Issuing agency

Labelers get their identifiers through an issuing agency, currently GS1, HIBCC or ICCBBA. The agency's rules decide the format of the UDI on the label.

Issuing agency means an organization accredited by FDA to operate a system for the issuance of unique device identifiers. Label has the meaning set forth in section 201(k) of the Federal Food, Drug, and Cosmetic Act.

21 CFR, 830.3