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

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 Pike Corporate Center, 1009 Lenox Drive, Suite 202,
    Lawrenceville, NJ 08648
    Contact Person: Siobhan O’Bara
    Phone: (937) 610-4226
    Web Site:
    Date of Initial Accreditation: December 17, 2013
    Initial Accreditation Granted through: December 17, 2016
  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:
    Date of Initial Accreditation: December 26, 2013
    Initial Accreditation Granted through: December 26, 2016
  3. Firm Name: ICCBBA
    Address: PO Box 11309, San Bernardino, CA 92423-1309
    Contact Person: Kaytee Ison
    Phone: (909) 793-6516
    Web Site:
    Date of Initial Accreditation: February 12, 2014
    Initial Accreditation Granted through: February 12, 2017

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 (March 9, 2016).

Page Last Updated: 10/17/2016
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