By: Susan Lubejko PhD and Abigail Copeland PhD, Regulatory Affairs Specialists at Mittal Consulting

On July 7, 2026, FDA published a draft commitment letter detailing proposed recommendations for the reauthorization of the Medical Device User Fee Amendments (MDUFA), which govern how medical device manufacturers interact with FDA and fund medical device review in the United States, for fiscal years 2028 through 2032 (MDUFA VI). While the recommendations are pending public commentary and Congressional approval, meaning they are subject to potential change before being finalized, MDUFA drafts provide a look into FDA’s current thinking on the fees and timelines associated with interactive programs and marketing submissions. Notably, sponsors will find the proposed changes to the Pre-Submission program of particular interest: the MDUFA VI draft introduces Deposit fees for initial Traditional Pre-Submissions and a new Focused Follow-Up Pre-Submission for feedback on targeted questions cutting the FDA feedback time almost in half.

Before jumping into the specifics, let’s take a brief look at the history of MDUFA. In the early 2000s, as medical device companies became frustrated with unpredictable FDA review timelines for their marketing applications, they worked with FDA to implement MDUFA, the medical device analog of a submission fee program already proven successful for FDA drug review, for more FDA commitment on predictable timelines.

MDUFA has been positively viewed by both industry and FDA and continuously re-renewed, bringing us to the current MDUFA VI renewal cycle.

Of particular interest in the MDUFA VI amendments are proposed changes to the Pre-Submission program. Pre-Submission usage has grown substantially in recent years. Last fiscal year alone, FDA reviewed a whopping 4502 Pre-Submissions, up 26% over the previous 5-year average and including both original pre-submissions and pre- submission supplements. To put this in perspective, in FY2025 FDA reviewed 4,151 510(k)s, the most typical marketing application, indicating that FDA reviewers can expect to encounter and spend time on just as many free-to-submit Pre-Submissions as user fee-driven marketing applications. However, Pre-Submissions are invaluable for Sponsors, especially those early in development of novel, complex technologies, as the process allows them to get on the same page early with the FDA in terms of device design, testing, and regulatory strategy, de-risking the oftentimes arduous pathway ahead.

Now let’s look at the two proposed changes to the Pre-Submission program. First is a proposed deposit of $2,000 for a device’s first original Pre-Submission that will be then credited to Sponsors upon the submission of a later marketing application. The rationale for this fee is to compensate FDA for the time-intensive review of such submissions and may reduce review load by encouraging Sponsors to pursue Pre-Submissions only when seriously considering a marketing application. Pre-Submission supplements are not subject to this fee, and the FDA review timeline for original and supplement submissions remains unchanged at 70 calendar days. While a $2000 fee may not seem like much now, MDUFA fees go up every renewal cycle, and over time, rising Pre-Submission fees may stifle early innovation from small companies. Importantly, it is not yet clear how the Pre-Submission deposit would be implemented for device types that do not have marketing application fees associated with them, such as pediatric and humanitarian use devices. Additionally, it is unclear if Pre-Submission deposit fees for Sponsors designated as small businesses will also be reduced, as these companies are currently offered discounted marketing submission fees. It will be essential for MDUFA to clarify how the fee will be handled in these key areas.

Second, MDUFA VI proposed a new Focused Follow-Up Pre-Submission, which would allow Sponsors to pose a single topic with a small number of focused questions to FDA, with a 45-day written feedback window instead of 70 days. The Focused Follow-Up Pre- Submission is great news for Sponsors who need quick clarification on one or two points, without the hold-up of the 70-day review timeline for feedback.

While the reduced review timeline of the proposed Focused Follow-Up Pre-Submission is undisputably positive, the proposed Pre-Submission deposit may raise concerns for small medical device manufacturers weighing the timing of their first FDA interaction. For Sponsors who are interested in providing public feedback on outlined recommendations, a public meeting discussing MDUFA VI will be held on August 5, 2026, and electronic comments will be accepted through August 6, 2026. Following the comment period and revisions, MDUFA VI will head to Capitol Hill for Congressional review with the finalized recommendations taking effect October 1, 2027.