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.
What You Need to Know? 👇
What is the compliance timeline for UDI implementation across different device classes?
Class III devices must comply by September 2014, implantable devices by September 2015, Class II devices by September 2016, and Class I devices by September 2018. Direct marking requirements have additional timelines for reusable devices.
Which medical devices are exempt from UDI requirements?
Class I devices with UPC codes meet UDI labeling requirements, Class I devices exempt from GMP requirements are entirely excepted, and certain device categories listed in 21 CFR 801.30 have general exceptions.
What are the two main components of a Unique Device Identifier?
A UDI consists of a Device Identifier (DI) - a fixed portion identifying the labeler and device model, and Production Identifier(s) (PI) - variable portions including lot numbers, serial numbers, expiration dates, or manufacturing dates.
Do software-based medical devices need UDI labeling?
Yes, stand-alone medical software must display UDI through easily readable plain-text when started or via menu command. Packaged software follows standard UDI labeling requirements with both plain-text and AIDC formats.
When is direct marking with UDI required on the device itself?
Devices intended for multiple uses and reprocessing between uses must bear permanent UDI directly on the device, unless exceptions apply for safety concerns, technological infeasibility, single-use devices, or previously marked devices.
How do manufacturers obtain UDIs for their medical devices?
Manufacturers must participate in a system operated by an FDA-accredited issuing agency. These agencies design and operate device identification systems conforming to technical standards and issue UDIs to participating labelers.
What You Need to Do 👇
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