CDRH has announced “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.” FDA has the news.
The TAP Pilot was launched in 2023 “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 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.”
TAP will be expanded to OHT8 and DHT1A in October of 2024, and to OHT6 in January of 2025. CDRH has “recruited numerous subject matter experts to support TAP, while also facilitating engagements between innovators and external, non-FDA parties that can provide insights into patient engagement, clinical evidence development, clinical practice, and new technology adoption and reimbursement.”
