Industry Negotiating With FDA for $500M Deal for MDUFA IV

Negotiations are moving apace between industry and the FDA to hash out the latest iteration of Medical Device User Fee Act.

According to meeting minutes documenting the negotionations that were posted last week, the FDA is estimating total costs of $500 million to implement additional resources for quality management, de novo, presubmissions and other programs under MDUFA IV.

During a Jan. 27 meeting, the FDA presented industry with several proposals that would be implemented over the five-year authorization period for MDUFA IV, such as establishing a team of 20 employees responsible for quality management.

Among other proposals, the FDA would hire 43 device coordinators to ensure consistency in process and feedback for each innovative device’s entire regulatory lifespan, from presubmission through marketing authorization.

In addition, the FDA proposed improving other programs, with 57 employees needed for pre-submission meetings, 61 employees for de novo reviews and 17 employees for third party 510(k) reviews.

FDA also proposed a program that would enable reviewers to use real-world evidence for premarket decision-making by building a system that links and improves the regulatory quality of data sources, such as electronic health records, healthcare claims and registries. Implementing the proposal would cost $10 million annually, plus 15 employees.

But, the FDA and industry appeared far apart regarding these proposals, according to the meeting minutes.

Industry representatives pointed out that the process enhancements and increased capacity reflected in the proposal would presumably improve decision times. Industry also identified some items in the proposal that may reduce reviewer workload.

The representatives agreed to consider the FDA’s ideas and develop a counter proposal to present at a Feb. 18 negotiation meeting. The minutes from that meeting have not been released yet.

Read the Jan. 20 minutes here: www.fdanews.com/02-16-MDUFA-1.pdf and the Jan. 27 minutes here: www.fdanews.com/02-16-MDUFA-2.pdf. ― Jonathon Shacat