FDA & CDS Pathways

If software diagnoses, treats, or informs clinical decisions without being part of a hardware device, it's Software as a Medical Device under FDA device law. The regulatory question isn't 'is it AI' — it's 'what does it claim to do and what's the risk if it's wrong'.

Risk class drives the pathway: most imaging CADe tools go 510(k) (substantial equivalence to a predicate device — 'like that cleared thing'); novel moderate-risk devices go De Novo; highest-risk go PMA (premarket approval — the full evidence bar).