MDUFA IV Negotiations to Get Underway With July Meeting

Negotiations on the fourth iteration of the Medical Device User Fee Act will swing into full gear July 13, with an FDA public meeting to assess the current MDUFA and ways to improve it.

Much is at stake as MUDFA IV will set fees for much of CDRH’s regulatory review activities and performance goals for the center for fiscal years 2018 through 2022. The last reauthorization process in 2011-2012 generated two public meetings, 14 stakeholder discussions and about three dozen industry conclaves.

One issue expected to come up is whether laboratory-developed tests will be included in user fee requirements, as the FDA moves ahead with plans to regulate them (IDDM, Feb. 6). In 2012, disagreement on whether labs should pay user fees delayed the agency’s final MDUFA III proposal by several months. In the end, the FDA didn’t subject labs to the fees, but CDRH Director Jeffrey Shuren has hinted that may not be the case in the upcoming reauthorization.

However, the FDA has never imposed fees on an industry that didn’t agree to pay them. If labs are going to pay user fees, they’ll need to feel they’re getting something out of the process, an industry source says.

AdvaMed and other industry insiders contacted by IDDM say it’s too early for MDUFA IV “wish lists.” During the 2012 negotiations, industry pressures led to the first concrete CDRH performance goals in the user fee agreement.

CDRH review times have significantly improved since MDUFA III as the agency moved to meet those goals. According to FDA data, the total average time to PMA decision dropped from 419 days for in 2010 to 321 days in 2013, while the 510(k) decision time shrank from 154 days to 126 days.

In 2014, the FDA collected $43.5 million in device application fees and $81.6 million in registration fees. – Elizabeth Orr