MDUFA VI Is Taking Shape: What Device Companies Should Do Now

By Jake Leys

The U.S. Food and Drug Administration (FDA) and the medical device industry have confirmed reaching an agreement in principle (AIP) and resolution on all remaining Medical Device User Fee Amendments VI (MDUFA VI) proposals and are now drafting commitment-letter language to memorialize the agreement. The draft commitment letter is expected to proceed through agency review, public notice and comment, and then submission to Congress for reauthorization. The commitment letter is where expectations are operationalized on review timelines, fee mechanics, De Novo and Pre-Submission processes, real-world evidence (RWE), and staffing transparency. The current program, MDUFA V, expires September 30, 2027, and MDUFA VI is anticipated to run FY 2028–FY 2032. The agreement in principle is not self-executing; new legislation will be required for FDA to continue collecting device user fees in future fiscal years.

Background

MDUFA authorizes FDA to collect user fees from industry to support the process for the review of medical devices, while the associated commitment letter sets performance goals, procedures, and program commitments that affect review timing, communication, fee planning, and submission strategy. For companies that are scaling or capital-constrained, those mechanics may shape budgets, hiring, and submission strategy. Negotiations on the next agreement began in October 2025 and progressed on what MDMA characterized at MedCon as a “record timeline.” At the MedCon 2026 MDUFA plenary on April 22, 2026, the Center for Devices and Radiological Health's (CDRH) Barbara Marsden (Acting Director, Office of Regulatory Programs, OPEQ) confirmed that the parties have “tentatively concluded negotiations pending resolution of documents that will memorialize the agreement.”

What the Public Record Shows

Public minutes from the FDA-Industry MDUFA VI reauthorization meetings and FDA's statements at MedCon point to four threads that matter most for device companies:

Staffing transparency

Staffing levels at CDRH became a focus of the negotiations, prompting discussion of additional transparency and future hiring commitments. Public minutes indicate FDA agreed to periodic reporting of staffing levels by office within CDRH, while sub-office reporting required further discussion. FDA also acknowledged the shared intent to hire substantial numbers of additional review staff, but the public record does not yet establish specific MDUFA VI hiring targets or hiring-linked fee adjustments. For manufacturers, the practical implication is greater visibility into CDRH staffing levels, but no guarantee that review capacity will be built or restored on a timeline that matches your submission calendar.

Fee mechanics

Marsden has publicly stated that user-fee funding will remain “largely the same” between MDUFA V and MDUFA VI. FDA has indicated that most firms could see lower submission and domestic registration fees in FY 2028 under the proposed fee structure. At the same time, FDA has proposed differentiating registration fees between foreign and domestic establishments (with foreign firms paying a higher rate) and proposed a flat fee for original Pre-Submissions, with the fee credited to the related subsequent marketing submissions as part of the fee-structure model. The net fee shift will likely affect non-U.S. registrants, multi-site operations, and programs that rely more heavily on Pre-Submission programs.

De Novo and Pre-Submissions

FDA and industry have reached agreement on multiple proposals to update both pathways, with industry expressing support for FDA's De Novo and Pre-Sub proposals at the February 18, 2026 meeting. Industry's stated De Novo concerns include the program's lower granting rate and higher rates of declines, withdrawals, and deletions compared with other marketing submission types. Specifics remain to be reflected in the commitment letter, but companies considering De Novo should expect continued attention to pathway-fit documentation, comparator logic, and core evidence narrative.

RWE funding is expected to be tied to premarket use and NEST

March 18, 2026 meeting minutes indicate FDA and industry agreed to move forward with commitment-letter language on RWE through the National Evaluation System for health Technology (NEST). NEST is an FDA-supported, stakeholder-driven system intended to generate medical device real-world evidence by linking and synthesizing data from sources such as clinical registries, electronic health records, and medical billing claims. Industry emphasized that agreement to fund RWE full-time equivalents was conditional on adoption of the NEST Mark, a developing tool intended to strengthen confidence in the relevance and reliability of real-world data for medical device scientific and regulatory goals, and that MDUFA VI RWE funding should be restricted to premarket submission activities within NEST, rather than used to subsidize broader lifecycle RWE work. Industry also emphasized that the funding should be housed under NEST and governed by the NEST Governance Committee.

Key Takeaways for Manufacturers

• Re-baseline budgets: Plan around largely flat program funding, with fee shifts likely (e.g., foreign establishment registration differential, original Pre-Sub flat fee), and FDA's signal that most firms could see lower submission and domestic registration fees in FY 2028.
• Treat staffing transparency as a planning tool: Build your pre-submission cadence and internal review timelines around the possibility of continued staffing and capacity uncertainty, even with periodic office-level reporting.
• Strengthen De Novo packages now: If De Novo is your pathway, lock down the intended use, comparator logic, and evidence narrative early.
• Plan RWE around premarket use: If you intend to use RWE for premarket submissions, monitor developments involving NEST and FDA's approach to RWE data-source development.
• Watch AI-device review capacity: Stakeholder feedback flagged FDA’s resources for evaluating complex AI devices as a live concern; the commitment letter is the place to look for any capacity and data-quality language relevant to AI submissions.

“MDUFA VI is quickly moving from negotiation into drafting. The companies that will benefit most are those that start aligning submission strategy with where FDA is allocating its limited resources.”

Jake Leys, Associate Attorney

How Gardner Law Can Help

Gardner Law helps FDA-regulated companies translate policy shifts into operational strategy. As MDUFA VI moves from AIP to commitment letter to legislation, we help clients calibrate their regulatory plans and tighten the documentation that will matter most under a resource-constrained, more transparent CDRH. Contact us to talk through what MDUFA VI means for your portfolio.