ARTICLE SUMMARY:
There are some notable program updates in the latest device user fee agreement regarding Pre-Submissions and “America First” fees, but the draft MDUFA VI framework presented at FDA headquarters this week is much more about stability than disruption.
FDA faced historic workforce challenges last year, but that fact barely received a mention at a meeting convened August 5 by the agency to present the draft MDUFA VI user fee agreement that will help fund hiring and review work through 2032.
The MDUFA program is intended to ensure FDA has appropriate resources and expertise to support efficient and predictable reviews of new medical devices, a goal that appeared threatened at various moments in 2025 when the federal government was dismissing staff, closing divisions, and rolling out retirement incentives on a large scales as part of Department of Government Efficiency (DOGE) initiatives.
The device center, however, appears to have weathered the storm. There haven’t been jarring signs of a downturn in review efficiency, and CDRH is hiring again. FDA and industry groups say they were able to negotiate a MDUFA VI deal without much of the contention that often slows down user fee talks. The agreement, notably, is one designed largely to maintain the status quo, with overall fee income expected to stay relatively even and the premarket review goals mostly constant.
