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On September 24, 2013, the Food and Drug Administration (FDA) published a final rule that establishes a unique device identification (UDI) system for devices. The objective for the UDI system is to facilitate adequate identification of medical devices through distribution and use to achieve multiple public health purposes, such as reducing medical errors, improved adverse event reporting, and more rapid and efficient resolution of recalls. With the collaboration of our healthcare and industry partners, FDA believes the UDI system will provide a leap forward in the quality of patient care on a national level. This article provides a background on the UDI system and the goals of the implementation from FDA’s perspective. In a subsequent article, we will discuss how hospitals can incorporate and benefit from this new labeling and data submission requirement.