FDA Draft MDUFA VI Could Signal Changes for Medical Devices

During FDA's August 5, 2026, public meeting, the agency discussed the official draft Medical Device User Fee Amendments VI (MDUFA VI) Commitment Letter, which outlines performance goals, user fee policies, and program enhancements for fiscal years (FYs) 2028 through 2032. The draft commitment letter largely maintains the review framework established under MDUFA V while refining several areas intended to improve communication and efficiency. The public comment period closed Aug. 7, 2026. FDA is expected to transmit its recommendations to Congress by Jan. 15, 2027, with the goal of completing the process before the end of the 2026 calendar year.

For companies across the medical device industry, including contract manufacturers, specification developers, re-packagers, re-labelers, and their advisors, the proposal could affect submission planning, interactions with FDA, and user fee policies over the next authorization cycle. The current authorization of the program (MDUFA V) expires Sept. 30, 2027. When it does, new legislation is required for FDA to continue collecting device user fees for FY 2028 — 2032 (MDUFA VI). 

MDUFA VI emphasizes refinement rather than transformation

Unlike previous MDUFA reauthorizations that introduced significant new programs, MDUFA VI primarily focuses on enhancing processes established under MDUFA V while maintaining existing review performance expectations.

For stakeholders, the most notable changes introduced in MDUFA VI involve: 

• Different annual establishment registration fees for domestic vs. foreign manufacturers, 
• New user fee for certain initial pre-submissions, 
• Annual cap on pre-submission performance commitments, 
• New focused follow-up pre-submission pathway, 
• Supervisory review for inconsistent pre-submission feedback,  
• Introduction Meeting requirement for De Novo submissions, 
• Establishment of "Not Grantable" letter for De Novo submissions, 
• Expanded focus on review consistency across FDA review divisions, and  
• Continued support for established initiatives including Total Product Life Cycle (TPLC) Advisory Program (TAP), National Evaluation System for health Technology (NEST), Accreditation Scheme for Conformity Assessment (ASCA), digital health review modernization, and patient engagement and patient science programs.

Several of these proposed changes may have practical implications for the medical device industry.

Proposed changes to the pre-submission program

The proposed updates to FDA's Pre-Submission Program may represent the most significant operational changes in MDUFA VI.

FDA proposes a new $2,000 fee for certain initial pre-submissions, which would be credited toward a future marketing submission fee.

FDA also intends to maintain current written feedback timelines but limit this commitment to the first 5,000 pre-submissions received each fiscal year beginning in FY 2028. Because pre-submission volume has steadily increased in recent years, pre-submissions that are not among the first 5,000 cohort could experience delayed feedback. The new limit may also discourage some sponsors from pursuing pre-submissions later in the calendar year.

Additional proposed changes include a new focused follow-up pre-submission pathway with a 45-day review timeline for narrow follow-up questions related to a recent pre-submission, as well as the option to request supervisory review for inconsistent feedback. The focused follow-up pathway is intended to expedite responses to limited questions, while the supervisory review process extends an option already familiar to many sponsors through premarket submissions.

New user fee proposals

FDA emphasized throughout the public meeting that user fees would be maintained, relative to inflation, through FY 2032 to improve predictability and support the agency's public health mission.

One notable departure from prior MDUFAs is that MDUFA VI would implement different annual establishment registration fees for domestic and foreign manufacturers. For FY 2028, FDA proposes annual registration fees of $12,043 for domestic establishments and $17,043 for foreign establishments. According to FDA, the proposed differential reflects the additional resources required to oversee foreign firms marketing medical devices in the U.S.

Another difference between MDUFA V and a proposed recommendation in MDUFA VI is the threshold for which small businesses may qualify for a reduced annual registration fee. Under MDUFA VI, fee waivers would apply to very small domestic business entities with annual gross receipts or sales of $500,000 or less, provided they have no foreign affiliates and do not manufacture devices subject to Good Manufacturing Practice requirements.

Exponent's review of the 2nd Quarter FY 2026 MDUFA V Performance Report showed only eight applications qualified for a waiver. No application qualified for a reduced fee. By lowering the sales amount for which a firm can claim a waiver but removing the requirement to demonstrate financial hardship, it remains to be seen if the usage of the de minimis benefit of qualifying U.S. small businesses will appreciably change. 

Although these provisions remain subject to Congressional approval, organizations with global operations may wish to evaluate how the proposed fee structure could affect long-term U.S. market planning.

More structured interactions for De Novo submissions

For De Novo submissions received on or after Oct. 1, 2027, MDUFA VI introduces a structured Introduction Meeting between FDA and the applicant within the first 30 FDA days of review. This is intended to promote early alignment and review efficiency.

MDUFA VI also establishes the possibility of issuing a "Not Grantable" letter. Similar to a PMA "Not Approvable" letter, this allows applicants an opportunity to address major deficiencies before FDA issues a decline decision.

Improving review consistency

FDA acknowledged that sponsors with cross-cutting issues should not have different evidentiary requirements simply because different offices are reviewing their submissions.

Through MDUFA VI, FDA intends to facilitate consistent review practices in at least one specific, high-impact topic area each fiscal year. To support these efforts, FDA plans to analyze data from multiple sources, engage review staff and managers, share best practices, provide training and support, and monitor the effectiveness of improvements over time.

IT modernization and continuous improvement

FDA also discussed several information technology initiatives intended to enhance communication and submission management.

The draft commitment letter describes an interactive tool to help FDA and external stakeholders identify the most appropriate resource or communication channel. Although optional, the tool is not expected before Sept. 30, 2030.

FDA also intends to expand the Customer Collaboration Portal by creating a communication mechanism that provides "a comprehensive repository of interactions" by Sept. 30, 2029. Additional planned improvements include user fee status notifications, submission formatting checks, and greater automation of submission processing.

Training and programmatic support

Throughout the public meeting, FDA and industry representatives, as well as patient groups, healthcare providers, and other stakeholders, emphasized the importance of adequate training and programmatic support to help FDA continue meeting performance goals while implementing new initiatives.

Key takeaways for the medical device industry

While MDUFA VI largely preserves the existing regulatory framework established under MDUFA V, the proposed refinements could influence regulatory strategy in several areas.

1. MDUFA VI is primarily an optimization effort, not a transformational one. FDA is maintaining core MDUFA V performance frameworks while refining areas where stakeholders identified gaps.
2. The largest practical impact will likely be felt in the pre-submission program, through new fees, annual volume caps, focused follow-up opportunities, and supervisory review mechanisms.
3. Foreign medical device organizations can evaluate the proposed registration fee differential as part of long-term U.S. market planning.
4. Companies pursuing De Novo pathways may benefit from earlier FDA engagement and more structured review interactions.
5. Review consistency remains a major FDA priority, potentially improving predictability across review offices over the next authorization cycle.