The Center for Devices and Radiological Health (CDRH) is expanding 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.

Launched in 2023 as part of the Medical Device User Fee Amendments (MDUFA) V reauthorization, TAP aims to expedite the development of high-quality, safe, effective, and innovative medical devices critical for public health. The program encourages early and strategic communication between developers of Breakthrough Devices, CDRH, patient advocates, physician professional societies, and payers, to make the process of bringing innovative devices to market faster, more predictable, and more 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), meeting all MDUFA goals. The expansion schedule is as follows:

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

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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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