FDA Issues Final Rule Establishing UDI System for Medical Devices

The U.S. Food and Drug Administration (FDA) has issued a final rule requiring most medical devices in the United States to begin carrying a unique device identifier (UDI) within the next seven years. Originally proposed in July 2012 (see the July 10, 2012, HRC Alerts), the UDI system is intended to improve the quality of information in medical device adverse event reports, which will help FDA identify product problems more quickly, better target recalls, and improve patient safety. The system will require the label and device packaging of most medical devices to include a UDI provided in a plain-text format, as well as in a form that uses automatic identification and data capture technology. If a device is intended to be used more than once and intended to be reprocessed before each use, it must also be directly marked with a UDI to allow accurate identification even when the device is no longer accompanied by its label or package.