FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

GS1 Issues New Guidelines That Reflect New UDI Requirements

June 11, 2019
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GS1 released updated guidance to help devicemakers comply with new unique device identifier requirements under the FDA’s updated standards.

The new guidelines identify the GS1 identification and barcode standards that correlate to the FDA’s UDI Rule requirements and explains how to implement the standards within the context of the FDA rule. 

The 62-page guidance document provides updates on GS1 company prefixes and barcode scanners as well as updates on the global trade item number (GTIN) data structure and how to determine which GTIN structure to use and what barcode options are available.

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