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](https://x.com/DrMakaryFDA/status/2008583173349974145).
One document deals with [“general wellness” products](https://www.fda.gov/media/90652/download), which are often referred to as “wearables,” and the other pertains to [clinical decision support software](https://www.fda.gov/media/109618/download) used by clinicians.
## Wearables Guidance: A New Era of Innovation
The wearables guidance covers products like smart watches, smart rings, and other sensors that track various health parameters. Makary spoke of these products’ “profound ability to identify early physiologic changes, screen for diseases, and help people in their quest to be healthier.”
According to the updated guidance, products can qualify as general wellness as long as they don’t make claims about treating or preventing a certain disease. They can, however, state that they can help promote or maintain a healthy weight, for instance, or promote relaxation or manage stress.
## AI in the Clinic: A New Era of Medical Innovation
“They tried to make the line clearer on what is wellness, versus what is a medical device,” said John Torous, MD, director of the digital psychiatry division at Beth Israel Deaconess Medical Center in Boston, who has conducted research on mental health apps.
“In the past, if it claimed to treat a disease or illness, that would make it a medical device that would have to be regulated. Now, they said products can mention the illness if they offer general wellness support for the illness.”
## A New Era of Medical Innovation
Also, a company called WHOOP received an [FDA warning letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/whoop-inc-709755-07142025) over a product that could measure and track blood pressure. While the FDA told the company the product is a device, the company pushed back, including in a [press release on its website](https://www.whoop.com/us/en/thelocker/why-whoop-stands-behind-blood-pressure-insights/?srsltid=AfmBOookJbEVKZ-yCPFlF3wOEbvqrRTiCZYCwpwxRWNdr583fN6FosNM).
“I think under this new guidance, [WHOOP’s blood pressure tracker] would be allowed,” Torous said. Indeed, in the guidance document, the agency states that it “may consider certain products that use non-invasive sensing (e.g., optical sensing) to estimate, infer, or output physiologic parameters (e.g., blood pressure, oxygen saturation, blood glucose, heart rate variability) to be general wellness products.”
