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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.

  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

  • 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
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