Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi everyone, hoping someone can help us out.  We are a Canadian manufacturer of a class 1 medical device.  Last year we registered and obtained a barcode from GS1 US to comply with the FDA's UDI requirements to market our device in the US.  As part of design control, we wanted to complete a barcode verification scan to ensure compliance.  GS1 US apparently does not offer this service and we have been redirected to GS1 Canada.  GS1 Canada will not provide this service for barcodes that they have not generated.  Is there anyone else in a similar scenario - what services are others using to verify their barcodes?  And a secondary question (concern) is whether we, as a Canadian company, should have had the barcode issued from GS1 US in the first place?  (The reason we did was through following the steps on the FDA's website for certified issuing agencies Contact an FDA-Accredited Issuing Agency   - in which GS1 US is one of the 3 issuing agencies, and not GS1 Canada). 

U.S. Food and Drug Administration		remove preview
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. View this on U.S. Food and Drug Administration >

Hello Anon,

First, why not get a bar code verifier yourself in-house like an Axicon or similar?  If you are going to be generating multiple bar codes from time to time, it might be a good investment - yes they are expensive initially, but might be better in the long period.  You might be able to find a third-party service organisation who can verify bar codes for you, but I think most of them are their offering to sell the bar code verifier.

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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 08-Feb-2023 09:28
From: Anonymous Member
Subject: Barcode verification service - GS1 barcode

This message was posted by a user wishing to remain anonymous

Hi everyone, hoping someone can help us out.  We are a Canadian manufacturer of a class 1 medical device.  Last year we registered and obtained a barcode from GS1 US to comply with the FDA's UDI requirements to market our device in the US.  As part of design control, we wanted to complete a barcode verification scan to ensure compliance.  GS1 US apparently does not offer this service and we have been redirected to GS1 Canada.  GS1 Canada will not provide this service for barcodes that they have not generated.  Is there anyone else in a similar scenario - what services are others using to verify their barcodes?  And a secondary question (concern) is whether we, as a Canadian company, should have had the barcode issued from GS1 US in the first place?  (The reason we did was through following the steps on the FDA's website for certified issuing agencies Contact an FDA-Accredited Issuing Agency   - in which GS1 US is one of the 3 issuing agencies, and not GS1 Canada). 

U.S. Food and Drug Administration		remove preview
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. View this on U.S. Food and Drug Administration >