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.
Recommended Actions
- Determine the laser classification of your medical device (Class III or IV)
- For Class IV laser products:
- Prepare full IDE application
- Comply with all requirements of 21 CFR 812
- For Class III laser products:
- Contact Division of Compliance for risk determination
- Prepare documentation on emission level, wavelength, and medical application
- If believing device should not be considered significant risk:
- Submit written justification with technical data to Division of Compliance
- Ensure compliance with labeling, promotion, and commercialization requirements
- Contact IDE Coordinator for assistance if needed in IDE submission preparation
- Establish proper documentation of operator qualifications and controls
- 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
- Promotion and commercialization of investigational devices must comply with 21 CFR 812
- Sponsors must obtain IDE approval before delivering devices to investigators for human use
Relevant Guidances
- Early Feasibility Medical Device Clinical Studies Including First in Human (FIH) Studies
- Benefit-Risk Factors in IDE Applications for Medical Device Clinical Investigations
- IDE Clinical Investigation Decision Process and Requirements
Related references and norms
- 21 CFR 812: Investigational Device Exemptions
Original guidance
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