FDA Accredits UDI Agencies

“FDA has accredited three organizations as UDI issuing agencies: GS1, Health Industry Business Communications Council (HIBCC), and International Council for Commonality in Blood Banking Automation (ICCBBA). This document contains information and links related to the format of the unique device identifier (UDI) for each FDA-accredited issuing agency. Each FDA-accredited issuing agency has a unique UDI format that has been approved by FDA during the initial accreditation process. Any changes to the format of the UDI by an issuing agency must be approved by FDA before implementation. Please contact the issuing agency directly to obtain a UDI and for any additional questions regarding the creation or implementation of the formats.” The full document from FDA is at the link provided.

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.