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.
Recommended Actions
- Review product portfolio to identify which laser products qualify for the exemption
- Ensure compliance with Federal performance standards through testing and certification
- Verify at least one product report has been submitted for a similar laser product
- Maintain annual reporting process for all products
- Establish a system to track and report accidental radiation occurrences
- Maintain required manufacturer records
- Implement a process for defect notification and product repairs/replacements
- Document compliance with all conditions of the exemption
- Keep records of all testing and certification activities
- 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
- Manufacturer must have submitted at least one product report on any similar laser product
- Annual reports are still required for all products tested and certified during the reporting year
- FDA reserves the right to request information or full reports if necessary
- Manufacturers must maintain certain records as per 21 CFR 1002.30(a) and 1002.31
Relevant Guidances
- Laser Products - Performance Standards and Safety Requirements
- 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
Related references and norms
- 21 CFR 1040.10: Performance Standards for Light-Emitting Products
- 21 CFR 1040.11: Specific Purpose Laser Products
Original guidance
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