Unique Device Identification

in 2007, Congress passed legislation directing the US Food and Drug Administration (FDA) to develop regulations establishing a Unique Device Identification (UDI) system for medical devices. This was reinforced in 2012 by the passing of the FDA Safety and Innovation Act (FDASIA). A national UDI system creates a common vocabulary for reporting and enhancing electronic tracking abilities.

FDA representative Jay Crowley will provide an update on FDA’s recently published proposed UDI regulation, the work of the US FDA UDI database pilot and the continued work of the International Medical Device Regulators Forum. Ask questions and take away key messages on harmonization.