FDA to Regulate More AI & Software Tools as Devices, Guidance Indicates

At the same time, FDA made minor conforming revisions to the Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices final guidance, as well as the Policy for Device Software Functions and Mobile Medical Applications final guidance, and FDA indicated that those guidances will continue to apply to CDS software that supports or provides recommendations to patients or caregivers.

FDA also recently issued a report on its Digital Health Software Pre-certification (Pre-Cert) Pilot Program concluding that the approach described in its working model is not practical to implement under current statutory and regulatory authorities. We analyze these developments in this article.

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