FDA's Unique Device Identification (UDI) System
FDA has issued a proposed rule on the establishment of a Unique Device Identification System. This system would require most medical devices distributed in the U.S. to carry a Unique Device Identifier (UDI). This system, comprised of the UDI code, application of the UDI to device labeling and packaging, and a related database, is designed to provide a standardized way to identify devices across all information sources and systems, including electronic health records and devices registries. When fully implemented, it will improve the quality of information in medical device adverse event reports, which will help the FDA identify product problems more quickly and efficiently, facilitate recalls of devices, and allow health care professionals, patients, device companies, FDA, and others to make better use of information gathered as a part of clinical practice to assure and enhance the safety, effectiveness and quality of medical devices.