medical devices

The U.S. Food and Drug Administration (FDA) has launched a voluntary program to help...

The U.S. Food and Drug Administration (FDA) has issued a guidance document for medical...

The International Medical Device Regulators Forum (IMDRF) has reportedly proposed an update to its...

This article discusses the IEC 60601 Amendments Project, for Medical Electrical Safety, some of the changes to the General and Collateral Standards of the Project, and their impact on manufacturers. The future of the 60601 series of standards is also discussed.

The U.S. Food and Drug Administration (FDA) has issued three final guidance documents in...

The U.S. Food and Drug Administration (FDA) is requesting input on a planned web-based...

The U.S. Food and Drug Administration (FDA) has issued a guidance document on the...

The U.S. Food and Drug Administration (FDA) has issued a guidance on how the...

The U.S. Food and Drug Administration (FDA) has provided updated clarification on its requirements...

The Commission of the European Union (EU) has issued common specifications for the reprocessing...