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.
What You Need to Know? 👇
What are the current compliance dates for UDI requirements for Class I and unclassified devices?
For Class I and unclassified devices (excluding I/LS/LS devices), FDA won’t enforce standard date formatting, UDI labeling requirements before September 24, 2022, and GUDID submission requirements before December 8, 2022. Direct marking requirements won’t be enforced before September 24, 2022.
Which Class I devices are exempt from GUDID submission requirements under FDA’s current policy?
Class I devices considered “consumer health products” - 510(k)-exempt devices sold directly to consumers over-the-counter that don’t fall into specific higher-risk categories like Class I Reserved devices, restricted devices, implantable devices, life-supporting devices, or certain professional healthcare facility devices.
What is FDA’s policy for devices manufactured before direct marking compliance dates that remain in inventory?
FDA won’t enforce direct marking requirements for non-sterile devices manufactured and labeled before their compliance dates when the device’s UDI can be derived from other directly marked information (catalog number, lot number, serial number) and the labeler has documented this method.
How can manufacturers determine if their Class I device qualifies as a “consumer health product”?
Consumer health products are 510(k)-exempt Class I devices sold directly to consumers over-the-counter that don’t fall into excluded categories: Class I Reserved devices, restricted devices, implantable devices, life-supporting devices, or certain reusable/wound care devices for professional healthcare facilities only.
What information must be documented for devices using alternative UDI construction methods?
Labelers must develop and make available a method for constructing the UDI from other directly marked information, ensure the UDI is readily available at point of use, and document or reference this method in the Device Master Record (DMR).
When will FDA develop new GUDID fields for alternative UDI construction documentation?
FDA intends to develop new GUDID field(s) to capture when devices use alternative UDI construction methods. The guidance recommends labelers use these new fields when they become available, but doesn’t specify an exact timeline for implementation.
What You Need to Do 👇
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