Free tool · FY2024 FDA performance data
Timeline Estimator
Phase-by-phase weeks from kickoff to clearance. Built from FDA's published median review times and Q-Submission program guidance. See exactly where your time goes.
510(k) Premarket Notification · with optional phases
Pre-Sub (optional)
2.8 months - 3.7 months
Briefing doc prep + 70-day FDA written response. Skip if predicate path is clear.
Submission preparation
2.8 months - 6.0 months
Predicate analysis, performance testing, software docs (IEC 62304), labeling.
FDA review
5.1 months - 6.9 months
FY2024 average review time 177 days. MDUFA goal 90 days but real time longer with AI requests.
Additional Information rounds
4 weeks - 2.8 months
1-3 rounds of FDA questions, sponsor on the clock during response prep.
Decision letter
1 weeks - 2 weeks
SE letter or NSE. NSE typically requires De Novo or PMA pivot.
Total estimated duration
11.8 months to 1.7 years
Real-world variance is high. Sponsors with prior FDA interactions and clean Pre-Sub feedback land near the low end. First-time sponsors with novel technology trend toward the high end or beyond.
Compass collapses the high end
Most variance comes from rework. The platform eliminates it.
The submission preparation phase is where teams lose months. Compass drafts every section against the predicate, the standard, and your evidence simultaneously. Confidence-gated, citation-chained, auditable. The "AI rounds" phase typically halves.
Try the sandboxSource: FDA Performance Reports (510(k), De Novo, PMA) FY2024. Q-Submission Program guidance (Sept 2023).
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