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Alternative Warning Statements for Laser Product User Information

This guidance addresses the alternative wording for caution statements in user information for laser products, specifically when the standard warning statement required by 21 CFR 1040.10(h)(1)(iv) may be inappropriate or misleading.

  1. Review current product labeling to determine if standard warning statement is appropriate
  2. If standard warning is inappropriate, develop alternative warning statements that better reflect actual product hazards
  3. Submit written application to the Bureau of Radiological Health for approval of alternative warning statements
  4. Include approved alternative warnings in initial or model change report documentation
  5. Ensure alternative warnings specifically address potential hazards from unauthorized product modifications
  6. Maintain documentation of approval for alternative warning statements

Key Considerations

Labelling

  • Alternative warning statements must be more appropriate than the required statement
  • Alternative statements must be related to the laser hazard possible from procedures not given in user instructions
  • The standard warning statement must be proven inappropriate for the product’s design or use
  • Alternative warnings must be specifically identified in the initial or model change report

Safety

  • Alternative warnings must address hazards from:
    • Removal of protective housing
    • Attempting to defeat nondefeatable interlocks
    • Other unauthorized modifications

Other considerations

  • 21 CFR 1040.10: Performance Standards for Light-Emitting Products

Original guidance

  • Alternative Warning Statements for Laser Product User Information
  • HTML / PDF
  • Issue date: 1980-08-25
  • Last changed date: 2020-03-17
  • Status: FINAL
  • Official FDA topics: Medical Devices, Radiation-Emitting Products, Radiology
  • ReguVirta summary file ID: b0a16056258c938d746acb4f86718383
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