How to word wellness claims for wearables and apps
The words a product uses can decide whether regulators treat it as wellness or as a medical device. A practical guide for product, marketing and regulatory teams, as of 5 November 2026.
The line in one sentence
Under the FDA's General Wellness policy, reissued on 6 January 2026, a low-risk product can display values, ranges, trends and baselines in the context of sleep, activity, stress or recovery, but leaves the wellness category if it references a disease, uses diagnostic thresholds, calls a result abnormal, claims to be medical grade, or prompts clinical action (FDA, General Wellness: Policy for Low Risk Devices, reissued 6 January 2026; Covington, 8 January 2026).
Say, and avoid
| Instead of | Say |
|---|---|
| "Detects health problems early" | "Shows how your recovery compares with your own recent baseline" |
| "Abnormal HRV" | "Lower than your usual range this week" |
| "Medical-grade accuracy" | "Measured during sleep; device and algorithm version recorded" |
| "Predicts when you will crash" | "A change from your recent normal. Rest and routine can affect it." |
| "Your score puts you in a high-risk band" | No condition, score band or risk label at all |
Words ATS-1 does not allow
- Clinical severity bands and screening cut-offs
- The words "risk", "predict", "detect" and "abnormal" in outputs
- Any disease or condition name in outputs or marketing
- The one allowed prompt: "Evaluation by a healthcare professional may be helpful."
These are the ATS-1 scope rules; every participant-facing interface also shows the crisis notice.
Uncertainty, stated plainly
For change signals, ATS-1 requires this disclosure: "At the level of one person, these signals are uncertain. In published studies they appeared before fewer than half of changes, and they appeared in about 25% of people whose state did not change." See the State-Change Signal and try the false-alarm calculator.
A pre-release wording check
- List every place a result appears: app, notifications, emails, store listing, website, sales deck.
- Remove disease names, thresholds and risk language from each.
- Compare each result with the person's own baseline, not a population number.
- State how the figure was obtained and its uncertainty.
- Ask for an independent review; a Triplane Readiness Assessment includes a wellness-wording review.
Not legal or regulatory advice
This guide is general information. Regulatory status depends on a product's intended use and claims; take regulatory advice.
Questions
Can a wellness app mention heart-rate variability?
Yes. Under the 2026 FDA guidance, a non-invasive HRV estimate can stay within wellness when it avoids disease claims and diagnostic thresholds.
Does this wording make a product a wellness product?
No wording guide can decide that. It reduces the risk of claims that move a product out of the wellness category.
Sources
Keep reading
Take the next step.
Wording for wellness products as of November 2026: what to say about sleep, HRV and recovery, what to avoid, and examples, per FDA guidance and ATS-1.