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

In 2025, the U.S. Food and Drug Administration (FDA or the Agency) issued a surprising number of enforcement letters to ...

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 ...

ARLINGTON, Va.--(BUSINESS WIRE)--The Medical Device Innovation Consortium (MDIC), the first public-private partnership created with the sole objective of advancing medical device regulatory science, ...

The FDA’s Center for Devices and Radiological Health has withdrawn its December 2017 final guidance for clinical evaluation ...