FDA Publishes Guidance On Radiology Images And Device Data For Submitting 510(k)s
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.
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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.
During a recent listening session on modernizing its recall process, the US FDA heard from industry, consumers, and patients — all of whom expressed a common theme: the agency needs to up its game in how it handles recalls.