MDUFA VI draft commitment letter would cut the 510(k) average to 112 days by 2032

MedDevice Startups Staff · Jul 8 · 3 min read · Via FDA MDUFA VI page

FDA published the draft MDUFA VI commitment letter on July 8, 2026, setting out performance goals and procedures for fiscal years 2028 through 2032. FDA and industry, represented by AdvaMed and MDMA, reached agreement in principle at their March 18, 2026 negotiation meeting after fourteen sessions starting October 29, 2025. MDUFA V expires September 30, 2027.

The 510(k) goal is the one to watch. Average total time to decision steps down from 128 calendar days in FY2028 to 124, 120, 116 and finally 112 in FY2032, while the underlying commitment stays at a MDUFA decision within 90 FDA days for 95 percent of submissions. That gap between 90 FDA days and 112 total days is industry time, and it is where most startups lose their quarter. De Novo requests keep a 150 FDA day goal for 90 percent, with an introduction meeting inside the first 30 FDA days for requests received after October 1, 2027. Original PMAs keep a 285 calendar day shared outcome goal.

Three additions change day-to-day practice. A Focused Follow-Up pre-submission, due to launch by December 30, 2027, gets a written response in 45 calendar days, but only for a follow-up question from a submission in the prior 180 days, on one substantial topic, in about ten pages. A not grantable letter for De Novo requests gives FDA a formal way to say no early, with a final determination within 75 calendar days of the response. Major deficiency letters must reflect a complete review and get supervisory sign-off before issuance, and later deficiencies are limited to issues raised by the response unless a new safety or effectiveness concern appears.

TAP converts from pilot commitments to goals: a teleconference within 21 days and written sprint feedback within 45 days for 90 percent of requests. FDA held its public meeting on August 5, 2026 under Docket FDA-2026-N-6655, and the package goes to Congress ahead of the September 30, 2027 deadline.

Questions & Answers

What are the proposed 510(k) review goals under MDUFA VI?

The draft commitment letter steps average total time to decision for 510(k)s from 128 calendar days in FY2028 to 124, 120, 116 and 112 by FY2032, while keeping the goal of a MDUFA decision within 90 FDA days for 95 percent of submissions.

What is a Focused Follow-Up pre-submission under MDUFA VI?

It is a new pre-submission type FDA would implement by December 30, 2027 with a 45-day written response goal. It is limited to follow-up questions from a submission within the previous 180 days, one substantial topic, and roughly ten pages. Requests that do not qualify convert to a traditional pre-submission.

When does MDUFA V expire and when is the public meeting on MDUFA VI?

MDUFA V expires September 30, 2027. FDA held a hybrid public meeting on the proposed MDUFA VI recommendations on August 5, 2026 under Docket FDA-2026-N-6655, with comments due August 7, 2026.

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