Senate, House Panels Release Clean Device User-Fee Discussion Draft

Leaders of key Senate and House committees released a no-surprises, clean discussion draft to reauthorize US FDA user fees for devices and drugs April 14, emphasizing to members of Congress the need to swiftly reauthorize user fees based on the provisions previously agreed upon between industry and the agency that are contained in the bill. The device industry and FDA laid out the elements for the fourth iteration of user fees for the industry (MDUFA IV), including $999.5m in pre-inflation fees to be paid between FYs 2018 and 2022, last August.

The FDA Reauthorization Act of 2017 includes the features of the MDUFA IV agreement that require statutory changes, including the amounts and structure of fees, and some other adjustments that are needed for FDA to honor commitments. (Also see "MDUFA IV Fees Unveiled: Changes For 510(k)s, Small Business, De Novos" - Medtech Insight, 26 October, 2016.) Separately, FDA has issued a