--- title: "IDE, Investigational Device Exemption | MedTech Terms" description: "FDA authorization to use an investigational device in a clinical study. 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Non-significant risk (NSR) studies, on the other hand, only require IRB approval and must meet abbreviated IDE requirements, as described in 21 CFR 812.2(b)." } }, { "@type": "Question", "name": "Who approves an IDE?", "acceptedAnswer": { "@type": "Answer", "text": "The FDA approves an Investigational Device Exemption for significant risk device studies. For non-significant risk studies, the IDE is considered in effect 30 days after IRB approval, provided the abbreviated requirements are met." } } ] } ] } --- [ 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. Investigational Device Exemption [All terms](/terms) Clinical & Trials [Clinical Evidence](/ecosystems/clinical-evidence)[Global Markets](/ecosystems/global-markets)IDE # Investigational Device Exemption FDA authorization to use an investigational device in a clinical study. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a [PMA](/terms/pma) or 510(k) submission to FDA. What the regulation says The FDA, under 21 CFR Part 812, outlines the requirements for an Investigational Device Exemption (IDE). These regulations govern clinical studies conducted to collect safety and effectiveness data on medical devices. The primary goal of an IDE is to permit the interstate shipment of investigational devices for research purposes. ## What this means in practice Significant risk (SR) device studies require an FDA-approved IDE and [IRB](/terms/irb) approval. Non-significant risk (NSR) studies require IRB approval and abbreviated IDE requirements. ## Examples - A company developing a novel implantable cardiac device applies for a full IDE from the FDA prior to initiating a clinical trial to evaluate its safety and efficacy. - A researcher conducting a study on an existing, legally marketed device for a new indication with minimal risk obtains IRB approval and follows abbreviated IDE requirements, without needing explicit FDA IDE approval. - A start-up developing a new diagnostic imaging device submits an IDE application to the FDA, detailing the study protocol, device description, and investigator qualifications. Common pitfalls - • Failing to distinguish between significant risk and non-significant risk device studies can lead to incorrect application of IDE regulations. - • Assuming that IRB approval alone is sufficient for all investigational device studies, neglecting FDA IDE requirements. - • Not understanding the abbreviated IDE requirements for non-significant risk devices can result in unnecessary administrative burden. - • Improperly classifying a device's risk can lead to non-compliance with FDA regulations for clinical investigations. - • Beginning a clinical study without proper IDE approval or exemption can result in regulatory action by the FDA. ## Frequently asked questions What is the primary purpose of an IDE? The primary purpose of an Investigational Device Exemption (IDE) is to allow the use of an investigational device in a clinical study to gather safety and effectiveness data needed for regulatory submissions like a [Premarket Approval](/terms/pma) (PMA) or 510(k) to the FDA. What is the difference between a significant risk and non-significant risk device study regarding IDEs? Who approves an IDE? ## Cross-references ### Used by Things that build on this term. - [ Premarket Approval(PMA) ](/terms/pma) ### Precedes Comes before in a typical workflow or lifecycle. - [ IDE Supplement ](/terms/ide-supplement) ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Clinical & Trials Institutional Review Board(IRB) Board that reviews and approves human-subjects research at an institution. ](/terms/irb)[ Regulatory Premarket Approval(PMA) FDA's most stringent device marketing application, required for high-risk Class III devices. ](/terms/pma) ### Clinical Trials & Evidence · From this learning path [ Clinical & Trials IDE Supplement Amendment to an approved Investigational Device Exemption for protocol or device changes. Adjacent lesson ](/terms/ide-supplement?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 Adverse Event(AE) Any untoward medical occurrence in a subject, whether or not related to the device. ](/terms/adverse-event?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) ### More in Clinical & Trials · Same category [ Clinical & Trials Feasibility Study Small clinical study evaluating initial safety, usability, and design parameters of an investigational device. ](/terms/feasibility-study)[ 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) Cited by Where this term appears across MedTech Terms. Learning paths (1) - [Clinical Trials & Evidence](/paths/clinical-trials-and-evidence)Lesson 1 of 18 Ecosystems (2) - [Clinical Evidence](/ecosystems/clinical-evidence) - [Global Markets](/ecosystems/global-markets) ## Mentioned in recent activity 1 entry Trials (1) [AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE ](https://clinicaltrials.gov/study/NCT07277946) Tissium · 2026-05-14 ## Latest in MedTech [View all](/latest?term=ide) Recent regulatory actions, publications, and trials matched to this term. Updated daily. - Trial 2026-05-14 [AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE ](https://clinicaltrials.gov/study/NCT07277946) Tissium · RECRUITING ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 eCFR· 1 ISO· 1 FDA· 1 1. [1 21 CFR Part 812 Verified eCFR · ecfr.gov ](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-812) 2. [2 ISO 14155 Standard Page Verified ISO · iso.org ](https://www.iso.org/standard/71690.html) 3. [3 FDA - Clinical Trials and Human Subject Protection Verified FDA · fda.gov ](https://www.fda.gov/science-research/science-and-research-special-topics/clinical-trials-and-human-subject-protection) 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 Acronym IDE Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=ide) Learn in 60 seconds Card Lesson Quiz FDA authorization to use an investigational device in a clinical study. - · Significant risk (SR) device studies require an FDA-approved IDE and IRB approval. - · Non-significant risk (NSR) studies require IRB approval and abbreviated IDE requirements. Remember this Watch out: Failing to distinguish between significant risk and non-significant risk device studies can lead to incorrect application of IDE regulations. Related terms - [Premarket Approval(PMA) ](/terms/pma) - [Institutional Review Board(IRB) ](/terms/irb) You may also need Auto-suggested from Clinical & Trials and shared keywords. - [Feasibility Study ](/terms/feasibility-study) - [Investigator Brochure(IB) ](/terms/investigator-brochure) - [Pivotal Trial ](/terms/pivotal-trial) - [Clinical Evaluation Plan(CEP) ](/terms/clinical-evaluation-plan) - [Electronic Data Capture(EDC) ](/terms/edc) - [First-in-Human Study(FIH) ](/terms/fih) [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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