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Alternative Identification Labeling Requirements for Class I Laser Products Integrated into Other Products

This guidance addresses the identification labeling requirements for certain Class I laser products, specifically those that are integrated into other products. It provides flexibility in manufacturer identification labeling while maintaining traceability for safety and compliance purposes.

  1. Verify if your laser product qualifies as Class I under all conditions
  2. Apply to CDRH for a unique identification code if planning to use alternative labeling
  3. Ensure proper documentation of product traceability despite alternative labeling
  4. Implement a labeling system that incorporates the assigned FDA/CDRH ID code
  5. Maintain records of all integrators who receive the products
  6. Establish a process to ensure no modifications are made to the certified product
  7. Create a system to track products through the supply chain despite alternative labeling

Key Considerations

Labelling

  • Product must have a permanently affixed tag or label
  • Alternative identification using FDA/CDRH ID code is permitted instead of manufacturer name and address
  • The code must be assigned by CDRH upon application

Safety

  • Product must remain Class I under all circumstances of operation, maintenance, service, or failure
  • No modifications to product performance or intended use are allowed

Other considerations

  • 21 CFR 1010.3: Identification requirements for electronic products
  • 21 CFR 1040.10 and 1040.11: Federal performance standard for laser products

Original guidance

  • Alternative Identification Labeling Requirements for Class I Laser Products Integrated into Other Products
  • HTML / PDF
  • Issue date: 1996-09-05
  • Last changed date: 2021-04-27
  • Status: FINAL
  • Official FDA topics: Medical Devices, Radiation-Emitting Products
  • ReguVirta summary file ID: 08a1e4f1e2971120c6faeba6bf57c4ad
This post is licensed under CC BY 4.0 by the author.