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 ...
The U.S. Food and Drug Administration says it will ease regulatory requirements for certain consumer wearable health devices.
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 ...
The FDA will ease regulation of digital health products, aiming to deregulate AI and promote its widespread use.
The Food and Drug Administration (FDA) updated its guidance on Tuesday to allow more wearables to fall into a general ...
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 ...
Americans cannot rely on the Food & Drug Administration (FDA) to guarantee that medical devices are safe, and a recent Government Accountability ...
Questions about cost and patient benefit loom as Congress considers automatic Medicare coverage for 'breakthrough' medical ...
After a quiet January marked by administrative transition and internal upheaval at FDA, enforcement activity has accelerated sharply in 2025. No warning letters were issued in the first month of the ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results
Feedback