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 the regulation says
The FDA guidance "Early Feasibility Studies for Medical Devices" describes feasibility studies as limited clinical investigations to evaluate a deviceWhat 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.
Related terms
Shared paths + categoryClinical & Trials
Pivotal Trial
Definitive clinical study designed to establish safety and effectiveness for marketing authorization.
Clinical Trials & Evidence · adjacent
Clinical & Trials
Investigational Device Exemption(IDE)
FDA authorization to use an investigational device in a clinical study.
Clinical Trials & Evidence
Clinical & Trials
Early Feasibility Study(EFS)
FDA program enabling early human evaluation of novel devices with limited preclinical data and iterative design.
Same category
Clinical & Trials
Adverse Event(AE)
Any untoward medical occurrence in a subject, whether or not related to the device.
Clinical Trials & Evidence · adjacent
Clinical & Trials
Adaptive Trial Design
Trial design that pre-specifies opportunities to modify aspects (sample size, arms, endpoints) based on interim data.
Clinical Trials & Evidence
Clinical & Trials
Clinical Evaluation Report(CER)
Documented assessment of clinical data demonstrating EU MDR conformity for a device.
Clinical Trials & Evidence
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Primary references
3 sourcesLink health: 3 verified· last checked 2026-06-20
FDA·1ICH·1ISO·1
- 1FDA EFS GuidanceVerifiedFDAfda.gov
- 2ICH GuidelinesVerifiedICHich.org
- 3ISO 14155 Standard PageVerifiedISOiso.org
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