IDE Content Requirements for Refractive Surgery Laser Clinical Investigations
This guidance provides a checklist of information typically required in an Investigational Device Exemptions (IDE) application for refractive surgery lasers, specifically excimer lasers. It covers the requirements for conducting clinical investigations to collect safety and effectiveness data to support a Premarket Approval Application (PMA).
Recommended Actions
- Prepare comprehensive IDE application following the checklist structure
- Conduct required laboratory and animal studies before IDE submission
- Develop detailed clinical protocol with safety and effectiveness endpoints
- Implement system hazard analysis and safety controls
- Establish standardized examination procedures and data collection methods
- Prepare required labeling and informed consent documents
- Obtain electrical safety certification
- Develop software validation procedures and documentation
- Plan for adequate subject follow-up and accountability
- Submit progress reports and expansion requests as needed during study
Key Considerations
Clinical testing
- Initial study should enroll sufficient subjects for PMA submission within one year
- Sample size of 300-400 subjects typically needed for each refractive indication
- Follow-up period of 1 year for PRK and 6 months for LASIK
- Loss to follow-up should not exceed 10% at one year
- Detailed accountability of treated subjects required
Non-clinical testing
- Prior laboratory studies including fluence calibrations, beam homogeneity, pulse stability tests required
- In vitro ablation tests of corneal tissue from human cadaver eyes needed
- Animal studies with study designs, testing procedures and results required
Human Factors
- Detailed description of examination conditions and techniques needed
- Standardized room lighting conditions for examinations required
- Patient questionnaire including questions about mesopic conditions required
Software
- Detailed description of software lifecycle and validation required
- Flow diagram showing software-hardware interaction needed
- Safety critical software functions must be identified
- Software validation and verification procedures required
Labelling
- Precautionary statements about visual performance under poor lighting conditions required
- Complete labeling for the device needed
- Informed consent forms required
Safety
- Detailed system hazard analysis required
- Fail-safe mechanisms for critical subsystems needed
- Safety critical functions and failure modes must be identified
- Electrical safety certification required
Other considerations
- Manufacturing description needed
- Environmental assessment or categorical exclusion required
- IRB agreements and investigator agreements needed
- Device description with components and principles of operation required
Relevant Guidances
- Design Controls for Medical Device Manufacturers
- Content of Premarket Submissions for Device Software Functions
- Applying Human Factors Engineering and Usability Engineering to Medical Devices
- Early Feasibility Medical Device Clinical Studies Including First in Human (FIH) Studies
- Design Considerations for Medical Device Pivotal Clinical Studies
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Informed Consent in Clinical Investigations: Requirements, Documentation, and Procedures
Related references and norms
- IEC 601-1-2: Medical electrical equipment safety standard
- UL544 76: Medical and Dental Equipment standard
- IEC CISPR 11 and 16: Electromagnetic compatibility measurement standards
- CFR 21 58: Good Laboratory Practice regulations
Original guidance
- IDE Content Requirements for Refractive Surgery Laser Clinical Investigations
- HTML
- Issue date: 1996-10-09
- Last changed date: 2020-03-18
- Status: FINAL
- Official FDA topics: Medical Devices, Radiation-Emitting Products, Investigational Device Exemption (IDE), Premarket
- ReguVirta summary file ID: edd4e2cc260c4001486fb15648042692
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