510(k) MDUFA decision performance goal

Under MDUFA V (FY2023–2027), the FDA commits to issuing a decision on 95% of Traditional 510(k) submissions within 90 FDA days, with a substantive interaction by day 60 and an acceptance-review decision by day 15. Special 510(k)s target 30 days. Crucially, these are FDA days — the clock stops whenever the agency issues an Additional Information request — which is why the 90-day headline and the real-world calendar (often 6–9 months) diverge. A separate Shared Outcome metric (~112 calendar days) includes sponsor time.