Three Device Areas Added to CDRH’s Device-Advancing TAP Program

CDRH has again expanded the Total Product Life Cycle Advisory Program (TAP), adding devices reviewed in three additional FDA offices.

The program will now include devices reviewed in the Office of Radiological Health and the Division of Ophthalmic Devices in the fall of 2024, followed by the Office of Orthopedic Devices in 2025.

CDRH launched the TAP pilot in 2023 “to help spur faster development of high-quality, safe, effective, and innovative medical devices,” CDRH Director Jeff Shuren said in a statement.

To date, CDRH says, the TAP pilot has enrolled 46 Breakthrough-Designated devices in the Office of Cardiovascular Devices and the Office of Neurological and Physical Medicine Devices.

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