The U.S. Food and Drug Administration has released new guidance defining how it will regulate wearable devices and artificial-intelligence-enabled software used to support healthy lifestyles, while limiting oversight of low-risk wellness technologies.
Under the updated framework, products such as fitness apps, activity trackers and wellness wearables will continue to be classified as non-medical devices, provided they do not make claims related to diagnosing, treating or preventing disease. Tools focused on promoting exercise, lifestyle management and general wellbeing will remain exempt from FDA medical-device regulation.
The agency also issued broader consumer warnings about the risks posed by unauthorized devices, emphasizing the importance of clearly distinguishing between wellness products and regulated medical technologies.
The guidance aims to strike a balance between encouraging innovation in digital health and protecting patient safety, particularly as artificial intelligence becomes more widely embedded in consumer health tools. The FDA clarified that AI-based symptom checkers and wellness software may be used to support health discussions but should not replace professional medical care.
Market reaction to the announcement was positive. Shares of continuous glucose monitor manufacturers Abbott, Medtronic and Dexcom closed between 1% and 4% higher, while U.S.-listed shares of fitness smartwatch maker Garmin rose nearly 3%.
The FDA said the guidance is designed to provide companies with regulatory clarity. Software and devices that only provide general health information without medical claims can operate outside FDA regulation. However, products that present themselves as medical-grade — such as those claiming to measure blood pressure or other diagnostic parameters — will remain subject to stricter oversight to prevent patients from making treatment decisions based on unvalidated or estimated data.
The updated stance follows enforcement action taken last year against fitness wearable company WHOOP, which received a warning letter from the FDA over its blood-pressure insights feature. The agency found that the feature crossed into medical-device territory by estimating systolic and diastolic values used in diagnosing hypertension.
The FDA continues to warn consumers about the growing availability of unauthorized health devices and reiterated that only products meeting medical-device standards should be relied on for clinical decisions.
