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

What You Need to Know? 👇

What are the key safety endpoints for refractive surgery laser IDE studies?

The FDA guidance specifies five major safety targets: less than 5% of subjects losing more than 2 lines of BSCVA, less than 1% with BSCVA worse than 20/40, less than 1% with haze beyond 6 months causing >2 lines BSCVA loss, less than 5% with induced astigmatism >2.0D, and less than 1% experiencing adverse events.

How many subjects are typically required for a refractive surgery laser IDE study?

A sample size of 300-400 subjects for each refractive indication is usually sufficient to assess safety and effectiveness targets. The exact number should be calculated based on expected adverse event rates and desired statistical power to detect meaningful differences in outcomes.

What device information must be submitted before IDE approval for refractive lasers?

Before IDE approval, sponsors must provide electrical safety certification, detailed descriptions of enabled/disabled features, and critical engineering aspects including ablation patterns, laser characteristics, beam calibration methodology, and comprehensive system hazard analysis with failure mode controls.

What are the effectiveness targets for myopic PRK under 7 diopters?

For myopes under 7D, minimum targets include 85% achieving UCVA of 20/40 or better, 75% within ±1.00D of attempted refraction, 50% within ±0.50D of attempted refraction, and 95% achieving refractive stability over time.

When can fellow eye treatments be performed in refractive surgery studies?

Fellow eye treatments should only be performed after establishing stability in the first treated eye, with no complications or adverse events present. The minimum time interval and specific stability criteria must be clearly defined in the protocol.

What contrast sensitivity testing requirements exist for refractive surgery IDE studies?

Contrast sensitivity and glare testing may be omitted if sponsors agree to include precautionary labeling about potential visual performance impairment under adverse conditions like night driving. However, substudies may be required for treatments with optical zones smaller than 6mm or other concerning characteristics.

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What You Need to Do 👇

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

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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 ID: edd4e2cc260c4001486fb15648042692