The DCB currently remains an investigational device and is not available for sale in the US. "Airiver Medical receives FDA ...

Medical device lobbyists called for more staffing transparency in user fee negotiations with the Food and Drug Administration ...

Employees at the Food and Drug Administration’s medical device center on Tuesday received notice that they would be cut amid massive layoffs at federal health agencies. The reductions included people ...

The Food and Drug Administration's headquarters is in Silver Spring, Maryland. This story was originally published on MedTech Dive. To receive daily news and insights, subscribe to our free daily ...

The Association for the Advancement of Medical Instrumentation (AAMI) officially welcomes speakers from the U.S. Food and Drug Administration (FDA) to its upcoming medical device standards conference, ...

Explore how FDA's risk-averse approach to clinical decision support software regulation reveals challenges in balancing ...

For decades, FDA’s Center for Devices and Radiological Health (CDRH) has been recognizing standards that can be referenced in premarket medical device submissions ...

The recent staff cuts at the U.S. FDA’s device center caught the attention of outsiders but also caught the attention of those who work on premarket applications for 510 (k) and PMA filings.

The U.S. Food and Drug Administration (FDA) has published its guidance agenda for Fiscal Year 2026, announcing plans for eight guidance documents to be released this upcoming year. It also named 12 ...