Reclassification Order Spurs FDA To Update Computer-Assisted Detection Devices Guidance
To mesh with a final order reclassifying medical-image analyzers, the US agency has also published a final guidance on computer-assisted detection (CADe) devices that was first finalized more than six years ago.
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The US FDA has updated guidance on computer-assisted detection devices that was first released in 2012. The document, which is intended to help developers win FDA approval of their products, was last updated in 2020.
The US agency will host a two-day meeting to discuss the evolution of artificial intelligence technology used to analyze radiological images when diagnosing patients and in advising radiologists to take optimal pictures. The takeaways from the meeting will be used by the FDA to help it develop its thinking on how to regulate such technology.
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.