Congress Unveils MDUFA Reauthorization Package

Congress unveiled its first draft of MDUFA user fee reauthorizations, with total dollar amounts in line with those previously negotiated by regulated industry.

The draft bill would extend the existing MDUFA programs through 2022, but would include new fees related to de novo medical device reviews. Capitol Hill chose not to adopt President Trump’s proposal, released earlier this year, for collecting more fees overall.

The base fee total to be collected over fiscal 2018 for devices would be $183.3 million, up from $130.2 million for the current fiscal year. That target amount would increase annually over the next five years, ending at $213.7 million for fiscal 2022.

The MDUFA reauthorization would also establish a pilot program allowing the FDA to certify and audit laboratories performing conformance testing, and would require the FDA to evaluate at least five device types.