The FDA’s January 2026 update to its “General Wellness: Policy for Low Risk Devices” guidance materially expands the types of wearable features that may avoid medical device regulation. Signaling a more flexible regulatory approach, the FDA indicated it will treat certain non-invasive physiological measurements — such as estimated blood pressure, oxygen saturation, blood glucose, and heart rate variability — delivered by wearables as “general wellness” outputs, provided they are intended solely for wellness purposes and meet low-risk criteria. The agency also added concrete, device-specific examples to illustrate the line between permissible wellness positioning and regulated medical device claims.
The general wellness category continues to exclude products that are implanted, are invasive in ways that raise safety concerns, or otherwise present a non-trivial risk without medical device controls.
The FDA’s guidance emphasizes that to remain a general wellness device, a wearable must be non-invasive, not implanted, and must avoid claims or contexts that suggest diagnosis, cure, mitigation, prevention, or treatment of disease. Further, the device should not prompt clinical intervention, and its output should not mimic clinical parameters unless validated. Positioning outputs as wellness insights, recovery support, fitness information, or lifestyle tracking is permissible, while implying clinical-grade accuracy, guiding therapy changes, or referencing disease management moves the product into medical device territory.
The FDA also emphasizes that all labeling, promotional claims, and marketing materials must remain consistent with a wellness-intended use and must not include comparative or superiority claims against FDA-cleared, authorized, or approved medical devices. This includes claims that suggest the wellness device can act as a substitute for an already approved device.
The FDA supplemented the guidance with concrete examples of wearables that may qualify as general wellness. One example describes a wrist-worn product that assesses activity and recovery and outputs multiple biomarkers such as hours slept, sleep quality, pulse rate, and blood pressure. Such a device remains a general wellness product unless its functionality or presentation implies a medical or clinical context. Another example addresses a wearable that provides blood glucose information for nutritional impacts in a non-diabetic population, clarifying that when not intended for diabetics or pre-diabetics and using minimally or non-invasive technology, such functionality can be treated as general wellness. The FDA also reiterates that products monitoring pulse rate or oxygen saturation during exercise or hiking can remain in the general wellness category when framed as fitness or recreational support.
Balancing compelling marketing with regulatory compliance is delicate. As the wellness market grows and manufacturers test the boundaries of permissible claims, the risk of increased enforcement by agencies such as the FDA and the FTC — and of competitor challenges in venues such as the BBB National Programs’ National Advertising Division — will continue to offer compliance challenges for manufacturers. Careful compliance can be the difference between continued marketing and a Warning Letter.
McGuireWoods continues to monitor developments related to FDA regulatory and compliance. For questions about related topics, contact the authors.