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A Relaxing 2026? FDA Updates General Wellness and Clinical Decision Support Software Guidance
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 parameters . . . to be general wellness products when such outputs are intended solely for wellness uses" provided they satisfy enumerated criteria. In some cases, they may display values, ranges, trends, baselines, or longitudinal summaries, contextualize outputs in relation to wellness domains, and send user notifications recommending follow-up evaluation.
CDS Software Guidance
In updating the 2022 guidance, FDA clarifies the scope of its oversight of CDS software intended for health care professionals ("HCP"), addressing the criteria that software functions must satisfy to be excluded from the "device" definition. Changes include:
- Time-Critical Decision-Making Removed from Criterion 3. FDA removed most language automatically excluding CDS intended for use in "time-critical decision-making"—which would subject it to regulation as a "device"—and reoriented it as a Criterion 4 factor. While providing more flexibility, maintaining such time-critical decision-making nature as a factor indicates higher risk of CDS constituting a "device," reflecting FDA's view of increased risk of automation bias when HCPs have insufficient time to consider other information.
- New Enforcement Discretion Policy for Criterion 3. FDA will exercise enforcement discretion for software functions providing only one option if that is the only clinically appropriate option, so long as the function meets the other criteria.
- Softened Criterion 4 Transparency Requirements. FDA eased the requirement to satisfy Criterion 4 by providing that a "summary of the general approach . . . at a level of detail appropriate for the intended user and use environment" only needs to be "sufficient for the intended HCP user to understand the basis of the recommendation[.]"
