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US FDA explains clinical study, pre-market requirements for computer-assisted detection devices

 
• By Vibha Sharma

The US Food and Drug Administration has issued updated versions of two related guidelines on computer-assisted detection (CADe) devices applied to radiology images and radiology device data. The guidelines explain how manufacturers should design and conduct clinical performance studies, and submit pre-market notification, or 510(k), applications for these products.

The US Food and Drug Administration has issued updated versions of two related guidelines on computer-assisted detection (CADe) devices applied to radiology images and radiology device data. The guidelines explain how manufacturers should design and conduct clinical performance studies, and submit pre-market notification, or 510(k), applications for these products.

Drafts of the documents were issued for stakeholder consultation in October 2009; these have been updated in light of comments from stakeholders and the feedback gathered from public meetings on this topic. For example, they have been revised to clarify the level of detail that the FDA would like to see regarding the description and operation of the CADe device and about test data reuse

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