Whoop Faces Off Against FDA Over Blood Pressure Monitoring Feature in Wearable Device

The high-end wellness tracker by Whoop, renowned for its screenless design, recently finds itself at the center of a debate with the US Food and Drug Administration (FDA) over its new blood pressure monitoring feature.

First announced in May, the Whoop MG now faces regulatory scrutiny as the FDA considers it to be operating as a medical device. Consequently, the manufacturer must secure certification through the FDA, a directive communicated by the agency back in mid-July.

However, Whoop has expressed its intention to continue offering the blood pressure monitoring feature. In a statement released in July, Whoop emphasized that the feature is designed for wellness purposes, aimed at providing insights into how the body reacts to daily life, rather than diagnosing or treating any conditions.

More recently, Whoop has engaged with the FDA again, affirming its decision not to remove the blood pressure monitoring feature. A letter dated August 4, obtained by Bloomberg, states that Whoop believes it is beyond the FDA’s jurisdiction to regulate the product and thus will not be complying with the regulatory requirements.

In addition, Whoop has requested a meeting with the FDA to discuss the matter further, expressing its intent to engage in constructive dialogue with agency officials. As of now, it remains unclear whether the FDA has responded to Whoop’s request for a meeting.

Previously, Whoop was warned by the FDA that prompt action was necessary to address any violations. The original FDA letter stated that failure to rectify this matter may result in regulatory action being initiated without further notice, potentially including seizure, injunction, or civil money penalties. It remains uncertain what course of action will ensue in this ongoing disagreement.

The launch of the Whoop MG has not been without incident. Initial batches of the tracker reportedly faced “rare and isolated” issues where the device malfunctioned. In response, Whoop provided replacement devices to those affected by these issues, which were said to be impacting a small number of members, and did not align with the experiences of the majority of users.