CES 2026: FDA eases rules for wearables that avoid medical claims
Fitness trackers, sleep monitors and AI health tools just got a clearer runway in the US. The FDA has introduced new guidance that officially keeps most wellness wearables out of medical device regulation, as long as they steer clear of clinical claims.
FDA shifts focus to high-risk claims, not general wellness
The announcement came on January 6 during a keynote by FDA Commissioner Marty Makary. Speaking at CES 2026 and later on Fox Business, he laid out a vision that aims to keep government oversight out of the way for tools that simply promote healthier lifestyles. That includes the vast majority of fitness trackers, heart rate monitors and sleep tools on the market today.
This isn’t a blanket free pass. If a wearable claims to diagnose or manage a disease, that still pulls it into regulated territory. But if it just tracks metrics like steps, resting heart rate, or estimated sleep stages, without promising clinical-grade accuracy or medical outcomes, it stays exempt.
Makary made the agency’s position clear. The FDA wants to match “the speed of Silicon Valley,” giving more predictability to tech companies and investors. The key dividing line is risk. Low-risk wellness tools are safe to innovate around, even if they overlap with features found in regulated medical devices.
Where the line gets enforced
The updated guidance makes specific reference to blood pressure estimation, drawing from last year’s warning letter to WHOOP. The company had begun surfacing systolic and diastolic estimates through its Blood Pressure Insights feature. The FDA responded by saying that crossed into medical device claims. Estimating a figure is not a problem on its own, but using that figure to suggest someone might be hypertensive triggers regulatory scrutiny.
In other words, you can show someone a number. But if you tell them what to do with it, and it sounds like medical advice, you’ve entered a different category.
The new rules also cover AI models. The agency clarified that large-scale AI tools like ChatGPT or Google’s search results are generally safe from FDA crackdowns, even if users ask about symptoms. As long as the software is not intended to treat, diagnose, or recommend a clinical course of action, it falls outside the agency’s scope.
That doesn’t mean anything goes. Makary said the FDA would still step in if a product creates safety concerns. One example would be if a consumer stops or adjusts medication based on feedback from an unregulated device.
Investors and developers take notice
The market reacted quickly. Shares of glucose monitor manufacturers Dexcom, Abbott, and Medtronic all rose modestly after the announcement. Garmin also saw a nearly 3% bump, reflecting the clearer landscape now facing fitness-focused tech.
For developers, this guidance confirms what many had already suspected. The FDA is more concerned about what companies claim than what their sensors measure. Calling your data “medical grade” comes with strings attached. Calling it a wellness insight leaves you in safer territory.
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