USA – FDA will begin accepting breakthrough devices for TAP pilot in 2023

The US Food and Drug Administration (FDA) will start accepting products into its total product lifecycle advisory program (TAP) pilot starting in January. The agency will only accept 15 cardiovascular breakthrough devices into the pilot program in the first year.

The TAP pilot was a controversial component of the Medical Devices User Fee Amendments (MDUFA V) negotiations between FDA and the medical device industry. While the Center for Devices and Radiological Health (CDRH) argued for additional funding to run the program, which they claimed would benefit sponsors by getting early input for product development from external stakeholders, industry groups were skeptical of the program. Ultimately, industry groups agreed to test the program as a pilot before fully funding it. (RELATED: MDUFA V: We have a dealRegulatory Focus 8 March 2022)

On 11 October, FDA published a notice on how it plans to proceed with the TAP pilot, which will be open to a limited number of sponsors starting on 1 January 2023…