FDA’s 2026 CDS and General Wellness Guidance Updates

By Amanda Johnston

Why Design, Claims, and UX Now Drive Regulatory Risk

For companies developing digital health products, wearables, or software-enabled devices, FDA’s latest guidance updates provide important clarification on how certain products may fall within, or outside, FDA oversight.

On January 6, 2026, FDA issued revised guidance addressing Clinical Decision Support (CDS) Software and General Wellness: Device Policy for Low Risk Devices. While public statements from FDA leadership and subsequent media coverage have emphasized reduced regulatory burden for certain low-risk technologies, a close comparison of the guidance documents reflects a more targeted refinement of FDA’s approach.

FDA has not broadly deregulated these products or changed the underlying statutory framework. Instead, the Agency has clarified the contours of its enforcement discretion in ways that are particularly relevant to how products are designed, presented, and understood by users. As a result, regulatory risk is increasingly influenced by design choices, claims, and user experience, reflecting FDA’s broader focus beyond the underlying technology or data inputs.

CDS: Flexibility Through Discretion, Not Exemption

The statutory framework for Non-Device CDS remains unchanged. What has changed is FDA’s willingness to rely more explicitly on enforcement discretion for certain software functions that sit near the edge of the statutory criteria. The revised guidance reflects a more pragmatic approach to CDS outputs, including certain risk scores and single-option recommendations, while preserving FDA’s ability to intervene when automation, time-critical use, or limited transparency could undermine independent clinical judgment.

FDA did not expand the statutory exemption for CDS. Instead, it chose discretion rather than reinterpretation of the law. That distinction matters because enforcement discretion can be narrowed or withdrawn and places greater emphasis on how CDS tools are positioned and used in practice. Time-sensitive workflows, highly automated outputs, and features that effectively substitute for clinician judgment remain higher risk. Companies should expect FDA to assess not only what a CDS tool outputs, but how clinicians are expected to rely on it in real-world workflows.

General Wellness: Measurement Is Not the Line. Interpretation Is

The revised General Wellness guidance provides clearer direction for wearables and sensor-based products, particularly those that estimate, infer, or output physiologic parameters. FDA now expressly acknowledges that certain non-invasive sensing of parameters such as heart rate, blood pressure, oxygen saturation, glucose, or heart rate variability may fall within general wellness when intended solely for wellness use and subject to specific guardrails.

The practical shift is this: physiologic measurement alone no longer determines regulatory status; interpretation does. FDA draws sharper boundaries around alerts, ranges, contextualization, and claims. Products fall outside the general wellness policy if they characterize outputs as diagnostic or abnormal, reference clinical thresholds, prompt or guide specific clinical action or medical management, or imply substitution for FDA-cleared/approved devices. Disclaimers alone are not sufficient to overcome design or presentation choices that signal medical use.

As a result, regulatory weight has shifted toward user interface design, visual cues, notifications, and how outputs are framed over time. Products that previously relied on the absence of explicit disease claims may now face scrutiny based on how users are likely to interpret and act on the information presented.

WHOOP in Context

We previously reported on FDA’s 2025 Warning Letter to WHOOP, which underscores this point. While the revised General Wellness guidance now articulates a conditional path for certain non-invasive physiologic estimates to be treated as wellness, the case of WHOOP illustrates the continuing enforcement risk when features, presentation, or marketing drift toward “medical-grade” positioning or imply diagnosis or clinical management. The updated guidance does not eliminate that risk; it clarifies how to avoid it.

Practical Implications for Digital Health Companies

Across both CDS and General Wellness guidances, FDA has shifted regulatory risk upstream, away from sensors or algorithms alone and toward how products are designed, validated, and communicated.

In light of these shifts, companies should reassess:

• UX/UI decisions, including color coding, ranges, and alerts
• Claim language across labeling, marketing, and investor materials
• Internal validation supporting “wellness” ranges or outputs
• How and when users are prompted to seek professional input
• Governance and review processes across product, regulatory, legal, and marketing teams

For companies operating near clinical boundaries, these updates do not necessarily require abandoning features or pursuing full FDA premarket pathways. They do, however, require intentional design choices and disciplined claim control to remain within FDA’s enforcement discretion.

“FDA’s updated guidances provide flexibility, but that flexibility is conditional. Companies that understand where enforcement discretion begins and ends can often preserve it through disciplined product design and claim control.”
Amanda Johnston, Partner, Gardner Law

How Gardner Law Can Help

Gardner Law advises digital health and medical device companies on how to apply FDA’s newly issued CDS and General Wellness guidances to real-world products and product roadmaps. We help companies evaluate whether features fall within enforcement discretion, identify design- and claims-driven regulatory risk, and recommend practical adjustments or, where appropriate, plan and sequence the right regulatory pathway.

If you would like to understand how these revised guidances affect your current product, planned features, or pipeline strategy, we are happy to discuss.