The Most Important MDUFA VI Change May Not Be the Fees
The proposed agreement quietly shifts attention toward review predictability, communication quality, and shared responsibility for delays.
The proposed MDUFA VI agreement includes several changes likely to attract immediate attention: lower submission fees, a fee for certain pre-submissions, faster follow-up feedback, revised de novo procedures, and additional coordination between FDA and CMS.
The more consequential theme is less dramatic.
FDA and industry appear to be building a system that is increasingly explicit about predictability—where delays occur, how disagreements are handled, when communication should happen, and which party owns which portion of the timeline.
The draft keeps most core review goals from MDUFA V while proposing that average total time to decision for a 510(k) fall from 128 calendar days in FY2028 to 112 days by FY2032. The PMA shared-outcome goal would remain 285 calendar days.
“Shared outcome” is doing quite a bit of work there.
The draft commitment letter states directly that FDA and applicants share responsibility for total-time-to-decision goals. FDA can improve its review process without fixing an applicant’s unstable claims, incomplete testing rationale, drifting product configuration, or slow response to an additional information request.
There is still no user fee that converts ambiguity into evidence.
The scale of the program helps explain the emphasis. FDA reported more than 21,000 device submissions in FY2025, including 4,151 510(k)s and 69 de novo requests. Approximately 30,000 device establishments were registered, 54% of them outside the United States. Small businesses accounted for 51% of 510(k) submitters and 81% of de novo submitters.
Those companies enter through the same regulatory pathways with very different levels of infrastructure, experience, and ability to absorb another review cycle.
MDUFA VI appears designed to remove some of the friction around that reality.
For de novo requests, the proposal adds an applicant meeting within the first 30 FDA days and formalizes a potential “Not Grantable” letter with defined response and decision timelines. FDA would also continue providing the basis for deficiencies in 95% of applicable letters and introduce a survey focused specifically on the quality of deficiency communications.
The agreement also addresses consistency across and within FDA’s Offices of Health Technology. At least eight high-impact review topics would be identified during the five-year period, with FDA reporting on the actions taken and whether they worked.
That matters because review inconsistency is not merely frustrating. It creates financial exposure when prior feedback appears to shift, familiar evidence strategies encounter unfamiliar expectations, or two teams interpret the same requirement differently.
Proposed upgrades to the Customer Collaboration Portal, automated intake, real-time verification and two-way communication point in the same direction: fewer procedural mysteries and more visible accountability.
That visibility cuts both ways.
As FDA makes the process more measurable, applicant delays become easier to identify. Agency time will be tracked. Sponsor time will remain visible. Earlier meetings will surface assumptions sooner. Structured communication will make it harder to blame every missed milestone on “FDA being FDA.”
MDUFA V has reportedly met, or is on track to meet, 46 of 48 performance goals for FY2023 through 2025. MDUFA VI is therefore being presented as refinement rather than rescue—focused on efficiency, consistency, communication and infrastructure.
That may be the most important executive signal.
FDA is not proposing a radically different regulatory system. It is proposing one that documents expectations more clearly and exposes execution gaps earlier.
For aligned organizations, that should create real planning advantages.
For everyone else, the process may become more predictable while the outcome remains just as surprising.
You can read the draft document and add your comments to the Federal Register here: https://www.fda.gov/industry/medical-device-user-fee-amendments-mdufa-fees/medical-device-user-fee-amendments-2028-mdufa-vi
