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Laser Products Sold in Kit Form: Identification, Certification and Compliance Requirements

This guidance addresses the requirements for laser products sold in kit form, specifically focusing on their identification, certification, and compliance with performance standards when properly assembled according to manufacturer's instructions.

  1. Develop comprehensive assembly instructions suitable for untrained users
  2. Implement design controls to prevent assembly errors affecting compliance
  3. Create and validate appropriate identification and certification labels
  4. Conduct pre-market testing with maximum radiation levels
  5. Establish a system to track manufacturing dates for compliance purposes
  6. Include clear safety warnings and critical assembly steps in documentation
  7. Implement quality controls to ensure all kit components meet standards
  8. Create a verification process to ensure kits are complete before shipment
  9. Establish a post-market surveillance system to monitor product safety
  10. Maintain documentation of compliance with all applicable standards

Key Considerations

Non-clinical testing

  • Pre-testing of product design with maximized laser radiation levels is required

Human Factors

  • Design should prevent untrained assemblers from making mistakes leading to non-compliance
  • Assembly instructions must be clear enough for untrained assemblers to follow

Labelling

  • Products must have identification label as specified in 21 CFR 1010.3
  • Certification label as specified in 21 CFR 1010.2 is required
  • Manufacturer must supply appropriate labels to purchaser
  • Certification label must indicate compliance with HEW standards effective on date of manufacture

Safety

  • All safety-critical assembly operations must be clearly identified
  • Clear warnings must be provided against alterations or omissions that could lead to non-compliance
  • Manufacturer must ensure compliance throughout product’s useful life under reasonably foreseeable conditions

Other considerations

  • 21 CFR 1040.10: Performance Standards for Light-Emitting Products
  • 21 CFR 1010.2: Certification
  • 21 CFR 1010.3: Identification

Original guidance

  • Laser Products Sold in Kit Form: Identification, Certification and Compliance Requirements
  • HTML / PDF
  • Issue date: 1976-10-14
  • Last changed date: 2020-03-16
  • Status: FINAL
  • Official FDA topics: Medical Devices, Radiation-Emitting Products
  • ReguVirta summary file ID: 8020a39d8e37b2e0154591a4f3d357e3
This post is licensed under CC BY 4.0 by the author.