Whoop vs FDA – Whoop bravely doubles down.
More: Whoop 5 Review
As initially reported by Bloomberg, Whoop Inc., a fitness band manufacturer, has decided not to disable its Blood Pressure Insights (BPI) feature despite a warning from the FDA.
The essence of the original FDA warning was that Whoop’s Blood Pressure Insights feature constitutes a medical device and hence requires its approval.
Whoop disagreed, and its CEO argued it is a wellness feature that does not require FDA approval. More specifically, the argument is that the BPI feature merely helps Whoop members to understand how their body responds to their lifestyle and not to diagnose or treat any condition.
WHOOP Fights Back Against FDA Warning – A Detailed Examination
However, the FDA’s argument seems to be strengthened by its claim that Whoop is estimating an aspect of physiology that is not low-risk and is inherently associated with a hypertension diagnosis. Therefore, this falls under the FDA remit. On 13 August, the FDA reiterated its position, stating that the agency “has not authorized BPI for any use, including for the measurement or estimation of a user’s blood pressure.”
Whoop has further indicated it wishes to meet for constructive dialogue. Its stance is now less confrontational, with the company insisting that the FDA has misinterpreted its feature as a “medical tool”, adding that it is labelled as a wellness-focused tool and is not intended to diagnose cardiovascular medical issues.
We believe it is not within the FDA’s authority to regulate the product. We therefore do not intend to remove the app. [Whoop]
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Brave, or bravely stupid – we will see. Usually the FDA doesn’t back down or lose on these cases
yes i would have thought the same.
to make matters worse, Wahoo is probably an easier target for the FDA to make their point than when pitted against someone like Apple.