medical devices

The U.S. Food and Drug Administration (FDA) has published a final rule that brings...

The U.S. Food and Drug Administration (FDA) has issued an updated Guidance on its...

The U.S. Food and Drug Administration (FDA) has issued a series of recommendations for...

The U.S. Food and Drug Administration (FDA) has issued a final guidance to help...

The U.S. Food and Drug Administration (FDA) has published a draft guidance intended to...

As part of its effort to streamline the process for reporting malfunctioning medical devices,...

The U.S. Food and Drug Administration (FDA) has launched a new pilot program intended...

The U.S. Food and Drug Administration (FDA) is seeking public comment on a proposed...

The U.S. Food and Drug Administration (FDA) has announced user fees applicable to medical...

To streamline the oversight of manufacturers’ quality systems, and encourage improved product safety on a global scale, the International Medical Device Regulators Forum (IMDRF) has developed the Medical Device Single Audit Program (MDSAP).