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title: "Submission cost & timeline estimator · AI SaMD"
description: "Planning numbers for AI/ML device submissions: fees, review weeks, deficiency-letter count, prep cost across FDA, EU MDR, MHRA, HC, PMDA, TGA, NMPA."
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[Back to AI SaMD Playbook](/)Planning 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.

Pathway

-   FDA 510(k) · AI/ML-enabled SaMD
    
    United States
    
-   FDA De Novo · AI/ML-enabled SaMD
    
    United States
    
-   FDA PMA · AI/ML high-risk
    
    United States
    
-   EU MDR Class IIa · AI high-risk
    
    European Union
    
-   EU MDR Class IIb · AI high-risk
    
    European Union
    
-   EU MDR Class III · AI high-risk
    
    European Union
    
-   UK MHRA · UKCA route (post-2030)
    
    United Kingdom
    
-   Health Canada Class III · ML-enabled
    
    Canada
    
-   China NMPA Class III · AI medical device
    
    China
    
-   PMDA Class III · AI program-medical-device
    
    Japan
    
-   TGA Class IIb · AI software medical device
    
    Australia
    

Small Business Determination (US only) Predicate / reference devices 

Zero predicates pushes a 510(k) toward De Novo · adds 4–6 months and 6–7× the fee.

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.

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