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.

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

Potential blockbusters and root-cause treatments from Eli Lilly, Merck, Takeda and others could get a regulatory nod this ...

The FDA classification underscores the urgency of the situation and the potential danger posed by the contaminated products.

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 ...

Wearable health devices may soon operate under looser regulatory oversight following new guidance from the FDA ...

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

Five Carrot Top County Kitchens hummus varieties have been recalled due to undeclared sesame.The products were sold in ...

Less than two weeks after rejecting Sanofi’s investigational multiple sclerosis drug, the FDA has publicly shared the ...

FDA feedback supports 505(b)(2) filing in H2 2026; No additional studies required beyond current planned 32-subject clinical ...