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    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 the regulation says
    The FDA guidance "Early Feasibility Studies for Medical Devices" describes feasibility studies as limited clinical investigations to evaluate a device

    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.

    Examples

    • An early feasibility study for a novel cardiac stent might involve implanting the device in a small number of patients to assess immediate patency and delivery system performance.
    • A feasibility study for a new surgical robot could evaluate the surgeon's ability to perform specific tasks and identify necessary software or hardware adjustments.
    • A small study might test a new diagnostic imaging agent in a limited patient population to optimize dosing and imaging protocols before a larger trial.
    Common pitfalls
    • •Confusing feasibility studies with pivotal trials, which are designed for definitive efficacy and safety.
    • •Failing to establish clear endpoints and success criteria for the feasibility study itself.
    • •Underestimating the resources and regulatory oversight still required for even a limited feasibility study.
    • •Not adequately addressing data privacy and informed consent requirements specific to clinical investigations.
    • •Expanding the scope of a feasibility study beyond its intended purpose, leading to underpowered or inconclusive results.

    Frequently asked questions

    The primary goal is to gather preliminary data on safety and performance, refine device design elements, and optimize clinical procedures before initiating a larger, pivotal clinical trial. It helps ensure the subsequent pivotal study is well-designed and justifiable.
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    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-06-20
    FDA·1ICH·1ISO·1
    1. 1
      FDA EFS Guidance
      Verified
      FDAfda.gov
    2. 2
      ICH Guidelines
      Verified
      ICHich.org
    3. 3
      ISO 14155 Standard Page
      Verified
      ISOiso.org

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