FDA Issues Updated Guidance on Low-Risk General Wellness Devices and Clinical Decision Support Software

The FDA’s revised guidance documents on low-risk general wellness devices and clinical decision support (CDS) software supersede the agency’s prior policies. The updates clarify regulatory boundaries, introduce targeted compliance expectations, and reflect the agency’s evolving approach to modern health technologies.

Low-Risk General Wellness Devices: Key Changes in 2026 Guidance

The 2026 guidance on low-risk general wellness products replaces the 2019 version, preserving the FDA’s policy of not regulating low-risk “general wellness” products as medical devices while introducing material clarifications for contemporary wearables and software. The core policy remains: The FDA does not intend to regulate low-risk general wellness products as medical devices, provided they are intended solely for general wellness use and present low risk to users and other persons.

Notable updates include:

• Expanded Scope for Physiologic Outputs: The guidance details conditions under which certain functions that estimate or display physiologic parameters (e.g., blood pressure, oxygen saturation, glucose, heart rate variability) may be considered “general wellness.” Permissible outputs must be non-invasive, intended solely for wellness, and avoid clinical claims, thresholds, or prompts for medical management. If outputs mimic values used for clinical purposes, the outputs should be supported by manufacturer testing or peer reviewed literature.

• Explicit Disqualifying Features: The FDA’s guidance document further identifies labeling, advertising, user interface, and functional elements that will render a product a regulated device. These include references to specific diseases, clinical thresholds, treatment guidance, claims of clinical equivalence, or intended use statements for diagnosis, screening, monitoring, or management.

• Limited Notifications to Seek Professional Evaluation: The guidance clarifies that a product may still qualify as a general wellness product if it includes a notification suggesting that users consult a health care professional when outputs warrant attention, provided such prompts do not name a specific disease or condition, characterize outputs as “abnormal” or diagnostic, or include clinical thresholds or recommendations.

• Updated Examples and Administrative Changes: The guidance includes new examples reflecting current technologies, including wearables estimating physiologic parameters via optical sensors (with appropriate support). Invasive technologies, such as microneedle glucose sensors, remain outside the policy and would be regulated as medical devices.

Practical Implications

Manufacturers of wellness wearables and software seeking to fall under the policy should align intended use, product claims, user experience, and marketing materials with a strictly wellness-oriented posture, document support for any physiologic outputs, and avoid features that could imply diagnosis, thresholds, or medical management. The guidance provides clearer compliance signposts but leaves open questions regarding the sufficiency of validation of what constitutes permissible contextual information.

Clinical Decision Support Software: Refinements in the 2026 Update

The January 6 guidance on CDS software, intended to help developers assess whether CDS functions are excluded from the medical device definition under section 520(o)(1)(E) of the Federal Food, Drug, and Cosmetic Act, supersedes the FDA’s 2022 version. The new version retains the statutory four-criterion framework and introduces targeted refinements with practical impact for developers and providers.

Key changes include:

• Enforcement Discretion for Single-Output Recommendations: The FDA now states it will exercise enforcement discretion for CDS functions that output a single clinically appropriate recommendation, provided all other statutory criteria are met. This creates a narrow pathway under enforcement discretion; the guidance does not define “only clinically appropriate option.”

• Clarified Definition of “Medical Information”: The guidance emphasizes that inputs must be supported by well-understood and accepted sources, and that context matters. Developers should expect closer scrutiny of reference sources, guidelines, and evidence used in CDS functions.

• Elevated Usability and Disclosure Expectations: The update expands expectations for enabling independent clinician review of recommendations, stressing plain language, appropriate detail, and avoidance of information overload. Presentation and usability are integral to compliance, particularly in mitigating automation bias and supporting decision making in time-critical contexts.

• Continuity and Expanded Examples: Most examples from the 2022 guidance are retained, with new scenarios illustrating the enforcement discretion policy and clarifying boundaries for device oversight.

Practical Implications

Developers should ensure rigorous documentation of sources, validation, and user interface design that enables independent clinician review. Providers integrating CDS should expect more granular disclosures and usability-focused outputs. Given the narrow, conditional nature of the single-output policy, companies should maintain device-like documentation and controls. Companies with products or portfolios shaped to prior guidance should review and update documentation, labeling, and user experience to align with the 2026 refinements. For both general wellness products and CDS software, the updated documents reward disciplined validation, careful source curation, and thoughtful presentation of information. Where products approach regulatory boundaries, early engagement with the FDA may be advisable.

Conclusion

The 2026 FDA documents provide a clearer, more contemporary roadmap for compliance in the rapidly evolving consumer health technology market. While preserving core FDA policies, the updates introduce explicit boundaries, conditional flexibility, and usability requirements that will shape product development, marketing, and regulatory strategy. Companies should align practices with the FDA’s clarified standards and remain vigilant for further developments in FDA policy.

If you have any questions on the FDA’s 2026 guidance updates, please contact Emily Cowley Leongini, Abha Kundi, or a member of our Food, Drug, Medical Device & Cosmetic team.