Back to AI SaMD PlaybookPlanning tool · indicative numbers, not regulatory advice
Submission cost & timeline estimator
Pick a pathway. Get the user fee, the realistic prep window, the regulator review goal, and the deficiency-letter count you should budget for. Sources cited beside every number · update before you put any of this in a board deck.
Government user fee
$24,335
Standard rate
Regulator review (days)
90 – 180
12–26 weeks calendar time
Deficiency letters expected
1 – 3
Plan response capacity for the high end
Internal preparation
4–9 months · estimated total prep + consultancy $97,340 – $292,020
Includes V&V, clinical evidence assembly, cybersecurity documentation, PCCP drafting, eSTAR/eDocs build, and RA/QA cycles. Excludes clinical-trial costs and post-market surveillance build-out.
Basis
MDUFA V FY2026 fee schedule; FDA 510(k) decision goals; AI/ML lifecycle draft (Jan 2025).
Notes
Most AI 510(k)s receive at least one Additional Information request, often on validation data representativeness or PCCP scope.
Indicative only · check the current published fee schedule before quoting.