Total Product Life Cycle Advisory Program (TAP)
UPDATE: December 9, 2025
As of December 9, 2025, there are 106 devices enrolled in the FDA’s TAP Pilot.
The TAP Pilot is now accepting enrollment requests for Breakthrough Designated devices and those included in the Safer Technologies Program (STeP) reviewed by the:
- Division of Ophthalmic Devices (DHT1A)
- Office of Cardiovascular Devices (OHT2)
- Office of Neurological and Physical Medicine Devices (OHT5)
- Office of Orthopedic Devices (OHT6)
- Office of Radiological Health (OHT8)
An independent third-party assessment of the TAP Pilot is now available here.
TAP: Medical Device Accelerator
The FDA’s Center for Devices and Radiological Health (CDRH) launched the voluntary Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot to help spur more rapid development of high-quality, safe, effective, and innovative medical devices that are critical to public health. The TAP Pilot is one of the commitments between the FDA and industry as part of the MDUFA V reauthorization.
TAP’s primary goal is to expedite patient access to innovative medical devices by providing early, frequent, and strategic communications with the FDA and by facilitating engagement with other key parties for developers of devices of public health importance. To achieve this goal, a dedicated cadre of FDA TAP advisors proactively provide solutions-focused engagement that is tailored to each TAP innovator’s needs in advancing devices to market and patient access.
Feedback or questions about TAP may be submitted to TPLC-Advisory-Program@fda.hhs.gov.
Related Information
- TAP Independent Assessment Report – December 9, 2025 [PDF - 1.1 MB]
- TAP Pilot Engagement Tips (resource)
- CDRH Statement – July 1, 2024
- CDRH Statement – October 2, 2023
- CDRH Statement – October 11, 2022
- Federal Register: Medical Devices; Voluntary Total Product Life Cycle Advisory Program Pilot, October 11, 2022