The FDA has sent an End of Enforcement notice to consumer wearable device company Whoop, putting a formal end to the agency’s investigation into its blood pressure tech use.
Last July, the FDA issued a warning letter specific to Whoop's “Blood Pressure Insights” (BPI) feature, saying it was becoming a medical device that would require proper 510(k) clearance.
But in January this year the FDA reversed course, saying the company's wearable can, in fact, fall under “general wellness” exemptions, rather than requiring the U.S. regulator's stricter medical device clearance. The device, which has a subscription model, also runs electrocardiogram readings and atrial fibrillation detection.
Now, the FDA has completely dropped its enforcement action.
A spokesperson for the company told Fierce Med Tech: “The FDA has formally shared an End of Enforcement with Whoop, noting that it does not intend to enforce device requirements against their Blood Pressure Insights feature.”
The spokesperson said that Whoop has “had transparent and positive conversations” with the FDA and made “proactively targeted modifications to Blood Pressure Insights and its labeling that further reinforce the feature’s wellness purpose.”
The company added that changes are “purely visual and [do] not interfere with the feature benefits.”
The spokesperson said more broadly that this action shows the “FDA is beginning to recognize the benefits for consumers of responsible, low-risk wellness technologies that support their proactive health.”
They added that it “reinforces the distinction between wellness products and medical devices while supporting continued innovation in consumer health.”
This rounds off a good quarter for Whoop. On March 31, the company revealed a major $575 million funding investment boost for its series G, putting it at a $10.1 billion valuation.
Whoop said the financing would help fuel a global hiring spree.