The Center for Devices and Radiological Health said it is on track to meet review times specified by user fee agreements, ...

Keeping up with medical device news today can feel like a full-time job. New gadgets, new rules, and big company moves happen ...

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

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 (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 ...