Investigational Device Exemptions (IDE) Requirements for Refractive Surgery Excimer Lasers

Recommended Actions

1. Prepare comprehensive device description including all critical engineering aspects
2. Develop detailed investigational plan with clear safety and effectiveness targets
3. Establish robust data collection and management procedures
4. Implement appropriate patient selection criteria and follow-up schedule
5. Conduct required laboratory and animal testing before human studies
6. Obtain necessary electrical safety certifications
7. Prepare complete hazard analysis documentation
8. Develop comprehensive informed consent documents
9. Establish monitoring procedures for the investigation
10. Create detailed documentation of manufacturing methods and controls

Key Considerations

Clinical testing

• Follow-up period of 1 year for PRK and 6 months for LASIK required
• Sample size of 300-400 subjects typically needed for each refractive indication
• Loss to follow-up should not exceed 10% at one year
• Detailed accountability of treated subjects required
• Specific safety and effectiveness targets must be met (e.g., <5% losing >2 lines BSCVA)

Non-clinical testing

• Prior laboratory studies required including:
  • Fluence calibrations
  • Beam homogeneity measurements
  • Pulse stability testing
  • Fluence control and fail-safe systems testing
  • Beam and eye alignment systems testing
• Animal studies results must be provided

Human Factors

• Detailed surgical procedure description required
• Training requirements must be specified
• Patient questionnaire including questions about mesopic conditions required

Software

• Description of software lifecycle
• Flow diagrams of software function and hardware interaction
• Validation and verification procedures for safety-critical software
• Software certification information if applicable

Labelling

• All device labeling must be provided
• Informed consent documents required
• Precautionary statements about night vision/glare effects needed

Safety

• Electrical safety certification required
• Detailed system hazard analysis needed
• Fail-safe mechanisms must be described
• Safety monitoring procedures required

Other considerations

• Manufacturing description required
• Environmental assessment or categorical exclusion needed
• IRB agreements and investigator agreements required
• Device pricing information if device will be sold during study

Relevant Guidances

• Design Considerations for Medical Device Pivotal Clinical Studies
• Keratomes and Replacement Keratome Blades for Corneal Surgery
• Early Feasibility Medical Device Clinical Studies Including First in Human (FIH) Studies
• Human Factors Information Needed in Medical Device Marketing Submissions (Draft)
• Content of Premarket Submissions for Device Software Functions
• Applying Human Factors Engineering and Usability Engineering to Medical Devices

Related references and norms

• IEC 601-1-2: Medical electrical equipment safety standard
• IEC CISPR 11 and 16: Electromagnetic compatibility testing standards
• UL544 76: Medical and Dental Equipment safety standard
• BS 5724: Medical electrical equipment safety standard
• JIS T1001: Medical electrical equipment safety standard

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Original guidance

• Investigational Device Exemptions (IDE) Requirements for Refractive Surgery Excimer Lasers
• HTML
• Issue date: 1996-10-09
• Last changed date: 2025-01-31
• Status: FINAL
• Official FDA topics: Premarket, Radiation-Emitting Products, Investigational Device Exemption (IDE), Medical Devices
• ReguVirta summary file ID: edd4e2cc260c4001486fb15648042692