FDA to expand total product lifecycle program

July 3, 2024- The FDA announced that beginning Oct. 1, the TAP Pilot will expand to include the Office of Radiological Health and the Division of Ophthalmic Devices. On Jan. 1, 2025, the TAP Pilot will also expand to include the Office of Orthopedic Devices. To date, the FDA has enrolled 46 devices in the TAP Pilot.

The FDA’s Center for Devices and Radiological Health has launched the voluntary Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot to help spur more rapid development of high-quality, safe, effective and innovative medical devices that are critical to public health. TAP’s primary goal is to expedite patient access to innovative medical devices by providing early, frequent and strategic communications with the FDA and facilitating engagement with other key parties for developers of devices of public health importance.

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