Medical Devices

UDI Issuing Agencies

An FDA-accredited issuing agency (IA) is an organization that operates a system for assignment of UDIs according to the UDI Rule. The UDI Rule permits multiple IAs and provides a process through which an applicant would seek FDA accreditation as an IA. See 21 CFR 830 Subpart C.

Applicants seeking initial FDA accreditation as an issuing agency shall notify the FDA via email at

The systems for the issuance of UDIs that are operated by FDA-accredited issuing agencies must conform to certain international standards (21 CFR 830.20). Additionally, the FDA-accredited issuing agencies must fulfill their responsibilities outlined in 21 CFR 830.120 and regularly apply for renewal of their accreditation (21 CFR 830.110). 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 (DI) + production identifier (PI)) to take advantage of the PIs in UDI (e.g., expiration date, lot, serial number) and to meet customer requirements.

FDA has accredited the following three IAs listed below. Information in the original applications was current as of the date of initial accreditation. Labelers should contact an IA directly if they are interested in using the IA’s system for the issuance of UDIs.

  1. Firm Name: GS1
    Address: Princeton South Corporate Center, 300 Charles Ewing Blvd., Ewing, NJ 08628
    Contact Person: Siobhan O’Bara
    Phone: (937) 435-3870
    Web Site:
    Status: Accredited
  2. Firm 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
    Web Site:
    Status: Accredited
  3. Firm Name: ICCBBA
    Address: PO Box 11309, San Bernardino, CA 92423-1309
    Contact Person: Erwin Cabana
    Phone: (909) 793-6516
    Web Site:
    Status: Accredited

FDA will continue to post its decisions on requests submitted by prospective issuing agencies as they become available. The FDA has compiled a listing of information related to UDI Formats by FDA-Accredited Issuing Agency (January 27, 2017).

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