FDA Announces Final Rule Establishing UDI System for Medical Devices

November 1, 2013 | Evaluations & Guidance


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, 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 labeling and packaging of most medical devices to include a UDI provided in a plain-text format, as well as in a form that supports automatic identification and data capture (AIDC) technology such as bar coding. If a device is intended to be used more than once and intended to be reprocessed before each use, it must also...

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