Key Updates in FDA’s 2026 General Wellness and Clinical Decision Support Software Guidance

At a Glance

• Companies that make or sell wearables or wellness products should carefully review product claims, labels, and marketing to ensure they focus only on general wellness, not on specific diseases or conditions.
• For companies developing new products or updating existing products, it will be important to ensure that product design and intended use fit FDA’s definition of low-risk general wellness products.
• For companies making clinical decision support software intended to fall outside of the medical device definition, FDA now expects developers to provide clear, accessible documentation for health care professionals (HCPs) about how the software works. The greater the extent to which the software is a “black box” to HCPs, the greater the risk that FDA will assert that the product is a medical device.
• While FDA’s focus is on clinical validity and transparency, companies should also be sure to consider HIPAA privacy requirements if handling protected health information (PHI).

While US Food and Drug Administration (FDA) leaders were attending the annual Consumer Electronics Show, the agency issued updated guidance documents on January 6, 2026, concerning general wellness products and clinical decision support (CDS) software, superseding previous FDA guidance on these topics. 

1. General Wellness: Policy for Low-Risk Devices (2026 General Wellness Guidance) includes several material clarifications and expansions that are likely to affect product classification, claim development, and enforcement risk assessments, superseding FDA’s 2019 guidance.
2. Clinical Decision Support Software (2026 CDS Guidance) is refining the interpretation of when CDS functions are excluded from the definition of a medical device under Section 520(o)(1)(E) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), superseding FDA’s 2022 guidance.

Both guidance documents are nonbinding, yet provide important insight into how FDA plans to draw regulatory boundaries for software-driven products that may implicate medical device considerations. In both cases, neither guidance document represents a sea change from the previous approaches. Instead, FDA has offered some important clarifications and, most importantly, additional examples to help industry navigate compliance in this dynamic space. Below is a summary of material changes relevant to industry stakeholders.

Executive Summary

Wearables and Wellness

Taking a broader approach of what constitutes nondevice wellness products than the previous guidance, noninvasive wearables that estimate health metrics (like heart rate or blood glucose) can claim general wellness status if intended solely for wellness use; pose minimal risk; and avoid disease, diagnostic, or clinical management claims.

Focus on Low-Risk

Only products that are noninvasive and pose little safety risk qualify as “general wellness” products. Anything riskier (implanted, using lasers/radiation, etc.) falls outside the 2026 General Wellness Guidance and may be subject to medical device regulation.

Clearer CDS Rules

CDS software is not regulated as a device if it supports, not drives, health care professionals’ (HCP) decisions, uses validated data, and lets clinicians independently review recommendations.

Transparency Required

CDS developers must provide easy-to-understand information, whether through labeling, documentation, or directly in the app, about how recommendations are generated.

FDA Guidance = Policy Direction

These documents are not law, but they show how FDA will likely approach wellness and CDS products going forward. That said, how FDA operationalizes these guidance documents may not become clear unless and until the agency begins to take enforcement action in this fast-evolving space. 

Key Takeaways from the 2026 Updates

1. General Wellness Products

Expanded Clarity for Biometric and Sensor-Based Products

FDA may treat noninvasive sensing products estimating physiologic parameters — like blood pressure, heart rate, or glucose — as general wellness products when intended solely for wellness purposes and posing minimal risk. All labeling, instructions, and promotional materials of the product must align with the product’s wellness-focused intended use, with limited notifications suggesting professional evaluation allowed only if they do not reference specific diseases or diagnostic thresholds.

Test for Being Considered Low-Risk

The 2026 General Wellness Guidance applies only to low-risk products. Products that are invasive, implanted, or involve interventions or technologies, like lasers or radiation, that could pose safety risks without regulatory controls are not considered low-risk. The guidance includes a framework for determining whether a product qualifies for general wellness status.

Examples of Low-Risk General Wellness Products

FDA has provided illustrative examples showing when wearable products may be considered low-risk general wellness products and when they fall outside that category. Noninvasive wearable products that measure activity, recovery, sleep, pulse, or fitness-related biomarkers generally qualify as low-risk general wellness products, provided their claims avoid references to disease and the measurements are appropriately validated. Products that involve invasive or other higher-risk features, or that could pose safety concerns, may still be marketed using general wellness claims; however, such products do not meet the low-risk criterion and may fall outside the general wellness framework.

2. Clinical Decision Support Software 

As a reminder, certain CDS software functions are carved out of the statutory definition of “medical device” if they meet all four of the following criteria under section 520(o):

1. Not intended to acquire, process, or analyze a medical image or a signal from an in vitro diagnostic device or a pattern or signal from a signal acquisition system
2. Intended for the purpose of displaying, analyzing, or printing medical information about a patient or other medical information (such as peer-reviewed clinical studies and clinical practice guidelines)
3. Intended for the purpose of supporting or providing recommendations to a health care professional about prevention, diagnosis, or treatment of a disease or condition
4. Intended for the purpose of enabling such health care professional to independently review the basis for such recommendations that such software presents so that it is not the intent that such health care professional rely primarily on any of such recommendations to make a clinical diagnosis or treatment decision regarding an individual patient. 

Intended to Support Recommendations to Health Care Professionals

The 2026 CDS Guidance provides additional examples clarifying that CDS software may remain outside device regulation when it supports HCP decision-making using well-understood clinical data, generates recommendations for HCP review and finalization, and does not analyze medical images, signals, patterns, or other complex inputs. These are contrasted with discrete or episodic measurements, such as vital signs collected at a visit, that are generally well understood and do not involve analysis of continuous signals or complex physiological data streams, and which would not constitute a “pattern.” CDS software that relies on continuous or near-continuous measurements, image analysis, real-time or near-term predictions, emergent clinical scenarios, genomic or other nonvalidated data, or that effectively drives diagnosis or immediate clinical action generally remains subject to FDA oversight. 

Heightened Focus on Independent Review and Explainability to Mitigate Automation Bias

The 2026 CDS Guidance places a greater emphasis on transparency regarding data inputs, underlying logic, and how recommendations are generated — particularly for algorithmic or AI-driven CDS, evidencing increased FDA attention to automation bias and how HCPs interpret CDS outputs. FDA will consider software automation and the time-sensitive nature of HCP decisions to ensure clinicians can independently evaluate recommendations. That said, FDA conveyed that it intends to exercise enforcement discretion under Criterion 3 when the software provides only one recommendation that is clinically appropriate and all other criteria are met, as illustrated with several examples. Relatedly, FDA has changed its mind on one example that was identified in the previous guidance as a device function and is now identified as a nondevice function: software that identifies patients who are within the indicated population for a chemotherapeutic agent based on an analysis of patient-specific medical information.

Clearer Treatment of “Medical Information about a Patient”

The 2026 Guidance takes a broader interpretation of “medical information about a patient” to includes patient-specific data used in or related to clinical care, such as information shared between HCPs or with patients for clinical decisions. Device data, including in vitro diagnostic (IVD) test results used per FDA labeling, generally fall under this definition, as do peer-reviewed studies, clinical guidelines, and other independently verified, evidence-supported medical information. In a change from the 2022 guidance, whether information is commonly discussed in clinical conversations is not solely determinative; relevance to patient care and support by accepted sources is key.

Practical Implications for Industry

Product Claims and Marketing Materials

Companies that make or sell wearables or wellness products should carefully review product claims, labels, and marketing to ensure they focus only on general wellness, not on specific diseases or conditions. Products that estimate physiologic parameters such as heart rate or blood pressure may not be considered low-risk if their claims, functionality, or outputs imply medical use, guide clinical decision-making, or substitute for FDA-authorized devices. Any mention of health risks or encouraging users to seek professional evaluation should be carefully worded and avoid referencing specific diseases. 

Risk Assessment and Product Design

FDA has clarified what counts as “low-risk” for wearables and wellness devices. Products that are invasive, implanted, or use risky technologies (like lasers or radiation), are not considered low-risk and will face stricter oversight. For companies developing new products or updating existing products, it will be important to ensure that product design and intended use fit FDA’s definition of low-risk general wellness products. 

Software Transparency

For companies making CDS intended to fall outside of the medical device definition, FDA now expects developers to provide clear, accessible documentation for HCPs about how the software works. This includes explaining what data the software uses, the logic or rationale underlying its recommendations, and how outputs are generated. This is especially important for AI-driven or algorithmic tools. This transparency can be provided through product labeling, user manuals, supporting documentation, or directly within the software interface (such as help sections or explainability features). The key is that HCPs must be able to access and understand this information so they can independently evaluate the software’s recommendations. The greater the extent to which the software is a “black box” to HCPs, the greater the risk that FDA will assert that the product is a medical device. 

Partner and Data Considerations

FDA’s guidance clarifies that “medical information about a patient” includes a broad range of patient-specific data from validated and reliable sources, such as device data, test results, and clinical guidelines. Companies should ensure that any data used or shared with partners meets these standards and is clearly documented. While FDA’s focus is on clinical validity and transparency, companies should also be sure to consider HIPAA privacy requirements if handling protected health information (PHI). 

In Conclusion

The 2026 FDA guidance documents reflect an evolution toward greater clarity, transparency, and alignment in digital health regulation. Stakeholders should review these updates carefully and consider their impact on product development, regulatory strategy, and compliance programs.

This summary is for informational purposes only and does not constitute legal advice. For questions about specific products or regulatory strategies, consult with regulatory counsel or reach out to FDA’s Digital Health Center of Excellence.