US FDA drafts guidance on computer-assisted detection devices

The US Food and Drug Administration has issued two related draft guidance documents on computer-assisted detection (CADe) devices applied to radiology images and radiology device data1.

One of the documents provides recommendations relating to premarket notification submissions (ie the “510(k)” process)2; the other contains recommendations on how to design and conduct clinical studies of these devices3, which are computerised systems that incorporate pattern recognition and data analysis capabilities intended to identify, or direct