FDA’s Center for Devices and Radiological Health (CDRH) this week announced the expansion of its Total Product Life Cycle Advisory Program (TAP) pilot to include the Office of Neurological and Physical Medicine Device.
The pilot, which was soft launched on Jan. 1, 2023 (FY23), is to help ensure that United States patients have access to high-quality, safe, effective, and innovative medical devices “first in the world for years to come by promoting early, frequent, and strategic communications between the FDA and medical device sponsors,” according to the pilot’s FDA landing page.
Additionally, it’s intended to demonstrate the “feasibility and benefits of process improvements to the FDA’s early interactions with participants and stakeholders that support the vision for TAP,” according to FDA. Of note, the TAP pilot is one of FDA’s commitments to industry as part of the MDUFA V reauthorization.
Having started the launch focusing on The Office of Health Technology 2 (OHT2): Office of Cardiovascular Devices because of its historical number of granted breakthrough designations, workload, staffing levels, and experience with review paradigms involving rapid interactions like Early Feasibility Studies, it will soon expand to include the Office of Neurological and Physical Medicine Devices. The pilot will expand starting Oct. 1, 2023, but is still accepting requests for enrollment for cardiovascular devices.
Currently, FDA has enrolled five devices in the TAP pilot, but intends to enroll up to 15 through the Office of Cardiovascular Devices. Over the next five years, the administration intends to continue expanding the program to other OHTs.
The proposed timeline includes:
- FY24: The pilot will continue supporting devices previously enrolled while expanding to enroll up to 45 additional devices in at least two
OHTs — up to 60 total devices through FY24.
- FY25: While continuing to support the previous 60 devices, it will expand to enroll up to 65 additional devices in at least four OHTs — up to 125 total devices enrolled through FY25.
- FY26-27: The pilot with continue its relationship with previous devices and will expand to enroll up to 100 additional devices each fiscal year within existing OHTs or to additional OHTs — up to 225 total devices through FY26 and up to 325 total devices through FY27.
At this time, FDA devices regulated by the Center for Biologics Evaluation and Research are outside the scope of the pilot. CDRH also does not intend to enroll combination products.
As part of the pilot, FDA will provide strategic engagement for innovative devices of public health importance. This will include improving participants experiences with the administration by providing more timely premarket interactions; enhancing the regulatory experience through the device development and review process, including FDA staff; improving earlier identification, assessment, and mitigation of device development risk; creating regular, solution-focused engagement between review teams, participants, and other stakeholders; and collaborating to better understand expectations for evidence generation, improved submission quality, and the efficiency of the premarket review process.
To request enrollment into the pilot for cardiovascular devices — as well as neurological and physical medicine devices starting October 1 — FDA asks that potential participants follow posted criteria, including:
- Devices will be those granted Breakthrough Device designation.
- Will have not submitted a pre-submission about the device after being granted a Breakthrough Device designation.
- Devices will be early in their development process — have not yet initiated a pivotal study for the device — at time of enrollment.
- There will be a maximum of one device enrolled per participant per fiscal year.