MDUFA VI Draft Agreement: What Medical Device Companies Need to Know

26 Aug 2026

Key Proposed Changes Could Reshape FDA Device Reviews through 2032

The U.S. Food and Drug Administration’s (FDA) proposed Medical Device User Fee Amendments VI (MDUFA VI) agreement could significantly shape medical device regulation from fiscal year 2028 through 2032. MDUFA governs the user fees paid by the medical device industry and, in return, establishes FDA performance goals and process commitments for reviewing device submissions. The current MDUFA V program expires September 30, 2027, making MDUFA VI an important development for companies planning regulatory submissions beyond that date.

In March 2026, FDA and the medical device industry reached an agreement in principle on the remaining MDUFA VI proposals. The draft Commitment Letter focuses on improving review efficiency, predictability, and regulatory capacity while supporting newer approaches to medical device development. Importantly, the agreement remains a draft and will need to move through the federal legislative process before becoming the framework for the next user-fee cycle.

Faster, More Predictable FDA Reviews

One of the most notable changes is a greater emphasis on Total Time to Decision, which considers the overall time from submission to the FDA to decision rather than only FDA’s active review time. For certain premarket approvals (PMA) and panel-track supplements, the proposed shared goal is 285 calendar days. For 510(k)s, the proposed goal would gradually improve from 128 days in fiscal year 2028 to 112 days in fiscal year 2032. These are shared goals rather than guarantees, meaning applicants will also play an important role by submitting complete information and responding promptly to FDA requests.

The draft also proposes changes to the Pre-Submission process, including a new Focused Follow-Up Pre-Submission pathway intended to provide more targeted regulatory feedback. The FDA would establish more defined timelines for accepting Pre-Submissions, scheduling meetings, and providing written feedback. For companies developing novel or complex technologies, these changes could make early FDA engagement more predictable and help resolve regulatory questions before a formal marketing submission is filed.

Another significant proposal involves deficiency letters. The FDA intends to provide more comprehensive deficiency letters based on its review of the application at that stage, with subsequent deficiencies generally limited to issues arising from the applicant’s response or newly identified safety or effectiveness concerns. The objective is to reduce uncertainty and minimize situations in which companies repeatedly address new issues throughout the review process.

Preparing for a Changing Regulatory Landscape

MDUFA VI also reflects the changing nature of medical technology. The draft includes dedicated attention to digital health, real-world evidence, patient science and engagement, consensus standards, third-party 510(k) review, and international harmonization. These areas could become increasingly important as the FDA evaluates software-based devices, artificial intelligence, connected technologies, alternative sources of clinical evidence, and globally developed products.

For manufacturers, the practical impact of MDUFA VI may extend beyond shorter review targets. Companies will need to place greater emphasis on submission quality, strategic use of Pre-Submissions, realistic understanding of FDA Days versus calendar-day targets, and early consideration of emerging regulatory pathways. The proposed changes could reward organizations that engage with the FDA early and build regulatory strategy into product development rather than treating regulatory review as a final step.

What Happens Next?

The financial side of MDUFA VI is also important. The FDA and industry have proposed continuing the core user-fee structure while making targeted investments in staffing and operational capacity. Preliminary discussions have also indicated potential changes to certain submission and registration fees. However, companies should not treat proposed fee amounts as final because the ultimate structure will depend on legislation and subsequent FDA fee-setting.

The key point is that MDUFA VI is not yet final. The FDA released the draft Commitment Letter and held a public meeting on August 5, 2026, as part of the ongoing reauthorization process. Until Congress enacts the necessary legislation, companies should continue operating under the current MDUFA V framework while monitoring developments closely. For the medical device industry, MDUFA VI represents a potential shift toward a more predictable and collaborative review process, with greater emphasis on total time to decision, early FDA engagement, emerging technologies, and modern regulatory science. While the final details may change, companies expecting to bring products to FDA in fiscal year 2028 and beyond should begin considering how the proposed framework could affect their regulatory strategy, development timelines, and submission planning.

For manufacturers looking to stay ahead of MDUFA VI, the FDA’s dedicated MDUFA VI reauthorization page is the best starting point for the latest draft agreements, meeting materials, public comments, and updates. Click here for the FDA’s MDUFA VI resource page.

Manufacturers should also monitor FDA’s CDRH news and events for upcoming public meetings and regulatory-science events, including the September 25, 2026, meeting on regulatory science innovations. Click here for the CDRH News and Updates page.

Industry associations, regulatory conferences, and device-focused professional forums can provide additional perspective by bringing together manufacturers, former FDA officials, regulatory experts, and other stakeholders to interpret what the proposed changes could mean in practice.

Together, these resources can help companies distinguish between what is proposed, what is ultimately enacted, and what the changes may mean for their regulatory strategy.