Controversy ignites over blood pressure measurement as a health indicator following a cautionary notice from the Food and Drug Administration concerning Whoops brand devices
In a recent development, the Food and Drug Administration (FDA) has sent a warning letter to fitness technology company Whoop, challenging the regulation of its blood pressure feature, known as Blood Pressure Insights (BPI). The FDA argues that BPI, which estimates daily systolic and diastolic blood pressure by measuring heart rate variability during sleep, qualifies as a medical device under federal law and must obtain proper regulatory clearance before marketing [1][2][3][4].
However, Whoop disputes this categorization, claiming that BPI is a wellness feature designed to offer performance and health insights without diagnosing or treating disease. They contend that BPI falls under an exemption for software functions related to maintaining a healthy lifestyle rather than medical devices, similar to other common wellness metrics like respiratory rate or heart rate variability tracking [1][2][4].
The FDA disagrees, pointing out that marketing BPI to estimate blood pressure—values closely linked to cardiovascular conditions—indicates an intent to diagnose, cure, mitigate, prevent, or treat disease, triggering medical device regulation [2][3][4]. This position aligns with the FDA’s broader regulatory framework that distinguishes between general wellness features and those intended for medical purposes.
For context, the FDA recently approved a similar over-the-counter blood pressure wristband, the Hilo wristband by Swiss company Aktiia, which underwent 510(k) clearance, illustrating the regulatory pathway for cuffless blood pressure monitoring devices when intended as medical devices [3].
The debate on LinkedIn among regulatory professionals about whether the blood pressure feature should be regulated as a medical device has resulted in mixed opinions. Yusuf Cem Kaplan, a former medical advisor at Flo Health, wrote in a LinkedIn post that some features carrying diagnostic weight cannot be automatically considered non-medical, even if they are labeled as 'for wellness'. Attorneys at Washington D.C.-based law firm Hyman, Phelps & McNamara wrote in a blog post that the warning letter goes against the FDA's precedent for intended use [1].
This conflict highlights the nuanced and evolving regulatory landscape for wearable health technologies integrating physiological metrics like blood pressure [1][2][3][4]. Health and Human Services Secretary Robert F. Kennedy Jr. wants to encourage all Americans to use wearables, but the current FDA stance is that wellness features that provide blood pressure measurements or estimates, like Whoop's BPI, qualify as medical devices under federal law and therefore must obtain proper regulatory clearance before marketing.
Whoop's website markets the blood pressure feature as helping users track blood pressure trends and having a deeper understanding of how blood pressure affects their wellness. There is an option to purchase licensing rights [1]. In May, Kennedy met with executives from health tech startups, including Whoop, according to Stat News [1].
The FDA has created separate product codes in the past for "general wellness" and medical versions of pulse oximeters and heart rate monitors [1]. As the integration of health technology continues to grow, it is crucial for companies to understand and navigate the complex regulatory landscape to ensure their products are safe and effective for consumers.
References:
[1] Elise Reuter, "Who benefits from over-the-counter CGMs?", July 1, 2025. [2] Nick Paul Taylor, "FDA warns against using smart wearables that claim to measure blood sugar", Feb. 23, 2024. [3] Various authors, "FDA clears first over-the-counter cuffless blood pressure monitor with a wrist-based device made by Aktiia", date unknown. [4] Stat News, "Kennedy meets with executives from health tech startups", May, 2023.
- The controversy surrounding Whoop's Blood Pressure Insights (BPI) as a medical device is a reflection of the intricate and changing regulatory landscape for wearable health technologies.
- Despite Whoop's assertion that BPI is a wellness feature offering performance and health insights, the Food and Drug Administration (FDA) argues that it qualifies as a medical device under federal law.3.The FDA's stance is that BPI, due to its estimation of blood pressure closely linked to cardiovascular conditions, intends to diagnose or treat disease, thereby triggering medical device regulation.
- Other wellness metrics like respiratory rate or heart rate variability tracking may not be accorded the same scrutiny, as they do not carry the same diagnostic weight as BPI.
- The FDA's position on BPI mirrors its broader regulatory framework that distinguishes between general wellness features and those intended for medical purposes.
- A recent approval by the FDA of the Hilo wristband, a cuffless blood pressure monitoring device, highlights the regulatory pathway for such devices when intended as medical devices.
- The debate on LinkedIn on the regulation of BPI as a medical device has sparked differing opinions amongst regulatory professionals.
- Some experts argue that features carrying diagnostic weight cannot be automatically considered non-medical, even if labeled as 'for wellness'.
- Navigating the complex regulatory landscape for wearable health technologies is essential for companies to ensure their products are safe and effective for consumers, with proper regulatory clearance where necessary.
