This guidance document provides recommendations to industry, systems and service providers, consultants, FDA staff, and others regarding clinical performance assessment of computer-assisted detection (CADe) devices applied to radiology images and radiology device data (often referred to as “radiological data” in this document). CADe devices are computerized systems that incorporate pattern recognition and data analysis capabilities (i.e., combine values, measurements, or features extracted from the patient radiological data) 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 (i.e., a physician or other health care professional), referred to as the “clinician” in this document. We have considered the recommendations on documentation and performance testing for CADe devices made during the public meetings of the Radiology Devices Panel on March 4-5, 2008 and November 17-18, 2009. We have also considered the public comments received on the draft guidance announced in the Federal Register on October 21, 2009 (74 FR 54053).

In addition, FDA has issued a final order reclassifying Medical image analyzers applied to mammography breast cancer, ultrasound breast lesions, radiograph lung nodules, and radiograph dental caries into Class II (special controls) and subject to premarket notification (510(k)) requirements (See Reclassification of Medical Image Analyzers Federal Register Final Order 85 FR 3545 (issued January 22, 2020)). This guidance provides recommendations that may be useful for compliance with the special controls codified in 21 CFR 892.2070(b)(1) and noted in italic font for clarity in the guidance.