FDA Radiology CADe Device Guidance

FDA has published a guidance, Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data—Premarket Notification [510(k)] Submissions, with recommendations for 510(k) submissions for computer-assisted detection (CADe) devices applied to radiology images and radiology device data. The document says CADe devices are computerized systems that incorporate pattern recognition and data analysis capabilities and are intended to identify, mark, highlight, or in any other manner direct attention to portions of an image, or aspects of radiology device data, that may reveal abnormalities during interpretation of patient radiology images or patient radiology device data by the intended user, a healthcare professional.

The guidance contains Introduction, Background, Scope, Describing the Device in a 510(k), Standalone Performance Assessment, Clinical Performance Assessment, User Training, and Labeling.