Accredited Issuing Agencies — GS1, HIBCC, ICCBBA
FDA has accredited three organisations to assign Device Identifiers (DIs) to medical devices:
GS1
GS1 is the largest and most widely used issuing agency globally. GS1 assigns:
- GTIN (Global Trade Item Number) as the base identifier
- GS1-128 barcode (linear, for outer packaging)
- GS1 DataMatrix (2D, for small devices/labels)
- GS1 QR Code (emerging use)
GS1 is the dominant choice for most medical device manufacturers worldwide.
HIBCC (Health Industry Business Communications Council)
HIBCC assigns its own identifier format:
- HIBC (Health Industry Bar Code) format
- Includes both linear and 2D barcode options
- Widely used in the US healthcare sector, particularly for surgical instruments and implants
ICCBBA (International Council for Commonality in Blood Banking Automation)
ICCBBA manages the ISBT 128 standard — used primarily for:
- Human blood, blood components, and cellular therapy products
- HCT/Ps (human cells, tissues, and cellular/tissue-based products)
Choosing an issuing agency
For most medical device manufacturers, GS1 is the appropriate choice given its global adoption and compatibility with supply chain systems. HIBCC is a reasonable alternative for US-centric manufacturers. ICCBBA is primarily for blood and tissue products.