Benefit-Risk Factors in IDE Applications for Medical Device Clinical Investigations
This guidance explains the principal factors that FDA considers when assessing benefits and risks of original IDE applications, IDE amendments and IDE supplements for human clinical investigations of certain medical devices to determine safety and effectiveness. It applies to studies subject to IDE requirements, including postmarket studies, particularly for significant risk devices. The guidance covers both diagnostic and therapeutic devices but does not provide device-specific data or study requirements.
Recommended Actions
- Develop comprehensive risk management plan including:
- Risk analysis
- Risk control measures
- Residual risk evaluation
- Prepare detailed device description including:
- Device identification
- Principle of operation
- Key specifications
- Materials
- Software/hardware features
- Design appropriate study oversight mechanisms:
- IRB review
- Data monitoring committee
- Adverse event reporting procedures
- Implement robust informed consent process with:
- Clear risk communication
- Description of benefits
- Study requirements
- Establish investigator/site requirements:
- Training requirements
- Experience criteria
- Resource capabilities
- Create monitoring plan with:
- Safety assessments
- Data collection procedures
- Reporting timelines
- Document benefit-risk assessment addressing:
- Context of investigation
- Risk assessment
- Benefit assessment
- Patient preferences
- Uncertainty evaluation
- Ensure compliance with:
- IDE regulations
- Human subject protection requirements
- Study monitoring requirements
- Records and reporting requirements
Key Considerations
Clinical testing
- Clinical investigations must comply with informed consent requirements under 21 CFR part 50
- Study design should be scientifically sound and generate useful knowledge
- Study oversight through IRB, Clinical Events Committee, Data Monitoring Committee required
- Frequent follow-up assessments to monitor subject safety and device effectiveness
- Timely reporting of serious adverse events
- Pre-specified plan for periodic participant outcome assessments
Non-clinical testing
- Quality of prior nonclinical investigations important to reduce uncertainty
- Non-clinical testing can complement or replace need for clinical testing in some cases
- Biocompatibility and other safety testing should be completed before clinical studies
- Animal studies may be needed to evaluate procedural risks
Human Factors
- Implementation of informed consent process that adequately conveys risks and benefits
- Plan to capture human factors information during study to modify procedures/device as needed
- Identification of qualified investigators with adequate training
- Use of specialized/experienced study sites
Labelling
- Must be labeled for investigational use only
- Communication of safety information to study subjects about foreseeable risks
- Clear communication among study sites regarding safety information
- Adequate informed consent documents
Biocompatibility
- Biocompatibility testing required before clinical studies
- New materials need to be fully characterized
- Assessment of degradation products for absorbable devices
Safety
- Basic safety protection against physical hazards must be addressed
- Risk management plan required including:
- Risk analysis
- Risk control measures
- Residual risk evaluation
- Safety monitoring and reporting requirements
- Pre-specified stopping rules
Other considerations
- Patient preferences should be considered when available
- Disease/condition characteristics impact benefit-risk assessment
- Alternative treatment availability affects acceptable risk levels
- Different uncertainty considerations at different stages of development
- Study design should be least burdensome while maintaining scientific validity
Relevant Guidances
- Applying Human Factors Engineering and Usability Engineering to Medical Devices
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Design Controls for Medical Device Manufacturers
- Informed Consent in Clinical Investigations: Requirements, Documentation, and Procedures
Related references and norms
- ANSI/AAMI/ISO 14971: Medical Devices - Application of risk management to medical devices
Original guidance
- Benefit-Risk Factors in IDE Applications for Medical Device Clinical Investigations
- HTML / PDF
- Issue date: 2017-01-13
- Last changed date: 2020-10-20
- Status: FINAL
- Official FDA topics: Medical Devices, Premarket, Biologics, Investigational Device Exemption (IDE), Clinical - Medical
- ReguVirta summary file ID: 5f40212d68ca38061e938b0bba011ef0
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