insights
Introduction
Early dialogue with the FDA has long been one of the most valuable tools in a device developer's regulatory toolkit — and, notably, a free one. The Pre-Submission (Q-Submission) program lets sponsors ask the agency specific questions before they commit to a testing plan or a marketing submission. A proposal in FDA's draft MDUFA VI commitment letter would change part of that equation for the first time: it would attach a fee to the initial Pre-Submission.
Key Takeaways:
- FDA's draft MDUFA VI commitment letter (FY2028–2032) proposes a $2,000 deposit fee for an initial traditional Pre-Submission, credited toward a later marketing application fee if one is filed.
- Pre-Submission supplements and the new Focused Follow-Up Pre-Submissions would remain fee-exempt, and the 70-calendar-day review timeline is unchanged.
- The proposal responds to surging demand: FDA reviewed 4,502 Pre-Submissions in FY2025 — about 26% above the prior five-year average, and more than the 4,151 510(k)s reviewed that year.
- The tradeoff is real: a modest fee may sharpen how sponsors use Pre-Subs, but it could also deter smaller and early-stage companies from seeking FDA input when it matters most.
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What's actually being proposed
The draft MDUFA VI commitment letter would introduce a $2,000 deposit on an initial traditional Pre-Submission, credited back against a later marketing application fee if the program advances to one. FDA frames the fee as compensation for review time and as a way to discourage filings from sponsors who aren't seriously pursuing a marketing pathway. Importantly, this is a proposal within the FY2028–2032 user-fee negotiations — not a fee in effect today — and the review clock stays at 70 calendar days.
Why now
The program has, in a sense, become a victim of its own usefulness. FDA reviewed 4,502 Pre-Submissions in FY2025, roughly a quarter above the prior five-year average and more than the number of 510(k)s the agency cleared in the same year. When a free, high-value channel grows that quickly, a fee becomes a predictable lever to manage demand and recover review effort.
The regulatory-strategy tradeoff
There's a reasonable case on each side.
A fee — even a small, creditable one — could encourage sponsors to use Pre-Subs more deliberately and to invest more in the quality of the questions they bring to FDA. Sharper questions tend to yield more useful answers, and a lighter, higher-signal queue could benefit everyone.
The concern is friction at exactly the wrong moment. Early FDA feedback shapes regulatory strategy, testing, clinical requirements, and ultimately development cost. For an established company, $2,000 is negligible against a program budget. For a first-time innovator or an early-stage startup, it's another gate — and the real risk isn't the dollar amount, it's that the fee nudges a team to skip the conversation that would have prevented a far more expensive misstep later. The credit toward a future marketing fee also only helps sponsors who reach that submission.
The question that matters
The open question is whether the fee improves the efficiency and value of the Pre-Submission process or discourages sponsors from seeking regulatory alignment early enough to avoid costly missteps. The answer will depend on the final MDUFA VI terms — and, in the meantime, this is still a proposal in an open comment process, so sponsors who feel strongly can weigh in through the Federal Register docket.
Whatever the outcome, the underlying lesson holds: a Pre-Submission delivers the most value when the questions are specific and the regulatory strategy has been thought through first. That's true at $0, and it will be just as true at $2,000.
