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.
Recommended Actions
- Review current product labeling to determine if standard warning statement is appropriate
- If standard warning is inappropriate, develop alternative warning statements that better reflect actual product hazards
- Submit written application to the Bureau of Radiological Health for approval of alternative warning statements
- Include approved alternative warnings in initial or model change report documentation
- Ensure alternative warnings specifically address potential hazards from unauthorized product modifications
- 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
- Manufacturers must obtain approval from the Director, Bureau of Radiological Health for alternate means or wording
- The guidance applies particularly to Class I laser products and sealed consumer products
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
- User Instructions for Medical Laser Products: Safety Information and Radiation Hazard Protection Requirements
- Reproduction of Hazard Warning Labels in User Instructions for Laser Products with Cosmetic Enclosures
- Warning Label Requirements for Multiple Wavelength and Dye Laser Products
Related references and norms
- 21 CFR 1040.10: Performance Standards for Light-Emitting Products
Original guidance
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