The FDA announced wearable devices providing non-medical information won't face regulation, offering clarity on digital ...

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

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

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

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 U.S. Food and Drug Administration (FDA) announced on Tuesday that it will limit regulatory oversight of wearable devices ...

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

The Food and Drug Administration today released two guidance documents; one related to low-risk wellness products (including ...

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

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

FDA’s decision to limit regulations of non-medical grade wearables marks a notable shift toward regulatory restraint in digital health. FDA announced its plan to stop subjecting non-medical grade ...

8. Guidance document: Off-The-Shelf Software Use in Medical Devices FDA itself has said that section 3.2.2 of this guidance is out-of-date because it characterizes laboratory information management ...