement with manufacturers early on in a product’s development, the agency said Tuesday.

The Food and Drug Administration outlined its plans for the first phase of its Total Product Life Cycle Advisory Program, also known as the TAP Pilot program, in a Federal Register notice slated to officially publish Wednesday. The program is one of the commitments the FDA made in its user fee agreement with the medical device industry. Industry user fees, which were reauthorized for the next ...