MedTech Terms
    The authoritative reference
    All terms

    Feasibility Study

    Small clinical study evaluating initial safety, usability, and design parameters of an investigational device.

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

    Definition

    Feasibility studies generate preliminary safety and performance data, refine procedures, and inform the design of a pivotal trial. They are not powered for definitive efficacy claims.

    What this means in practice

    FDA encourages early sponsor engagement (Q-Sub) on feasibility design to maximize the value of the data for subsequent pivotal planning.

    Primary references

    3 sources
    FDA·1ICH·1ISO·1
    1. 1
      FDA EFS Guidance
      FDAfda.gov
    2. 2
      ICH Guidelines
      ICHich.org
    3. 3
      ISO 14155 Standard Page
      ISOiso.org

    Inline markers like [1] jump to the matching reference above.