FDA will begin accepting breakthrough devices for TAP pilot in 2023

Regulatory NewsRegulatory News | 11 October 2022 |  By 

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 deal, Regulatory 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.
“Consistent with the MDUFA V commitment letter, FDA initially intends to include only devices with a granted Breakthrough designation in the TAP Pilot in FY 2023 – FY 2025 and intends to include devices with a granted Breakthrough designation or request for inclusion in the Safer Technologies Program (STeP) in FY 2026 – FY 2027,” FDA said. “At this time, devices regulated by the Center for Biologics Evaluation and Research (CBER) are outside the scope of the TAP Pilot.”
“In addition, given the complexities involved with the review of combination products, including coordination with review staff outside of CDRH, we anticipate that it will be difficult for sponsors of combination products to benefit fully from the TAP Pilot,” the agency added. “Therefore, at this time, we do not intend to enroll combination products in the Pilot.”
FDA intends to accept only 15 cardiovascular devices in the first year of the pilot program through its Office of Health Technology 2 (OHT2): Office of Cardiovascular Devices because historically it tends to get the largest number of breakthrough device designations, workload, staffing levels and expertise. The agency notes that as of 30 June OHT2 has granted 163 Breakthrough designations which accounts for almost a quarter of the 687 Breakthrough designations granted by CDRH since the program started.
However, FDA said it plans to expand the program to other OHTs and devices they review as it learns more about the program through the pilot.
“Specifically, as stated in the MDUFA V commitment letter, in FY 2024, the TAP Pilot will continue to support devices enrolled in the previous fiscal year and will expand to enroll up to 45 additional devices in at least two OHTs (i.e., up to 60 total devices enrolled through FY 2024),” the agency said. “In FY 2025, the TAP Pilot will continue to support devices enrolled in previous fiscal years and will expand to enroll up to 65 additional devices in at least four OHTs (i.e., up to 125 total devices enrolled through FY 2025).”
By FY2027 FDA said it plans to enroll an additional 100 devices each fiscal year which could mean up to 325 total devices. By that time the agency said it will also take into consideration the lessons learned from the OHTs that are a part of the pilot program and announce the addition of new OHTs at least 30 days before the start of each fiscal year.
FDA said that when sponsors are going through the Breakthrough designation process or inclusion in the STeP process, it will inform them that they may be eligible for the TAP pilot program. If they take the agency up on the offer, regulators will enroll devices on a first come, first served basis.
“Enrollment in the TAP Pilot, including in the Soft Launch, does not change any statutory or regulatory requirements that may apply to the TAP Pilot device or participant, including, but not limited to, investigational device exemption (IDE) requirements, premarket notification requirements, premarket approval requirements, and/or De Novo classification requirements,” FDA cautioned. “It is the sponsor’s responsibility to ensure compliance with applicable laws and regulations.”


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