U.S. FDA’s Proposed UDI System May Set Worldwide Standard

The U.S. Office of Management and Budget has approved the U.S. Food and Drug Administration’s (FDA) long-awaited proposed rule on a unique device identifier (UDI), clearing it for release by the agency. The rule, once implemented, will provide the cornerstone for a modern postmarket device surveillance program that could become the world’s industry standard.
International Medical Device Regulatory Monitor