Laser Products - Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 Standards
This guidance outlines FDA's approach regarding manufacturers' compliance with FDA's performance standards for laser products, specifically addressing the conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1. It applies to all laser products, including those that are both medical devices and electronic products.
What You Need to Know? 👇
What is the purpose of FDA Laser Notice No. 56?
FDA Laser Notice No. 56 allows manufacturers to conform to specific IEC standards (60825-1 Ed. 3 and 60601-2-22 Ed. 3.1) instead of certain FDA requirements in 21 CFR 1040.10 and 1040.11, reducing regulatory duplication while maintaining safety standards.
Which IEC standards are recognized as comparable to FDA laser performance standards?
FDA recognizes IEC 60825-1 Edition 3 and IEC 60601-2-22 Edition 3.1 as comparable to most requirements in 21 CFR 1040.10 and 1040.11, except for specific clauses identified as “not comparable” in the guidance.
Do laser products still need FDA certification if following IEC standards?
Yes, certification under 21 CFR 1010.2 is still required. However, manufacturers can use specific certification statements referencing conformance with IEC standards and Laser Notice No. 56 instead of full FDA compliance statements.
What are the key differences between IEC and FDA laser safety requirements?
Main differences include FDA’s broader definition of collateral radiation (including X-rays), requirements for component laser products, different classification approaches for removable systems, and mandatory recertification requirements for product modifications.
Does Laser Notice No. 56 replace previous FDA laser guidance documents?
No, Laser Notice No. 56 supplements but does not replace Laser Notice No. 50. Both guidances remain valid, with No. 56 covering newer editions of IEC standards while No. 50 addresses earlier editions.
Are there any FDA requirements that remain unchanged under this guidance?
Yes, several FDA requirements remain unaffected, including certification (21 CFR 1010.2), identification (21 CFR 1010.3), variances, exemptions, and specific provisions for surveying lasers and demonstration laser products that have no IEC equivalents.
What You Need to Do 👇
Recommended Actions
- Ensure conformance with applicable clauses of IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1
- Implement appropriate testing program following good manufacturing practices
- Document all testing results and maintain records
- Apply proper certification labeling with required statements
- Submit product reports and supplemental reports as required using Form FDA 3632
- Ensure quality system addresses radiation safety and conformity to standards through design controls
- Pay special attention to safety interlock requirements for Class IIIb or IV lasers
- Review and comply with all applicable safety requirements
- Maintain proper documentation of compliance with both FDA and IEC requirements
- Consider including additional useful information from non-comparable IEC clauses in FDA submissions where appropriate
Key Considerations
Non-clinical testing
- Testing must be performed in accordance with the standard on individual articles or through a testing program following good manufacturing practices
- Testing results must be documented and maintained in company records
- Classification testing may be requested by FDA to confirm proper laser product classification
Labelling
- Certification label must be permanently affixed or inscribed on the product
- Label must be legible and readily accessible when product is fully assembled
- Label must be in English language
- Specific certification statements are required depending on whether the product is a medical device or not
Safety
- Safety interlocks must have redundancy or safe-failure for Class IIIb or IV laser radiation protection
- Protective housing requirements must be met
- Remote interlock connector requirements must be met
- Key control requirements must be met
- Beam attenuator requirements must be met
- Scanning safeguard requirements must be met
Other considerations
- Products must comply with classification requirements
- Accessible emission limits must be respected
- Location of controls requirements must be met
- Viewing optics requirements must be met
- User information requirements must be met
Relevant Guidances 🔗
- Alternative Warning Statements for Laser Product User Information
- Beam Attenuator and Emission Indicator Requirements for Class II and IIIa Visible Laser Systems
- Laser Products - Performance Standards and Safety Requirements
- 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
- Alternative Identification Labeling Requirements for Class I Laser Products Integrated into Other Products
- Significant Risk Determination for Investigational Medical Laser Devices
- Classification of Electron Beam Accelerators Used as Laser Energy Sources
- Safety Requirements for Medical Laser Delivery Systems and Interlock Mechanisms
- Remote Interlock Connector Requirements for Laser Products
- User Instructions for Medical Laser Products: Safety Information and Radiation Hazard Protection Requirements
- Reproduction of Hazard Warning Labels in User Instructions for Laser Products with Cosmetic Enclosures
- Viewing Optics Performance Requirements for Surveying Laser Products
- Warning Label Requirements for Multiple Wavelength and Dye Laser Products
Related references and norms 📂
- IEC 60825-1 Ed. 3: Safety of laser products - Part 1: Equipment classification and requirements
- IEC 60601-2-22 Ed. 3.1: Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
Original guidance
- Laser Products - Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 Standards
- HTML / PDF
- Issue date: 2023-02-21
- Last changed date: 2023-02-21
- Status: FINAL
- Official FDA topics: Radiation-Emitting Products, Laser Notice, Export, Medical Devices, Radiological Health, Radiology, Import
- ReguVirta ID: bd61e943b00025cddea0904f155181da