Essentially, FDA deemed the BPI feature to constitute a device because of the relationship between measuring blood pressure and diagnosing high or low blood pressure.
Certain wearable products, such as watches or rings that monitor blood pressure, may soon be considered medical devices subject to regulation after a U.S. Food and Drug Administration (FDA) warning letter provided insight into FDA’s current thinking on general wellness products. Wearables manufacturers with products that have functions that are “inherently associated” with a diagnosis—such as blood pressure and hypo- or hypertension—should keep appraised of FDA’s actions in regulating products that were once thought to be outside of the definition of a device and within the definition of a general wellness product.
General wellness products are excluded from the definition of a “medical device” under Section 520(o)(1)(B) of the Food Drug and Cosmetic Act because their software is “[intended] for maintaining or encouraging a healthy lifestyle and [unrelated] to the diagnosis, cure, mitigation, prevention or treatment of a disease or condition.” Thus, general wellness products do not have to comply with pre-market notification or approval or post-market requirements because they are not devices. FDA indicated in a 2019 guidance, and reiterated as recently as September 2022, that it “does not intend to examine low risk general wellness products” to determine whether they could be classified as devices. In that same guidance, FDA stated that, for example, it would not exercise regulatory authority over a wearable intended to monitor users’ pulse rates during exercise and hiking.
However, a recent warning letter to WHOOP Inc., dated July 14, 2025, may reveal FDA’s new position on products claiming the general wellness product exception. WHOOP markets a wearable product with a “Blood Pressure Insights” (BPI) feature that monitors blood pressure. WHOOP states that this is a wellness feature that is “common in wearable technology” similar to tracking respiratory rate or heart rate variability. Yet, FDA’s warning letter stated that per WHOOP’s online statements and in response to FDA inquiries, BPI was marketed with the “[intent] for those users to measure or estimate their blood pressure” and to provide “daily systolic and diastolic blood pressure estimations” and “[deliver] medical-grade health & performance insights.”
Despite WHOOP’s position that blood pressure monitoring is a general wellness feature, FDA found that the BPI product feature constitutes a device:
[T]he product is intended to provide a measurement or estimation of a user’s blood pressure, which is inherently associated with the diagnosis of hypo- and hypertension, and is therefore intended for use in the diagnosis of a disease or other condition, or in the cure, mitigation, treatment, or prevention of disease.
Essentially, FDA deemed the BPI feature to constitute a device because of the relationship between measuring blood pressure and diagnosing high or low blood pressure. FDA supported this conclusion by pointing to WHOOP’s statements that “higher blood pressure” could indicate poor sleep, as well as the product’s design, which includes a target blood pressure range.
FDA concluded, therefore, that the device is both adulterated and misbranded until it goes through either the pre-market approval or pre-market notification process.
In doing so, FDA rejected the argument that the Section 520(o) general wellness product exception applies to the WHOOP product. FDA clarified that BPI is not intended either to “maintain” or “encourage” a healthy lifestyle because of the “implied” causal link between blood pressure management and wellness results, such as poor sleep. FDA also reiterated that its intended use falls within the definition of a device because the product is “inherently associated” with a diagnosis, and WHOOP has stated that BPI can identify “higher blood pressure.”
As noted, FDA published guidance in 2019 on low-risk general wellness products. At the time, FDA indicated that it would not examine low risk general wellness products to determine whether they may be devices. To receive this treatment, products must be a wellness product that presents a “low risk” to user safety. While FDA considers whether a product is invasive or implanted, it also considers products not to be low risk if FDA “actively regulates products of the same type.” Importantly, FDA in its warning letter to WHOOP referenced that FDA has both reviewed and cleared as devices other blood pressure measurement products that do not explicitly reference diagnosing high or low blood pressure. One such product is Omron’s wearable blood pressure monitor. While FDA did not connect this statement to its low risk analysis, the agency did generally state that estimating blood pressure is not low risk because an erroneous blood pressure reading could result in delay or lack of treatment.
FDA’s analysis of WHOOP’s product may be unique to the BPI feature, WHOOP’s statements and the presence of similar products cleared as devices. Nevertheless, it may also be a signal to wearables manufacturers to expect increased oversight in this area. Wearables manufacturers with products that have functions that are “inherently associated” with a diagnosis, including but not limited to blood pressure measurements, should keep appraised of FDA’s movements in regulating general wellness products.
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