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Laser Light Show Variance Renewal and Amendment Procedures

This guidance outlines procedures for renewal and amendment of laser light show variances, specifically for Class IIIb or IV laser shows that exceed Class IIIa demonstration laser product limits. It aims to streamline the variance renewal process while maintaining public safety standards.

  1. Review current variance status and ensure it meets the criteria for automatic renewal
  2. Implement system for timely submission of annual reports by September 1st
  3. Maintain comprehensive documentation of all laser projectors used in shows
  4. Create and maintain records of setup, alignment, and testing procedures
  5. Establish process for tracking and reporting any radiation-related incidents
  6. Keep copies of Laser Notice 55, variance amendment notice, annual reports, and CDRH acknowledgments with show records
  7. Implement system to track and verify compliance with all variance conditions
  8. Create procedure for identifying and reporting any product defects or compliance issues

Key Considerations

Safety

  • Annual reports must be submitted by September 1st, covering the previous 12-month period
  • Setup, alignment, and testing procedures records must be maintained
  • Accidental radiation occurrences must be reported
  • Normal clearance distances must be maintained
  • Only visible wavelength range (400-700 nm) emissions are permitted under this guidance

Other considerations

  • 21 CFR 1040.10: Performance Standards for Light-Emitting Products
  • 21 CFR 1040.11: Specific Purpose Laser Products
  • 21 CFR 1010.4: Variances
  • 21 CFR 1002: Records and Reports

Original guidance

  • Laser Light Show Variance Renewal and Amendment Procedures
  • HTML / PDF
  • Issue date: 2007-09-24
  • Last changed date: 2024-10-23
  • Status: FINAL
  • Official FDA topics: Medical Devices, Radiation-Emitting Products
  • ReguVirta summary file ID: 9e70b3bda1b6ed02d71179f25ab658f7
This post is licensed under CC BY 4.0 by the author.