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UDI Labeler Resources

Overview

 

In 2013, the Food and Drug Administration (FDA) released a final rule establishing a unique device identification system designed to adequately identify devices through distribution and use. The final rule requires device labelers to include a unique device identifier (UDI) on device labels and packages, except where the rule provides for an exception or alternative. Each UDI must be provided in a plain-text version and in a form that uses automatic identification and data capture (AIDC) technology. The UDI will also be required to be directly marked on a device that is intended for more than one use, and intended to be reprocessed before each use. Dates on device labels and packages are to be presented in a standard format that is consistent with international standards and international practice.
 

A UDI is a unique numeric or alphanumeric code that consists of two parts:
 

    • the lot or batch number within which a device was manufactured;
    • the serial number of a specific device;
    • the expiration date of a specific device;
    • the date a specific device was manufactured;
    • the distinct identification code required by §1271.290(c) for a human cell, tissue, or cellular and tissue-based product (HCT/P) regulated as a device
 

All UDIs are to be issued under a system operated by an FDA-accredited issuing agency.


Obtain Labeler Code


If you would like to obtain a labeler code for your medical device, please go to GS1 US at http://www.gs1us.org/industries/healthcare/gs1-healthcare-us-initiative/fda-udi or Health Industry Business Communications Council® (HIBCC) at http://www.hibcc.org/udi-labeling-standards/


For use within NCPDP standards, only the DI portion of the UDI will be reported and the PI portion will be ignored. Please be aware the NCPDP Telecommunication Standard used for transmission of pharmacy transactions is currently limited to a 19-byte identifier for the product. A DI assignment of greater than 19-bytes by GS1 can be reformatted in accordance to the NCPDP Product Identifier Standard. A HIBCC DI assignment of greater than 19-bytes cannot be accommodated within the NCPDP Telecommunication Standard.


Additional Resources


FDA’s Unique Device Identifier (UDI) Website