--- title: "Feasibility Study, Definition | MedTech Terms" description: "Small clinical study evaluating initial safety, usability, and design parameters of an investigational device." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/feasibility-study#term", "name": "Feasibility Study", "description": "Feasibility studies generate preliminary safety and performance data, refine procedures, and inform the design of a pivotal trial. 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It helps ensure the subsequent pivotal study is well-designed and justifiable." } }, { "@type": "Question", "name": "How do feasibility studies differ from pivotal trials in terms of statistical power?", "acceptedAnswer": { "@type": "Answer", "text": "Feasibility studies are typically not statistically powered to make definitive claims about device efficacy or long-term safety. Their focus is on exploratory data and procedural refinement, whereas pivotal trials are powered to demonstrate clinical benefit and safety outcomes." } }, { "@type": "Question", "name": "Are feasibility studies subject to regulatory oversight?", "acceptedAnswer": { "@type": "Answer", "text": "Yes, even though they are preliminary, feasibility studies for medical devices are still subject to regulatory requirements, including Institutional Review Board, IRB, approval and informed consent processes, similar to other clinical investigations. Refer to 21 CFR Part 812 for Investigational Device Exemptions, IDE, regulations." } }, { "@type": "Question", "name": "Can data from a feasibility study be used in a regulatory submission?", "acceptedAnswer": { "@type": "Answer", "text": "While not sufficient for definitive claims, data from well-conducted feasibility studies can support design rationale, risk assessments, and the justification for proceeding to a pivotal trial within a regulatory submission. They demonstrate a foundational understanding of the device's interaction with patients." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Clinical & Trials](/terms?cat=Clinical%20%26%20Trials) 6. / 7. Feasibility Study [All terms](/terms) Clinical & Trials [Clinical Evidence](/ecosystems/clinical-evidence)[Startup Lifecycle](/ecosystems/startup-lifecycle) # Feasibility Study Small clinical study evaluating initial safety, usability, and design parameters of an investigational device. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition Feasibility studies generate preliminary safety and performance data, refine procedures, and inform the design of a [pivotal trial](/terms/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](/terms/pre-submission)) 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 What is the primary goal of a medical device feasibility study? 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. How do feasibility studies differ from pivotal trials in terms of statistical power? Are feasibility studies subject to regulatory oversight? Can data from a feasibility study be used in a regulatory submission? ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Clinical & Trials Pivotal Trial Definitive clinical study designed to establish safety and effectiveness for marketing authorization. ](/terms/pivotal-trial)[ Clinical & Trials Investigational Device Exemption(IDE) FDA authorization to use an investigational device in a clinical study. ](/terms/ide)[ Clinical & Trials Early Feasibility Study(EFS) FDA program enabling early human evaluation of novel devices with limited preclinical data and iterative design. ](/terms/efs) ### Clinical Trials & Evidence · From this learning path [ Clinical & Trials Adverse Event(AE) Any untoward medical occurrence in a subject, whether or not related to the device. Adjacent lesson ](/terms/adverse-event?from=clinical-trials-and-evidence)[ Clinical & Trials Adaptive Trial Design Trial design that pre-specifies opportunities to modify aspects (sample size, arms, endpoints) based on interim data. ](/terms/adaptive-trial?from=clinical-trials-and-evidence)[ Clinical & Trials Clinical Evaluation Report(CER) Documented assessment of clinical data demonstrating EU MDR conformity for a device. ](/terms/cer?from=clinical-trials-and-evidence)[ Clinical & Trials IDE Annual Progress Report Annual report sponsors must submit to FDA summarizing the progress of an approved IDE study, including enrollment, deviations, and adverse events. ](/terms/ide-annual-report?from=clinical-trials-and-evidence) ### More in Clinical & Trials · Same category [ Clinical & Trials IDE Supplement Amendment to an approved Investigational Device Exemption for protocol or device changes. ](/terms/ide-supplement) Cited by Where this term appears across MedTech Terms. Learning paths (1) - [Clinical Trials & Evidence](/paths/clinical-trials-and-evidence)Lesson 13 of 18 Ecosystems (2) - [Clinical Evidence](/ecosystems/clinical-evidence) - [Startup Lifecycle](/ecosystems/startup-lifecycle) ## Mentioned in recent activity 1 entry Trials (1) [Single Arm, Monocentric, Pilot Feasibility Study on an Interactive Virtual Reality Program in 20 Complex In-clinic Palliative Care Patients ](https://clinicaltrials.gov/study/NCT07545928) University Hospital, Strasbourg, France · 2026-09-01 ## Latest in MedTech [View all](/latest?term=feasibility-study) Recent regulatory actions, publications, and trials matched to this term. Updated daily. - Trial 2026-09-01 [Single Arm, Monocentric, Pilot Feasibility Study on an Interactive Virtual Reality Program in 20 Complex In-clinic Palliative Care Patients ](https://clinicaltrials.gov/study/NCT07545928) University Hospital, Strasbourg, France · NOT\_YET\_RECRUITING ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 FDA· 1 ICH· 1 ISO· 1 1. [1 FDA EFS Guidance Verified FDA · fda.gov ](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/investigational-device-exemptions-ides-early-feasibility-medical-device-clinical-studies-including) 2. [2 ICH Guidelines Verified ICH · ich.org ](https://www.ich.org/page/ich-guidelines) 3. [3 ISO 14155 Standard Page Verified ISO · iso.org ](https://www.iso.org/standard/71690.html) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Clinical evidence intersecting with device security? We support clinical-stage MedTech teams whose investigational devices touch patient data or hospital networks. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Clinical & Trials Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=feasibility-study) Learn in 60 seconds Card Lesson Quiz Small clinical study evaluating initial safety, usability, and design parameters of an investigational device. - · FDA encourages early sponsor engagement (Q-Sub) on feasibility design to maximize the value of the data for subsequent pivotal planning. - · They are not powered for definitive efficacy claims. Remember this Watch out: Confusing feasibility studies with pivotal trials, which are designed for definitive efficacy and safety. Related terms - [Early Feasibility Study(EFS) ](/terms/efs) - [Pivotal Trial ](/terms/pivotal-trial) - [Investigational Device Exemption(IDE) ](/terms/ide) You may also need Auto-suggested from Clinical & Trials and shared keywords. - [Primary and Secondary Endpoints ](/terms/primary-secondary-endpoint) - [First-in-Human Study(FIH) ](/terms/fih) - [Electronic Data Capture(EDC) ](/terms/edc) - [Investigator Brochure(IB) ](/terms/investigator-brochure) - [Bayesian Trial Design ](/terms/bayesian-trial) - [Performance Study (IVDR) ](/terms/ivdr-performance-study) [All Clinical & Trials terms](/terms?cat=Clinical%20%26%20Trials) From the Blue Goat network Related resources and services on this topic. - [ MedTech Launchpad MedTech funding rounds, accelerators, and launch resources. ](https://medtechlaunchguide.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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