FDA UDI Compliance

The FDA’s Unique Device Identifier (UDI) system was designed to track medical devices through the entire distribution and use cycle.

While the UDI deadlines for Class 2 and 3 medical devices have come and gone, Class 1 medical device manufacturers face a September 24, 2020 compliance date. UDI requires that device labels and device packages bear a UDI and that key data for these devices be submitted to the FDA’s GUDID.

Download the Guide to UDI compliance

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Use UDI compliance as an opportunity to digitally transform labeling

  • Consolidate labeling systems and processes
    Maintaining multiple labeling systems is expensive, not to mention time consuming. Disparate systems can produce label variations and inaccuracies. Standardize on a single platform for labeling that integrates with core business systems to streamline the entire labeling process.
  • Empower business users
    Having business users create label templates using a simple, Microsoft Word-like user interface means that costly IT resources can focus on other mission critical projects.
  • Eliminate errors and mitigate risk
    Label errors are costly mistakes considering they are one of the main causes of medical device recalls. Digitizing your labeling eliminates the need for error-prone, manual processes and establishes a secure and controlled label design and approval process.
  • Streamline your supply chain
    Establish consistent labeling processes across all manufacturing sites to transform the supply chain and eliminate the need for costly, separate labeling operations at each location.

Explore our label management system

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Have Questions?

Contact our UDI team

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What is a UDI?

A UDI is a unique numeric or alphanumeric code displayed in both human readable (plain text) and machine readable (AIDC) form that consists of two parts: a device identifier (DI) and production identifier(s) (PI).

The Device identifier (DI) is a mandatory, fixed portion of a UDI that identifies the specific version or model of a device and the labeler of that device.

The production identifier (PI) includes lot or batch number, serial number, expiration date, and date of manufacture.

UDI is a unique identification code assigned to medical devices by the labeler of the device

Create UDI compliant labels with our label designer

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Learn more about UDI compliance

Case Study

Medical device company achieves global UDI compliance while improving accuracy and reducing costs

Download case study

Dental device manufacturing case study

Case Study

Global dental device manufacturer achieves compliant UDI labeling and Oracle integration

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Blog post

The Class II UDI deadline is past. Enterprise labeling is the future.

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Blog post

What you need to know about the UDI compliance date extension

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Blog post

UDI labeling: common mistakes and best practices.

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Blog post

Who bears responsibility for submitting UDI data to the GUDID?

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