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  1. Device Advice: Comprehensive Regulatory Assistance

Contact an FDA-Accredited Issuing Agency

Contact an FDA-Accredited Issuing Agency

An FDA-accredited issuing agency is an organization accredited by the FDA to operate a system for assigning unique device identifiers (UDIs) according to the Unique Device Identification System final rule.  The final rule permits multiple issuing agencies.

The FDA has accredited the following issuing agencies. Contact an issuing agency directly if you want to use their system for issuing UDIs for your device.

GS1

Issuing Agency Name GS1
Address

Princeton Pike Corporate Center
1009 Lenox Drive, Suite 202
Lawrenceville, NJ 08648

Contact Person Siobhan O’Bara
Phone 937-610-4226
Email gs1usudi@gs1us.org
Web Site https://www.gs1.org
Status Accredited
Accreditation Info Application, Approval Letter, Accreditation Extension Letter
Info for Labelers Information on Using the GS1 System for UDI Requirements

Health Industry Business Communications Council (HIBCC)

Issuing Agency Name Health Industry Business Communications Council (HIBCC)
Address

2525 E. Arizona Biltmore Circle, Suite 127
Phoenix, AZ 85016

Contact Person Allison Mehr
Phone 602-381-1091 ext. 101
Email allisonmehr@hibcc.org
Web Site https://www.hibcc.org
Status Accredited
Accreditation Info Application, Approval Letter, Accreditation Extension Letter

ICCBBA

Issuing Agency Name ICCBBA
Address

PO Box 11309
San Bernardino, CA 92423-1309

Contact Person Erwin Cabana
Phone 909-793-6516
Email erwin.cabana@iccbba.org
Web Site https://www.iccbba.org
Status Accredited
Accreditation Info Application, Approval Letter, Accreditation Extension Letter

UDI Formats by Issuing Agency: The FDA has compiled a listing of information related to UDI Formats by FDA-Accredited Issuing Agency (January 27, 2017). The examples given in this document may not include all AIDC options offered by a particular issuing agency

UPCs: Labelers who license Universal Product Codes (UPCs) directly from an FDA-accredited issuing agency need proper controls over UPC assignment and use which advances the goals of the UDI program.

While a UPC may serve as the UDI for Class I devices if a UPC is present on the device label and device packages (21 CFR 801.40(d)), the labeler may choose to use the full UDI (device identifier + production identifier) to take advantage of the production identifier data (such as expiration date, lot, serial number) and to meet customer requirements.



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