Total Product Life Cycle Advisory Program (TAP)
UPDATE: April 23, 2026
The Centers for Medicare and Medicaid Services (CMS) and the FDA have announced a new Medicare coverage pathway: the Regulatory Alignment for Predictable and Immediate Device (RAPID) Coverage Pathway. RAPID will accelerate beneficiary access to eligible devices with Breakthrough Designation. More details about the RAPID pathway are available here.
For TAP innovators with devices currently enrolled in the Pilot, those with Breakthrough-designated devices not currently enrolled in TAP, and/or those interested in pursuing RAPID, read more here.
As of April 23, 2026, there are 122 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)
On May 1, 2026, TAP is expanding to include the Division of Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A); and the Office of Surgical and Infection Control Devices (OHT4).
On July 1, 2026, TAP is expanding to include the Division of Implantable Dental Devices, Restorative and Surgical Dental Devices, Ear, Nose, and Throat Devices (DHT1B), Division of Anesthesia Devices, Respiratory Devices, and Sleep Disordered Breathing Devices (DHT1C), Division of Obstetrical and Reproductive Health, Gynecological and Surgical, Urological, and Incontinence and Female Urological (DHT3B); Division of Injection Devices, Infusion Devices, and General Hospital Devices (DHT3C), and the Office of In Vitro Diagnostics (OHT7).
An independent third-party assessment of the TAP Pilot is 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