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

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

In a pair of guidance documents released Tuesday, the regulator clarified the types of wellness features and clinical ...

This week in Pedersen's POV, our senior editor argues against FDA's huge shift in digital health — made without public ...

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

FDA announces wearable devices providing non-medical info won't face regulation, offering clarity on digital health ...

FDA Commissioner Marty Makary called these changes “common-sense reforms” that could expedite the development of cell and ...

The Food and Drug Administration (FDA) updated its guidance on Tuesday to allow more wearables to fall into a general ...

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

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

Three key themes emerged across the mifepristone documents: consistent safety findings, lack of ideological bias in staff ...

With the new year, it is time to provide a forecast of the legislative and regulatory landscape.