FDA Eases Oversight on Health Wearables in Significant Policy Change
The U.S. Food and Drug Administration (FDA) announced a major regulatory shift on January 6, 2026. The change eases oversight requirements for consumer wearable health devices and wellness software. FDA Commissioner Dr. Marty Makary unveiled these changes at the Consumer Electronics Show in Las Vegas. He emphasized that the agency needs to move at “the speed of Silicon Valley.”
Under the new guidance, low-risk devices such as heart rate monitors, fitness trackers, and non-invasive wearables providing general health metrics will no longer face the same premarket requirements as medical devices. This relaxation of rules applies to products that provide information for wellness purposes without making clinical medical claims. However, devices claiming medical-grade accuracy or intended for diagnosing specific conditions will still require full FDA oversight.
Dr. Makary explained, “We want to let companies know, with very clear guidance, that if their device or software is simply providing information, they can do that without FDA regulation.” The policy also extends to certain AI-enabled wellness products. However, the FDA emphasized that products designed to detect serious conditions or guide treatment remain subject to stringent regulatory oversight to ensure patient safety.
Source: Consumer Affairs