The U.S. Food and Drug Administration’s (“FDA” or “the Agency”) Center for Devices and Radiological Health (“CDRH”) recently announced the launch of its Total Product Life Cycle Advisory Program (“TAP”) Pilot. The first phase of this voluntary initiative, called TAP Pilot Soft Launch, will be conducted during fiscal year (“FY”) 2023 with enrollment beginning on January 1, 2023.
The Agency committed to establishing the TAP Pilot as part of the MDUFA V reauthorization, and the Agency’s long-term vision for TAP is “to help spur more rapid development and more rapid and widespread patient access to safe, effective, high-quality medical devices of public health importance.” As part of the TAP Pilot, the FDA will provide strategic engagement for such devices by:
- Improving participants’ experiences with the FDA by providing for more timely premarket interactions
- Enhancing the experience of all participants throughout the device development and review process, including FDA staff
- Facilitating improved strategic decision-making during device development, including earlier identification, assessment, and mitigation of device development risk
- Facilitating regular and solutions-focused engagement early in device development between FDA review teams, participants, and other stakeholders, such as patients, providers, and payers
- Collaborating to better align expectations regarding evidence generation, improve submission quality, and improve the efficiency of the premarket review process
The TAP Pilot initially will be limited to devices granted Breakthrough Device Designation in FY2023 – FY2025, but will expand to devices with a granted request for inclusion in the Safer Technologies Program (“STeP”) in FY 2026 – FY 2027. Devices regulated by the Center for Biologics Evaluation and Research (“CBER”) are outside the TAP Pilot, and CDRH does not intend to enroll combination products at this time. Further, the FDA intends to enroll devices with the following criteria:
- Potential participants will not have submitted a Pre-Submission about the device after being granted a Breakthrough Device Designation (or inclusion in STeP in FY 2026 – FY 2027)
- Devices will be early in their device development process (e.g., a pivotal study for the device has not yet been initiated) at the time of enrollment
- Each potential participant will have a maximum of one device enrolled in the TAP Pilot per fiscal year
In FY 2023, enrollment will be limited to up to 15 devices reviewed in the Office of Health Technology (“OHT”) 2: Office of Cardiovascular Devices. In the future, the Agency intends to expand the TAP Pilot to enroll more devices and to include devices reviewed in other OHTs.
The FDA is seeking requests for enrollment in the TAP Pilot Soft Launch for FY 2023 beginning January 1, 2023. Enrollment will be considered on a first-come, first-served basis. The Agency is also accepting feedback regarding the TAP Pilot until 11:59 pm EST on January 10, 2023.
While the TAP Pilot does not change any statutory or regulatory requirements that apply to the TAP Pilot device, including the statutory standards for clearance or approval, it may help drive efficiencies with respect to engagement with the FDA’s review teams and device development decision-making. Further, the TAP Pilot does include early engagement between FDA review teams and other stakeholders – including payors. While we do not anticipate that the TAP Pilot will directly address Medicare coverage for medical technology, there will likely be some potential evolution in Medicare coverage over the next year. Specifically, a regulatory proposal by the Centers for Medicare & Medicaid Services (“CMS”) to provide accelerated coverage for breakthrough medical technology had originally been anticipated in October 2022; however, the government’s Office of Information & Regulatory Affairs website appears to now indicate an April 2023 release of the so-called “Transitional Coverage for Emerging Technologies” (“TCET”) proposed rule, designed to shorten the so-called medtech “Valley of Death” between approval and coverage for breakthrough devices.
Contact Goodwin FDA team members for any questions or assistance related to the TAP Pilot. Contact Matt Wetzel for any questions or assistance related to the proposed TCET pathway.