The Food and Drug Administration has told Whoop that it must get its wearable blood pressure tool approved as a medical device, but the Boston tech company is refusing to submit it to the agency for regulation — and refusing to stop selling it.
Whoop makes a wristband that tracks the wearer’s fitness and health, measuring indicators such as heart rate, heart rate variability, and sleep quality. The FDA considered the device a general wellness product not subject to regulation until May, when Whoop introduced a feature that estimates the wearer’s blood pressure.
Since then, the FDA has repeatedly told Whoop that the software tool, called Blood Pressure Insights, should be regulated as a medical device and meet the higher standards applied to medical-grade technologies. In the agency’s most recent letter, sent in July, the FDA warned that continuing to distribute the device without regulatory approval violated federal law.
But in a response sent Aug. 4, Whoop rejected the FDA’s assessment, saying the software didn’t meet the definition of a medical device and the company would continue to offer the feature. The company, which shared the letter with the Globe, also argued the move went against the goals of the Trump administration.
“Seeking to regulate the feature as a medical device also runs counter to the stated policy of the Secretary of the Department of Health and Human Services, Robert F. Kennedy Jr., of ‘clearing away regulatory barriers so innovation can thrive,’ ” Whoop said in the letter.
Whoop’s refusal to comply with the FDA’s request is uncommon, legal experts said. The FDA, which oversees the safety of medical devices and pharmaceuticals, is usually the ultimate decider of what comes under its jurisdiction and which devices can be sold to help people manage or treat health conditions.
Chris Robertson, a Boston University law professor who teaches FDA law, said any communication from the FDA to a company is typically enough to make the company get in line with federal standards.
“You’re playing with fire here,” Robertson said. “That means that Whoop is taking a real calculated gamble.”
Whoop was founded in 2012 by Will Ahmed, a Harvard squash player who wanted to help athletes optimize their performance and recovery. The privately held company, which was last valued at $3.6 billion in 2021, has amassed a cohort of athletic superstars to promote its products, including soccer legend Cristiano Ronaldo, top-ranked tennis player Aryna Sabalenka, and Super Bowl-winning quarterback Patrick Mahomes.
Wearable technology sits in a gray area when it comes to regulation. The wearables market, estimated by one market intelligence group to be worth $84 billion in 2024, is rapidly expanding, and companies are racing to add new features that give users unique health measurements.
Smart wristbands, watches, and rings that assess heart rates don’t have to get cleared as medical devices. But Whoop competitors, such as Apple and Fitbit, have sought FDA approval for certain software tools in recent years.
The crux of Whoop’s argument rests on the 21st Century Cures Act, a 2016 law that exempts wellness software features from the definition of a medical device, so long as those features aren’t related to the diagnosis, prevention, or treatment of a disease. Blood Pressure Insights, Whoop said, is only intended to be used as a way to gauge a person’s performance, quality of sleep, and stress levels.
The FDA, however, has rejected Whoop’s characterization of the blood pressure tool. In its letter, the agency said the product qualifies as a medical device because its measurements are “inherently associated with the diagnosis of a disease or condition,” such as hypertension, or high blood pressure.
Conventional blood pressure cuffs are regulated as medical devices.
Whoop has registered one of its products with the FDA, securing medical device approval for its Heart Screener tool. That tool measures the heart’s electrical activity to alert users to potentially abnormal heart rates and atrial fibrillation, a common type of abnormal heart rhythm.
The FDA said it doesn’t comment on “ongoing investigations, compliance matters, or enforcement activities except with the company involved.”
The confrontation is reminiscent of the clash more than a decade ago between the FDA and the personal genomics platform 23andMe, said health law expert Frances Miller, who also teaches at BU.
The FDA and 23andMe went back and forth on whether the company’s health test — which the company claimed could tell customers their risk of conditions like gallstones, heart disease, or arthritis — constituted a medical device.
In 2013, the FDA sent a warning letter to 23andMe much like the one it sent Whoop, and 23andMe ultimately capitulated.
But the landscape looks different today, Miller said. The FDA has experienced significant cuts under President Trump, and federal agencies as a whole have lost power. In addition, Kennedy has publicly stated his vision that “every American is wearing a wearable within four years.”
Whether Whoop will win its fight against regulation is unclear, Miller said.
“I could have given you a very confident answer a year and a half ago,” Miller said. “Not now. They’re pushing the envelope.”
Marin Wolf can be reached at marin.wolf@globe.com.