The next Medical Device User Fee Amendments, which will set how much the FDA can raise from the industry in fees over a ...

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 ...

Many people who were fired from the Food and Drug Administration’s medical device center last week had their termination letters rescinded over the weekend, according to Advamed and three FDA ...

Yesterday, the U.S. Food and Drug Administration (FDA) updated its website to provide new information on data integrity concerns relating to medical devices. Over a year ago, FDA’s device center, the ...

The FDA’s Center for Devices and Radiological Health (CDRH) will have its hands full with the roll-out of the overhauled quality management regulation, but this will have ripple effects on industry as ...