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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.

  1. Prepare comprehensive device description including specifications and materials
  2. Identify appropriate predicate device(s) and conduct detailed comparison
  3. Generate necessary performance data through bench, in vitro, in vivo, and clinical testing as required
  4. Develop complete labeling package following format guidance:
    • Clear intended use/indications statements
    • Comprehensive instructions for use
    • All required safety information
  5. Validate software if device is software-controlled
  6. Document sterilization validation for sterile components
  7. Prepare 510(k) Summary or Statement
  8. Organize submission following recommended format with all required sections
  9. Review submission against guidance requirements before submitting to FDA
  10. 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

  • 21 CFR 1040.10 & 1040.11: Performance Standard for Light-Emitting Products
  • 21 CFR 801: Labeling
  • 21 CFR 812: Investigational Device Exemptions

Original guidance

  • Content and Format Requirements for Medical Laser 510k Submissions
  • HTML / PDF
  • Issue date: 1995-05-31
  • Last changed date: 2020-03-17
  • Status: FINAL
  • Official FDA topics: Medical Devices, Radiation-Emitting Products, Radiology, Premarket
  • ReguVirta summary file ID: c4c156bebd61f1bc0c17812df35efcbc
This post is licensed under CC BY 4.0 by the author.