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Exemption from Reporting Requirements for Low Risk Class I Laser Products

This guidance outlines FDA's exemption of specified low power laser products from certain reporting and recordkeeping requirements due to their low risk of exposure to laser radiation and minimal health risks. It specifically applies to Class I optical disc products, Class I laser products for home/office use, and laser products that don't allow human access to radiation above Class I limits.

  1. Review product portfolio to identify which laser products qualify for the exemption
  2. Ensure compliance with Federal performance standards through testing and certification
  3. Verify at least one product report has been submitted for a similar laser product
  4. Maintain annual reporting process for all products
  5. Establish a system to track and report accidental radiation occurrences
  6. Maintain required manufacturer records
  7. Implement a process for defect notification and product repairs/replacements
  8. Document compliance with all conditions of the exemption
  9. Keep records of all testing and certification activities
  10. Establish a process to monitor and ensure continued compliance with exemption conditions

Key Considerations

Non-clinical testing

  • Manufacturers must test and certify that exempted Class I laser products comply with Federal performance standards (21 CFR 1040.10 and 1040.11)

Safety

  • Products must not allow human access to laser radiation exceeding Class I accessible emission limits under any condition
  • Manufacturers must continue reporting accidental radiation occurrences
  • Manufacturers must maintain compliance with notification of defects requirements
  • Manufacturers must comply with repurchase, repairs, or replacement requirements

Other considerations

  • 21 CFR 1040.10: Performance Standards for Light-Emitting Products
  • 21 CFR 1040.11: Specific Purpose Laser Products

Original guidance

  • Exemption from Reporting Requirements for Low Risk Class I Laser Products
  • HTML / PDF
  • Issue date: 2006-01-05
  • Last changed date: 2020-03-19
  • Status: FINAL
  • Official FDA topics: Medical Devices, Radiation-Emitting Products
  • ReguVirta summary file ID: d717579beffee7705ab393dcacd9439e
This post is licensed under CC BY 4.0 by the author.