FDA announced its plan to stop subjecting non-medical grade wearable devices to FDA regulations in an effort to clarify the agency’s approach on AI and digital health.

The agency issued a guidance document to go hand and hand with the announcement to provide clarity to both industry and FDA staff on the Center for Devices and Radiological Health's (CDRH) compliance policy for products of low risk promoting a healthy lifestyle or referred to as general wellness products.²

According to FDA’s guidance document, a general wellness product is intended for use that relates to maintaining or encouraging a general state of health or a healthy activity, or an intended relation between the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions, and where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition.²

The guidance builds on the agency’s existing policy classifying low-risk wellness tools, such as fitness apps and activity trackers encouraging exercise, as non-medical devices exempt from tight regulation, provided they don’t associate claims related to disease diagnosis or treatment.¹

"We want to let companies know, with very clear guidance, that if their device or software is simply providing information, they can do that without FDA regulation," Marty Makary, FDA Commissioner told Fox Business. Makary continued, saying, "The only stipulation is if they make claims of something being medical grade, like a clinically appropriate, clinical grade blood pressure measurement. We don't want people changing their medicines based on something that's just a screening tool or an estimate of a physiologic parameter.”

When asked about the accuracy of these general wellness devices Makary told Fox News, "If they're not making claims that they are medical grade, let's let the market decide. Let's let doctors choose from a competitive marketplace which ones they recommend for their patients.”

What led FDA to its decision?

In a statement on its website, FDA explained that its renewed approach on regulating general wellness products aims to bring clarity to its staff and the industry. FDA Commissioner Makary explains that the FDA’s desire for clarity stems from government agencies struggling with the rapid pace of both artificial intelligence and technological advancements, in which Makary argues that the FDA must be "proactive" in its approach, as reported by Fox News.

Marty Makary’s statement on guidance for support tools

Along with the agency’s guidance on general wellness products, FDA also announced a new guidance on support tools such as Google and ChatGPT, in which FDA commissioner Makary commented on the agency’s decision.

"If something is simply providing information like ChatGPT or Google, we're not going to outrun that lion. We're not going to go in there and say, 'There's one result that is inaccurate; therefore, we've got to shut this down,'" Makary said to Fox News. "We have to promote these products and, at the same time, just guard against major safety concerns."

Sources

1. FDA commissioner Says non-Medical-Grade Wearable data Exempt from Regulation Fox News January 6, 2026 https://www.foxbusiness.com/media/fda-commissioner-says-non-medical-grade-wearable-data-exempt-regulation
2. General Wellness: Policy for Low Risk Devices U.S. Food and Drug Association January 6, 2026https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-wellness-policy-low-risk-devices