Hello Breanne
The US FDA does not specify a technology - pretty much anything machine readable is ok, considering that technologies change and manufacturers know their own customers. Barcodes are much more widely used than RFID tags or other technologies. If you're using GTINs, GS1 recommends Datamatrix-format 2D barcodes. Linear barcodes used to be compatible with more scanners, but most have upgraded to read 2D codes, and linear barcodes take up more space on a label than 2D codes.
Here's a nice guide to where different linear, 2D, and 3D barcode formats are commonly seen: https://www.gs1us.org/upcs-barcodes-prefixes/barcode-types
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Anne LeBlanc
United States
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Original Message:
Sent: 22-Jun-2023 12:35
From: Breanne Cuddington
Subject: UDI barcode requirements
Hello,
Are there any regulatory requirements pertaining to the use of 2D (QR Code) versus 3D barcodes on package labels for medical devices? Are they interchangeable, is one required in some markets but not others? Any guidance is greatly appreciated.
Thank you!
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Breanne Cuddington
Regulatory Affairs Lead
Kitchener ON
Canada
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