MDUFA Reauthorization

As noted in last month’s update, the process behind developing a new Medical Device User Fee Amendments (MDUFA) has been a slow slog. The current MDUFA IV is set to expire at the end of September 2022 and must be reauthorized by Congress before then or the FDA will have to cease product reviews and other related regulatory approval/enforcement activities. The FDA and industry missed the mandated deadline of January 15 for submitting a negotiated draft agreement.

After a long and contentious process, both groups announced a user fee deal recently, two months late. The deal states the FDA will receive $1.784 billion in user fees from medical device industry users over the next five years but that number could go up to $1.9 billion if the agency meets all its performance goals.

The significant increase in user fees will go toward funding increased and more complex product review applications that requires more resources and specialization.

The agreement sets out performance goals for the FDA’s 510(k), pre-submission, de novo and premarket approval program. It includes funding for the FDA’s proposed Total Product Life Cycle Advisory Program (TAP) as a pilot using $110 million from MDUFA IV carryover funds as well as an additional $45 million from base funding. The deal would cap user fee carryover funds to three months and any additional funds would be used to reduce sponsor registration fees. Also, MDUFA V sets new hiring targets, and failure to do so, would industry to claw back some of that funding.

The proposed MDUFA V agreement was quickly given Congressional scrutiny, first at a House Energy & Committee hearing and subsequently before the Senate Health, Energy, Labor & Pensions Committee.

FDA said it will hold a virtual public meeting April 19 to obtain comments on the medical device user fee amendments, perspectives it must provide to Congress as part of the overall agreement package.

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