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U.S. Food and Drug Administration (FDA)

FDA Issues Digital Health and AI Glossary

The U.S. Food and Drug Administration (FDA) has released a helpful glossary of commonly used terms in connection with digital health devices and medical devices that use artificial intelligence (AI) or machine learning.

FDA Classifies Radiofrequency Toothbrush as Medical Device

The FDA has classified a radiofrequency-based electric toothbrush as a medical device, establishing regulations to ensure the safety and effectiveness of this emerging dental technology.

FDA Releases List of Proposed Guidances for FY 2025

The Center for Devices and Radiological Health at the U.S. Food and Drug Administration has published an extensive list of guidance documents that it intends to publish or develop in fiscal year 2025.

FDA Drafts Guidance on Chemical Analysis for Medical Device Biocompatibility

The FDA released draft guidance on chemical analysis for medical device biocompatibility assessment. This approach can reduce testing time and animal testing. Public comments are accepted until November 19th through the Federal Rulemaking Portal.

List of Medical Devices Incorporating Virtual Reality Technology Updated

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.
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FDA Releases Paper on Health Equity for Medical Devices

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.

FDA Annual Medical Device Regulations Conference Set

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.

FDA Expands Advisory Program for Medical Devices Life Cycle

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.

FDA Updates Recognized Standards List

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.

New FDA Guidance Targets Quality of Refurbished Medical Equipment

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