FDA's cautionary letter towards Whoop sparks conversation about blood pressure as a health indicator in wellness standards
In a recent turn of events, wearable technology company Whoop has received a warning letter from the Food and Drug Administration (FDA) regarding their blood pressure insights feature. The letter, issued on Monday, states that the feature is an unapproved medical device and must comply with regulatory requirements.
The FDA's stance goes against the company's claim that the blood pressure feature is a wellness feature, not a medical device. However, Yusuf Cem Kaplan, a former medical advisor at Flo Health, argues that features carrying diagnostic weight should not be considered non-medical just because they are marketed as 'for wellness'.
The blood pressure feature provides daily systolic and diastolic blood pressure estimates by measuring heart rate variability during sleep. The FDA notes that providing blood pressure estimation is not a low-risk function, and blood pressure measurements are inherently associated with the diagnosis of hypo- and hypertension.
This incident highlights the FDA's approach to regulating wellness features. According to attorneys at Washington D.C.-based law firm Hyman, Phelps & McNamara, the warning letter goes against the FDA's precedent for intended use. The FDA has created separate product codes in the past for "general wellness" and medical versions of pulse oximeters and heart rate monitors.
However, when devices or features start to imply or support medical diagnosis or treatment, the FDA may classify them as medical devices. This happened in July 2025 when the FDA issued a warning letter to Whoop stating that its BPI feature, intended to diagnose or assess blood pressure conditions, is an unapproved medical device and thus must comply with regulatory requirements.
In practice, medical versions of such devices must undergo rigorous clinical validation including bench testing, clinical trials, and peer-reviewed studies to ensure clinical accuracy and reliability. They also must receive FDA clearance or approval before marketing and comply with post-market regulations. Consumer wellness versions may rely on estimation algorithms and proxy measures but must avoid making diagnostic claims to remain outside FDA medical device oversight.
The FDA's warning to Whoop underscores the importance of clear communication regarding the intended use and regulatory status of health-related features in wearable technology. The agency has also warned against using smart wearables that claim to measure blood sugar without FDA authorization.
Meanwhile, Health and Human Services Secretary Robert F. Kennedy Jr. has expressed a desire to encourage all Americans to use wearables. The implications of the FDA's decision on wearable technology companies and the future of digital health remain to be seen.
References:
- Who benefits from over-the-counter CGMs? by Elise Reuter.
- FDA warns against using smart wearables that claim to measure blood sugar by Nick Paul Taylor.
- FDA warns Whoop over blood pressure feature by Stat News.
- The FDA's Warning Letter to Whoop: What It Means for the Future of Wearables by Jonah Comstock.
- Analytics from the blood pressure feature in Whoop's wearable technology have been deemed an unapproved medical device by the Food and Drug Administration (FDA).
- The FDA's stance on Whoop's blood pressure feature draws a line between health wellness features and medical devices.
- Yusuf Cem Kaplan, a former medical advisor at Flo Health, supports the argument that features carrying diagnostic weight should not be considered non-medical.
- The blood pressure feature on Whoop measures heart rate variability during sleep to provide daily systolic and diastolic blood pressure estimates.
- Regulatory requirements must be met by the blood pressure feature on Whoop, as it is considered a medical device, not a wellness feature.
- The FDA's warning letter to Whoop sets a precedent for devices or features that have medical implications, regardless of their marketed purpose.
- Upon receiving FDA clearance or approval, medical versions of devices like Whoop's blood pressure feature must comply with post-market regulations and undergo rigorous clinical validation.
- The FDA's decision on the blood pressure feature in Whoop's wearable technology underscores the importance of clear communication regarding the intended use and regulatory status of health-related features in technology, including smart wearables that claim to measure blood sugar.
