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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 (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,” CDRH Director Jeff Shuren said in a statement.
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