FDA Says Many Fitness Wearables, AI Tools Exempt From Regulation

‘We need to get out of the way as a regulator,’ the agency’s commissioner said.

Food and Drug Administration Commissioner Marty Makary in Washington on July 29, 2025. Saul Loeb/AFP via Getty Images

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 Food and Drug Administration (FDA) said tools used to help make clinical decisions are sometimes exempt from FDA oversight, such as those not intended to analyze medical images.