Health|May 21, 2026|2 min read

After warning letter, Whoop and FDA in discussions about controversial blood pressure feature

Wearable maker Whoop has not resolved its dispute with the FDA over a blood pressure feature launched last year. The FDA warned Whoop in July 2025 that the feature requires regulatory review as a medical device, though Whoop argues it qualifies as a wellness product exempt from FDA oversight.

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STAT

Contributor

SAN FRANCISCO — Whoop, the wearable technology company, is currently in a dispute with the Food and Drug Administration (FDA) regarding a blood pressure feature that was introduced last year, as indicated by a senior health executive from the organization.

In July 2025, the FDA issued a warning to Whoop concerning this feature, which provides users with daily estimates of both systolic and diastolic blood pressure readings, classifying it as a medical device that necessitates FDA review. Conversely, Whoop maintains that this feature qualifies as a wellness product and is therefore exempt from FDA regulation.

In January, the FDA revised its guidelines on general wellness products, expanding the definition to encompass those that deliver information regarding blood pressure, as long as they are not intended for disease diagnosis or treatment. To avoid being categorized as medical devices, these products must also adhere to additional criteria, including non-invasive methods and the stipulation that they do not present values mirroring clinically validated measurements unless substantiated.

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