FDA Commissioner Dr. 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 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.We had a problem loading this article. Please enable javascript or use a different browser. If the issue persists, please visit our help center.
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