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.
What You Need to Know? 👇
What is FDA Laser Notice 53 and when does it apply to medical device manufacturers?
FDA Laser Notice 53 provides guidance on alternate labeling methods for laser products when standard labeling requirements are impractical due to size, configuration, design, function, sterilization, or other considerations. It allows enforcement discretion without prior FDA approval.
Can manufacturers use alternate labeling for laser medical devices without FDA pre-approval?
Yes, under Laser Notice 53, manufacturers can use alternate labeling methods without prior CDRH approval when standard labeling placement is impractical. However, they must document justification and retain records for potential FDA review.
What are acceptable alternate labeling methods for small laser medical devices?
Acceptable alternate methods include placing required labels on product packaging, in user instructions, or on alternate portions of the product when standard placement locations are not feasible due to device constraints.
What documentation requirements exist when using alternate labeling for laser products?
Manufacturers must document the alternate labeling approach in their product report and maintain in-house justification for the alternate means. This documentation must be available for CDRH review upon request.
What enforcement actions can FDA take if alternate labeling is deemed inappropriate?
If CDRH determines that alternate labeling was inappropriately used, they may require product recall for relabeling or mandate changes to future production labeling in accordance with 21 CFR 1003 and 1004.
Which FDA regulations govern certification and labeling requirements for laser medical devices?
The primary regulations are 21 CFR 1010.2 (certification), 1010.3 (identification), and 1040.10(g) (warning labeling). These specify standard labeling requirements and provisions for alternate means approval when standard methods are impractical.
What You Need to Do 👇
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