Barcode Quality and UDI Compliance Link between label content, barcode quality, and UDI compliance • FDA requires quality control of medical device labels by whomever is producing the label and applying it to the product packaging • GS1 standard requires that barcode meet the GS1 General Specification Table 6 є Barcode type (e.gGS1 -128, GS1-Data Matrix) є Barcode size, height module minimum dimension є Minimum print quality per ISO 15416/15416