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 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
Phone: (937) 610-4226
Web Site: http://www.gs1.org
- 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: http://www.hibcc.org
- Firm Name: ICCBBA
Address: PO Box 11309, San Bernardino, CA 92423-1309
Contact Person: Kaytee Ison
Phone: (909) 793-6516
Web Site: http://www.iccbba.org
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).