Unique Device Identification System: Implementation and Compliance Requirements
This guidance provides clarification on key provisions of the UDI Rule, which establishes a unique device identification system for medical devices. It covers UDI basics, placement requirements, GUDID database requirements, direct marking requirements, and various exceptions/alternatives.
Recommended Actions
- Determine device classification and applicable compliance dates
- Select FDA-accredited issuing agency for UDI assignment
- Implement proper date format on labels
- Establish process for assigning new DIs when device changes occur
- Request GUDID account and prepare for data submission
- Evaluate need for direct marking based on device intended use
- Review exceptions and alternatives applicable to your devices
- Implement UDI in both plain-text and AIDC formats
- Update quality system procedures to incorporate UDI requirements
- Train relevant personnel on UDI system requirements and procedures
Key Considerations
Software
- Stand-alone software must provide UDI through plain-text statement when started or through menu command
- Software updates require new Device Identifier (DI) only if resulting in new version/model
- Packaged software must follow standard UDI labeling requirements
Labelling
- UDI must appear in both plain-text and AIDC format
- Date format must be YYYY-MM-DD
- Each package configuration requires unique DI
- Label must indicate presence of non-visible AIDC technology
- UDI placement required on device label and packages
Other considerations
- Devices intended for multiple uses and reprocessing require direct marking
- Class I devices have specific exceptions
- Labeler is responsible for UDI compliance
- GUDID database submission required with specific data elements
- Various exceptions available for certain device categories
Relevant Guidances
- Global Unique Device Identification Database (GUDID) Data Submission and Management Requirements
- Unique Device Identifier (UDI) Form and Content Requirements
- 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 Requirements for Convenience Kits
Related references and norms
- 21 CFR 801: Labeling
- 21 CFR 830: Unique Device Identification
- 21 CFR 820: Quality System Regulation
Original guidance
This post is licensed under CC BY 4.0 by the author.