The U.S. Food and Drug Administration (FDA) has issued a warning letter to the fitness-tracking company WHOOP over its “Blood Pressure Insights” (BPI) feature. FDA concluded that BPI is a medical device because it provides daily systolic and diastolic blood-pressure estimations, data inherently linked to diagnosing hypertension, and that WHOOP marketed the feature without the required clearance or approval.
This shows how easily a wellness or fitness tool can cross the line into regulated medical-device territory.
Why the FDA Flagged WHOOP
WHOOP promoted BPI as delivering “medical-grade health and performance insights” and used a color-coded gauge to show whether users were within a target blood-pressure range. Even though the company included disclaimers and argued that BPI was a “general wellness” feature, the FDA determined that:
- Providing a blood-pressure estimate, even without explicitly diagnosing hypertension, makes the feature a medical device.
- Disclaimers don’t override function. Because BPI outputs a clinical measurement and links it to health outcomes, fine print cannot change its regulatory status.
- Inaccurate readings could delay treatment for high blood pressure, a condition associated with stroke, heart failure, and other serious complications.
As a result, the FDA deemed BPI adulterated and misbranded under the Federal Food, Drug, and Cosmetic Act and warned WHOOP to stop marketing BPI until proper authorization is obtained.
Why This Matters
The wearables market is booming, with products like the Oura Ring, Cefaly migraine headband, and countless health-tracking apps gaining traction. But if a product measures or estimates a physiological metric such as blood pressure, oxygen saturation, heart rhythm, or glucose levels, it can quickly trigger FDA oversight.
The implications are clear:
- Marketing claims drive risk. Words like “medical-grade,” “diagnose,” or even “monitor” invite FDA attention.
- Features matter as much as labels. Even a color scale or ‘target range’ can signal an intended medical use, regardless of wellness branding.
- Compliance planning is critical. If you intend to offer health data or integrate wearables into your services, you may need an FDA regulatory pathway, such as 510(k) clearance, before launch.
Reach out to the Lengea team to help and for the latest developments on this important issue.