MDUFA V inches closer to approval

After more than two months of delays, the Food and Drug Administration and the medtech industry finally hammered out a new agreement that will determine the FDA’s priorities for the next five years, and how much it can collect from medical device companies in fees to fund its efforts.

The Medical Device User Fee Amendments (MDUFA V) went to Congress at the end of March, and lawmakers must finalize the deal before Sept. 30, when the current version expires.

It’s not clear what sticking points held up the deal, though Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, hinted at some differences of opinion between medical device companies.

“The medical device industry is very heterogeneous and it has very diverse opinions. That can take time to work through,” Shuren said in a March 30 hearing before the House Subcommittee on Health.

The agreement sets out $1.78 billion in funding between 2023 and 2027 for the FDA. If it meets certain performance goals, including hiring targets, the agency could see up to $1.9 billion.

The House Energy and Commerce Committee and the Senate Committee on Health, Education, Labor and Pensions are each working on their own versions of the bill, with a significant addition by the latter that would expand regulation of cosmetics, supplements and in-vitro diagnostics. MedTech Dive