Why Did the FDA Send WHOOP a Warning Letter?

Will Ahmed says WHOOP is on good terms with the FDA now, after a long process and public disagreements. About four years before this conversation he wanted blood pressure from the wrist. A cuff was the usual tool, and no product then on the market measured blood pressure accurately from the wrist.

WHOOP asked members into a stress, sleep, and blood pressure study. 70,000 people enrolled and uploaded a reading every day for weeks, beside the data the band already collected. The team built an algorithm it wanted near medical-device accuracy and launched blood pressure insights as wellness, not as a diagnosis. The FDA, on this account, evaluates products that make a medical diagnosis. Heart-rate tracking for exercise and sleep counts as wellness, while AFib detection or heart-attack prediction is regulated. Blood pressure had been treated as medical only. WHOOP treated stress, sleep, and well-being as a wellness use and launched.

The FDA said the feature had to be regulated and sent a warning letter. The disagreement was public. WHOOP held its position. Ahmed thinks the FDA later updated its guidelines, from this case and from industry feedback, so blood pressure can also be wellness. Blood pressure insights is still available. The wrist ECG, taken by putting fingers on the band, is a separate FDA-cleared 510K product.