Dive Brief:
- The Food and Drug Administration has dropped a warning letter against wearable device firm Whoop following changes the company made to its blood pressure feature.
- In a closeout letter posted Tuesday, the FDA said it does not intend to enforce device requirements on the modified version of Whoop’s feature, consistent with guidance the agency issued earlier this year that would exempt more wearable features from oversight.
- Whoop CEO Will Ahmed said in a Wednesday LinkedIn post that the regulatory update was a “major development” and praised the updated wellness guidance.
Dive Insight:
When the FDA sent a warning letter to Whoop in July, the agency said blood pressure is inherently related to medical diagnosis. The letter sparked a debate about whether blood pressure should be regulated as a medical device or a wellness feature, with CEO Ahmed defending the feature and many medtech experts saying the FDA was likely to hold its ground.
The FDA ultimately changed its stance in a January guidance, concluding that blood pressure measurements don’t have to be regulated as medical devices if they’re used for wellness purposes.
Whoop first rolled out its blood pressure insights feature last year, which provided daily systolic and diastolic blood pressure estimates based on heart rate and blood flow patterns during sleep. The company has made some changes to the feature since receiving the warning letter, including adjustments to the dial boundaries to prevent any confusion that the feature is classifying blood pressure in a clinical manner, a Whoop spokesperson wrote in an email.
“When the FDA first issued the warning letter, many experts advised Whoop that removing the feature was the only path forward,” Ahmed wrote on LinkedIn. “But we believed in the strength of science and our responsibility to the members who rely on it.”
The CEO added that Whoop looks forward to working with the FDA in the future as the company brings more regulated medical technologies to market.
