The FDA and the medical device industry are officially in negotiations for the sixth medical device user fee agreement (MDUFA VI), negotiations which are taking place as fees under the current agreement are rising significantly.
Less than a week before the meeting, the FDA published a breakdown of user fees for fiscal year 2026, which calls for a total
Fees for a variety of device premarket applications will rise significantly in fiscal year 2026, but those increases will for the most part be less than 10%. Establishment registration fees may see the largest increase, rising to more than $11,400, an increase of more than 20% from approximately $9,300 in FY 2025.
MDUFA V included several new requirements for the FDA, such as hiring targets for agency review staff. The agreement stipulates that a failure to meet hiring targets would result in funds being used to offset lower facility registration fees. MDUFA V also imposed a cap on user fee carryover monies, which would also generate lower facility registration fees for the following fiscal year when the cap is exceeded.
The agenda for the Aug. 4 meeting for MDUFA VI included presentations by a wide range of stakeholder groups, including the Advanced Medical Technology Association (AdvaMed). AdvaMed indicated in an Aug. 4 press release that it would like to see a continuation of fiscal accountability in MDUFA VI.
Scott Whitaker, President and CEO of AdvaMed, said MDUFA V “was a historic agreement that brought greater accountability and reliability to the [premarket] review process, and we look forward to this next agreement building on that success.”
Three members of the AdvaMed management team appeared live at the Aug. 4 hearing, including Janet Trunzo, senior executive vice president for technology and regulatory affairs. Trunzo said 2025 marks AdvaMed’s 50th anniversary and that the association had recently created a new division dedicated to digital health technologies.
Trunzo said each user fee agreement either built on the achievements of the previous agreement or corrected for unanticipated difficulties. One example of this is that the first user fee agreement “contained goals that turned out to be too complex,” she stated, adding that measures were incorporated into MDUFA II to correct those problems.
Each user fee cycle has called for significant increases in industry’s investment in the agency’s capabilities, including additional hirings for the agency’s personnel. However, Trunzo said the FDA and industry “are now in a position of merely fine tuning the current program” rather than adding significantly to the scope of programs funded by user fees.
Zach Rothstein, executive director of AdvaMedDx, the association’s in vitro diagnostics division, also stated that MDUFA VI presents an opportunity to “fine tune” the user fee program. He stated that the focus on premarket engagement in MDUFA IV was a significant development as the related pre-submission programs allowed test developers to obtain more insight into the agency’s expectations.
Rothstein said the emphasis on international regulatory harmonization in MDUFA V is also of great importance to AdvaMedDx members. Another important consideration is the user fee program’s adjustments for smaller companies, a feature which is critical to bringing state of the art in vitro diagnostics to market.
Representing the AdvaMed Medical Imaging Division was Patrick Hope, who emphasized that user fees are critical to sustaining FDA staffing levels, which in turn are essential for the timely premarket review of device applications. Hope said the next user fee agreement should sustain the improvements in premarket review times under MDUFA V, but added, “we do not currently anticipate any need for major new programmatic initiatives or major new commitments.”
The FDA has not yet identified dates for any future meetings for the MDUFA VI agreement. The existing user fee agreement expires Sept. 30, 2027, but the FDA must submit a final agreement for MDUFA VI to Congress no later than Jan. 15, 2027.