After warning letter, Whoop and FDA in discussions about controversial blood pressure feature
Whoop remains in discussions with the FDA over its blood pressure feature, which the agency warned last year requires review as a medical device, despite Whoop’s claim it qualifies as wellness-focused. The FDA updated guidance in January to clarify criteria for blood pressure monitoring in wellness products, but Whoop’s compliance remains unresolved.
Whoop, a wearable technology company based in San Francisco, is still engaged in discussions with the U.S. Food and Drug Administration (FDA) regarding its blood pressure monitoring feature. The FDA issued a warning to Whoop in July 2025, stating that the feature—providing daily estimates of systolic and diastolic blood pressure—qualifies as a medical device and requires regulatory review. Whoop has argued that the feature falls under wellness purposes, exempting it from FDA oversight. However, the agency’s stance remains firm, as the feature’s clinical measurements could impact user health decisions. In January 2026, the FDA updated its guidance on general wellness products, explicitly addressing blood pressure monitoring. The new rules allow such products to avoid medical device classification if they meet specific criteria, including being non-invasive and avoiding clinically validated values unless properly tested. Whoop’s feature must now align with these updated standards, but the company has not yet resolved the dispute. The FDA’s scrutiny highlights broader challenges in regulating health-related wearables, particularly as technology blurs the line between consumer wellness and medical diagnostics. Whoop’s ongoing discussions with the agency reflect the need for clearer regulatory frameworks in this evolving sector.
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