Lexology January 22, 2026
On Jan. 6, 2026, the U.S. Food and Drug Administration (FDA) updated the final guidance documents General Wellness: Policy for Low Risk Devices (the General Wellness Guidance) and Clinical Decision Support Software (the CDS Guidance), which supersede the previous versions of these final guidance documents issued in 2019 and 2022, respectively.
While FDA guidance documents do not establish legally enforceable responsibilities, they do describe the agency’s current thinking on a topic and remain relevant for informing industry actions to comply with federal law. Stakeholders that have relied upon the prior versions of these final guidance documents may wish to closely review these updates to determine the potential impact on their products and business. Further, stakeholders may need to remember that,...
Today's Sponsors
Today's Sponsor