MedPage Today January 9, 2026
Agency premiered two updated guidance documents at the Consumer Electronics Show
At the Consumer Electronics Show in Las Vegas, FDA Commissioner Marty Makary, MD, MPH, announced that his agency issued two new guidance documents aimed at easing regulation of digital health products.
Both guidance documents “will promote more innovation with AI [artificial intelligence] and medical devices,” Makary said in a video from the floor of the show that he posted on X.
One document deals with “general wellness” products, which are often referred to as “wearables,” and the other pertains to clinical decision support software used by clinicians.
The wearables guidance covers products like smart watches, smart rings, and other sensors that track various health parameters. Makary spoke of these...
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