Post

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.

  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

  • 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
This post is licensed under CC BY 4.0 by the author.