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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. 

medical tyvekOverview 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. 

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 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.

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.


Frequently Asked Questions (FAQs) About the UDI System

The following are some answers to frequently asked questions about the UDI system.

Does the U.S. FDA UDI Rule mandate specific barcodes or AIDC methods?

No, the U.S. FDA UDI Rule does not call for the use of a particular barcode or AIDC technology. 

Can additional information be encoded in a GS1 barcode that is being used for UDI?

Yes, the U.S. FDA UDI Rule does not forbid the encoding of additional information in a GS1 barcode. 

What standardized date format is followed in the U.S. FDA UDI Rule?

The U.S. FDA UDI Rule follows this standardized date format: YYYY-MM-DD.

Is the UDI standardized date format the same as the ISO standardized date format?

Yes and no. The U.S. FDA UDI Rule follows the YYYY-MM-DD format, which is an ISO standard. However, the ISO standard also includes other date formats that are not allowed by the U.S. FDA UDI Rule, such as YYYY-MM.

Does the day need to be specified in expiration dates and production dates?

Yes, days must be specified in dates under the U.S. FDA UDI Rule.

What is the best barcode to use?

Companies must choose the data carrier that is right for them based on their application, including the type, use, size, and scanning environment of the device. Many healthcare applications use the GS1-128 and GS1 DataMatrix. However, other barcodes, such as the GS1 Composite and DataBar, can be equally suitable.


Contact DoraniX for Your UDI Printing Needs

It is important to follow UDI printing guidelines when creating labels for medical devices. Otherwise, the product may be found non-compliant by the FDA, meaning it would not be eligible for legal sale. That’s why it is important to invest in quality label printers. 

For a printer you can count on to create labels that meet all necessary requirements and restrictions, turn to the experts at DoraniX. We specialize in serialized data printing, including barcoding for unique device identification. We can configure our printers to clearly code on a variety of materials used in the medical device industry, such as Tyvek pouches, Tyvek lids, and foil/poly pouches. To learn more about our UDI label printers, contact us or request a quote today.