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Industry Challenges FDA's User Fee Markup

During the first round of user fee negotiations, industry questioned FDA's estimated cost of $750 million needed to continue the device user fee program between 2018 and 2022. Lobby groups for the device industry continue to emphasize user fees should supplement congressional appropriations to pay for FDA's review of devices.

Industry is questioning FDA's plans to raise $750 million for device reviews in the next iteration of the Medical Device User Fee Act program, MDUFA IV, which will run from fiscal year 2018 to FY 2022.

Industry representatives and FDA met Sept. 9 at the agency's Maryland White Oak Campus to kick off the first round of user fee negotiation meetings. According to meeting minutes posted online by FDA Sept. 25, the agency provided industry its financial analysis and estimated cost of keeping its device review process going

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