As digital health technologies continue to proliferate, regulatory boundary setting has become increasingly critical. FDA’s 2026 update to its General Wellness policy refines the Agency’s enforcement posture for low-risk products. For regulatory professionals, this guidance provides essential insight into FDA’s current interpretation of device scope and risk.
On January 6, 2026, the U.S. Food and Drug Administration (FDA) issued an updated General Wellness: Policy for Low Risk Devices guidance, superseding the 2019 version. While nonbinding, the document articulates FDA’s current compliance policy and enforcement discretion framework for certain products that promote a healthy lifestyle but do not warrant active device oversight. The guidance is particularly relevant to sponsors developing consumer-facing software, wearables, and wellness technologies. Some key take-home messages from the guidance are critical to appreciate.
First, the intended use statement for a devise is the primary jurisdictional trigger for its designation as a general wellness device versus a device that requires formal approval.FDA reiterates that “general wellness products” are defined by intended use, as reflected in labeling, advertising, user interfaces, and functionality. Permissible claims are limited to maintaining or encouraging a general state of health or healthy activities (e.g., fitness, sleep, stress management, weight management, mental acuity).
Importantly, the guidance preserves a narrow allowance for disease-referenced claims only when framed as helping users “reduce risk” or “live well” with chronic conditions, provided the relationship between lifestyle and disease outcomes is well established and broadly accepted. Any express or implied diagnostic, therapeutic, or disease management claim places the product outside the scope of this policy
Second, “Low Risk” is an independent and mandatory threshold for enforcement. Meeting the general wellness definition alone is insufficient. FDA applies a separate risk-based assessment, excluding products that are invasive, implanted, or rely on technologies that may pose safety concerns absent regulatory controls (e.g., lasers, neurostimulation, radiation, microneedles).
FDA further emphasizes that device classification status (e.g., Class I) is not determinative for purposes of this policy. Regulatory professionals should assess whether CDRH actively regulates comparable products and whether special controls exist to mitigate known risk factors that may disqualify a product from enforcement discretion
Third, the FDA plans on an enhanced scrutiny of software outputs and physiologic parameters. The 2026 guidance provides expanded granularity for software-based wellness functions and wearable technologies that estimate or infer physiologic parameters such as heart rate, sleep metrics, blood pressure, glucose trends, or oxygen saturation.
FDA’s enforcement discretion applies only where outputs are non-invasive, validated where appropriate, and explicitly excluded from clinical decision-making. Products must not present diagnostic thresholds, medical-grade claims, treatment prompts, or substitute for FDA-authorized devices. Even subtle UI elements—alerts, alarms, or “abnormal” flags—may undermine a wellness positioning if they imply medical management.
This guidance reflects FDA’s continued effort to balance innovation with patient safety by delineating a compliance-safe harbor for low-risk wellness products while preserving oversight authority where medical risk is present.
For regulatory teams, early alignment between intended use, technological risk, and promotional claims is essential. Misalignment across labeling, UX design, and marketing can rapidly negate enforcement discretion. In an increasingly crowded digital health landscape, disciplined regulatory positioning is now a core product strategy.
