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.
What You Need to Know? 👇
What makes an investigational medical laser device a significant risk device?
Class IV laser products used in medical investigations are generally considered significant risk devices due to potential for serious harm. Higher power Class III lasers may also qualify depending on emission level, wavelength, and medical application.
Do all investigational medical laser devices require FDA approval before human testing?
Yes, manufacturers cannot deliver new medical devices to investigators without an IDE - either formally approved by FDA or deemed granted under abbreviated requirements for non-significant risk devices.
What regulatory pathway applies to Class III laser medical devices under investigation?
Sponsors should obtain a determination from the FDA Division of Compliance whether their Class III laser investigation involves significant risk, as this determines the applicable regulatory requirements under 21 CFR 812.
When can a medical laser investigation qualify for abbreviated IDE requirements?
If both the sponsor and institutional review board consider the investigation to involve no significant risk, the sponsor may qualify for abbreviated IDE requirements under Section 812.2(b).
What documentation is required to challenge significant risk classification for laser devices?
Sponsors must write to the FDA Division of Compliance providing justification with supporting technical data if they believe their Class IV laser investigation should not be considered significant risk.
Who can sponsors contact for assistance with laser device IDE submissions?
Sponsors can contact the IDE Coordinator of the Bureau of Radiological Health at (301) 443-3426 for assistance in developing IDE submissions or interpreting IDE regulations.
What You Need to Do 👇
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