FDA Launches Total Product Life Cycle Advisory Program

The FDA started the year with a soft launch of its Total Product Life Cycle Advisory Program (TAP) pilot, with the intention of enrolling up to 15 devices in fiscal 2023.

The TAP pilot, part of the agency’s user fee commitments to industry for fiscal 2023 to 2027, initially will focus on devices that get Breakthrough Device designations from the Center for Devices and Radiological Health (CDRH).

The program eventually will include devices participating in CDRH’s Safer Technologies Program, which aims to encourage development of safer alternatives to currently available treatments or diagnostics.

The FDA plans to increase the number of enrolled devices each fiscal year with the pilot enrolling up to 45 more devices in fiscal 2024, up to 65 more in 2025 and up to 325 devices through fiscal 2027.