FDA commissioner says non-medical-grade wearable data exempt from regulation

FDA announces wearable devices providing non-medical info won't face regulation, offering clarity on digital health ...
Medical Device and Diagnostic Industry (MD+DI)

FDA’s New Rules for Wearables

FDA plans limited regulation of wearable medical devices, boosting Apple, Fitbit, Oura stocks as 50% of Americans use fitness ...
GlobalData on MSN

FDA announces regulatory exemptions for ‘non-medical grade’ devices

FDA commissioner Marty Makary revealed at the 2026 CES trade show in Las Vegas that low-risk devices will face less ...

US FDA to limit regulation of health and fitness wearables, commissioner says

The U.S. Food and Drug Administration said on Tuesday that it will limit regulation of wearable devices and software designed ...
Becker's Hospital Review

FDA: Nonmedical wearable health data won’t face oversight

FDA nonmedical wearable health data devices providing general health info will not face regulation, clarifying guidance for ...
STAT

FDA announces sweeping changes to oversight of wearables, AI-enabled devices

The FDA will ease regulation of digital health products, aiming to deregulate AI and promote its widespread use.
MedTech Dive

FDA exempts more wearable, AI features from oversight

In a pair of guidance documents released Tuesday, the regulator clarified the types of wellness features and clinical decision support tools that don’t fall under medical device oversight.
The American Bazaar

FDA moves to ease oversight of wearable health and wellness devices

Wearable health devices may soon operate under looser regulatory oversight following new guidance from the FDA ...
Arabian Business

FDA exempts non-medical-grade wearable data devices from regulation

These technologies are improving all the time. If they’re not making claims that they are medical grade, let’s let the market ...