Federal health agency issues warning to Whoop, igniting discussions about blood pressure as a measure of overall health
A debate has been sparked among regulatory professionals on LinkedIn following the Food and Drug Administration's (FDA) warning letter to Whoop, a company selling a wearable wristband, for marketing a blood pressure insights feature without FDA authorization.
The blood pressure feature on Whoop's wearable wristband provides daily systolic and diastolic blood pressure estimates by measuring heart rate variability during sleep. However, the FDA states that blood pressure measurements are inherently associated with the diagnosis of hypo- and hypertension, and are therefore intended for use to diagnose, treat or prevent disease.
According to FDA regulations, any device that displays or interprets blood pressure data may be classified as a medical device depending on its intended use. If the device’s function moves from general wellness to providing diagnostic information or clinical utility, it falls under FDA medical device regulation.
Whoop disagrees with the FDA's assertion that the blood pressure feature should be reviewed as a medical device before being available in the U.S., claiming it is a wellness feature, not a medical device. The company's website markets the blood pressure feature as a means to help users track blood pressure trends and have a deeper understanding of how blood pressure affects their wellness.
Attorneys at Washington D.C.-based law firm Hyman, Phelps & McNamara wrote in a blog post that the FDA's warning letter to Whoop goes against the FDA's precedent for intended use. They note that the FDA has created separate product codes in the past for "general wellness" and medical versions of pulse oximeters and heart rate monitors.
Yusuf Cem Kaplan, a former medical advisor at Flo Health, wrote in a LinkedIn post that blood pressure is one of those features that carry diagnostic weight no matter how gently it is presented. Some concerns have been raised that blood pressure could be viewed as a clinical metric no matter how it is presented.
In May, Health and Human Services Secretary Robert F. Kennedy Jr. met with executives from health tech startups, including Whoop, according to Stat News. He wants to encourage all Americans to use wearables. The FDA has cleared the first over-the-counter cuffless blood pressure monitor with a wrist-based device made by Aktiia earlier this month, indicating a potential shift in the FDA's stance on wearable devices that measure blood pressure.
The debate among regulatory professionals on LinkedIn reflects the complexity of defining what constitutes a wellness feature versus a medical device, particularly in the context of emerging technology. The FDA's warning letter to Whoop marks a significant development in the regulation of wearable devices that measure blood pressure and could set a precedent for future cases.
- The debate on LinkedIn among regulatory professionals revolves around the FDA's warning to Whoop over marketing a blood pressure insights feature without authorization, highlighting the blood pressure feature on Whoop's wearable wristband.
- This feature provides daily systolic and diastolic blood pressure estimates by measuring heart rate variability during sleep, triggering the FDA's assertion that it could be a medical device due to its association with the diagnosis of hypertension and hypotension.
- According to FDA regulations, any device displaying or interpreting blood pressure data may be classified as a medical device, depending on its intended use, with a shift from general wellness to providing diagnostic information or clinical utility falling under FDA medical device regulation.
- Whoop disagrees with the FDA's classification, claiming the blood pressure feature is a wellness feature, not a medical device, and markets it as a means to track blood pressure trends and gain a deeper understanding of how blood pressure affects health and wellness.
- Attorneys at Hyman, Phelps & McNamara argue in a blog post that the FDA's warning to Whoop goes against its precedent, citing separate product codes for "general wellness" and medical versions of pulse oximeters and heart rate monitors in the past.
- Yusuf Cem Kaplan, a former medical advisor at Flo Health, shares concerns that blood pressure could be viewed as a clinical metric no matter how gently presented, adding to the complexity of defining a wellness feature versus a medical device in the context of emerging technology.
- In a potential shift, the FDA cleared the first over-the-counter cuffless blood pressure monitor with a wrist-based device made by Aktiia earlier this month, indicating a potential change in the FDA's stance on wearable devices that measure blood pressure.
- The ongoing debate among regulatory professionals on LinkedIn underscores the complexity of defining wellness features versus medical devices in the digital health sector, with the FDA's warning to Whoop marking a significant development and possible precedent for future cases in medtech, regulation, technology, general news, and health and wellness.
