FDA Says Whoop’s Blood Pressure Feature Is Illegal, but It’s Still Active (for Now)
When Whoop introduced new hardware and membership levels in May, one of the devices was called MG, which stood for “Medical Grade.” Among the big features that seemed to justify the upgrade was a feature called “Blood Pressure Insights.” But now the FDA has sent Whoop a warning letter saying Whoop is promoting an uncertified medical device.
Whoop is a screenless fitness tracker with a comprehensive set of features that track a user’s fitness, sleep, and other health-related metrics. (You can read about my health tracking experience with Whoop here .)
In a message to members posted today to the r/Whoop subreddit, Whoop said that despite the FDA letter, the Blood Pressure Info feature “remains available” to Life members. That’s the highest membership level and the only one that was advertised as including Blood Pressure Info. Whoop also said that any FDA regulatory issues don’t affect devices sold outside the U.S.
If you have a Whoop 4.0 or 5.0, this doesn’t apply to you either; the issue is specific to the blood pressure feature offered in the premium Life subscription ($359 per year) with the MG (“medical grade”) device.
Why the FDA Intervened (and How Whoop Responded)
According to the FDA letter, measuring and reporting users’ blood pressure data classifies the Blood Pressure Information feature as a medical device. Medical devices capable of measuring blood pressure must be cleared by the FDA before being released to the market.
Note that the FDA’s letter is addressed to the Blood Pressure Information feature , not the Whoop MG itself. Whoop, as noted in the letter, argued (to the FDA) that the blood pressure feature falls under the definition of software designed to “maintain or promote a healthy lifestyle,” and therefore is not subject to the medical device regulations.
The FDA counters that blood pressure measurement is “intrinsically related to the diagnosis of hypo- and hypertension and, therefore, is intended for use in the diagnosis of disease or other conditions and in the treatment, mitigation, prevention, or cure of disease.” The FDA notes that they have approved other blood pressure monitors that do not make direct disease claims, and they believe the Whoop readings are no different.
Whoop takes a different view, telling its followers: “Wellness features like these are common in wearables without FDA approval, like tracking your breathing rate or heart rate variability, and provide valuable information to help you make more informed decisions. Blood pressure is no exception.”
You can read the FDA’s full warning letter here, which asks Whoop to respond with an explanation of how they will comply moving forward. You can also read Whoop’s notice to members here , where the company explains why they believe they are not violating the law and states that the Blood Pressure Info feature remains available.
What could this mean for Whoop?
To be fair, Whoop may have gone a bit overboard with its MG (“medical grade”) version of its band. The standard model without blood pressure is the Whoop 5.0, which offers the company’s verified fitness and health metrics for $199 a year (the “One” membership) or $239 a year (the “Peak” membership). But the Whoop MG is an upgraded version that comes with a $359-a-year “Life” membership.
What does this significant price increase get you? According to Whoop’s pricing page , there are three features, two of which Whoop says are “medically monitored”: ECG readings and irregular heart rhythm notifications. Both of these features can alert you to heart rhythm problems. According to Whoop’s country availability page , ECG readings are available in 39 countries, including the U.S. This feature requires you to place your fingers on the metal clasp of the device and hold them there while the device takes a reading.
Meanwhile, irregular heart rhythm notifications are available in 36 countries, but the US is not one of them.
Blood pressure is the third feature (or second, if you’re in the U.S.) that Life’s subscription includes. That means if Whoop eventually has to turn it off, you’re essentially paying an extra $120 a year to get an ECG reading, a pretty standard feature on modern smartwatches. Heck, you can buy the entire Apple Watch SE for $169 , and it has an ECG app. (And it lasts for over a year.) So if the company has to stop offering blood pressure data, the expensive subscription doesn’t make much sense.
“Since this is one of the perks of Life, I hope that if this feature is removed, there will be compensation since we paid for it,” one Reddit user wrote in response to Whoop’s statement. For now, the feature is still available — likely while Whoop continues to defend its position with the FDA.