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.
What You Need to Know? 👇
What is FDA Laser Notice 30 about?
FDA Laser Notice 30 provides guidance on alternate wording for caution statements in laser product user information when the standard warning required by 21 CFR 1040.10(h)(1)(iv) is inappropriate or misleading for certain products.
When can manufacturers use alternative caution statements for laser products?
Manufacturers can use alternative caution statements when: 1) the required warning is inappropriate for the product’s design/use, 2) the alternative is more appropriate, and 3) it relates to laser hazards from non-instructed procedures.
What is the standard FDA caution statement for laser products?
The standard caution statement is: “Caution - use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure” as required by 21 CFR 1040.10(h)(1)(iv).
Which laser products commonly need alternative caution statements?
Class I laser products and sealed consumer products commonly need alternative caution statements because they often have no user-accessible controls or adjustments that could result in hazardous radiation exposure during normal operation or maintenance.
Do manufacturers need FDA approval for alternative laser caution statements?
Yes, manufacturers must apply for approval from the Director of the Bureau of Radiological Health before using alternative caution statements, and should identify these alternatives in their initial or model change reports.
What should alternative laser caution statements address?
Alternative caution statements should address laser hazards that could result from procedures not covered in user instructions, such as removing protective housing or attempting to defeat non-defeatable interlocks or safety mechanisms.
What You Need to Do 👇
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 đź”—
- 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 đź“‚
- 21 CFR 1040.10: Performance Standards for Light-Emitting Products