Submission pathway decision tree
Explore FDA submissions and EU conformity routes using your confirmed device status. Each supported route connects to its checklist and cost estimate.
Intended purpose & confirmed device status
510(k)
Substantial equivalence
De Novo
Novel Class I / II rationale
PMA
Class III approval requirements
EU conformity
MDR / IVDR + AI Act scope
Illustrative routes, not an exhaustive classification map. Exemptions and special pathways require separate assessment.
Decision 1
Which market are you planning for?
This guide covers FDA submissions and EU conformity assessment. Assess other markets independently.
Educational orientation only. This guide does not determine device qualification, class, substantial equivalence or authorization. AI does not by itself establish a submission pathway. Assess risk classification if your device status is not yet defined.