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

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

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 ...
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 ...
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.
Politifact

A product says it's ‘FDA approved,’ ‘FDA registered’ or ‘FDA certified.’ What does that even mean?

An Instagram ad catches your eye. You click to the product’s website and find reassurance: The product, it says, is "FDA certified" or was "produced in an FDA registered facility." Mention of the U.S.