Alternative Identification Labeling Requirements for Class I Laser Products Integrated into Other Products
This guidance addresses the identification labeling requirements for certain Class I laser products, specifically those that are integrated into other products. It provides flexibility in manufacturer identification labeling while maintaining traceability for safety and compliance purposes.
Recommended Actions
- Verify if your laser product qualifies as Class I under all conditions
- Apply to CDRH for a unique identification code if planning to use alternative labeling
- Ensure proper documentation of product traceability despite alternative labeling
- Implement a labeling system that incorporates the assigned FDA/CDRH ID code
- Maintain records of all integrators who receive the products
- Establish a process to ensure no modifications are made to the certified product
- Create a system to track products through the supply chain despite alternative labeling
Key Considerations
Labelling
- Product must have a permanently affixed tag or label
- Alternative identification using FDA/CDRH ID code is permitted instead of manufacturer name and address
- The code must be assigned by CDRH upon application
Safety
- Product must remain Class I under all circumstances of operation, maintenance, service, or failure
- No modifications to product performance or intended use are allowed
Other considerations
- The policy applies to products that will be integrated into other products
- The integrator is intended to be the primary contact for service
- Products can be held in ready-to-ship inventory for different integrators without relabeling
Relevant Guidances
- Laser Products - Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 Standards
- Laser Illuminated Projectors (LIPs) - Classification, Safety Requirements and Labeling
- Military Laser Products: Department of Defense Exemption Requirements and Compliance Process
- Laser Products - Performance Standards and Safety Requirements
Related references and norms
- 21 CFR 1010.3: Identification requirements for electronic products
- 21 CFR 1040.10 and 1040.11: Federal performance standard for laser products
Original guidance
- Alternative Identification Labeling Requirements for Class I Laser Products Integrated into Other Products
- HTML / PDF
- Issue date: 1996-09-05
- Last changed date: 2021-04-27
- Status: FINAL
- Official FDA topics: Medical Devices, Radiation-Emitting Products
- ReguVirta summary file ID: 08a1e4f1e2971120c6faeba6bf57c4ad
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