Policy & regulation · Sep 9
If FDA Reviews AI Devices Like Doctors, Approval Is Only Round One
The signal for medtech builders is not panic. It is that adaptive clinical AI may need continuing proof of competence after clearance.
- Treat the FDA discussion paper as a signal, not a binding rule.
- Build monitoring, update review, and clinical escalation into adaptive AI products early.
- Separate current legal obligations from likely evidence expectations for postmarket oversight.