Content and Format Requirements for Medical Laser 510k Submissions
This guidance document provides recommendations for the content and organization of premarket notifications (510(k)s) for medical lasers. It aims to assist both FDA reviewers and manufacturers in the preparation and review of 510(k) submissions for medical laser devices.
Recommended Actions
- Prepare comprehensive device description including specifications and materials
- Identify appropriate predicate device(s) and conduct detailed comparison
- Generate necessary performance data through bench, in vitro, in vivo, and clinical testing as required
- Develop complete labeling package following format guidance:
- Clear intended use/indications statements
- Comprehensive instructions for use
- All required safety information
- Validate software if device is software-controlled
- Document sterilization validation for sterile components
- Prepare 510(k) Summary or Statement
- Organize submission following recommended format with all required sections
- Review submission against guidance requirements before submitting to FDA
- Maintain complete documentation to support submission claims
Key Considerations
Clinical testing
- Clinical data necessary when bench and animal testing alone cannot adequately predict safety and effectiveness
- Clinical data must demonstrate that the laser and accessories:
- Allow surgeon to reach intended site
- Operate in controlled manner
- Achieve intended surgical effect and patient outcome safely and effectively
- Study design and parameters vary based on clinical questions to be answered
Non-clinical testing
- Bench testing required to validate specifications and compare operating characteristics
- In vitro testing including cell culture and tissue effects evaluation
- In vivo animal testing including histopathology comparing effects between proposed and predicate devices
Software
- Software validation information required if device is software controlled
- Must follow FDA Reviewer Guidance for Software Evaluation
Labeling
- Must meet 21 CFR 801 and 21 CFR 1040.10/1040.11 requirements
- Must include:
- Device labels and packaging
- User manual with installation, use instructions, maintenance procedures
- Promotional materials
- Clear statement of intended use and indications
- Warnings, precautions, contraindications
- Directions for use
- Bibliography supporting labeling claims
Biocompatibility
- Complete listing of all materials that may contact patient required
- For sterile components, must provide sterilization validation information
Safety
- Must meet performance standard for light emitting products (21 CFR 1040.10 & 1040.11)
- Safety warnings and precautions required in labeling
- Adverse effects must be listed and described
Other considerations
- Detailed device description required
- Side-by-side comparison to legally marketed predicate device
- Performance data requirements when descriptive comparisons insufficient
- Information on all accessories and components
- 510(k) Summary or Statement required
Relevant Guidances
- Content and Format Requirements for Medical Laser 510k Submissions
- Software Validation for Medical Device Production, Quality Systems, and Device Components
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Content of Premarket Submissions for Device Software Functions
- Laser Products - Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 Standards
- Submission Requirements for Terminally Sterilized Medical Devices
Related references and norms
- 21 CFR 1040.10 & 1040.11: Performance Standard for Light-Emitting Products
- 21 CFR 801: Labeling
- 21 CFR 812: Investigational Device Exemptions
Original guidance
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