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

IOM's 510(k) Reform Proposals To Have Limited Impact On MDUFA Talk - InsideHealthPolicy.com: "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."