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.
What You Need to Know? 👇
What are the identification requirements for Class I laser products under FDA regulations?
All laser products must display manufacturer name and address on a permanently affixed label per 21 CFR 1010.3. This enables product traceability for recalls due to defects or non-compliance with federal performance standards.
Can manufacturers use codes instead of company names on Class I laser product labels?
Yes, FDA allows codes like “FDA/CDRH ID: XXXX” instead of manufacturer names for certain Class I lasers that meet specific criteria, including unchanged performance and radiation levels not exceeding Class I limits.
What conditions must be met to omit manufacturer names from laser product identification labels?
Three criteria: the certified product remains unmodified in performance/use, laser radiation stays within Class I limits under all conditions, and the label contains an FDA/CDRH-assigned identification code.
Why would laser manufacturers want to avoid putting their company name on product labels?
Manufacturers of components like CD players or ROM units integrated into larger systems prefer the final product manufacturer to be the primary service contact, allowing flexible inventory management.
How does FDA ensure traceability when manufacturer names are replaced with codes on laser products?
FDA’s Center for Devices and Radiological Health assigns unique identification codes to manufacturers upon application, maintaining traceability while allowing anonymous labeling for qualifying Class I laser products.
What types of Class I laser products typically qualify for alternative identification labeling?
Compact disc players, CD ROM units, and similar components that are integrated into music systems, automobiles, or computers, where the final product manufacturer provides primary customer service.
What You Need to Do 👇
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