Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Does anybody know if there are minimum height barcode requirements for labelling of medical devices? I've read a few different guidances, but nothing that can clearly tell me if the barcode is required to fall under certain dimensions. Our labels have been sent out to a qualified 3rd party for validation and have come back with grades 'C and above as per the requirements, so I am not sure if I should be concerned with the actual dimensions if they have passed. 
Any experience is much appreciated-Thanks!

Hello Anon

If you are using GS1 as your UDI issuing agency, take a look at table 6 in the GS1 General Specifications document (available on the GS1 website).  The table is relevant to non-retail regulated healthcare items, and provides minimum, target, and maximum dimensions for various GS1 barcode formats.

If you are using HIBCC as your UDI issuing agency, I apologize that I am not familiar with their requirements.

Best Regards,  Lauren

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Lauren Kamer RAC
Director of Regulatory
United States
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Original Message:
Sent: 07-Jan-2019 15:38
From: Anonymous Member
Subject: UDI Barcode Dimension Requirements

This message was posted by a user wishing to remain anonymous

Does anybody know if there are minimum height barcode requirements for labelling of medical devices? I've read a few different guidances, but nothing that can clearly tell me if the barcode is required to fall under certain dimensions. Our labels have been sent out to a qualified 3rd party for validation and have come back with grades 'C and above as per the requirements, so I am not sure if I should be concerned with the actual dimensions if they have passed.
Any experience is much appreciated-Thanks!

The size specifications are not a requirement of the FDA UDI regulation, but rather are found in the barcode standards for each Issuing Agency (i.e. GS1's General Specifications). These dimensions are not mandatory requirements but if you choose to deviate from them it would be a good practice to document why. Also as barcode reader technology is improving, allowing for successful scanning of smaller barcodes, Issuing Agencies are likely to review the recommended dimensions, especially in relation to UDI.

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Lena Cordie
Victoria MN
United States
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Original Message:
Sent: 07-Jan-2019 15:38
From: Anonymous Member
Subject: UDI Barcode Dimension Requirements

This message was posted by a user wishing to remain anonymous

Does anybody know if there are minimum height barcode requirements for labelling of medical devices? I've read a few different guidances, but nothing that can clearly tell me if the barcode is required to fall under certain dimensions. Our labels have been sent out to a qualified 3rd party for validation and have come back with grades 'C and above as per the requirements, so I am not sure if I should be concerned with the actual dimensions if they have passed.
Any experience is much appreciated-Thanks!