Concept renderThe January 6, 2026 FDA general wellness guidance lists sleep trend tracking and recreational heart-rate monitoring as wellness claims. Disease references, diagnostic thresholds, clinical-action alerts and medical-grade claims take a product out. This page compares the wording and lists what to check on your own product.
If you write the screens and marketing for a sleep, heart-rate or HRV wearable, one risky word can feel like the line between a wellness product and a regulated device. This page sets the FDA general wellness guidance side by side with a list of what to measure on your own product. It covers general wellness only, does not address medical device rules, and is not legal advice. Have regulatory counsel review your final claims.
Everything below is read from the FDA document and one eCFR section, as of October 31, 2026.
What does the current guidance say, in its own words?
The version in force was issued January 6, 2026. Each quote below is copied from the FDA PDF, as of October 31, 2026.
| Topic | FDA wording | What it means for copy and screens | Source |
|---|---|---|---|
| Issue date | Document issued on January 6, 2026. This document supersedes “General Wellness: Policy for Low Risk Devices” issued on September 27, 2019. | Advice written against the 2019 text is out of date. | FDA guidance, as of October 31, 2026 |
| Sleep | Claims to promote sleep management, such as to track sleep trends; | Listed as a general wellness claim. | FDA guidance, as of October 31, 2026 |
| Heart rate | Claims to enhance an individual’s participation in recreational activities by monitoring the consequences of participating in such activities, such as to monitor heart rate or monitor frequency or impact of collisions. | Heart-rate monitoring during recreation is named directly. | FDA guidance, as of October 31, 2026 |
| Optical estimates such as HRV | FDA may consider certain products that use non-invasive sensing (e.g. optical sensing) to estimate, infer, or output physiologic parameters (e.g. blood pressure, oxygen saturation, blood glucose, heart rate variability) to be general wellness products when such outputs are intended solely for wellness uses | The text lists six conditions that go with this: non-invasive, no safety-risk technology, no disease purpose, no substitution for cleared devices, no prompting of clinical action, and no clinical-mimicking values unless validated. | FDA guidance, as of October 31, 2026 |
| What you may display | Products that meet the aforementioned criteria may display values, ranges, trends, baselines, or longitudinal summaries, and may contextualize these outputs in relation to sleep, activity, stress, recovery, or similar wellness domains. | Values, ranges, trends, baselines and summaries are allowed in a wellness context. | FDA guidance, as of October 31, 2026 |
| What takes you out | Products are not general wellness products if their labeling, advertising, user interface, or functionality includes any of the following: 1. references to specific diseases, clinical conditions, or diagnostic thresholds; 2. alerts, alarms, or prompts that recommend or require specific clinical action or medical management; 3. treatment guidance intended to inform or direct medical management; 4. claims of clinical equivalence, clinical accuracy, medical or clinical grade, or substitution for an FDA-authorized, cleared, or approved medical device; | The list continues with a fifth item. Read it in the guidance itself. | FDA guidance, as of October 31, 2026 |
| ECG | electrocardiogram recording and analysis devices, and any product that is intended to provide outputs used to make treatment decisions (e.g., medication dosing). | Named as outside general wellness. | FDA guidance, as of October 31, 2026 |
| Notification limit | do not characterize the output as abnormal, pathological, or diagnostic; | One of four constraints on a “see a professional” style notification. | FDA guidance, as of October 31, 2026 |
| Marketing scope | FDA expects that a product intended for general wellness use will have labeling (including instructions for use, user-facing claims, promotional materials, and marketing communications) that is consistent with, and does not exceed, the product’s stated intended use. | Your ads and app store text are held to the same intended use as the device. | FDA guidance, as of October 31, 2026 |
| Worked example | Therefore, this product meets both factors for a low risk general wellness product, provided the product has validated values for blood pressure. | FDA’s example: a wrist wearable with sleep, pulse and PPG blood pressure qualifies provided the blood pressure values are validated. Clinical-context claims disqualify it. | FDA guidance, as of October 31, 2026 |
What common mistakes follow from the text?
These come from engineering reasoning about the quoted criteria. None describes an enforcement case or an incident at any company, and we cite none. For how ECG and PPG heart sensors differ in hardware, see ECG wearables: sensors, electrodes and the FDA line.
- A word that lands on a trigger. Triggers apply to labeling, advertising, user interface or functionality. A disease name or a diagnostic threshold in a single screen string can match trigger 1, even if the manual never uses it. A notification that calls an output abnormal or diagnostic breaks the notification constraint quoted above.
- Marketing that outruns the intended use. The guidance expects promotional material and marketing communications to be consistent with, and not exceed, the stated intended use. A store listing written by a different team from the firmware team is where this tends to happen.
- A “see a professional” prompt that grows. The notification is allowed only inside four constraints. A later release that adds a named condition or a clinical threshold would break the first or third constraint.
- Advice built on the 2019 text. The 2026 document supersedes the 2019 one, so an internal checklist or agency memo from before January 6, 2026 may cite criteria that are no longer the current text.
- Copying an ECG feature name for a PPG feature. An electrocardiograph is a Class II device under 21 CFR 870.2340, and FDA names ECG recording and analysis devices as outside general wellness. Calling a PPG pulse readout an ECG invites that comparison.
What should you check on your own product?
Nothing in the guidance can be tested by us for your product. These checks run on your own build and your own copy. Record what you find and why you decided as you did.
| What to check | How to capture it | Raw data to record |
|---|---|---|
| Every user-visible string | Export all strings from the app, firmware menus, packaging and help pages into one file. Search it against a list of disease names, “abnormal”, “diagnostic”, “medical grade” and similar terms your team writes down. | The exported file, the search list and the version of each build searched. |
| Every notification path | List each push message, on-device prompt, email and badge. Trace what event fires it and what text it shows. | Trigger condition, exact text, whether it recommends action, and who reviewed it. |
| Marketing against intended use | Put the written intended use next to the website, store listing, ads and sales deck. Mark any sentence that goes beyond it. | Intended use text, each page URL or file name, date reviewed, and the edits made. |
| Comparisons to clinical equipment | Search copy and test reports for any sentence that sets your reading beside a clinical device. | Sentence, location, the reference device named, and the decision taken. |
| Evidence behind any clinical-looking value | For each output that resembles a clinical value, collect the validation record your team holds. | Test protocol, raw reference and device readings, the people and conditions covered, and who signed off. Manufacturer test data may be needed from your supplier. |
| Release gate | Add a claim review step to your release checklist so each firmware and app version is checked before it ships. | Checklist copy per release, reviewer name, and open items. |
What should you ask before you publish a claim?
Take this list to your product, marketing and regulatory counsel.
- What is the written intended use of the product, and does every screen, ad and listing fit inside it?
- Which of the five “not general wellness” items could any of our features match, and who checked?
- Do we show any disease name, clinical condition or diagnostic threshold anywhere, including help text?
- Does any notification recommend a clinical action, and if one says to see a professional, does it meet all four constraints?
- Which outputs look like clinical values, and what validation do we hold for each?
- Have we compared our product to a medical device anywhere in writing?
- Which date did we read the guidance, and who re-checks it before each release?
- Has regulatory counsel reviewed the final copy?
Questions about wellness claims
Is a heart-rate or sleep feature always general wellness?
No. The guidance lists sleep trend tracking and recreational heart-rate monitoring as examples of general wellness claims, but a product leaves the category when its labeling, advertising, user interface or functionality matches any of the listed triggers. Read the full text at FDA general wellness guidance, as of October 31, 2026.
Can a wearable show HRV?
The January 6, 2026 text names heart rate variability among parameters that non-invasive optical sensing may estimate while still being a general wellness product, when outputs are intended solely for wellness uses and the other conditions are met. In FDA’s worked example, a blood pressure value qualifies provided it is validated.
Can I tell the user to talk to a doctor?
The guidance allows a “see a professional” notification only under four constraints: no named disease, no abnormal, pathological or diagnostic wording, no clinical thresholds or treatment advice, and no ongoing disease-management alerts. Whether your exact wording fits is a question for counsel.
Does an ECG feature count as general wellness?
FDA names electrocardiogram recording and analysis devices as not general wellness. An electrocardiograph is also a Class II device under 21 CFR 870.2340 (eCFR, as of October 31, 2026). We did not review the other 21 CFR 870 sections here.
Is this legal advice?
No. This is an engineering team’s organization of an FDA document and one regulation. It covers general wellness only and does not address medical device rules. Ask regulatory counsel to review before you publish claims. Tell us about your wearable and we will explain how development works.
If you are planning a general wellness wearable and want the claim review built into the development gates, tell us about your wearable. You can also read about our health wearable development.
Sources
All pages accessed 2026-10-31. Re-read the live pages before relying on them.
- FDA, General Wellness: Policy for Low Risk Devices, issued January 6, 2026: https://www.fda.gov/media/90652/download (accessed 2026-10-31)
- eCFR, 21 CFR 870.2340 Electrocardiograph: https://www.ecfr.gov/api/renderer/v1/content/enhanced/current/title-21?part=870§ion=870.2340 (accessed 2026-10-31)
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