U.S. Food and Drug Administration (FDA)

The U.S. Food and Drug Administration has updated its list of authorized medical devices that incorporate augmented reality (AR) and virtual reality (VR) technologies.

As part of a broader effort to expand health outcomes across diverse populations in the U.S., the U.S. Food and Drug Administration (FDA) has published a Discussion Paper to facilitate a public discussion on how to advance health equity in connection with medical devices.

In partnership with the University of Georgia’s International Biomedical Regulatory Sciences Program (UGA), the U.S. Food and Drug Administration (FDA) will hold its 11th Annual Medical Device Regulations Conference (MDRC) on August 21st.

The Center for Devices and Radiological Health (CDRH) at the U.S. Food and Drug Administration (FDA) has announced the expansion of its program intended to foster more efficient and expeditious development of innovative medical devices.

The U.S. Food and Drug Administration (FDA) has updated its list of recognized international and national standards that can be used to demonstrate compliance with certain requirements for premarket review and authorization of medical devices.

The U.S. Food and Drug Administration (FDA) has published a Final Guidance to clarify...

The Center for Devices and Radiological Health (CDRH) at the U.S. Food and Drug Administration (FDA) has released its latest reports on the agency’s activities in support of the safety and innovation of medical devices.

The U.S. Food and Drug Administration (FDA) is once again seeking to ban the use of electrical stimulation devices in treating certain mental health issues.

Recognizing the growing deployment and use of AI-enabled technologies, the U.S. Food and Drug Administration has published a white paper on the use of AI in medical products and devices.

The FDA has published a draft guidance on assessing the thermal effects of medical devices that intentionally or unintentionally produce tissue temperature changes.