FDA Updates UDI Formats

Food and Drug Administration (FDA) and the Center for Devices and Radiological Health (CDRH) 

UDI Formats by FDA-Accredited Issuing Agency

November 3, 2015

FDA has accredited three organizations as UDI issuing agencies:

  • GS1
    • http://www.gs1.org/
  • Health Industry Business Communications Council (HIBCC)
    • http://www.hibcc.org/
  • International Council for Commonality in Blood Banking Automation (ICCBBA)
    • https://www.iccbba.org/

This document contains information and links related to the format of the unique device identifier (UDI) for each FDA-accredited issuing agency.

Each FDA-accredited issuing agency has a unique UDI format that has been approved by FDA during the initial accreditation process. Any changes to the format of the UDI by an issuing agency must be approved by FDA before implementation.

Please contact the issuing agency directly to obtain a UDI and for any additional questions regarding the creation or implementation of the formats.

FDA is working with the issuing agencies and other stakeholders to establish a change control schedule. The next version of this document will include this schedule

Please note that standards development organizations that are helping to promote standard adoption of UDI in electronic health information1 are currently working on recommendations for UDI representation and transmission. When available, links to these documents will be available at the UDI webpage: www.fda.gov/udi

Download the FDA Document

 

Download “UDI-format-FDA-Accredited-Issuing-Agencies-November-3-2015.pdf”
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