MDUFA VI: FDA Medical Device User Fee Reauthorization 2027–2032 — What Manufacturers Need to Know

What Is MDUFA and Why It Matters for Every Device Company

The Medical Device User Fee Amendments (MDUFA) are the financial backbone of FDA device review. Every five years, the FDA and the medical device industry renegotiate an agreement that determines how much companies pay in user fees for 510(k) submissions, PMA applications, De Novo requests, and establishment registrations — and what the FDA commits to in return for those fees.

The current agreement, MDUFA V, expires at the end of fiscal year 2027 (September 30, 2027). Its replacement, MDUFA VI, will govern device user fees from fiscal year 2028 through 2032. The FDA and industry reached an "agreement in principle" in March 2026, and the commitment letter is expected to be finalized and sent to Congress for approval later in 2026.

This is not a routine administrative matter. MDUFA determines how many reviewers CDRH can hire, how fast your submissions get reviewed, how transparent the agency is about staffing and performance, and how much you pay for every interaction with the FDA. The stakes are particularly high this cycle because CDRH is operating with roughly 22% fewer staff than it had in 2024, following the HHS workforce reductions that eliminated approximately 4,400 FDA employees agency-wide.

This article breaks down what MDUFA VI contains, how it differs from MDUFA V, what it means for your fees and timelines, and how to prepare.

MDUFA by the Numbers: A Quick Primer

Before diving into MDUFA VI specifics, it helps to understand what user fees fund and how the system works.

Current MDUFA V Fees (FY 2026)

User fees fund approximately 35-40% of CDRH's total budget, with the remainder coming from congressional appropriations. Under MDUFA V, the industry agreed to pay higher fees in exchange for the FDA hiring 500+ additional CDRH staff. The premise was that more reviewers would mean faster, more predictable reviews.

Then the HHS cuts happened. Many of the positions funded by MDUFA V user fees were eliminated, creating a situation where industry paid for capacity that no longer exists.

How MDUFA Works

The Context: Why MDUFA VI Is Different

MDUFA reauthorization is always significant, but the 2027-2032 cycle carries unusual weight for three reasons:

1. CDRH Staffing Crisis

Since September 2024, the FDA lost approximately 21% of its total workforce. CDRH was hit especially hard: approximately 22% of its staff was eliminated, reducing the center from roughly 2,260 people to an estimated 1,800. This is the same center that MDUFA V funded to hire 500+ additional staff.

The staffing shortage has produced measurable impacts: delayed pre-submission meetings, reduced guidance document output, and longer informal interactions with reviewers. While CDRH has maintained that it is meeting its statutory MDUFA V review timeline commitments, the ground-level experience reported by manufacturers and consultants tells a more complicated story.

2. Political Direction: "America-First" Fee Policy

The Trump administration has directed the FDA to pursue an "America-First" approach to user fees. This translates into a restructured fee system where foreign establishments would pay higher registration fees, while many domestic companies could see lower submission and registration costs starting in FY 2028.

The rationale is to incentivize domestic medical device manufacturing and strengthen US supply chains. The practical effect depends on your company's geographic footprint.

3. Real-World Evidence Evolution

The FDA has been steadily expanding its use of real-world evidence (RWE) in regulatory decision-making. MDUFA VI negotiations included discussions about formalizing RWE provisions in the commitment letter, potentially creating new pathways or expectations for how manufacturers can use real-world data to support submissions and post-market obligations.

What MDUFA VI Contains: Key Provisions

Based on the April 2026 agreement in principle and public meeting minutes from the negotiation process, MDUFA VI addresses four major areas.

Provision 1: CDRH Staffing Restoration

The single most important element of MDUFA VI is a commitment to hire "substantial numbers of additional review staff" at CDRH. Industry representatives specifically asked for language ensuring that funding for MDUFA V staffing levels continues in MDUFA VI, and the FDA acknowledged this shared intent.

Key points:

• Marginal staffing increases above the MDUFA V baseline are included in the fee calculations
• The focus is on rebuilding CDRH capacity over the first two years of the agreement (FY 2028-2029)
• Staffing transparency is a formal part of the agreement, responding to industry concerns about visibility into CDRH workforce levels
• The agreement does not specify exact hiring numbers — those will appear in the final commitment letter

For manufacturers, this is the most consequential provision. CDRH's current understaffing affects every interaction with the agency, from pre-submission feedback to 510(k) review quality. Rebuilding capacity is essential for the system to function as intended.

Provision 2: "America-First" Fee Restructuring

MDUFA VI introduces a split fee structure for establishment registration:

The FDA has stated that changes to the statutory fee structure will result in most firms seeing lower fees in FY 2028, with decreases to submission fees and domestic registration fees. Foreign firms will bear a larger share of the establishment fee burden.

This is a significant departure from the historical approach of uniform fees regardless of geography. Companies with manufacturing operations outside the US should model the financial impact carefully.

Provision 3: Real-World Evidence Integration

MDUFA VI includes provisions related to the evolving role of real-world evidence in the regulatory process. While the specific language is still being finalized, the negotiations addressed:

• How RWE can be used to support premarket submissions
• Post-market evidence generation expectations
• Alignment with FDA's existing RWE framework
• Potential new performance metrics related to RWE review

This reflects the broader regulatory trend toward accepting diverse evidence sources beyond traditional clinical trials, particularly for devices with established predicates or post-market data.

Provision 4: Fee Stability

According to Barb Marsden, acting director of the Office of Regulatory Programs at CDRH, MDUFA VI keeps user-fee funding at approximately MDUFA V levels with no major new initiatives. The focus is on "shoring up review fundamentals and rebuilding CDRH capacity" rather than expanding into new regulatory areas.

This is notable because it means MDUFA VI is primarily a restoration agreement rather than an expansion agreement. The priority is getting CDRH back to where it should be, not adding new commitments.

Fee Projections: What You Will Likely Pay

While exact FY 2028 fees will be published in the Federal Register before October 1, 2027, the MDUFA VI framework suggests the following directional changes:

For Domestic Manufacturers

For Foreign Manufacturers

The "America-First" restructuring primarily affects establishment registration fees. Submission fees are expected to decrease or remain stable for most firms regardless of location.

How MDUFA VI Affects Your Regulatory Strategy

Impact on Review Timelines

The primary value of MDUFA VI for manufacturers is the commitment to restore CDRH staffing. If the hiring targets are met:

• 510(k) reviews: The 90-day target should become more consistently achievable, though actual timelines will depend on how quickly CDRH can recruit and train new reviewers
• Pre-submission meetings: Availability should improve as staffing increases, though this may take 12-18 months from the start of MDUFA VI
• De Novo and PMA: Higher-complexity reviews that were most affected by staffing losses should see the most improvement
• Informal interactions: Email responses, teleconferences, and Q&A feedback should become more timely

However, these improvements are back-loaded. CDRH will need to hire, onboard, and train new staff, which takes 6-12 months per reviewer. The first year of MDUFA VI (FY 2028) may still feel similar to current conditions, with meaningful improvements arriving in FY 2029-2030.

Impact on Small Businesses

The small business fee waiver program (which reduces fees by approximately 75% for qualifying companies with gross receipts under $100 million) is expected to continue under MDUFA VI. Small businesses that qualify should see the same proportional reductions applied to the new, potentially lower base fees.

Impact on Pre-Submission Strategy

Given the staffing transition period, manufacturers should:

• Continue filing pre-submissions early — do not assume faster turnaround in FY 2028
• Request in-person or virtual meetings rather than relying solely on written feedback
• Build extra buffer time into regulatory timelines through at least FY 2029
• Monitor CDRH staffing reports once they become available under the new transparency provisions

The Negotiation Timeline: How We Got Here

Understanding the negotiation process helps contextualize what MDUFA VI contains and what was left out.

The negotiations were described by MDMA president Mark Leahey as following a "historic timeline" — reaching agreement faster than previous MDUFA cycles. FDA transparency was credited as a key factor in the swift agreement.

What MDUFA VI Does NOT Include

Understanding what was left out is as important as what was included:

• No major new review initiatives: Unlike MDUFA V, which introduced significant new performance metrics, MDUFA VI is focused on fundamentals
• No specific AI/ML review framework: While AI devices are increasingly common, MDUFA VI does not establish dedicated AI review tracks (these continue under separate FDA guidance)
• No restructuring of the breakthrough device program: The breakthrough pathway continues under existing authority
• No changes to the small business qualification criteria: The $100 million gross receipts threshold remains
• No new post-market surveillance mandates: PMS requirements continue under existing statutory authority

Practical Preparation: What Manufacturers Should Do Now

1. Budget Planning (Immediate)

Model the impact of the new fee structure on your FY 2028 budget. If you are a domestic manufacturer, plan for potentially lower fees. If you have foreign establishments, prepare for higher registration costs. The exact numbers will be available when the commitment letter is published.

2. Submission Pipeline Review (Q3 2026)

Assess your submission pipeline for FY 2027-2028. If you have submissions that could be filed before October 2027, consider whether accelerating makes sense to lock in current MDUFA V fee levels. If you have flexibility, waiting for MDUFA VI's potentially lower submission fees may save money.

3. Small Business Qualification (Annual)

If your company qualifies as a small business (gross receipts under $100 million), ensure your qualification is current. The fee reduction is approximately 75% and applies to all submission types except establishment registration.

4. Regulatory Strategy Adjustment (FY 2028-2029)

Do not assume immediate improvement in review timelines. The first 12-18 months of MDUFA VI will be a staffing rebuild period. Build realistic timelines into your product development and launch plans.

5. Monitor CDRH Transparency Reports (Ongoing)

MDUFA VI includes staffing transparency provisions. When CDRH begins publishing staffing data, use it to calibrate your timeline expectations. Reviewer availability is the single most important factor in how fast your submission moves through the queue.

6. Engage with the Process (Before Congressional Vote)

If MDUFA VI will significantly affect your business — particularly if you are a foreign manufacturer facing higher fees — consider submitting comments during the congressional review period or participating in industry association advocacy efforts.

Comparison: MDUFA V vs. MDUFA VI

What Happens If Congress Does Not Authorize MDUFA VI

This is the scenario no one wants but everyone should plan for. If Congress fails to pass MDUFA reauthorization legislation before September 30, 2027:

1. FDA cannot collect user fees starting October 1, 2027
2. CDRH loses 35-40% of its budget overnight
3. Review operations slow dramatically — the agency would need to furlough significant portions of its review staff
4. All submissions continue to be accepted but review times would extend substantially
5. Previous MDUFA failures (2012, when PDUFA briefly lapsed) resulted in FDA sending furlough notices but Congress ultimately acted

The medical device industry and FDA both have strong incentives to avoid this outcome. Congressional authorization is expected well before the deadline, but the possibility is worth monitoring, particularly given the current political environment.

Bottom Line

MDUFA VI is a restoration agreement focused on rebuilding CDRH capacity after the devastating workforce losses of 2024-2025. The key takeaways for manufacturers:

• Fees: Most domestic firms will pay less; foreign firms will pay more for establishment registration
• Timelines: Do not expect immediate improvement — meaningful gains will take 12-18 months from the October 2027 start date
• Strategy: Build buffer into your regulatory timelines through FY 2029, and adjust budget models for the new fee structure
• Opportunity: The staffing transparency provisions give manufacturers unprecedented visibility into CDRH capacity — use this data to inform your planning

The agreement represents a pragmatic approach: stabilize the system first, then build. For an agency that lost 22% of its device review workforce, that is the right priority.