Whoop Defies FDA Warning, Refuses to Remove Blood Pressure Tool

Whoop, a fitness band maker, has refused to remove its blood-pressure tracking tool despite a warning from the US FDA. The FDA stated that the tool means the Whoop is operating as a medical device, but Whoop believes it's not within the FDA's authority to regulate it. Whoop has requested a meeting with the FDA and plans to continue offering the wellness feature to consumers.

Fitness band maker Whoop Inc. has refused to disable its blood pressure tracking tool despite a warning from the U.S. Food and Drug Administration (FDA). The FDA has stated that the feature, known as Blood Pressure Insights, means Whoop's device is operating as a medical device, a classification that requires regulatory approval. However, Whoop maintains that the tool is intended for wellness purposes and not for diagnosing or treating medical conditions. The company has requested a meeting with the FDA and plans to continue offering the feature to consumers.

The FDA's warning letter, issued on July 14, stated that the Blood Pressure Insights feature is intended to measure blood pressure, which is inherently associated with the diagnosis of hypo- and hypertension. The FDA considers blood pressure measurements to be a high-risk function, given the potential consequences of erroneous readings, such as stroke, heart attack, and premature death. The agency has cited evidence from Whoop's website and product design to support its classification of the feature as a regulated device.

Whoop has pushed back on the FDA's interpretation, arguing that the feature is intended for wellness purposes and not for diagnosing or treating medical conditions. The company has also cited scientific evidence supporting non-medical uses of blood pressure information. In a letter to the FDA dated Aug. 4, Whoop stated that it believes the FDA lacks the authority to regulate the product and that it does not intend to remove the app.

The standoff between Whoop and the FDA is a significant development in the regulatory landscape for wearable technology. The FDA has been increasingly active in regulating high-risk physiological measurement products, and this case may set a precedent for other companies in the industry. The outcome of this dispute could have broader implications for the digital health sector, as it could influence how the FDA interprets and enforces its regulations on wearable devices.

References:

[1] https://www.bloomberg.com/news/articles/2025-08-14/whoop-refuses-to-remove-blood-pressure-tool-despite-fda-warning
[2] https://natlawreview.com/article/what-watch-whoop-warning-letter