Unique Device Identification Policy for Class I and Unclassified Devices: Compliance Dates and Requirements
This guidance outlines FDA's policies regarding UDI compliance dates for Class I and unclassified devices, direct marking requirements, and GUDID database submission requirements. It specifically addresses compliance policies for consumer health products and provides clarification on direct marking requirements for devices in inventory.
Recommended Actions
- Determine if your Class I device qualifies as a “consumer health product” based on the guidance criteria
- For non-consumer health products, prepare GUDID submission before December 8, 2022
- Implement UDI labeling and standard date formatting by September 24, 2022 for Class I and unclassified devices
- For devices requiring direct marking:
- Document method for deriving UDI from other marked information in Device Master Record
- Prepare to use new GUDID fields for documenting UDI construction method when available
- Review inventory to identify devices manufactured before compliance dates and apply appropriate policies
- Contact FDA UDI Help Desk for clarification on device classification as consumer health product if needed
- Monitor FDA’s UDI webpage for additional updates on compliance dates and policies
Key Considerations
Labelling
- Standard date formatting and UDI labeling requirements under 21 CFR 801.18, 801.20, and 801.50 for Class I and unclassified devices (non-I/LS/LS) will not be enforced before September 24, 2022
- Class I devices may use UPC as UDI on labels and packages
Other considerations
- GUDID submission requirements will not be enforced for consumer health products (510(k)-exempt Class I devices sold OTC)
- GUDID submission requirements for Class I and unclassified devices extended by 75 days to December 8, 2022
- Direct marking requirements for Class I and unclassified devices will not be enforced before September 24, 2022
- Special provisions for devices in inventory manufactured before compliance dates
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 System: Implementation and Compliance Requirements
Related references and norms
- 21 CFR 801.18: Standard date formatting requirements
- 21 CFR 801.20: UDI labeling requirements
- 21 CFR 801.45: Direct marking requirements
- 21 CFR 801.50: UDI requirements for standalone software
- 21 CFR 830.300: GUDID submission requirements
Original guidance
- Unique Device Identification Policy for Class I and Unclassified Devices: Compliance Dates and Requirements
- HTML / PDF
- Issue date: 2022-07-25
- Last changed date: 2022-07-22
- Status: FINAL
- Official FDA topics: Medical Devices, UDI, Labeling, Biologics
- ReguVirta summary file ID: b484581f4d77d8f42f95543721fb14eb
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