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.
Recommended Actions
- Develop comprehensive assembly instructions suitable for untrained users
- Implement design controls to prevent assembly errors affecting compliance
- Create and validate appropriate identification and certification labels
- Conduct pre-market testing with maximum radiation levels
- Establish a system to track manufacturing dates for compliance purposes
- Include clear safety warnings and critical assembly steps in documentation
- Implement quality controls to ensure all kit components meet standards
- Create a verification process to ensure kits are complete before shipment
- Establish a post-market surveillance system to monitor product safety
- 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
- Date of manufacture is considered the date when components are assembled as a complete package for shipment
- Manufacturer is responsible for compliance throughout the product’s useful life
Relevant Guidances
- Laser Products - Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 Standards
- Laser Products - Performance Standards and Safety Requirements
- Alternative Warning Statements for Laser Product User Information
- Significant Risk Determination for Investigational Medical Laser Devices
- Safety Requirements for Medical Laser Delivery Systems and Interlock Mechanisms
- Reproduction of Hazard Warning Labels in User Instructions for Laser Products with Cosmetic Enclosures
- Laser Light Shows and Displays: Requirements for Aircraft Safety and Visual Control
- Use of Visible Laser Beam as Emission Indicator for Class II and Class IIIa Laser Products
- 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 1010.2: Certification
- 21 CFR 1010.3: Identification
Original guidance
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