FDA Guidance: Clinical Performance Assessment, Considerations for Computer-Assisted Detection Devices Applied to Radiology Image, 7/12

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In July 2012, the US FDA published this guidance for industry and FDA staff, Clinical Performance Assessment: Computer-Assisted Detection Devices Applied to Radiology Images and Radiological Device Data – Premarket Authorization (PMA) and Premarket Notification [510(k)] Submissions.

This document provides recommendations regarding clinical performance assessment of computer assisted detection (CADe) devices applied to radiology images and radiological device data.

CADe devices are computerized systems that incorporate pattern recognition and data analysis capabilities and are intended to identify, mark, highlight, or direct attention to portions of an image, or aspects of radiological data to reveal abnormalities during interpretation of patient data.