ACR® 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:
- Developing and implementing a post-market monitoring plan.
- Providing access to instructions for use in the user interface.
- Providing a means of exporting retrievable AI results to the end user.
- Limiting distribution of the device to facilities with appropriate training programs—such programs must include a description of the “qualified end users” of the device (i.e., those with necessary qualifications and training to independently interpret medical images without the aid of the device, such as radiologists).
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.
