FDA Arranges Initial Public Meeting for MDUFA VI Discussions Prior to Bargaining
The Food and Drug Administration (FDA) is gearing up for the next phase of its Medical Device User Fee Amendments (MDUFA) program, with a public meeting scheduled for August 4, 2022. The meeting aims to discuss recommendations for the next medical device user fee period, covering fiscal years 2028 to 2032.
Currently, MDUFA V remains in effect through FY 2027, with established user fee rates (approximately $366.5 million in FY 2026 revenue). The FDA is preparing for the next reauthorization period, MDUFA VI, and has announced a series of public meetings in 2025 to discuss reauthorization and proposed changes.
The FDA is seeking input from stakeholders on various aspects of the upcoming user fee program, including fee structures, regulatory science priorities, and program enhancements. The proposed changes are expected to build on the experiences gained from MDUFA V and address evolving regulatory science needs and user fee funding requirements.
One of the key areas under consideration to improve user fee implementation is support for electronic submissions like eSTAR for De Novo submissions, which will be required starting October 1, 2025. This change, while streamlining submission and review processes under MDUFA V, is likely to influence future program refinements in MDUFA VI.
During the meeting, the FDA will also be seeking recommendations on what current MDUFA features should be reduced or stopped to "ensure the continued efficiency and effectiveness of the medical device review process." The agency will also be asking what changes could be made to the current fee structures and amounts to better advance the goals of the agreement, including facilitating product development and timely access for consumers.
The FDA's initial question at the start of the MDUFA V process was about what the medtech ecosystem should "look like" in 2027 and how user fees could help achieve this goal. This question has been retained but tweaked for the upcoming negotiations. The FDA will also be focusing on what is working or should be added at the start of the reauthorization process for fiscal years 2023 to 2027.
Early in the Trump administration, layoffs at the FDA raised doubts about the agency's ability to meet its obligations under user fee programs. However, according to executives from Stryker and Boston Scientific, the FDA later reinstated staff funded by device user fees within a week or two after being laid off.
The FDA's progress on MDUFA V goals was evident in data published in February 2022, showing an average of 312 days taken to reach a decision on premarket approval applications filed in fiscal year 2023, down from 364 days in 2022.
Stakeholders are encouraged to engage in FDA consultations to influence the program's direction moving forward. The FDA's public meeting on August 4, 2022, provides an opportunity for the public to discuss recommendations for industry funding of regulatory services from fiscal years 2028 to 2032.
- The FDA's next phase of the Medical Device User Fee Amendments (MDUFA) program is set for August 4, 2022, focusing on recommendations for the next medical device user fee period from 2028 to 2032.
- In the upcoming user fee program, the FDA is seeking input on aspects like fee structures, regulatory science priorities, and program enhancements to align with the evolving healthcare industry and regulatory needs.
- To streamline submission and review processes, the FDA plans to require electronic submissions like eSTAR for De Novo submissions starting October 1, 2025, which may influence future program refinements.
- During the meeting, the FDA will ask for recommendations to reduce or stop certain MDUFA features to maintain the efficiency and effectiveness of the medical device review process.
- The FDA aims to discuss what changes should be made to the current fee structures and amounts to better advance the goals of the agreement, facilitating product development and timely access for consumers.
- Initially seeking to understand what the medtech ecosystem should look like in 2027, the FDA will now focus on what is working or should be added during the reauthorization process for fiscal years 2023 to 2027.
- Overcoming previous concerns about meeting obligations, the FDA has reinstated staff funded by device user fees after layoffs during the early Trump administration.
- Data published in February 2022 showed an average of 312 days taken to reach a decision on premarket approval applications, demonstrating the FDA's progress on MDUFA V goals.
- Stakeholders are encouraged to engage in FDA consultations and provide their opinions on the direction of the program from 2028 to 2032 during the August 4, 2022, public meeting.
