HIBCC Guideline: Understanding FDA’s Proposed UDI Requirement

September 1, 2012
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What is a UDI and the GUDID?

The Unique Device Identifier (UDI) is a system used to mark and identify medical devices within the healthcare supply chain. On September 24, 2013 the Food and Drug Administration (FDA) established a UDI system that requires manufacturers to include both a plain-text version of the identifying data, and a version encoded using Automatic Identification Data Capture (AIDC) technology such as linear or two-dimensional bar codes, RFID tags, etc.

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