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MDUFA IV Fees Unveiled: Changes For 510(k)s, Small Business, De Novos

Prior to a Nov. 2 public meeting on the tentative MDUFA IV deal between FDA and industry, the agency released its proposed commitment letter and new details on the structure of user fees in the deal, including an increased 510(k) rate, more protection for small businesses and a new fee for de novo submissions.

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A week before CDRH is set to hold a public meeting to discuss the latest medical device user-fee proposal, the agency released full details of the tentative MDUFA IV deal struck with industry in August, including the planned structure of user-fee payments from fiscal years 2018 to 2022 and the FDA commitment letter.

The details of FDA's commitments and performance goals have previously been reported by Medtech Insight.(Also see "MDUFA IV Takes Shape: A Catalogue Of Draft Commitments" - Medtech Insight, 29...

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