FDA UDI /GS1 Requirements for Barcode Verification Checking of barcode content, format and quality • Need to deconstruct barcode to confirm correct and correctly formatted data • Need to check print/mark quality to confirm that codes will be readable UDI ruling expects that you will follow the issuing agency’s rules and guidelines • All issuing agencies require barcode quality of grade C (numerical grade of 1.5) or better • In the case of GS1, these are specific.
“An unreadable bar code is the same as a missing bar code, which would mean non-compliance” http://www.gs1.org/docs/barcodes/1D_Barcode_verification_implementation_guideline.pdf http://www.gs1.org/docs/barcodes//2D_Barcode_Verification_Process_Implementation_Guideline.pdf