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 ...
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 ...
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 ...
ConsumerAffairs

FDA relaxes rules for wearable health devices

The U.S. Food and Drug Administration says it will ease regulatory requirements for certain consumer wearable health devices.
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 ...
CounterPunch

The FDA Fails to Protect Americans from the Medical Device Industry

Americans cannot rely on the Food & Drug Administration (FDA) to guarantee that medical devices are safe, and a recent Government Accountability ...