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

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

The FDA has been called out for its refusal to ban formaldehyde in hair straightening products, jeopardizing the health of ...

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

FDA commissioner Marty Makary revealed at the 2026 CES trade show in Las Vegas that low-risk devices will face less ...

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

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

Owlet, Inc. OWLT is benefiting from increased regulatory clarity in the infant monitoring market, a factor that may strengthen its competitive positioning over time. As safety and accuracy gain ...

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

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

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

The FDA’s new draft guidance on Bayesian methodology signals a shift toward more flexible, data-driven clinical trial designs, enabling sponsors to use prior data and adaptive approaches to improve ...