MedCon: TAP pilot off the ground four devices enrolled

Updated 27 April 2023 to clarify when a device is eligible for the TAP pilot.

COLUMBUS, OH – 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)

Douglas Kelly, deputy center director for science at CDRH, said the TAP pilot focuses on the commercial adoption of devices in a new way for the FDA by bringing in providers, patients and payers early in the process to discuss what evidence is needed by all the different players, reducing some of the downstream risk for device companies.

“The idea is to get everybody together at the beginning of the process because when you don’t… you have a longer than expected time through the FDA, and then whatever evidence you’ve developed for the FDA may not be appropriate for the other stakeholders that ultimately have a huge impact on commercialization,” Kelly said.

The pilot is being phased in, with the soft launch enrolling a total of up to 15 cardiovascular devices on a first-come, first-serve basis. The initial goals of the soft launch are frequent engagement with FDA teams, rapid turnaround on interaction requests, building relationships with stakeholder groups, and recruiting and onboarding additional staff, Hillebrenner said. “We have an idea about how we’re going to do this, but I think we all knew going in we would need to iterate quite a bit if we were going to get it right,” he said.

In FY 2024, the program will open to an additional 45 devices across cardiovascular devices and one other Office of Health Technology (OHT). By FY 2027, the program will ramp up to 325 total devices across more OHTs.

To be eligible, devices must have been granted Breakthrough designation but cannot have submitted a pre-submission after that point. Devices should also be early in the development process, before the initiation of a pivotal study, at the time of enrollment. Sponsors can only have one device enrolled in the pilot per fiscal year.

CDRH plans to post updates on the TAP website about the number of enrolled devices in the pilot. The center will begin considering requests for enrollment for FY 2024 on 1 October 2023.

MedCon: TAP pilot off the ground four devices enrolled

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