New FDA Guidelines: A Boost for Health Wearables and Wellness Devices
In a noteworthy policy shift, the U.S. Food and Drug Administration has revised its guidelines, permitting a wider range of health wearables and wellness devices to circumvent rigorous regulatory scrutiny. The revised guidelines, unveiled in early January 2026 at the Consumer Electronics Show, broaden the definition of “general wellness” products to encompass non-invasive devices that monitor blood pressure and blood glucose levels—metrics previously deemed inherently medical.
“The FDA is liberating wearable devices for general wellness that have been entangled in bureaucratic procedures for far too long,” declared FDA Commissioner Marty Makary while announcing the changes. The guidelines aim to foster innovation while upholding safety standards for low-risk wellness products designed exclusively for promoting healthy lifestyle choices.
Industry experts anticipate this regulatory shift will trigger an influx of innovative wellness wearables in the market over the forthcoming two years. Rene Quashie, vice president of digital health at the Consumer Technology Association, pointed out that “a lot of wearables companies are going to be happy at the clarity” offered by the new guidelines.
Source: Fierce Healthcare