The FDA’s Center for Devices and Radiological Health has withdrawn its December 2017 final guidance for clinical evaluation ...

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, ...

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 U.S. Food and Drug Administration has launched a new initiative, the Technology-Enabled Meaningful Patient Outcomes for Digital Health Devices Pilot, or TEMPO. It's designed as a voluntary effort ...