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

CDRH initiated the TAP Pilot in 2023 as part of the Medical Device User Fee Amendments (MDUFA) V reauthorization. The program aims to accelerate the development of high-quality, safe, effective, and innovative medical devices crucial to public health.

TAP fosters early, frequent, and strategic communications between developers of Breakthrough Devices, CDRH, and other stakeholders, including patient advocates, physician professional societies, and payers. This collaborative approach aims to expedite the market entry and patient access to innovative devices of public health significance, making the process faster, more predictable, and transparent.

So far, the TAP Pilot has enrolled 46 Breakthrough Designated Devices within the Office of Cardiovascular Devices (OHT2) and the Office of Neurological and Physical Medicine Devices (OHT5), achieving all its MDUFA goals. CDRH is excited to extend TAP to support innovators and devices in new clinical areas as outlined.1

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References

  1. Center for Devices and Radiological Health. (2024, July 1). CDRH announces expansion of the Total Product Life Cycle Advisory Program. U.S. Food And Drug Administration. https://www.fda.gov/medical-devices/medical-devices-news-and-events/cdrh-announces-expansion-total-product-life-cycle-advisory-program

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