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

Executive Summary

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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