MDUFA VI Reauthorization Public Meeting Hears Many Perspectives on Device User Fees

On August 4, 2025, FDA hosted a public meeting related to the reauthorization of the Medical Device User Fee Act for fiscal years 2028 through 2032 (MDUFA VI).  The FDA invited public comment on the following questions and most speakers remarks provided perspectives related to these question (90 FR 24633).

• What is your assessment of the overall performance of MDUFA V thus far?
• What current features of MDUFA should be reduced or discontinued to ensure the continued efficiency and effectiveness of the medical device review process?
• What new features should FDA consider adding to the program to enhance the efficiency and effectiveness of the medical devices review process?
• What changes, if any, 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 meeting kicked off with remarks from FDA Commissioner Dr. Martin Makary who commented on the history of medical device user fees, improvements to FDA’s reviews since the first MDUFA was established, goals for modernization, use of common sense, and to make interactions with the agency a user-friendly process.  Next, CDRH Director Dr. Michelle Tarver spoke on the CDRH vision for patients in the US to have access to safe and effective medical devices of public health importance first in the world.  Dr. Tarver noted that the device center is strong and has met or exceeded review timelines established in MDUFA V.  Other topics touched on by Dr. Tarver include: the record use of pre-subs and proposal to further streamline the process, such as by submission type and evidence phase; use of real world evidence and the need for continued collaboration across the total product life cycle; digital health and the agency’s support of responsible innovation; expansion of the use and scope of the Accreditation Scheme for Conformity Assessment (ASCA); strengthening patient-centered development; and providing expanded dashboards with new metrics to improve visibility of the agency’s progress against the MDUFA V performance goals.  Dr. Tarver wrapped up stating that while CDRH has made progress in ensuring it has top talent, that they will need critical resources under MDUFA VI, and that CDRH staff will require leading edge scientific training.  This comment comes with some irony given the mass layoffs across FDA earlier this year.

The remainder of the meeting presented perspectives external to FDA, including panels from:  MedTech industry; patients and consumers; scientific, academic, and health care professionals; and the public.

Remarks from the MedTech panel focused on fine tuning the current FDA processes and highlighted the value of the pre-sub process and the importance of transparency and understanding of where user fees are spent.   This panel also noted that while not opposed to FDA’s use of medical device user fees to improve post-market activities, the program was intended for pre-market improvements.  Finally, this panel emphasized that user fees provide resources to FDA to support timeliness and predictability and are not and have never been a guarantee of approval.

Patient and consumer groups requested that patient advocacy groups be included as more formal partners in the MDUFA negotiations and also highlighted the need for MDUFA goals related to the quality of FDA reviews in addition to timeliness of reviews.  In contrast to the view of the MedTech panel, this panel recommended user fees support improvements to post-market initiatives within the Agency, noting that there have been higher numbers of adverse events in the last 10 years and questioning whether MDUFA pressure for premarket review speed has had an unintentional consequence of more adverse events.  One speaker on this panel noted that device user fees are a fraction of drug user fees, even for the biggest companies and commented that they believe user fees, especially for 510(k)s, are too low.

The scientific, academic, and healthcare professional panel noted that collaboration with FDA and developers is essential, especially with new technologies such as AI-enabled devices.  This panel also highlighted the need to ensure regulatory frameworks are inclusive of all populations, especially children.

The presenters from the public brought a variety of views.  Some felt FDA should be fully funded through appropriations, expressed concern with recent FDA reductions in force and recommended regulation of laboratory developed tests be considered as part of the MDUFA bill, such as the previous VALID act, which we have blogged on previously (link).  Others recommended user fees be increased, the program be expanded to provide robust postmarket safety information to the public, that MDUFA include a pilot program for use of digital twins and to reduce clinical trial requirements with in silico testing, and to make MDUFA performance goals more patient centric with a focus on quality and not just speed of review.

FDA’s Total Product Lifecycle Advisory Program (TAP) pilot was discussed by many over the course of the meeting.  Dr. Tarver noted that TAP is designed to expedite patient access by making the path to market more efficient and predictable and that 100% of quantitative performance metrics had been met in the pilot with 93 devices currently enrolled.  The MedTech panel commented that while the goals of TAP are laudable, that they fall outside of FDA’s purview and recommended revisiting the Breakthrough Program to incorporate the elements of TAP that are in FDA’s control.  Conversely, the patient and consumer panel as well as the scientific, academic, and health care professionals panel praised TAP for the integrated approach and bringing the patient and payor voices to the table earlier in the development process, and recommended the program be maintained and grown.

Across all presenters, the common goal of timely patient access to safe and effective devices was reiterated.  Public input on the user fee reauthorization can be submitted at https://www.regulations.gov/, Docket No. FDA-2025-N-1157 until September 4, 2025.