The Food and Drug Administration (FDA) is issuing two new guidance documents to clarify how it will regulate artificial intelligence in consumer-facing health technologies, FDA Commissioner Marty Makary said while speaking at the Consumer Electronics Show.

Makary, in a video posted on X, said that the guidance is intended to provide clearer guardrails for companies developing AI-powered wearables and clinical decision support tools, while encouraging innovation. He described the move as part of the agency’s effort to keep pace with what he called an “AI revolution” in medical devices.

The first guidance addresses wearable technologies, stating that low-risk products designed to promote general wellness will not be subject to FDA oversight. Devices or software marketed as “medical” or “clinical grade,” however, will remain regulated. 

Makary further says that the distinction is meant to prevent consumers from making medical decisions based on tools intended only for screening or general information.
The second guidance focuses on clinical decision support software, including AI tools used by physicians. The FDA said it will generally avoid regulating products that provide information and allow clinicians to independently assess recommendations, while maintaining oversight of tools that offer automated medical conclusions without transparency.