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Significant Risk Determination for Investigational Medical Laser Devices

This guidance provides criteria for determining when an investigational medical laser device should be considered a significant risk device, requiring a full IDE application to FDA. It specifically addresses laser products used in medical applications for diagnosing, curing, mitigating, or treating disease.

  1. Determine the laser classification of your medical device (Class III or IV)
  2. For Class IV laser products:
    • Prepare full IDE application
    • Comply with all requirements of 21 CFR 812
  3. For Class III laser products:
    • Contact Division of Compliance for risk determination
    • Prepare documentation on emission level, wavelength, and medical application
  4. If believing device should not be considered significant risk:
    • Submit written justification with technical data to Division of Compliance
  5. Ensure compliance with labeling, promotion, and commercialization requirements
  6. Contact IDE Coordinator for assistance if needed in IDE submission preparation
  7. Establish proper documentation of operator qualifications and controls
  8. Implement appropriate risk assessment procedures considering all specified factors

Key Considerations

Clinical testing

  • Investigations involving Class IV laser products generally must be considered significant risk devices
  • Higher power Class III laser products may be considered significant risk devices depending on:
    • Emission level
    • Wavelength
    • Medical application
  • IRB or FDA may determine any investigation to involve significant risk after considering:
    • Controls
    • Patient characteristics
    • Operator qualifications

Human Factors

  • Operator qualifications must be considered in risk assessment

Labelling

  • Investigational devices must comply with specific labeling requirements as per 21 CFR 812

Safety

  • Class IV laser products are considered to present potential for serious harm
  • Higher power Class III laser products may present significant risks based on their specifications

Other considerations

  • 21 CFR 812: Investigational Device Exemptions

Original guidance

  • Significant Risk Determination for Investigational Medical Laser Devices
  • HTML / PDF
  • Issue date: 1981-05-18
  • Last changed date: 2021-01-26
  • Status: FINAL
  • Official FDA topics: Medical Devices, Radiation-Emitting Products, Laser Notice
  • ReguVirta summary file ID: 9be2888c2f7d333529ba1650d0091971
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