Blood pressure on fitness bands and smartwatches: what the FDA's 2026 wellness guidance says

Some fitness bands, smartwatches and smart rings show a blood pressure figure, and the FDA has addressed such features in several documents since July 2025. In September 2025 the agency warned consumers that many blood pressure devices sold over the counter, including software features on smartwatches and smart rings, had no FDA authorization, and noted that such devices may be sold through online marketplaces. In January 2026 it issued guidance saying that some wearables estimating blood pressure could be treated as low-risk wellness products. WHOOP, whose Blood Pressure Insights feature drew an FDA warning letter in 2025, received a close-out letter in June 2026.

What the FDA told WHOOP in 2025

The warning letter, dated July 14, 2025, said WHOOP was marketing Blood Pressure Insights in the US without clearance or approval. Quoting WHOOP's website, the FDA described the feature as giving daily systolic and diastolic blood pressure estimations, and noted that the site listed it among WHOOP's "medical-grade health & performance insights". The agency said it had not authorized the feature for any use and found it adulterated, for lacking premarket approval, and misbranded, for lacking a 510(k) notification.

The FDA's reasoning was that a blood pressure estimate is inherently linked to diagnosing high or low blood pressure, even when given as a daily range rather than a real-time reading. It pointed to the feature's gauge, color-coded green, yellow and orange around a target range, and said WHOOP's disclaimers were not enough, citing evidence that people were using the feature to monitor their hypertension. It also judged that blood pressure estimation was not a low-risk function, because a falsely low or high reading could have significant consequences.

WHOOP's side appears in the same letter. According to the FDA, the company met agency staff on May 15 and May 27, 2025, and argued in a June 2, 2025, letter that the feature was not a medical device, citing the provision of federal law that excludes software for maintaining or encouraging a healthy lifestyle. The FDA wrote that WHOOP said it intended to keep marketing the feature.

What the January 2026 guidance changed

On January 6, 2026, the FDA issued a new version of its guidance "General Wellness: Policy for Low Risk Devices", replacing the 2019 edition. Each page is marked as containing nonbinding recommendations. It says the FDA may consider products that use non-invasive sensing, such as optical sensors, to estimate physiologic parameters including blood pressure, oxygen saturation and blood glucose to be general wellness products, as long as the outputs are for wellness only and the product meets a list of conditions.

Under those conditions, the product must not be invasive or implanted, must not use technology that could pose a safety risk without specific regulatory controls, must not be intended to diagnose or treat a disease, must not be meant to replace an FDA-authorized device, and must not prompt specific clinical action. It may show values that look like clinical ones only if they have been validated, for example by the maker's own testing or peer-reviewed literature. A product meeting the conditions may display values, ranges, trends and baselines and relate them to sleep, activity, stress or recovery.

The guidance also lists what takes a product out of the wellness category, among them naming specific diseases or diagnostic thresholds, alerts that call for clinical action, treatment guidance, and claims of clinical equivalence, clinical accuracy or medical grade. A wellness product may still tell users that a check by a healthcare professional may be helpful when readings fall outside wellness ranges, provided the message names no disease or condition, does not call the reading abnormal, gives no clinical thresholds, diagnoses or treatment recommendations, and is not an ongoing alert for managing a condition. One of the guidance's examples is a wrist-worn wearable reporting sleep, pulse rate and blood pressure from an optical sensor, which the FDA says qualifies as a low-risk wellness product provided its blood pressure values are validated.

The WHOOP close-out letter

On June 17, 2026, the FDA wrote to WHOOP that, based on changes the company had made to Blood Pressure Insights and its labeling in response to the warning letter, and consistent with the updated guidance, it does not intend to enforce device requirements for the feature as modified. The letter says it covers only that modified feature, not any other product, feature or later change. It does not describe what WHOOP changed.

A wellness estimate is not a cleared feature

Not enforcing is not the same as reviewing: under the guidance, the FDA says it does not intend to examine low-risk wellness products for compliance with premarket review. Apple's Hypertension Notification Feature for Apple Watch, cleared on September 11, 2025, works differently: according to its 510(k) summary, it analyzes data from the watch's optical (PPG) sensor over multiple days and notifies users who may have hypertension, and it is not intended as a method of blood pressure surveillance. Its 510(k) summary reports a validation study in which 2,229 people without a previous diagnosis of hypertension enrolled, measured against an FDA-cleared home blood pressure monitor, with 1,863 providing enough data for the main analysis.

In our plain-language reading, those figures mean the feature notified about four in ten study participants whom the reference monitor showed to have hypertension, and stayed silent for about nine in ten of those without it. For stage 2 hypertension, the summary gives a sensitivity of 53.7%. WHOOP, for its part, holds a separate FDA clearance, for an ECG feature cleared on April 4, 2025.

What is still unsettled

The September 16, 2025, safety communication is still on the FDA's website, and the page shows no update since that date. It says blood pressure wearables fall outside the wellness policy, being neither solely for wellness use nor low risk, and its list of affected devices covers any unauthorized smartwatch or smart ring feature that claims to measure or estimate blood pressure. On our reading, this page and the later January 2026 guidance now point in different directions for wellness-only estimates, and we found no FDA statement reconciling them.

A separate draft guidance, also from January 2026, sets out the clinical testing the FDA recommends for cuffless blood pressure devices that seek authorization as medical devices. It is marked not for implementation. For people whose medical care depends on accurate readings, the FDA's safety communication advises talking to a health care provider about an FDA-authorized device, and says authorized blood pressure devices will generally carry product code DXN in the FDA's 510(k) database.