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# Clinical Assessments for Computer Detection Devices Guide
- URL: https://www.fdaweb.com/clinical-assessments-for-computer-detection-devices-guide/
- Published: 2022-09-28T12:00:00.000Z
- Updated: 2026-09-14T18:00:59.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5152848

FDA has issued a revised final guidance entitled “Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in Premarket Notification (510(k)) Submissions.” The document provides recommendations on clinical performance assessments of computer-assisted detection (CADe) devices applied to radiology images and radiology device data. “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),” the agency says.

The guidance also provides recommendations that may be useful for compliance with the special controls codified in 21 CFR 892.2070(b)(1), FDA says. Additionally, it has been revised with minor updates to reflect the issuance of the final rule, “Medical Devices; Medical Device Classification Regulations to Conform to Medical Software Provisions in the 21st Century Cures Act.”