Much has changed in the 10 years since the US FDA released the first Unique Device Identification (UDI) regulation. This session will provide an overview of the various UDI regulations around the world. The various regulations will be compared and contrasted to describe some of the key differences. The session will provide insight on future UDI requirements and the growing interest in medical device traceability by healthcare providers, regulators, and others in the healthcare eco-system. A summary of how RFID may be impacted by UDI regulations will be included.
SPEAKER: Dennis Black, UDI Program Director, Central Regulatory Affairs, BD