Reproduction of Hazard Warning Labels in User Instructions for Laser Products with Cosmetic Enclosures

What You Need to Know? 👇

What are the requirements for reproducing laser hazard warnings in user manuals?

21 CFR 1040.10(h)(1)(iii) requires user instructions to contain legible reproductions of all labels and hazard warnings required by regulations, showing their locations on the product.

Can manufacturers omit warning label reproductions if they’re hidden by cosmetic enclosures?

Yes, CDRH allows omission of warning reproductions for labels covered by cosmetic enclosures that aren’t visible during operation or maintenance, but they must appear in service literature.

What happens if laser products don’t comply with warning reproduction requirements?

FDA won’t take enforcement action under the Radiation Control Act if deviations don’t compromise public health and safety, even if technically noncompliant with performance standards.

When must hidden warning labels be visible on laser products?

Hidden warning labels must be visible during service activities and reproduced in service literature according to 21 CFR 1040.10(h)(2)(ii) specifications.

What is the purpose of cosmetic enclosures on laser products?

Cosmetic enclosures preserve aesthetic integrity and discourage users from opening laser products while maintaining protective housing functionality underneath.

Which CFR sections govern laser product warning label requirements?

21 CFR 1040.10(g) and 1040.11 specify required labels and hazard warnings, while 21 CFR 1040.10(h) governs their reproduction in user instructions.

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What You Need to Do 👇

Recommended Actions

1. Review current user documentation to identify required hazard warnings and labels
2. Assess visibility of warning labels in different product configurations (operation, maintenance, service)
3. Update operation and maintenance manuals to include only visible warning labels
4. Ensure service documentation includes all required warning labels and hazard warnings
5. Verify that any labels reproduced in documentation are legible
6. Document justification if omitting any warning labels from operation/maintenance documentation
7. Implement a process to ensure warning labels are visible during service operations
8. 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

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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

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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 ID: 5e2e2e8ef7a14ea263edca2efd267d17