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CDRH Announces Expansion of the Total Product Life Cycle Advisory Program

Today, the Center for Devices and Radiological Health (CDRH) is announcing 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.

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.

Questions?

If you have questions about TAP, contact TPLC-Advisory-Program@fda.hhs.gov.