The FDA gives the warning messenger of cutting-edge, healthy wearable technology manufacturer Whoops makes your health and wellness field multiply and tremble. Health Technology is the result of the 21st Century Therapy Act and may be sold legally in the United States without the need for a pre-FDA market license if only This technology is designed to help consumers maintain a healthy lifestyle and no Designed to serve medical or therapeutic purposes.
What are the FDA's allegations?
The FDA claims that Hoop’s blood pressure insight (“BPI”) is a “medical device” rather than a “health and wellness” product because blood pressure is measured and then provides insights about such measurements, which is related to “medical use.” According to the FDA, blood pressure measurement is different compared to other types of wearable characteristics because it is “inherently associated with the diagnosis of hypotension and hypertension.”
What about Whoop’s marketing materials?
The FDA conducted a comprehensive review of Whoop's marketing and promotions, including Hoop's website. The FDA confirmed that it provided “Daily systolic and diastolic pressure estimates,“And help consumers”Understand how blood pressure affects their performance and well-being“Land outside the regulatory exemption health category. Whoop claims that BPI provides “medical grade” health and performance insights, which is an additional feed from the FDA, and HOOP intends to make BPI serve health care, not just health, not health.
If most wearable features are “low risk”, why not Whoop?
According to the FDA, under the FDA's “General Health: Low Risk Device Policy”, BPI will not be classified as a “low risk” device because the nature of providing blood pressure estimates is not a low risk function. The FDA claims that hypertension is the most common and most modifyable risk factor for cardiovascular disease in the United States, and that incorrect readings can have a significant adverse effect on users.
What is Whoop’s response?
Hoop issued a statement on July 15, 2025, challenging the FDA's argument. It notes that BPI “is designed to help you understand how your body responds to daily life, rather than diagnosing or treating any condition,” and compares the feature with other features commonly found in wearable technology, such as tracking respiratory rate. Since most wearable tracking features do not require pre-FDA market approval, Hoop's position is that the FDA is misled when applying the law to BPI.
Is there something special about some wearables?
The FDA warning letter brings focus to the spotlight, and there is tension between the healthy wearables industry and the scope of the FDA's power to regulate medical devices. The warning letter does express the obvious special issues associated with blood pressure measurements by the FDA, suggesting that the U.S. hypertension is associated with intimate blood pressure links in patients with heart disease. This may indicate that reviews of products targeting blood pressure have been higher than other health indicators. This is also consistent with the approach taken by other blood pressure monitoring devices such as Aktiia (cuffless blood pressure monitor), which obtained a 510 (k) gap in July for over-the-counter use.
What does a warning letter mean for the wearable industry?
Any action by the FDA on the 100-day events arising from the warning letter appears to be inconsistent with the current government’s driving force to encourage the public to use wearable devices regularly. During a June House Health Subcommittee hearing, Health Secretary Robert F Kennedy Jr said he hopes every citizen wears a smartwatch or fitness tracker for four years, a goal that will be supported by “one of the biggest advertising campaigns in HHS history.” Additionally, the White House has just announced a move with the private sector toward a patient-centric healthcare ecosystem, which has allowed them to take health insights into the hands of consumers.
Businesses considering the introduction of new wearable technology should consider the well-known and carefully consider the intended use and marketing strategies of the technology.
Orrick can help Life Sciences and HealthTech companies review their marketing materials, equipment status and FDA compliance before the market to ensure market launch. Orrick is at the forefront of legal innovation and also provides quality services in technology, energy and infrastructure, as well as finance. Check out the news and insights for updates. If you have any questions, please contact the author (Thora Johnson, Georgia Ravitz and Anna Booth) or other members of the Orrick team.