Whoop fights FDA over regulation of blood pressure tool

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 to users. The company, which shared the letter with The Boston 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.”

Wearable technology sits in a grey 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.

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 Boston University.

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.