Lexology January 15, 2026
The United States Food and Drug Administration (FDA) issued revisions this month to its guidance documents “Clinical Decision Support Software” (CDS Guidance) and “General Wellness: Policy for Low Risk Devices” (General Wellness Guidance).
The updates illustrate the evolution of FDA’s regulatory approach to CDS and general wellness devices since the enactment of the 21st Century Cures Act (Cures Act) in 2016, which exempted certain categories of software from the medical “device” definition. These are the second updates to the final versions of the CDS Guidance and General Wellness Guidance documents since they were originally issued in 2016 and 2019, respectively.
Both documents reflect an attempt to provide greater clarity on the line between device and non-device functions while emphasizing additional...
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