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 South Corporate Center |
| Contact Person | Siobhan O'Bara |
| Phone | (937) 610-4225 |
| [email protected] | |
| 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 |
| Contact Person | Allison Mehr |
| Phone | 602-381-1091 ext. 101 |
| [email protected] | |
| 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 |
| Contact Person | Erwin Cabana |
| Phone | 909-793-6516 |
| [email protected] | |
| 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 should have proper controls over Universal Product Code (UPC) assignment and use to advance the goals of the UDI system.
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.