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FDA UDI Barcode Format Requirements

by Jan Sher

In the United States, the Food and Drug Administration (FDA) established a system designed to help adequately identify medical devices from manufacturing to distribution to patient use. It is known as the unique device identification (UDI) system.


Overview of the UDI System

The UDI system requires labelers of the device (generally the manufacturer) to add unique device identifiers on the labels and packages of the device. There are exceptions and alternatives to this rule. For example, if the device has a multi-use design that requires it to be reprocessed before each use, the UDI must also be marked directly on the device.  

Another requirement of the UDI system is submitting the device information to the Global Unique Device Identification Database (GUDID). The device labeler must send the device’s unique identifiers—typically just the device identifier (DI), which identifies the labeler and the specific device model or version—so interested parties can obtain the information as needed. 

Understanding UDI Formats

A UDI is a unique numeric or alphanumeric sequence that contains a device identifier (DI) and production identifier (PI). As stated above, the DI indicates the device’s labeler and specific model or version. It is a mandatory and fixed element. The PI indicates one or more of the following regarding a device: lot or batch number, serial number, expiration date, manufacturing date, and distinct identification code as per §1271.290(c). It is a conditional and variable element. 

Device Identifier

This information must be indicated on the device labels and packages and, in certain cases, on the device itself in two forms: human-readable and machine-readable. The former is generally presented as plain text, while the latter is commonly presented as a barcode. 

Machine-Readable UDI (Barcode) Format

Machine-readable UDI formats are read using automatic identification and data capture (AIDC) technology. It allows the UDI to be entered into an electronic record database or another computer system quickly and easily. 

Meeting the FDA requirements for UDI barcode services format necessitates adherence to one of three standards systems: GS1, Health Industry Business Communications Council (HIBCC), or International Council for Commonality in Blood Banking Automation (ICCBBA). The GS1 system features 14 numeric characters, the H1BCC system features 6 to 23 alphanumeric characters, and the ICCBBA system features 18 alphanumeric characters. Due to its international reach and broad market adoption, the GS1 system is now the most commonly used. Typical GS1-related barcodes include GS1-128 linear barcodes and S1 Data Matrix 2D barcodes.

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Human-Readable UDI (Date) Format

Any dates in human-readable UDIs must be in the proper format to prevent user confusion and misconceptions. In most cases, the standard format is year-month-day (YYYY-MM-DD). However, there are a few exceptions. For example, the date of manufacture for FDA-regulated electronic products should include the month without abbreviation followed by the full year, e.g., March 2021. The AIDC may also include dates that take the form of characters, which do not need to be in the human-readable data format.

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