On October 2, 2023, the FDA announced the voluntary Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot is now accepting enrollment requests for both the Office of Cardiovascular Devices (OHT2) and the Office of Neurological and Physical Medicine Devices (OHT5).
As of April 30, 2024, the FDA has enrolled 45 devices in the TAP Pilot.
The FDA’s Center for Devices and Radiological Health (CDRH) has launched the voluntary Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot. TAP is intended to help ensure that U.S. patients have access to high-quality, safe, effective, and innovative medical devices for years to come by promoting early, frequent, and strategic communications between the FDA and medical device sponsors.
The TAP Pilot is one of the commitments between the FDA and industry as part of the MDUFA V reauthorization.
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