IOM’s 510(k) Reform Proposals To Have Limited Impact On MDUFA Talks

The Institute of Medicine’s controversial recommendation to scrap the 510(k) device clearance process is unlikely to affect stalled medical device user fee negotiations, sources said, noting that even though FDA indicated it will not use the expert group’s proposal, there are still unknown regulatory factors facing industry that are not addressed by the report and could fuel hesitation by product manufacturers to enter a five-year deal. FDA meanwhile pushed forward in the talks, telling device industry stakeholders in a recent meeting that it wants a user fee agreement by the end of the month to meet statutory deadlines, according to meeting minutes.

In light of IOM’s conclusion that the 510(k) clearance process does not prove the safety and efficacy of medical devices, several industry sources said the report will not impact user fee talks because the expert proposals do not weigh in on issues that will affect FDA’s ability to meet performance goals. The discussions have been stalled over regulatory uncertainties, including some components of FDA’s own 510(k) reform plan that were expected to be addressed by the IOM, although the panel did not chime in on those agency proposals.

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