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

January 7, 2026

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.

The announcement came on January 6 during a keynote by FDA Commissioner Marty Makary. Speaking at CES 2026 and later on Fox Business, he laid out a vision that aims to keep government oversight out of the way for tools that simply promote healthier lifestyles. That includes the vast majority of fitness trackers, heart rate monitors and sleep tools on the market today. Gadgets & Wearables