Wellness versus medical device: where the line sits
A summary for product and regulatory teams, as of 3 November 2026, with sources. It is general information, not legal or regulatory advice.
United States: the FDA's 2026 wellness guidance
On 6 January 2026 the FDA reissued its General Wellness guidance and its Clinical Decision Support guidance (Covington, 8 January 2026; King & Spalding; FDA, General Wellness: Policy for Low Risk Devices). Under the revised wellness guidance, non-invasive wearables that estimate measures such as blood pressure, oxygen, glucose or heart-rate variability can remain wellness products. They lose that status if they:
- Name a disease or condition
- Use diagnostic thresholds, or labels such as "abnormal"
- Claim to be "medical grade" or clinically accurate
- Send alerts intended to manage a disease
One neutral prompt is allowed: "Evaluation by a healthcare professional may be helpful."
A recent example
In July 2025 the FDA issued a warning letter treating a wearable's blood-pressure feature as an unapproved device (FDA warning letter, 14 July 2025). The 2026 guidance now includes a wrist-worn blood-pressure example that can qualify as wellness when it references no disease, as summarized in Covington, 8 January 2026.
European Union
- Software is a medical device when its intended purpose is medical. The Commission's software qualification guidance, MDCG 2019-11, was revised in June 2025 without substantive change (European Commission, MDCG 2019-11 Rev.1, 17 June 2025).
- The AI Act prohibits emotion recognition in workplaces and education, which has applied since February 2025 (EU AI Act, Regulation (EU) 2024/1689). ATS-1 places deployment to EU employers and education providers out of scope.
Health and neural data in US states
- Washington's My Health My Data Act covers consumer health data well beyond HIPAA (Washington Attorney General).
- Five states have laws on neural data: Colorado, California, Montana, Connecticut and Vermont. Colorado, California and Montana also cover peripheral nervous system data, which could reach signals such as heart-rate variability (Cooley, 23 June 2026).
- The FTC's Health Breach Notification Rule, amended in 2024, can apply to health apps and their vendors (FTC, April 2024).
How ATS-1 applies these lines
ATS-1 writes the boundary into the specification: no disease claims, no severity bands or cut-offs, none of the words "risk", "predict", "detect" or "abnormal", and the crisis notice on every participant-facing interface. See the scope. Its inputs are wearable, questionnaire and laboratory data; it does not read brain activity.
Questions
Does following ATS-1 make a product a wellness product?
No specification can decide that. Regulatory status depends on the product's intended use and claims; take regulatory advice.
Is heart-rate variability a medical measure?
It can be used either way. Under the 2026 FDA guidance, a non-invasive HRV estimate can stay within wellness when it avoids disease claims and diagnostic thresholds.
Sources
Keep reading
Take the next step.
Where wellness ends and medical devices begin for wearables and apps, as of November 2026: the FDA's 2026 guidance, EU rules, state laws.