FDA Says Many Fitness Wearables, AI Tools Exempt From Regulation

FDA Says Many Fitness Wearables, AI Tools Exempt From Regulation

The Food and Drug Administration on Jan. 6 clarified that it will not regulate some artificial intelligence (AI) tools and wearables. In a guidance document, the FDA said that tools used to help make clinical decisions are sometimes exempt from FDA oversight, such as those not intended to analyze medical images. In a second document, the FDA said that it does not regulate “low risk products that promote a healthy lifestyle,” including “low risk …

CES 2026: FDA eases rules for wearables that avoid medical claims

Fitness trackers, sleep monitors and AI health tools just got a clearer runway in the US. The FDA has introduced new guidance that officially keeps most wellness wearables out of medical device regulation, as long as they steer clear of clinical claims. FDA shifts focus to high-risk claims, not general wellness The announcement came on January 6 during a keynote by FDA Commissioner Marty Makary. Speaking at CES 2026 and later on Fox Business, he…

FDA issues guidance on wellness products, clinical decision support software

The Food and Drug Administration today released two guidance documents; one related to low-risk wellness products (including certain wearable devices) and the other related to clinical decision support software. The guidance on low-risk wellness products clarifies the FDA’s interpretation of a provision within section 520 of the Food, Drug and Cosmetics Act, which states that software that is intended “for maintaining or encouraging a healthy li…