The US Food and Drug Administration has published final guidance to give developers of software systems that detect anomalies in medical imaging a better idea as to the agency’s thinking in reviewing premarket 510(k) submissions. The document, “Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in Premarket Notification (510(k)) Submissions,” issued on 28 September, supersedes the document of the same title issued in January 2020. (Also see "Reclassification Order Spurs FDA To Update Computer-Assisted Detection Devices Guidance" - Medtech Insight, 21 January, 2020.)
The FDA issued the original document in 2012. The new version has been updated for compliance with the final rule...