In October 2022, the FDA launched the “Total Product Life Cycle Advisory Program (TAP)” pilot to accelerate the development of innovative medical devices and technologies critical to public health. TAP facilitates “early, frequent, and strategic communication” with the FDA to enhance collaboration with manufacturers and third parties, speeding up patient access to innovative medical devices.
The pilot has included 46 breakthrough-designated cardiovascular and neurological devices. Starting this October, the FDA plans to accept radiological and ophthalmic devices into the program and has committed to adding orthopedic devices to TAP by January 1, 2025.
In a statement on the expansion of TAP, Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, indicated that as part of MDUFA V, the FDA is on track to enroll up to 60 TAP products by the end of FY 2024 (September 30). “The FDA has recruited numerous subject matter experts to support TAP and is promoting interactions between device developers and third parties to provide insights on topics such as technology adoption and reimbursement.”
In FY 2025 (starting October 1, 2024), the FDA aims to enroll up to 65 devices in TAP.
TAP Team
The dedicated FDA TAP advisory team actively addresses questions about device marketing and patient use, with deep and diverse expertise in medical technology, including:
- FDA product lifecycle regulatory expertise;
- Clinicians experienced in payer coverage policies and advisors from the American Medical Association’s CPT group;
- Professionals with extensive experience in the medical technology industry within venture capital firms and Fortune 500 companies, including R&D, marketing, operations, quality, and business development;
- Physicians serving on the executive and management committees of healthcare provider groups and holding leadership positions in medical professional associations.
TAP Inclusion Criteria
The FDA evaluates devices for TAP registration based on the following criteria, consistent with the MDUFA V commitment letter:
- Breakthrough Device Designation: The device must have a breakthrough device designation.
- Early Development Stage: After obtaining the breakthrough designation, no pre-submissions (including breakthrough sprint discussions) related to the device have been submitted. The device is in the early development stage (e.g., potential participants have not initiated pivotal studies on the device).
- Other Considerations: Each TAP participant may register one device per fiscal year (October 1 to September 30). The FDA does not currently intend to include combination products in TAP, and devices regulated by CBER are also ineligible. Eligible participants will be admitted on a first-come, first-served basis until the maximum enrollment for the fiscal year is reached.
Note: From October 1, 2025, devices included in the Safer Technologies Program (STeP) may also be eligible.
TAP Registration Process
To register a device for TAP, the sponsor can amend the Q-submission file granting the device its breakthrough designation. The amendment should include the following information:
- A subject title clearly stating “TAP Pilot Enrollment Request”;
- The device sponsor’s name and address;
- The Q-submission number under which the device was granted its breakthrough designation.
The FDA intends to notify potential participants in writing within 30 days whether the device has been admitted to TAP.
- If the device is registered, the FDA will contact the participant to schedule an initial meeting to outline TAP, expectations, and participation opportunities.
- If the device is not registered in TAP, the FDA will provide the reasons for this decision.
TAP Performance Metrics
As of FY 2024, the FDA is tracking the following quantitative performance metrics (linked to the FDA’s congressional budget):
- For 90% of interaction requests, CDRH will hold a teleconference within 14 days of receiving the request regarding the TAP device.
- For 90% of written feedback requests, CDRH will provide written feedback on biocompatibility and sterility topics related to the TAP device within 21 days of receiving the request.
- For 90% of written feedback requests, CDRH will provide written feedback on topics related to the TAP device (excluding biocompatibility and sterility) within 40 days of receiving the request.
About Accel
Accel Groups is a dedicated team of seasoned professionals in regulatory, clinical and market access. We help medical device and IVD manufacturers with complete product life cycle solutions from preclinical, strategy, clinical evaluation and trial, regulatory submission, to post market surveillance. Our regional principals have a minimum of 10+ years’ experience in their specialty to enable us to provide the regional in-depth expertise but with global one-stop shop solutions. Ask us about our Start-up kits for start-up companies with key countries regulatory pathway.
