Devices not making health claims will get a quicker path to market
January 7, 2026
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The U.S. Food and Drug Administration says it will ease regulatory requirements for certain consumer wearable health devices.
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Officials say the move is intended to speed innovation while maintaining patient safety.
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Industry groups welcomed the change, while some consumer advocates urged caution.
The U.S. Food and Drug Administration has announced that it will relax portions of its regulatory framework governing wearable health devices, a move the agency says is designed to encourage innovation and expand consumer access to digital health tools.
The agency used the venue of the CES 2026 show in Las Vegas to make the announcement. FDA Commissioner Marty Makary addressed attendees, saying the FDA needs to move at the speed of Silicon Valley.
Under the updated policy, some wearable devices that track metrics such as heart rate, physical activity, sleep patterns, and other noninvasive indicators will face fewer premarket review requirements. The FDA said the changes will primarily apply to low-risk products intended for general wellness rather than for diagnosing or treating specific medical conditions.
Wearable devices, including smartwatches, fitness bands, and sensor-equipped clothing, have become increasingly popular in recent years. Manufacturers have argued that existing regulatory pathways can be costly and time-consuming, particularly for products that pose minimal risk to consumers.
Will not apply to devices that make medical claims
The FDA emphasized that the relaxed rules will not apply to devices that make medical claims or are used for critical clinical decision-making. Products designed to detect serious conditions, guide treatment, or replace traditional medical devices will still be subject to full regulatory oversight.
Technology companies and digital health startups praised the announcement, saying it could shorten development timelines and lower barriers to entry.
Consumer and patient advocacy groups offered a more cautious response. Some warned that looser oversight could lead to confusion if consumers rely too heavily on wellness devices for medical guidance.
The FDA said it will continue to monitor the wearable device market and adjust its policies as needed. The agency also encouraged manufacturers to follow best practices for data accuracy, cybersecurity, and consumer disclosure, even when formal regulatory requirements are reduced.
The updated guidance is expected to take effect later this year.
What to consider
When choosing a wearable device, consumers should look beyond price and style and consider how the device will actually fit into their health, lifestyle, and privacy needs. Key factors include:
Accuracy and purpose
Not all wearables are designed for the same goals. Some focus on general wellness, like step counts and sleep tracking, while others monitor heart rhythm, blood oxygen, or stress indicators. Consumers should check whether the device is intended for fitness, wellness, or medical supportand understand that most are not diagnostic tools.
Data privacy and security
Wearables collect sensitive personal health data. Buyers should review how the manufacturer stores, uses, and shares that information, whether data is encrypted, and if users can control or delete their data. Clear privacy policies and strong security practices are especially important.
Regulatory status and claims
If a device makes health or medical claims, consumers should check whether it has FDA clearance or authorization. Devices marketed for general wellness typically face less oversight, which can affect how much confidence users should place in the results.
A wearable should work smoothly with a users smartphone, operating system, and preferred apps. Some devices function best within a specific ecosystem and may offer limited features if paired with other platforms.
Since wearables are often worn all day or overnight, comfort matters. Battery life can range from a day to several weeks, and durabilitysuch as water resistance and build qualitycan be important depending on how and where the device will be used.