The US Food and Drug Administration (FDA) is moving to relax regulatory requirements for low risk health and wellness wearables, software, and certain other non-medical grade devices.
Outlining the plans during a presentation at the 2026 Consumer Electronics Show (CES), taking place between January 6-9 in Las Vegas, Makary told attendees the FDA needed to move at “the speed of Silicon Valley”, as per a report by ConsumerAffairs.
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The exemptions will apply to low risk devices such as heart rate monitors and other wearables that are intended for tracking general healthcare metrics, while devices used for the diagnosis or treatment of specific medical conditions will remain in scope of existing premarket requirements.
In an interview with Fox Business programme Varney & Co, Makary explained: “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.
“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.”
The relaxed oversight plans will also influence health and wellness devices that use artificial intelligence (AI), resonating more broadly with an executive order issued by the White House in December 2025 that seeks to remove barriers to and encourage adoption of AI applications across sectors.
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By GlobalDataTouching on the matter with Fox Business, Makary continued: “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, [and] therefore we’ve got to shut this down.
“We have to promote these products and, at the same time, just guard against major safety concerns.”
In another move that Makary anticipates will get life-changing treatments “to patients faster”, the FDA removed a limitation on the use of real-world evidence (RWE) in December 2025, clearing the way for de-identified data to be used for medical device submissions. With this change, FDA reviewers will now consider the strength of submitted RWE on an application-by-application basis, adding that the new guidance will apply to “certain” types of medical device submissions.
