Alternative Labeling Methods for Laser Products
This guidance outlines FDA's enforcement discretion regarding alternate means of providing certification, identification, and warning labeling for laser products when standard labeling requirements are impractical due to various constraints.
Recommended Actions
- Assess if standard labeling requirements are impractical for your laser product
- If using alternate labeling methods:
- Document the alternate labeling approach in the product report
- Maintain detailed justification for the alternate labeling in-house
- Ensure the alternate labeling method effectively communicates required information
- Consider consulting with CDRH if uncertain about the applicability of this guidance to your product
- Establish a process to implement labeling changes if CDRH determines the alternate labeling is inadequate
- Keep records of all labeling decisions and justifications for potential CDRH review
Key Considerations
Labelling
- Alternate labeling methods are permitted without CDRH approval when standard labeling is impractical due to:
- Size
- Configuration
- Design
- Function
- Sterilization
- Acceptable alternate labeling methods include:
- Placement of labels on packaging
- Placement of labels in user instructions
- Placement of labels on alternate portions of the product
Other considerations
- Manufacturers must document the use of alternate labeling in the product report
- Justification for alternate labeling must be retained in-house for CDRH review upon request
- CDRH may require product recall for relabeling if they determine the alternate labeling is inadequate
Relevant Guidances
- 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
- Device Labeling Requirements and Content for Premarket Approval Applications
Related references and norms
- 21 CFR 1010.2: Performance Standards for Electronic Products: Certification
- 21 CFR 1010.3: Performance Standards for Electronic Products: Identification
- 21 CFR 1040.10(g): Performance Standards for Light-Emitting Products: Laser Products
Original guidance
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