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.
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.
The FDA is establishing a unique device identification system to adequately identify medical devices. Click here to submit UDI-related questions to the FDA Help Desk.
The International Medical Device Regulators Forum (IMDRF) was conceived in February 2011 as a forum to discuss future directions in medical device regulatory harmonization.