Boston-based wearable technology company Whoop has formally responded to a warning letter from the U.S. Food and Drug Administration regarding the regulatory status of its fitness tracker's Blood Pressure Insights (BPI) feature. The dispute centers on whether the company's 24/7 fitness trackers, which provide daily blood pressure estimates based on heart rate, sleep patterns, and other factors, should be classified and regulated as medical devices.
The FDA's July 14 letter to Whoop CEO Will Ahmed outlined the agency's position that any software providing blood pressure data requires evaluation and regulation as a medical device. The FDA argued that BPI goes beyond maintaining or encouraging a healthy lifestyle by establishing causal links between blood pressure measurements and wellness outcomes.
"A software function is not a device if it is intended for maintaining or encouraging a healthy lifestyle and is unrelated to the diagnosis, cure, mitigation, prevention or treatment of a disease or condition," the FDA said in its warning letter. "BPI is not intended to 'maintain' or 'encourage' a healthy lifestyle, as it implies a causal link between a user's blood pressure measurement and wellness results. For example, BPI and its labeling would indicate to a user that her poor sleep may be caused by high blood pressure identified by the device. Further … BPI is not unrelated to the diagnosis, cure, mitigation, prevention or treatment of a disease or condition, because it is inherently associated with the diagnosis of hypo- and hypertension, and because your firm's statements indicate that BPI is intended to identify 'higher blood pressure.'"
In its public response, Whoop firmly contested the FDA's interpretation, maintaining that BPI should be considered a wellness feature rather than a medical device.
"We respectfully disagree," the company said. "BPI is a wellness feature, not a medical device. It's designed to help you understand how your body responds to daily life, not to diagnose or treat any condition. Wellness features like this are common in wearable technology, like tracking your respiratory rate or heart rate variability, and provide valuable insights to support better decisions about your performance without requiring FDA clearance."
The company emphasized its commitment to responsible regulation, noting that it had previously secured FDA clearance for its ECG feature. "We've always supported responsible regulation, and we were proud to receive FDA clearance for our ECG feature," the company added. "But we also believe it's critical to protect access to wellness innovation, especially when wellness tools and features help people make smarter, more informed decisions to reach their full potential."
The FDA's warning letter included a notable cautionary statement that "other federal agencies" are monitoring Whoop's response and may consider the company's actions when evaluating federal contract awards. The ultimate resolution of this regulatory dispute remains uncertain, with potential implications for the broader wearable technology industry's approach to health-related features.
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