Summary
Publishes FDA’s final determination denying a requested partial exemption from premarket notification for specified radiology computer-aided detection, diagnosis, triage and notification devices. The order covers device categories under 21 CFR 892.2060–892.2090 and retains existing 510(k) requirements.
Healthcare Implications
Manufacturers of the covered radiology software must continue obtaining applicable FDA 510(k) clearance before marketing and meeting other device requirements. A previous clearance and proposed postmarket safeguards do not establish the requested exemption; this order does not prohibit all AI imaging products.