The Center for Devices and Radiological Health (CDRH) at the U.S. Food and Drug Administration (FDA) has announced the expansion of its program intended to foster more efficient and expeditious development of innovative medical devices.
The CDRH’s Total Product Life Cycle (TPLC) Advisory Program (TAP) is designed to encourage early communications between developers of breakthrough medical devices, the CDRH, and healthcare providers with the goal of speeding up the FDA’s review process and bringing new and advanced medical devices to market sooner.
Initially launched as a pilot program in 2023, the FCC says that it has already enrolled 46 Breakthrough Designated Devices under the Office of Cardiovascular Devices (OHT2) and the Office of Neurological and Physical Medicine Devices (OHT5). Now, according to an FDA press release issued in early July, the CDRH will expand TAP over the next six months to address breakthrough medical devices that fall under the purview of the Office of Radiological Health (OHTS), the Division of Ophthalmic Devices (DHT1A), and the Office of Orthopedic Devices (OHT6).
Read about the FDA’s expansion of the TPLC TAP.
Read additional details about TAP.
