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    Early Feasibility Study

    FDA program enabling early human evaluation of novel devices with limited preclinical data and iterative design.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    EFSs allow first-in-human use of a novel device based on less nonclinical evidence than a traditional IDE, with allowances for iterative device modifications during the study.

    What this means in practice

    Strategically valuable for breakthrough cardiovascular, neuro, and surgical devices needing early clinical signal to inform design freeze.

    Primary references

    3 sources
    Link health: 2 verified 1 bot-blocked· last checked 2026-05-09
    FDA·2ISO·1
    1. 1
      FDA EFS Guidance
      Bot-blocked
      FDAfda.gov
    2. 2
      ISO 14155 Standard Page
      Verified
      ISOiso.org
    3. 3
      FDA - Clinical Trials and Human Subject Protection
      Verified
      FDAfda.gov

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