FDA to Expand Total Product Life Cycle Program

Brief description of the dive:

• Food and Drug Administration will expand The agency said on Monday that as part of its product lifecycle advisory program (TAP).
• Officials plan to begin accepting radiology and ophthalmology medical devices into the program in October. The FDA has committed to adding orthopedic devices to TAP on Jan. 1, 2025.
• The expansion builds on work testing the program with cardiovascular and neurological devices. The FDA said it has approved 46 breakthrough devices under TAP and meets its Medical Device User Fee Amendments (MDUFA) targets.

Diving Insight:

The FDA created the TAP program to accelerate the development of innovative medical devices and technologies deemed critical to public health. TAP provides “early, frequent, and strategic communication” with the FDA and enables communication with device developers and third parties.

The agency outlined the program’s goals in its MDUFA V commitments. Officials initially faced opposition to TAP from industry representatives who The FDA said had a “fundamentally different view of the MDUFA program and its goals” during contract negotiations. But ultimately, the industry agreed to the TAP pilot during MDUFA V.

FDA (Food and Drug Administration) the pilot program has started in October 2022 and I expanded it to include neurological devices a year later.

On October 1, the Radiological Health Office and the Ophthalmic Devices Department will join TAP, doubling the number of units participating in the programThe Office of Orthopedic Devices will join on January 1, 2025.

Adding offices and divisions to the program will help FDA stay on track to achieve the goals it agreed to in MDUFA V. Agreement FDA calls Expand the program to at least four offices in fiscal year 2025, which begins October 1, and enroll up to 65 additional products in TAP that same year.

FDA has registered 46 breakthrough devices in the first two offices involved in TAP. Under MDUFA V, the agency has agreed to register up to 60 products by the September 30 end of fiscal year 2024.

Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement about the expansion that the agency is meeting all of the goals of MDUFA.

The FDA has “recruited a number of subject matter experts to support the TAP project,” Shuren said, and is facilitating interactions between device developers and outside entities that can provide input on issues such as technology implementation and reimbursement.