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Read moreACR® is preparing its response to an FDA request for comments regarding a petition asking for optional premarket flexibility for radiology CAD-type devices in exchange for post-market monitoring. This flexibility would be limited to eligible manufacturers of computer-aided detection (CADe), diagnosis (CADx), combined detection/diagnosis (CADe/x) and triage (CADt) devices.
Under this option, any manufacturer that already has at least one cleared CAD-type device could launch a similar CAD device without submitting a 510(k) premarket notification to FDA for review, with certain limitations. For example, a company with a prior CADt clearance, but not a clearance for a non-triage CAD device, could only access this flexibility for other CADt devices.
Additionally, the manufacturer must continue to satisfy FDA’s general and device-specific labeling and design verification/validation requirements (special controls), as well as new special controls focused on monitoring performance in real-world settings, such as:
While the additional special controls go beyond existing requirements, forgoing FDA’s premarket notification procedures would benefit the manufacturer by offering more flexibility while choosing testing methodologies to satisfy each of the special controls. For example, the petition mentions that FDA commonly recommends multi-reader/multi-case (MRMC) studies for showing “improved reader performance”—a special control that is essentially shared across CADe, CADx, and CADe/x device regulations, but for which MRMC studies are not explicitly required by regulatory language and thus alternatives could potentially be used. This would also reduce manufacturers’ regulatory costs and time-to-market, particularly benefiting manufacturers of multiple-finding devices.
FDA’s comment period closes Feb. 27. To help inform the College’s response, contact Michael Peters, ACR Senior Director of Government Affairs, by Jan. 27.
States Begin to Introduce Bills for 2026
States launch 2026 sessions with new bills on AI governance, rural radiation therapy, imaging workforce standards, and dose rules.
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