An FDA-accredited issuing agency (IA) is an organization that operates a system for assignment of UDIs according to the final rule. The final 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 email@example.com.
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.
- Firm Name: GS1
Address: Princeton Pike Corporate Center, 1009 Lenox Drive, Suite 202,
Lawrenceville, NJ 08648
Contact Person: Siobhan O’Bara, Senior Vice President - Industry Engagement
Phone: (609) 620-8046
Web Site: http://www.gs1.org
Date of Initial Accreditation: December 17, 2013
Initial Accreditation Granted through: December 17, 2016
- Firm Name: Health Industry Business Communications Council (HIBCC)
Address: 2525 E. Arizona Biltmore Circle, Suite 127, Phoenix, AZ 85016
Contact Person: Robert A. Hankin, PhD., President and CEO
Phone: (602) 381-1091
Web Site: http://www.hibcc.org
Date of Initial Accreditation: December 26, 2013
Initial Accreditation Granted through: December 26, 2016
- Firm Name: ICCBBA
Address: PO Box 11309, San Bernardino, CA 92423-1309
Contact Person: Pat Distler, Technical Director
Phone: (909) 793-6516
Web Site: http://www.iccbba.org
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).