Early Feasibility Medical Device Clinical Studies Including First in Human (FIH) Studies

What You Need to Know? 👇

What is an early feasibility study and how does it differ from traditional clinical trials?

An early feasibility study is a limited clinical investigation of a device early in development, typically before the device design is finalized. It evaluates initial clinical safety and device functionality in a small number of subjects (generally fewer than 10) when nonclinical testing cannot provide adequate information to advance development.

What are the key regulatory advantages of conducting an early feasibility study under IDE?

Early feasibility studies may be approved with less nonclinical data than traditional studies, allow broader device modifications under 5-day notification, enable contingent approval for anticipated changes, and utilize interactive review processes. This facilitates earlier clinical evaluation while maintaining appropriate subject protection measures.

What specific information must be included in the Report of Prior Investigations for early feasibility studies?

The report must include three sections: Background (clinical context, design concept, justification), Executive Summary (device evaluation strategy table, test summaries), and Detailed Reports (individual test reports, leveraged information). It should support expectation of acceptable clinical use and address basic safety requirements.

How does the device evaluation strategy table help justify an early feasibility study?

The device evaluation strategy systematically identifies device attributes, potential failure modes, effects of failure, design information, supportive data, required testing, and clinical mitigation strategies. This risk-based approach demonstrates why the available information adequately supports study initiation despite limited nonclinical data.

What enhanced human subject protection measures are required for early feasibility studies?

Enhanced protections include detailed informed consent explaining the early feasibility nature and potential unforeseeable risks, more frequent IRB oversight, qualified investigators at experienced sites, enhanced monitoring procedures, timely adverse event reporting, and consideration of data monitoring committees for additional independent oversight.

What types of device modifications can be made during an early feasibility study without prior FDA approval?

Broader modifications are permitted under 5-day notification including developmental changes that don’t significantly alter design principles, protocol changes that don’t affect subject safety or data validity, and modifications supported by enhanced risk mitigation strategies specific to early feasibility studies.

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What You Need to Do 👇

Recommended Actions

1. Clearly designate study as early feasibility study in IDE application
2. 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
3. Develop comprehensive device evaluation strategy including:
   • Device attributes and potential failure modes
   • Leveraged information
   • Testing plans
   • Risk mitigation strategies
4. Establish enhanced subject protection measures:
   • Detailed monitoring procedures
   • Frequent safety assessments
   • Comprehensive informed consent process
   • Regular IRB oversight
5. Create plan for potential device iterations including:
   • Changes appropriate for 5-day notification
   • Changes requiring contingent approval
   • Changes requiring 30-day interactive review
6. Implement design controls per 21 CFR 820.30
7. Develop protocol with:
   • Clear study objectives
   • Enhanced safety monitoring
   • Appropriate subject selection criteria
   • Regular data review points
8. 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

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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
• Q-Submission Program: Strategic Framework for FDA Interactions in Medical Device Development

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

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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 ID: 59c30e938081ba07dcaf40a42c2056ed