Early Feasibility Medical Device Clinical Studies Including First in Human (FIH) Studies
This guidance outlines FDA's approach for Investigational Device Exemptions (IDEs) for early feasibility medical device clinical studies, including certain First in Human (FIH) studies. It focuses on studies involving small numbers of subjects (generally fewer than 10) to evaluate device design concepts in the early stages of development, before the device design is finalized, when additional nonclinical testing may not provide the information needed to advance device development.
Recommended Actions
- Clearly designate study as early feasibility study in IDE application
- Engage with FDA through Pre-Submission process to:
- Discuss device evaluation strategy
- Define appropriate testing plan
- Identify potential device iterations
- Agree on risk mitigation approaches
- Develop comprehensive device evaluation strategy including:
- Device attributes and potential failure modes
- Leveraged information
- Testing plans
- Risk mitigation strategies
- Establish enhanced subject protection measures:
- Detailed monitoring procedures
- Frequent safety assessments
- Comprehensive informed consent process
- Regular IRB oversight
- Create plan for potential device iterations including:
- Changes appropriate for 5-day notification
- Changes requiring contingent approval
- Changes requiring 30-day interactive review
- Implement design controls per 21 CFR 820.30
- Develop protocol with:
- Clear study objectives
- Enhanced safety monitoring
- Appropriate subject selection criteria
- Regular data review points
- Maintain ongoing communication with FDA throughout study conduct
Key Considerations
Clinical testing
- Limited to small number of subjects (generally <10)
- Enhanced subject protection measures required
- More frequent oversight and monitoring needed
- Non-sequential enrollment may be appropriate
- Data monitoring committee may be valuable
Non-clinical testing
- Less nonclinical data may be acceptable compared to traditional feasibility/pivotal studies
- Testing using small sample sizes or short implant durations may be sufficient
- Focus on basic safety and device functionality
- Computational modeling can support initiation of early feasibility study
Human Factors
- Plan to capture human factors information during study to modify procedures/device as needed
- Operator technique challenges should be evaluated
- Device handling and procedural steps comprehension should be assessed
Labelling
- Must clearly indicate early feasibility nature of study
- Enhanced informed consent requirements
- Special considerations for subject information
Biocompatibility
- Basic biocompatibility testing required
- Focus on acute/short-term responses
- Additional testing may be completed concurrent with study
Safety
- Enhanced risk mitigation strategies required
- Close monitoring of adverse events
- Regular safety assessments
- Timely reporting of serious adverse events
Other considerations
- Design controls per 21 CFR 820.30 apply
- Interactive review process with FDA encouraged
- Flexible approach to device modifications during study
- Pre-submission interactions recommended
Relevant Guidances
- Design Controls for Medical Device Manufacturers
- Benefit-Risk Factors in IDE Applications for Medical Device Clinical Investigations
- IDE Clinical Investigation Decision Process and Requirements
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
Related references and norms
- 21 CFR 812: Investigational Device Exemptions
- 21 CFR 820.30: Design Controls
- 21 CFR 50: Protection of Human Subjects
- 21 CFR 56: Institutional Review Boards
- ISO 10993: Biological evaluation of medical devices
Original guidance
- Early Feasibility Medical Device Clinical Studies Including First in Human (FIH) Studies
- HTML / PDF
- Issue date: 2013-10-01
- Last changed date: 2020-02-28
- Status: FINAL
- Official FDA topics: Medical Devices, Investigational Device Exemption (IDE), Premarket, Good Clinical Practice (GCP)
- ReguVirta summary file ID: 59c30e938081ba07dcaf40a42c2056ed
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