Reproduction of Hazard Warning Labels in User Instructions for Laser Products with Cosmetic Enclosures
This guidance clarifies requirements for reproducing hazard warnings in user instructions for laser products, particularly addressing cases where protective housings are enclosed within external cosmetic enclosures.
Recommended Actions
- Review current user documentation to identify required hazard warnings and labels
- Assess visibility of warning labels in different product configurations (operation, maintenance, service)
- Update operation and maintenance manuals to include only visible warning labels
- Ensure service documentation includes all required warning labels and hazard warnings
- Verify that any labels reproduced in documentation are legible
- Document justification if omitting any warning labels from operation/maintenance documentation
- Implement a process to ensure warning labels are visible during service operations
- Review compliance with 21 CFR 1040.10(h)(2)(ii) for service literature requirements
Key Considerations
Labelling
- Labels and hazard warnings required by 21 CFR 1040.10(g)(6) or (g)(7) may be omitted from operation and maintenance information if not visible during normal operation or maintenance
- Labels and warnings must be visible during service
- Labels must be reproduced in service literature as specified in 21 CFR 1040.10(h)(2)(ii)
- Reproductions of labels in user instructions can be in color or black and white, but must be legible
Safety
- Protective housing warning labels must be accessible during service operations
- Any deviation from label reproduction requirements must not compromise public health and safety
Other considerations
- Manufacturers may use external “cosmetic” enclosures to preserve aesthetic integrity and discourage user access
- The policy allows for technical non-compliance with 21 CFR 1040.10(h)(1)(iii) if safety is not compromised
Relevant Guidances
- Laser Products - Performance Standards and Safety Requirements
- 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
Related references and norms
- 21 CFR 1040.10: Performance Standards for Light-Emitting Products
- 21 CFR 1040.11: Specific Purpose Laser Products
Original guidance
- Reproduction of Hazard Warning Labels in User Instructions for Laser Products with Cosmetic Enclosures
- HTML / PDF
- Issue date: 1985-02-05
- Last changed date: 2021-01-26
- Status: FINAL
- Official FDA topics: Medical Devices, Radiation-Emitting Products, Laser Notice
- ReguVirta summary file ID: 5e2e2e8ef7a14ea263edca2efd267d17
This post is licensed under CC BY 4.0 by the author.