The FDA Says Whoop’s Blood Pressure Feature Is Illegal, but It’s Still Active (for Now)

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The FDA Says Whoop’s Blood Pressure Feature Is Illegal, but It’s Still Active (for Now)

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When Whoop introduced its new hardware and membership tiers back in May, one of the devices was called the MG, with the abbreviation standing for “Medical Grade.” Among the big features ostensibly making it worth the upgrade was something called Blood Pressure Insights. But now the FDA has sent Whoop a warning letter saying that Whoop is marketing an unapproved medical device.

Whoop is a screenless fitness tracker with an extensive array of features that track a user’s fitness, sleep, and other metrics related to wellness. (You can read about my experiences tracking my health with Whoop here.)

In a message to members posted today on the r/Whoop subreddit, Whoop stated that, despite the FDA letter, the Blood Pressure Insights feature “remains available” to members on the Life tier. This is the highest tier of membership and the only one that was marketed as including Blood Pressure Insights. Whoop also stated that any regulatory issues with the FDA 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 solely about the blood pressure feature offered in the top-tier Life membership ($359/year) with the MG (“medical grade”) device. 

Why the FDA intervened (and how Whoop responded)

According to the FDA’s letter, measuring and reporting users’ blood pressure classifies the Blood Pressure Insights feature as a medical device. Medical devices that can measure blood pressure need to be approved by the FDA before they go to market. 

Note that the FDA’s letter is directed at the Blood Pressure Insights feature, not the Whoop MG hardware itself. Whoop argued (to the FDA, according to the letter) that the blood pressure feature falls under the definition of software that is intended for “maintaining or encouraging a healthy lifestyle,” and thus is exempt from the rules for medical devices. 

The FDA counters that the measurement of blood pressure is “inherently associated with the diagnosis of hypo- and hypertension, and is therefore intended for use in the diagnosis of a disease or other condition, or in the cure, mitigation, treatment, or prevention of disease.” The FDA notes that they have approved other blood pressure monitors that didn’t make direct claims about disease, and they consider Whoop’s blood pressure readings to be no different.

Whoop sees it differently, saying to members: “Wellness features like this are common in wearable technology without requiring FDA review, like tracking your respiratory rate or HRV, and provide valuable insights to support you in making better decisions. Blood pressure is no different.”

You can read the FDA’s entire warning letter here. It asks Whoop to reply with an explanation of how they will follow the rules going forward. You can also read Whoop’s notice to members here, where they explain why they believe they are not violating the law, and state that the Blood Pressure Insights feature remains available. 

What this could mean for Whoop

To be fair, Whoop was perhaps sticking its neck out a bit by offering an MG (“medical grade”) edition of its wristband. The standard model, without the blood pressure feature, is the Whoop 5.0, which provides the company’s established fitness and wellness metrics for either $199/year (the “One” membership) or $239/year (the “Peak” membership). But the Whoop MG is an upgraded version that goes with the “Life” membership for $359/year. 

What does that significant price hike buy you? Three features, according to Whoop’s pricing page, and two of those are “medically regulated,” in Whoop’s words: ECG readings and irregular heart rhythm notifications. Both of these can tell you if there are problems with the rhythm of your heartbeat. According to Whoop’s country-by-country availability page, ECG readings are available in 39 countries, including the U.S. This feature requires you to put your fingers on the device’s metal clasp and leave them there while it takes a reading.

Irregular heart rhythm notifications, meanwhile, are available in 36 countries, but the U.S. is not one of them.

Blood pressure is the third feature (or, if you’re in the U.S., the second) that the Life membership buys you. Which means that if Whoop ends up having to pull it, you’re essentially paying an extra $120 each year for the ability to take ECG readings—a pretty standard feature on smartwatches these days. Heck, you can buy an entire Apple Watch SE for $169, and it has an ECG app. (It also will last more than a year.) So if the company has to stop offering Blood Pressure Insights, the expensive subscription doesn’t make much sense. 

"Since this is one of the selling points of Life I'm hoping there's going to be compensation if this feature will be removed, we paid for it," said one Redditor in a reply to Whoop's statement. So far, the feature is still available—presumably while Whoop continues to argue its side to the FDA.

Source: The FDA Says Whoop’s Blood Pressure Feature Is Illegal, but It’s Still Active (for Now)