Industry, FDA Still Far Apart In MDUFA Negotiations

Industry and the FDA appear to be far from reaching an agreement on the fourth iteration of the Medical Device User Fee Act, based on newly released meeting minutes posted last week.

On Feb. 18, industry representatives presented a proposal package on presubmission improvements, performance goals for de novo requests, upgrades for the clinical laboratory improvements amendments waiver process and third party 510(k) reviews.

They also proposed providing $6 million to continue the independent assessment of the premarket review process and $4.5 million to develop the myDevices Portal and eSubmitter/Tracker.

However, industry representatives failed to include elements proposed by FDA officials during a Jan. 27 meeting, according to the agency.

Specifically, the FDA highlighted what it called high-priority areas, such as using real-world evidence for premarket decision-making and having agency staff ensure consistency across a device’s entire regulatory lifespan.

FDA officials also were concerned about the lack of a mechanism to address workload uncertainty. Industry representatives expressed a willingness to consider this proposal, and agency officials agreed to provide more details.

That said, industry representatives indicated that several of the FDA’s proposed initiatives were not priorities for user fee negotiations, and could be pursued in other ways.

Previous meeting minutes revealed that the agency was eyeing a $500 million deal to implement additional resources for several programs under MDUFA IV (IDDM, Feb. 28).

Another meeting was scheduled for March 4, but the minutes from that event have not been released.

Read the Feb. 18 minutes here: www.fdanews.com/03-16-MDUFAminutes.pdf. — Jonathon Shacat