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MDUFA Performance Goals & Timelines

Under MDUFA VI (FY2023–2027), FDA has committed to meeting defined review performance goals. These goals are measured as Total Time to Decision (TTD) — from the date FDA receives a substantially complete submission to the date of the final decision.

MDUFA VI review timelines​

510(k) submissions​

MetricGoal
Total Time to Decision (TTD)90 calendar days
Substantive Interaction (FDA reaches out)Within 60 calendar days
Refuse to Accept (RTA) reviewWithin 15 business days
Special 510(k) TTD30 calendar days

De Novo classification requests​

MetricGoal
Total Time to Decision150 calendar days
Substantive InteractionWithin 100 calendar days
Refuse to Accept reviewWithin 15 business days

Premarket Approval (PMA)​

Submission typeTTD Goal
Original PMA180 calendar days
Panel Track Supplement180 calendar days
180-day Supplement180 calendar days
Real-Time Supplement90 calendar days
HDE original180 calendar days

Q-Submissions (Pre-Subs)​

TypeResponse time goal
Pre-Submission (written response)90 calendar days
Pre-Submission (meeting)60 calendar days
Informational meeting30 calendar days
Submission Issue Request30 calendar days

What the clock includes (and excludes)​

The review clock pauses (stops) when:

  • FDA issues an Additional Information (AI) request — clock stops until submitter responds
  • A major deficiency letter is issued on a PMA — clock stops during response period

The review clock starts when:

  • FDA accepts the submission (passes the RTA/filing review)

MDUFA performance reports​

FDA publishes quarterly MDUFA performance reports measuring actual performance against these goals. Reports are available at:

Official resources​