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Document issued on November 17, 2017.


The UDI system seeks to improve the identification of medical devices by making it possible to rapidly and definitively identify a device and certain key attributes that affect its safe and effective use. This will facilitate more accurate reporting of adverse events by making it easier to pinpoint the device at issue in the submitted report. FDA,
health care providers, and industry may then more rapidly and precisely extract useful information from adverse event reports and thereby gain a better understanding of the underlying problems and improve the ability to take appropriate and better-focused corrective action.

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FDA new Guidance: Unique Device Identification: Direct Marking of Devices