CDRH issued a closeout letter to Whoop CEO Will Ahmed on June 17, 2026, ending the warning letter it sent on July 14, 2025. The dispute was over Blood Pressure Insights, a feature estimating daily systolic and diastolic pressure from heart rate and blood flow patterns during sleep. FDA's original position was that blood pressure is inherently related to medical diagnosis, which made the feature a device.
The closeout says FDA "does not intend to enforce the device statutory and regulatory requirements" for the modified product. Two things changed. Whoop revised the product and its labeling, including the dial boundaries, so the display no longer reads as a clinical classification. FDA revised its general wellness guidance on January 6, 2026 to permit non-invasive estimation of blood pressure for wellness purposes. Ahmed said many experts had advised that removing the feature was the only path forward.
The letter is narrow by design. It covers the modified product only, not other Whoop products and not future changes without further review. The pattern worth copying is the sequence: a company that kept the feature, argued the science, and adjusted the presentation ended up with a written FDA position naming its product. A company that had pulled the feature in July 2025 would have nothing.