FOR IMMEDIATE RELEASE
July 1, 2024

The following is attributed to Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health (CDRH)

CDRH is pleased to announce the continued expansion of the Total Product Life Cycle (TPLC) Advisory Program (TAP), which will include devices reviewed in the Office of Radiological Health (OHT8) and the Division of Ophthalmic Devices (DHT1A) in the fall of 2024, followed by the Office of Orthopedic Devices (OHT6) in 2025.

CDRH launched the TAP Pilot in 2023 as a commitment under the Medical Device User Fee Amendments (MDUFA) V reauthorization to help spur faster development of high-quality, safe, effective, and innovative medical devices that are critical to meeting public health needs.

TAP encourages early, frequent, and strategic communications between developers of Breakthrough Devices, CDRH, and others, such as patient advocates, physician professional societies, and payers, to make the path for innovative devices of public health importance to market and patient access faster, more predictable, and more transparent.

To date, the TAP Pilot has enrolled 46 Breakthrough Designated Devices in the Office of Cardiovascular Devices (OHT2) and the Office of Neurological and Physical Medicine Devices (OHT5) and is meeting all of its MDUFA goals. CDRH is excited to continue expanding TAP to cover innovators and devices in new clinical areas as follows:

• October 1, 2024
  • Office of Radiological Health (OHT8)
  • Division of Ophthalmic Devices (DHT1A)
• January 1, 2025
  • Office of Orthopedic Devices (OHT6)

CDRH has recruited numerous subject matter experts to support TAP, while also facilitating engagements between innovators and external, non-FDA parties that can provide insights into patient engagement, clinical evidence development, clinical practice, and new technology adoption and reimbursement. CDRH’s TAP advisors act as innovation ambassadors and can help identify sources that may provide input on a holistic value proposition that may inform improved strategic decision-making during product development across the MedTech ecosystem.

We look forward to expanding the TAP program, as well as the patient organizations, professional societies, and payers that may provide input to TAP participants, into the radiological, ophthalmic, and orthopedic fields to facilitate timelier and more widespread patient access to safe and effective medical devices in these additional clinical areas.

Additional Resources:

• Total Product Life Cycle Advisory Program (TAP)
• CDRH Provides Update on the Total Product Life Cycle Advisory Program Pilot