UDI Regulations & Guidance

Overview

On September 24, 2013, the U.S. Food and Drug Administration (FDA) issued a final ruling that created an industry standard system of labeling and tracking medical devices through Unique Device Identification (UDI). The implementation of the FDA's ruling occurs over the course of several years and affects medical device manufacturers, consumers, healthcare providers and healthcare systems. When fully implemented, UDI will offer many benefits by enhancing patient safety and providing greater efficiencies in healthcare delivery.

View the FDA's UDI final ruling and regulation.

The International Medical Device Regulators Forum (IMDRF) released a final UDI Guidance Document for the Unique Device Identification of Medical Devices on December 9, 2013. This document provides a framework for regulatory authorities from around the world to develop local, national, and global harmonized UDI systems.

View the UDI Guidance Document for Unique Device Identification of Medical Devices.