white paper

UDI Labeling Overview

The Food and Drug Administration’s Unique Device Identification (UDI) System is a new rule that has been created to ensure that medical device manufacturers label their devices so that the health care community, regulators, and the public can better identify medical devices during shipping, in storage, and at point-of-use. Unique device identifiers, according to the final UDI rule, must appear on labels for various classes of devices, product packaging, and in certain cases the medical devices themselves. Along with the UDI rule, the FDA has created the Global Unique Device Identification Database (GUDID) in which the medical device manufacturer will register each UDI so that any member of the public may look up a UDI to retrieve device and manufacturer information.

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