The US Food and Drug Administration (FDA) has enrolled the first four devices in its Total Product Life Cycle Advisory Program (TAP) pilot, while three other devices have been rejected so far.
The rejected devices had a combination of issues, including having already submitted a pre-submission after receiving a breakthrough device designation or were not early enough in the development process, Matthew Hillebrenner, acting associate director for total product life cycle review program innovation at FDA’s Center for Devices and Radiological Health (CDRH) told attendees at the 2023 MedCon conference, sponsored by the AFDO/RAPS Healthcare Products Collaborative and FDA.
Sponsors of devices that did not make it into the TAP pilot will receive a letter explaining the reasons for the decision, Hillebrenner said.
The TAP pilot is a voluntary program that promotes frequent and early interaction between FDA staff and device sponsors, as well as external stakeholders. The goal is to support the rapid development and availability of high-quality, safe medical devices for patients. The pilot, which began its “soft launch” in January 2023, was included in the Medical Devices User Fee Amendments (MDUFA V) reauthorization despite initial pushback from the medical device industry. (RELATED: FDA will begin accepting breakthrough devices for TAP pilot in 2023, Regulatory Focus 11 October 2022)…
