Unique Device Identification (UDI)

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The application standard for medical devices

Some industry committees have developed application standards mandating that their manufactures comply with their rules for barcode marking. An application standard outlines what type of symbology is acceptable, what ISO standard to grade against, the minimum acceptable grade, aperture size, x-dimension range, lighting required, and how the data within the barcode must be formatted.

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The FDA has mandated that all medical devices contain a Unique Device Identifier (UDI) by the year 2020. A UDI is a barcode containing a specific set of information that the FDA has required to be on all medical devices. The ruling requires that all medical devices be labeled with a barcode graded according to GS1 or HIBCC rules and list a product’s lot number, serial number, and expiration date if applicable. Additionally, the FDA requests that a portion of the information within each UDI barcode be submitted to the FDA’s Global Unique Device Identifier Database (GUDID). The information required depends on the medical device type.