TAP Pilot Enrollment & Expansion

TAP Enrollment Criteria

The FDA evaluates device enrollment into the TAP pilot based on the following criteria, consistent with the MDUFA V commitment letter:

Breakthrough Device Designation

• Devices will have a granted Breakthrough Device Designation.

Early Development Stage

• No pre-submissions (including Breakthrough sprint discussions) related to the device were submitted after Breakthrough Device Designation was granted.
• The device is early in the development process (for example, the potential participant has not yet initiated a pivotal study of the device).

Additional Considerations

• Devices reviewed by the following are eligible to enroll at this time:
  • Division of Health Technology 1A (DHT1A) within the Office of Health Technology 1 (OHT1): Ophthalmic Devices
  • Office of Health Technology 2 (OHT2): Cardiovascular Devices  
  • Office of Health Technology 5 (OHT5): Neurological and Physical Medicine Devices
  • Office of Health Technology 8 (OHT8): Radiological Health Devices 
• A maximum of one device may be enrolled for each TAP participant per fiscal year (October 1 – September 30).
• FDA does not intend to enroll combination products in TAP at this time, and devices regulated by CBER are not eligible to enroll in TAP.
• Eligible participants will be enrolled in the program on a first-come, first-served basis until the maximum enrollment number is achieved in a given fiscal year.

Note: Beginning October 1, 2025, devices included in the Safer Technologies Program (STeP) may also be eligible.

TAP Enrollment Process

To have a device considered for enrollment in the TAP pilot, the sponsor may submit an amendment to the Q-submission under which the device was granted Breakthrough Designation with the following information:

• Subject heading that clearly indicates “TAP Pilot Request for Enrollment”;
• Name and address of the device sponsor; and
• Q-Submission number under which the device proposed for enrollment in TAP was granted a Breakthrough Device Designation.

Within 30 days of receipt, the FDA intends to notify the potential participant in writing whether the device has been enrolled into the TAP pilot.

• If the device is enrolled, the FDA will contact the participant to schedule an initial meeting to provide an overview of TAP, the expectations, and engagement opportunities.
• If the device is not enrolled in the TAP pilot, the reasons for that decision will be provided.

TAP Expansion Schedule

The FDA is taking a phased-enrollment approach to implement the TAP pilot over the duration of MDUFA V - fiscal years (FY) 2023-2027 (October 1 through the following September 30).

• FY 2023: Enroll up to 15 devices reviewed by the Office of Cardiovascular Devices (OHT2).
• FY 2024: Enroll up to 60 total devices reviewed by OHT2 and the Office of Neurological and Physical Medicine Devices (OHT5).
• FY 2025: Enroll up to 125 total devices reviewed by DHT1A, OHT2, OHT5, OHT8 and, as of January 1, 2025, OHT6.
• FY 2026-27: Enroll up to 225 total devices in FY 2026 and 325 total devices in FY 2027 within existing OHTs or expand to additional OHTs, depending on lessons learned in prior years.

Selection of additional Offices of Health Technology within CDRH will be based on historical number of granted Breakthrough designations, workload, and available staffing and expertise; experience from prior years; and input from industry and other non-FDA parties.

TAP Pilot Performance Metrics

As of the beginning of FY 2024, the following quantitative performance metrics are being tracked:

• CDRH will engage in a teleconference with the participant on requested topic(s) pertaining to the TAP device within 14 days of the request for 90% of requests for interaction.
• CDRH will provide written feedback on requested biocompatibility and sterility topics(s) pertaining to the TAP device within 21 days of the request for 90% of such requests for written feedback.
• CDRH will provide written feedback on requested topic(s) pertaining to the TAP device other than biocompatibility and sterility within 40 days of the request for 90% of requests for written feedback.