Get our free email newsletter

FDA Expands Advisory Program for Medical Devices Life Cycle

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).

- Partner Content -

A Dash of Maxwell’s: A Maxwell’s Equations Primer – Part Two

Maxwell’s Equations are eloquently simple yet excruciatingly complex. Their first statement by James Clerk Maxwell in 1864 heralded the beginning of the age of radio and, one could argue, the age of modern electronics.

Read about the FDA’s expansion of the TPLC TAP.

Read additional details about TAP.

 

Related Articles

Digital Sponsors

Become a Sponsor

Discover new products, review technical whitepapers, read the latest compliance news, and check out trending engineering news.

Get our email updates

What's New

- From Our Sponsors -

Sign up for the In Compliance Email Newsletter

Discover new products, review technical whitepapers, read the latest compliance news, and trending engineering news.