Lexology January 22, 2026
The U.S. Food and Drug Administration (“FDA”) recently issued updated final guidance documents on general wellness products and clinical decision support (“CDS”) software, reflecting a pro-innovation and risk-based regulatory approach.
On January 6, 2026, FDA issued two updated final guidances—one on general wellness products and another on CDS software—which provide greater clarity and reflect FDA’s continued effort to address rapidly evolving technologies while maintaining a risk-based regulatory approach.
General Wellness Guidance
This guidance, last updated in 2019, clarifies FDA’s approach to “general wellness products” and describes which software functions are exempt from the “device” definition and which low-risk devices are subject to FDA enforcement discretion. FDA now considers “certain products that use non-invasive sensing to estimate, infer, or output physiologic...
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