Unique Device Identifier (UDI) Form and Content Requirements
This guidance describes the requirements and recommendations for the form and content of Unique Device Identifiers (UDI), including the two forms of UDI presentation, content clarification, use of data delimiters, and recommended data order. It applies to medical device labelers and FDA-accredited issuing agencies but does not apply to Universal Product Codes (UPCs).
What You Need to Know? 👇
What are the two required forms of UDI presentation on medical device labels and packages?
The UDI must be presented in both easily readable plain-text and automatic identification and data capture (AIDC) technology forms on device labels and packages, as specified in 21 CFR 801.40(a).
What components make up a Unique Device Identifier (UDI)?
A UDI consists of two main components: a Device Identifier (DI), which is a mandatory fixed portion identifying the device model and labeler, and a Production Identifier (PI), which is a conditional variable portion containing information like lot/batch, serial number, or expiration date.
Are data delimiters required in both forms of UDI presentation?
Yes, data delimiters must be included in both easily readable plain-text and AIDC forms of the UDI. They identify specific data elements within the UDI and enable proper parsing of DI and PI segments by users and electronic systems.
What international standards must UDIs conform to under FDA regulations?
UDIs must conform to ISO/IEC 15459 parts 2, 4, and 6, and use only characters from the invariant character set of ISO/IEC 646. These standards ensure global compatibility and proper unique identification functionality.
How do UDI requirements differ for stand-alone software distributed in packaged versus non-packaged form?
Non-packaged stand-alone software only needs UDI displayed as easily readable plain-text when started or through menu commands. Packaged software requires UDI in both plain-text and AIDC forms on labels/packages, plus plain-text display within the software.
Can additional non-UDI elements be included in UDI carriers, and how should they be formatted?
Yes, non-UDI elements like quantity may be included in UDI carriers, but they must use different data delimiters than DI and PI elements. Non-UDI elements should follow the PI in the easily readable plain-text format and are not considered part of the actual UDI.
What You Need to Do 👇
Recommended Actions
- Implement both plain text and AIDC forms of UDI on device labels and packages
- Ensure proper use of data delimiters to distinguish UDI elements
- Follow recommended order of information in plain text form
- Test print quality of barcodes using recommended standards
- Verify AIDC forms can be reliably read at points of use
- Consult FDA-accredited issuing agency for specific format guidelines
- For software devices, implement appropriate UDI display mechanisms
- Ensure clear distinction between UDI and non-UDI elements in labeling
- Document compliance with UDI system requirements
- Maintain proper controls over UDI assignment and use
Key Considerations
Software
- Stand-alone software not distributed in packaged form must display UDI in plain text at startup or through menu command
- Software version must be conveyed in the Production Identifier (PI)
- Stand-alone software in packaged form must display UDI at startup/menu and have UDI on package in both plain text and AIDC forms
Labelling
- UDI must be presented in two forms: easily readable plain-text and AIDC technology
- Plain text must include Device Identifier (DI) and Production Identifier (PI) if applicable
- Data delimiters must be included to identify specific data elements
- For multiple AIDC forms, only one plain text form is required
- AIDC presence must be disclosed if not visually evident
- Recommended order: DI first, followed by PI, then any non-UDI elements
Other considerations
- UDI must be issued under FDA-accredited issuing agency system
- AIDC must be machine-readable by barcode scanner or similar technology
- Print quality testing recommended for barcode forms
- Non-UDI elements may be included but must use different data delimiters
Relevant Guidances 🔗
- Unique Device Identification Requirements for Convenience Kits
- Direct Marking of Devices with Unique Device Identification (UDI) Requirements for Reusable Medical Devices
- Unique Device Identification Policy for Class I and Unclassified Devices: Compliance Dates and Requirements
- Unique Device Identification System: Implementation and Compliance Requirements
- Global Unique Device Identification Database (GUDID) Data Submission and Management Requirements
Related references and norms 📂
- ISO/IEC 15459-2: Information technology - Unique identifiers - Part 2: Registration procedures
- ISO/IEC 15459-4: Information technology - Unique identifiers - Part 4: Individual items
- ISO/IEC 15459-6: Information technology - Unique identifiers - Part 6: Unique identifier for product groupings
- ISO/IEC 15416: Bar code print quality test specification - Linear symbols
- ISO/IEC 15415: Bar code symbol print quality test specification - Two-dimensional symbols
- ISO/IEC TR 29158: Direct Part Mark Quality Guideline