MDUFA VI Reauthorization: What Medical Device Companies Need to Know Now
#MEDeviceBoston
Date: August 15, 2025
Estimated Read Time: 5 Minutes
Introduction
The wheels are turning once again on the FDA's Medical Device User Fee Amendments (MDUFA) reauthorization process. On August 4, 2025, the FDA hosted its first public meeting to kick off negotiations for MDUFA VI, which will cover fiscal years 2028 through 2032. This upcoming reauthorization isn't just bureaucratic paperwork—it's the foundation that determines how quickly and efficiently medical devices reach patients over the next five years. With the current MDUFA V set to expire on September 30, 2027, now is the time for industry stakeholders to understand what's at stake and how to make their voices heard.
Background: Understanding MDUFA
MDUFA is essentially the agreement that allows the FDA to collect user fees from medical device companies to supplement congressional funding. These fees directly support the FDA's review processes, staffing levels, and overall capacity to evaluate new medical technologies.
The current MDUFA V program has provided the FDA with substantial resources—more than $427 million authorized for fiscal year 2026 alone—in exchange for meeting specific performance goals like review timelines and staffing commitments. During the August 4th meeting, FDA leadership highlighted several achievements under the current program:
- FDA Commissioner Dr. Martin Makary emphasized improvements in review processes since the first MDUFA was established
- CDRH Director Dr. Michelle Tarver noted that the device center has met or exceeded review timelines established in MDUFA V
- Record use of pre-submission meetings and proposals to streamline these processes further
However, industry representatives like Mark Leahey, CEO of the Medical Device Manufacturers Association, called for the process to "return back to the basics," emphasizing the need for greater transparency in how these substantial funds are being utilized.
Impacts on the Medical Device Industry
The outcome of MDUFA VI negotiations will have far-reaching consequences for everyone in the medical device ecosystem:
- User fee rates will directly impact operating costs, especially for smaller companies
- Review timelines will affect product development strategies and time-to-market
- New programs or initiatives funded through user fees could create opportunities or challenges
- Predictability in the regulatory pathway influences investment decisions
- Changes to review processes could affect valuation models and risk assessments
Ultimately, the efficiency of the review process affects how quickly innovative technologies reach those who need them
The current annual establishment registration fee stands at $9,280 for FY 2025, with various application fees depending on submission type. These figures will likely increase under MDUFA VI, making it crucial for companies to plan accordingly.
What Medical Device Manufacturers Can Do Now
While formal negotiations between the FDA and industry are just beginning, there are several proactive steps companies can take:
- Submit comments to the public docket: The FDA is accepting public input until September 4, 2025, under Docket No. FDA-2025-N-1157. This is your opportunity to influence the direction of negotiations.
- Engage with industry associations: Organizations like AdvaMed and MDMA will be representing industry interests in negotiations. Make sure your concerns are communicated to these groups.
- Review your regulatory strategy: Consider how potential changes to user fees and review processes might affect your product pipeline and budget planning for 2028 and beyond.
- Monitor developments: The negotiation process will continue through 2026, with a final agreement needing congressional approval before September 2027. Stay informed about emerging proposals and their potential impacts.
- Prepare for potential fee increases: History suggests user fees will likely increase in MDUFA VI. Building this into your long-term financial planning now can prevent surprises later.
Stay Ahead of Regulatory Changes at MEDevice Boston 2025
Want to get the latest insights on MDUFA VI and other critical regulatory developments directly from the experts? MEDevice Boston 2025 is bringing together FDA officials, regulatory specialists, and industry leaders to discuss the evolving landscape of medical device regulation.
Sessions like "CAPA: What everyone needs to know about the Past to Prepare for the Future FDA QMSR and Risk Based Decision Making" with Kimberly Trautman and "Securing the Path to Market: A Real-World Guide to FDA Cybersecurity Compliance" will provide actionable strategies for navigating the complex regulatory environment.
Don't miss this opportunity to get ahead of regulatory changes that will shape the industry for years to come.
The MDUFA VI reauthorization process represents both an opportunity and a challenge for the medical device industry. By engaging early and staying informed, companies can help shape a regulatory framework that balances thorough review with efficient pathways to market.
As FDA Commissioner Dr. Makary noted during the public meeting, the goal should be to "make interactions with the agency a user-friendly process" while ensuring patient safety. Finding this balance will require active participation from all stakeholders throughout the negotiation process.
The next two years will be critical in determining how medical device regulation evolves for the following five. Companies that prepare now will be better positioned to navigate whatever changes emerge from the MDUFA VI agreement.
- FDA. (2025, August). Register for FDA's Public Meeting on Reauthorization of Medical Device User Fee Amendments. Retrieved from https://www.fda.gov/medical-devices/medical-devices-news-and-events/register-fdas-public-meeting-reauthorization-medical-device-user-fee-amendments-08042025
- FDA Law Blog. (2025, August). MDUFA VI Reauthorization Public Meeting Hears Many Perspectives on Device User Fees. Retrieved from https://www.thefdalawblog.com/2025/08/mdufa-vi-reauthorization-public-meeting-hears-many-perspectives-on-device-user-fees/
- Federal Register. (2025, June 11). Reauthorization of the Medical Device User Fee Amendments; Public Meeting; Request for Comments. Retrieved from https://www.federalregister.gov/documents/2025/06/11/2025-10551/reauthorization-of-the-medical-device-user-fee-amendments-public-meeting-request-for-comments
- MedTech Dive. (2025). FDA User Fees MDUFA 6 Funding. Retrieved from https://www.medtechdive.com/news/fda-user-fees-mdufa-6-funding/756887/
- FDA. (2025). Medical Device User Fee Amendments (MDUFA): Fees. Retrieved from https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa-fees