Feasibility Study
Small clinical study evaluating initial safety, usability, and design parameters of an investigational device.
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. FDA distinguishes early feasibility studies, traditional feasibility studies and pivotal studies, all usually run under an IDE. Feasibility results guide device iterations, endpoint selection and sample size estimates for the pivotal trial. Results are typically reported descriptively, and success criteria focus on safety and procedural performance rather than hypothesis testing.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.
- •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
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsDefinitive clinical study designed to establish safety and effectiveness for marketing authorization.
FDA authorization to use an investigational device in a clinical study.
FDA program enabling early human evaluation of novel devices with limited preclinical data and iterative design.
Clinical Trials & Evidence
· From this learning pathAny untoward medical occurrence in a subject, whether or not related to the device.
Trial design that pre-specifies opportunities to modify aspects (sample size, arms, endpoints) based on interim data.
Documented assessment of clinical data demonstrating EU MDR conformity for a device.
Annual report sponsors must submit to FDA summarizing the progress of an approved IDE study, including enrollment, deviations, and adverse events.
More in Clinical & Trials
· Same categoryWhere this term appears across MedTech Terms.
- Clinical Trials & EvidenceLesson 13 of 18
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Sources
3 sourcesEvery citation below opens the original document. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.
- 1FDA EFS GuidanceTier 2 VerifiedFDAfda.gov
- 2ICH GuidelinesTier 2 VerifiedICHich.org
- 3ISO 14155 Standard PageTier 1 VerifiedISOiso.org
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