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The U.S. Food and Drug Administration (FDA) last week made it faster and easier for manufacturers to push some wearables out to the consumer market by bypassing the agency’s medical device review process.
The agency also eased regulation of artificial intelligence or AI-enabled devices that doctors use for making decisions, FDA Commissioner Marty Makary announced at the Consumer Electronics Show in Las Vegas, the trade conference of the Consumer Technology Association.
Makary said in an X video that the changes “will promote more innovation with AI and medical devices.”
U.S. Health Secretary Robert F. Kennedy Jr. posted on X that wearable devices that support general wellness “have, for too long, been tied up in red tape.”
The @US_FDA is unlocking wearable devices for general wellness that have, for too long, been tied up in red tape. Wearables can help everyday Americans proactively take charge of their health, helping them steer clear of expensive interventions and chronic disease. Thank you,… https://t.co/pBNELnkEoI
— Secretary Kennedy (@SecKennedy) January 6, 2026
Critic: loosening regulations on wearables a ‘bad sign’
In its updated guidance on general wellness devices, the FDA clarified that non-invasive wearables that promote a healthy lifestyle could be considered wellness devices — not medical-grade devices requiring regulation — as long as they meet the agency’s definition of low risk.
Examples include smartwatches, smart rings, patches and other sensor-based technologies that track heart rate, glucose level, caloric intake and sleep patterns.
However, the FDA’s new guidance doesn’t address the privacy and consent issues associated with wearables, which track biometrics, said Miriam Eckenfels, director of Children’s Health Defense’s (CHD) Electromagnetic Radiation (EMR) & Wireless Program.
The new guidance also ignores concerns that some wearables may increase the user’s exposure to wireless radiation.
“The FDA loosening regulations for a broad rollout of wearables is a bad sign,” Eckenfels said. She noted that in June 2025, Kennedy caused an uproar among supporters when he said during congressional testimony:
“We’re about to launch one of the biggest advertising campaigns in HHS [U.S. Department of Health and Human Services] history to encourage Americans to use wearables … my vision is that every American is wearing a wearable within four years.”
“We do not share this vision,” Eckenfels said. “Quite the contrary, we oppose governmental pressure to incentivize the widespread use of wearables. They pose serious health risks, especially to children, and they threaten privacy.”
Kennedy later clarified his comments, stating:
“What I was trying to say is that I want this technology to be universally available as one of the ways people can get on top of their health. … Of course I don’t want to mandate it. And the idea of everyone’s body being hooked up to a data center somewhere is horrifying. This data should be private, and when it is shared with the device provider it must be subject to health privacy laws.”
New guidance doesn’t completely deregulate wearables
W. Scott McCollough, lead litigator for CHD’s EMR & Wireless cases, reviewed the FDA’s new guidance. He said the changes don’t completely deregulate wearables.
“Although the change was framed as deregulatory, the FDA really did not loosen much. … They mostly applied existing policies to the new technology.”
In other words, the new guidance generally just reaffirmed that wearables that are not used to diagnose, cure, mitigate, treat or prevent disease, and that do not affect the body’s structure or functions, fall into the category of “general wellness” devices, rather than “medical devices.”
The agency’s guidance also provided specific examples for modern wearables that fall into the “general wellness” category.
McCollough told The Defender in an email:
“What they *did not* address is the fact that wearables, whether medical devices or not, are also electronic products and potentially subject to additional regulation. This is where the EMR issues will have to be resolved.”
The FDA did not immediately respond when asked when it plans to acknowledge that wearables are electronic products.
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Relaxed regulation for AI tools that help doctors make decisions
In its updated guidance on Clinical Decision Support Software, the FDA outlined a softer regulatory approach to AI-enabled products that assist doctors in developing diagnoses and treatment options.
Previously, the agency considered products that delivered a single recommendation as medical devices that required FDA review.
Now, those products can enter the market without FDA review, as long as they meet other criteria set by the agency.
For instance, an AI product that helps summarize a radiologist’s findings would likely escape FDA review under the new guidance, STAT reported.
The FDA released the updated guidance without first holding a public comment period about the change, though stakeholders can provide feedback through the FDA website.
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