MDUFA VI: The Draft Deal Is Out, With a Faster 510(k) Clock

The next five years of FDA device review economics are now on paper. On 8 July 2026 FDA published its proposed recommendations for MDUFA VI — the user-fee agreement for fiscal years 2028 through 2032 — posted the draft commitment letter, and set a hybrid public meeting for 5 August. The statute gives the public thirty days to talk back before the recommendations go to Congress.

Why this notice exists

MDUFA reauthorization runs on statutory rails. Section 738A of the FD&C Act requires FDA to negotiate with industry, consult stakeholders, publish the resulting recommendations in the Federal Register, take thirty days of comments, hold a public meeting, and revise before presenting the package to the House Energy and Commerce and Senate HELP committees. This notice — and the 5 August meeting — is FDA discharging those steps. The negotiations themselves ran from October 2025 through March 2026 with the Advanced Medical Technology Association and the Medical Device Manufacturers Association, with monthly consultations alongside patient, consumer, and academic representatives; the minutes are on FDA's MDUFA VI page. FDA notes the recommendations “remain subject to change” until the final commitment letter is published.

The clocks

The shared outcome goals — the ones FDA and industry own jointly, measured in average Total Time to Decision — are the numbers a submission planner will care about first. For original PMAs and panel-track supplements the proposal holds 285 calendar days flat across all five years. For 510(k)s it commits to a ramp: 128 calendar days in FY 2028 stepping down to 112 by FY 2032. The core decision goals for most submission types — PMAs and their supplements, 510(k)s, CLIA waivers, BLA-related types — carry over from MDUFA V unchanged, which the notice presents as sustaining a program that is currently hitting its marks: all 14 calculable submission review goals met in FY 2023, and preliminary data showing FY 2024 and FY 2025 on track.

Pre-Submissions get a fee — and a fast lane

The Pre-Submission program keeps its goal — written feedback on at least 90 percent of Pre-Subs within 70 days, for up to 5,000 per year — and gains a second track: the Focused Follow-Up Pre-Submission, for targeted follow-up questions on a prior Pre-Sub, with a written response inside 45 calendar days. The other side of that bargain is money: FDA and industry agreed to propose amending the FD&C Act to charge a fee for initial Pre-Submissions, “to promote efficient use of the program”, with sponsors later receiving a corresponding credit on certain related marketing submission fees. Free, unlimited Pre-Subs have been a fixture of device strategy; a fee — even one recouped later — changes how liberally they get filed.

De Novos, deficiency letters, and consistency

• De Novo: the 150-FDA-day decision goal stays at 90 percent, joined by a structured Introduction Meeting within the first 30 FDA days and a “Not Grantable” letter, with a final grant-or-decline determination within 75 — at most 90 — calendar days of the sponsor's response.
• Deficiency letters: the 95-percent goal for stating the basis of each deficiency continues, plus a new survey of letter recipients on communication quality, feeding improvement work.
• Review consistency: a new commitment — at least one high-impact topic area improved per fiscal year, minimum eight across the five years, with industry supplying a prioritized list annually and FDA reporting back on what changed.
• Infrastructure: continued hiring, upgrades to the Customer Collaboration Portal, an interactive “Navigator” tool, and a Resource Capacity Planning capability with an implementation plan due by 31 March 2029.

What is not settled

The recommendations are a draft twice over: FDA may revise them after the meeting and comments, and Congress still has to legislate — the fee schedule itself, including the new Pre-Submission fee, requires amending the statute. The notice does not state fee amounts for FY 2028 onward; those come with the final package. What is fixed is the deadline that gives the process its urgency: MDUFA V authority expires 30 September 2027, and, as the notice puts it, new legislation will be required for FDA to keep collecting device user fees at all.