--- title: "IFU (statement), Indications for Use | MedTech Terms" description: "Description of the disease or condition the device will diagnose, treat, prevent, cure, or mitigate. Plain-English Regulatory definition for MedTech teams, with" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/indications-for-use#term", "name": "Indications for Use", "alternateName": "IFU (statement)", "description": "The Indications for Use statement is a specific statement of disease, condition, or anatomical site for which a device is intended, including the patient population.", "url": "https://medtechterms.com/terms/indications-for-use", "termCode": "indications-for-use", "inDefinedTermSet": { "@type": "DefinedTermSet", "name": "MedTech Terms", "url": "https://medtechterms.com/terms" } }, { "@type": "Article", "@id": "https://medtechterms.com/terms/indications-for-use#article", "headline": "IFU (statement), Indications for Use", "description": "Description of the disease or condition the device will diagnose, treat, prevent, cure, or mitigate.", "url": "https://medtechterms.com/terms/indications-for-use", "mainEntityOfPage": { "@type": "WebPage", "@id": "https://medtechterms.com/terms/indications-for-use" }, "about": { "@id": "https://medtechterms.com/terms/indications-for-use#term" }, "articleSection": "Regulatory", "inLanguage": "en", "keywords": "Indications for Use, IFU (statement), Regulatory, medical device, MedTech", "author": { "@type": "Person", "name": "Christian Espinosa", "jobTitle": "Founder, Blue Goat Cyber", "url": "https://bluegoatcyber.com" }, "publisher": { "@type": "Organization", "name": "MedTech Terms", "url": "https://medtechterms.com" }, "isPartOf": { "@type": "WebSite", "name": "MedTech Terms", "url": "https://medtechterms.com" }, "datePublished": "2026-05-05", "dateModified": "2026-05-05", "citation": [ { "@type": "CreativeWork", "name": "European Commission - Medical Devices", "url": "https://health.ec.europa.eu/medical-devices-sector_en", "publisher": { "@type": "Organization", "name": "European Commission" } }, { "@type": "CreativeWork", "name": "IMDRF Documents", "url": "https://www.imdrf.org/documents", "publisher": { "@type": "Organization", "name": "IMDRF" } }, { "@type": "CreativeWork", "name": "RAPS Regulatory Focus", "url": "https://www.raps.org/news-and-articles/news-articles", "publisher": { "@type": "Organization", "name": "RAPS" } } ], "mentions": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/intended-use#term", "name": "Intended Use", "url": "https://medtechterms.com/terms/intended-use" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/510k#term", "name": "510(k) Premarket Notification", "alternateName": "510(k)", "url": "https://medtechterms.com/terms/510k" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/pma#term", "name": "Premarket Approval", "alternateName": "PMA", "url": "https://medtechterms.com/terms/pma" } ] }, { "@type": "BreadcrumbList", "itemListElement": [ { "@type": "ListItem", "position": 1, "name": "Home", "item": "https://medtechterms.com/" }, { "@type": "ListItem", "position": 2, "name": "Terms", "item": "https://medtechterms.com/terms" }, { "@type": "ListItem", "position": 3, "name": "Regulatory", "item": "https://medtechterms.com/terms?cat=Regulatory" }, { "@type": "ListItem", "position": 4, "name": "Indications for Use", "item": "https://medtechterms.com/terms/indications-for-use" } ] }, { "@type": "FAQPage", "@id": "https://medtechterms.com/terms/indications-for-use#faq", "mainEntity": [ { "@type": "Question", "name": "How do Indications for Use differ from intended use?", "acceptedAnswer": { "@type": "Answer", "text": "Indications for Use are a specific subset of intended use, detailing the medical conditions or purposes for which a device is intended. Intended use is a broader concept encompassing the general purpose of the device and how it achieves its function." } }, { "@type": "Question", "name": "Why is the patient population important in Indications for Use?", "acceptedAnswer": { "@type": "Answer", "text": "Defining the patient population, including age, weight, and specific conditions, helps ensure the device is used appropriately for patients for whom its safety and effectiveness have been established." } }, { "@type": "Question", "name": "Can Indications for Use change?", "acceptedAnswer": { "@type": "Answer", "text": "Yes, changes to Indications for Use often require a new regulatory submission, such as a 510(k) or PMA supplement, as they can significantly impact a device's safety and effectiveness profile." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Regulatory](/terms?cat=Regulatory) 6. / 7. Indications for Use [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways)IFU (statement) # Indications for Use Description of the disease or condition the device will diagnose, treat, prevent, cure, or mitigate. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition The Indications for Use statement is a specific statement of disease, condition, or anatomical site for which a device is intended, including the patient population. What the regulation says The FDA defines "Indications for Use" as a statement describing the disease or condition the device will diagnose, treat, prevent, cure, or mitigate, including the target patient population, as detailed in 21 CFR 814.20(b)(3)(i) for PMAs and 21 CFR 807.87(e) for 510(k) submissions. This statement establishes the boundaries for a device's permitted use and is a critical component of its regulatory submission and [labeling](/terms/labeling). ## What this means in practice Indications for Use is a specific, regulatorily significant subset of [intended use](/terms/intended-use), captured in 510(k) and [PMA](/terms/pma) decision summaries. ## Examples - A continuous glucose monitor's Indications for Use state: "For use by people age 18 years and older with diabetes mellitus for the management of their diabetes through the measurement of glucose levels in interstitial fluid." - A surgical robot's Indications for Use specifies: "Intended for use in general laparoscopic surgical procedures to assist in the precise manipulation of instruments and visualization of the surgical field." - An in vitro diagnostic test's Indications for Use might declare: "For the qualitative detection of SARS-CoV-2 nucleocapsid protein antigen from nasal swab specimens collected from individuals suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset." Common pitfalls - • Confusing "Indications for Use" with "intended use" can lead to mislabeling and regulatory non-compliance. - • Failing to precisely define the patient population or conditions can result in a device being used off-label, creating safety risks. - • Inconsistent Indications for Use across different official documents, such as regulatory submissions and marketing materials, can trigger regulatory scrutiny. - • Not clearly delineating the specific disease or condition the device addresses can lead to ambiguity in its application and efficacy claims. - • Omitting contraindications or warnings within the labeling related to the Indications for Use can result in adverse events and regulatory actions. ## Frequently asked questions How do Indications for Use differ from intended use? Indications for Use are a specific subset of [intended use](/terms/intended-use), detailing the medical conditions or purposes for which a device is intended. Intended use is a broader concept encompassing the general purpose of the device and how it achieves its function. Why is the patient population important in Indications for Use? Can Indications for Use change? ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Regulatory Intended Use The objective intent of the manufacturer regarding the use of the device. ](/terms/intended-use)[ Regulatory 510(k) Premarket Notification(510(k)) FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate. ](/terms/510k)[ Regulatory Premarket Approval(PMA) FDA's most stringent device marketing application, required for high-risk Class III devices. ](/terms/pma) ### 510(k) Fundamentals · From this learning path [ Regulatory Predicate Device A legally marketed device used as the comparator in a 510(k) submission. Adjacent lesson ](/terms/predicate-device?from=510k-fundamentals)[ Regulatory De Novo Classification Request(De Novo) Pathway to classify novel low- to moderate-risk devices that lack a predicate. ](/terms/de-novo?from=510k-fundamentals)[ Regulatory Substantial Equivalence(SE) The legal standard a 510(k) device must meet versus a predicate. ](/terms/substantial-equivalence?from=510k-fundamentals)[ Regulatory Refuse to Accept(RTA) FDA administrative decision that a submission is incomplete and won't be substantively reviewed. Adjacent lesson ](/terms/rta?from=510k-fundamentals) ### De Novo & Breakthrough Pathways · From this learning path [ Regulatory Breakthrough Device Designation(BDD) FDA program providing expedited review for devices that treat life-threatening or irreversibly debilitating conditions. ](/terms/breakthrough-device?from=de-novo-and-breakthrough)[ Regulatory Combination Product Product comprised of two or more regulated components - e.g., drug-device, biologic-device. ](/terms/combination-product?from=de-novo-and-breakthrough)[ Regulatory Q-Submission (Pre-Submission)(Q-Sub / Pre-Sub) Voluntary mechanism to obtain FDA feedback before a formal premarket submission. ](/terms/q-sub?from=de-novo-and-breakthrough)[ Commercialization Pre-Submission Meeting(Q-Sub) Formal FDA feedback request prior to a marketing or IDE submission. ](/terms/pre-submission?from=de-novo-and-breakthrough) Cited by Where this term appears across MedTech Terms. Learning paths (2) - [510(k) Fundamentals](/paths/510k-fundamentals)Lesson 5 of 7 - [De Novo & Breakthrough Pathways](/paths/de-novo-and-breakthrough)Lesson 6 of 11 Ecosystems (1) - [Regulated Pathways](/ecosystems/regulated-pathways) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 European Commission· 1 IMDRF· 1 RAPS· 1 1. [1 European Commission - Medical Devices Verified European Commission · health.ec.europa.eu ](https://health.ec.europa.eu/medical-devices-sector_en) 2. [2 IMDRF Documents Verified IMDRF · imdrf.org ](https://www.imdrf.org/documents) 3. [3 RAPS Regulatory Focus Verified RAPS · raps.org ](https://www.raps.org/news-and-articles/news-articles) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Navigating an FDA or EU MDR submission? Blue Goat Cyber supports the cybersecurity content of premarket submissions, from threat models to the 524B narrative. [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 Regulatory Acronym IFU (statement) Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=indications-for-use) Learn in 60 seconds Card Lesson Quiz Description of the disease or condition the device will diagnose, treat, prevent, cure, or mitigate. - · Indications for Use is a specific, regulatorily significant subset of intended use, captured in 510(k) and PMA decision summaries. Remember this Watch out: Confusing "Indications for Use" with "intended use" can lead to mislabeling and regulatory non-compliance. Related terms - [Intended Use ](/terms/intended-use) - [510(k) Premarket Notification(510(k)) ](/terms/510k) - [Premarket Approval(PMA) ](/terms/pma) You may also need Auto-suggested from Regulatory and shared keywords. - [Clinical Performance (IVDR) ](/terms/ivdr-clinical-performance) - [Self-Test and Near-Patient Testing (IVDR) ](/terms/ivdr-self-test) - [Health Hazard Evaluation(HHE) ](/terms/health-hazard-eval) - [Use Specification ](/terms/use-specification) - [Genetic Testing Requirements (IVDR Article 4) ](/terms/ivdr-genetic-testing) - [Summary of Safety and Performance (IVDR)(SSP) ](/terms/ivdr-summary-safety-performance) [All Regulatory terms](/terms?cat=Regulatory) From the Blue Goat network Related resources and services on this topic. - [ MedTech Cybersecurity Standards Authoritative reference for the standards and guidances behind medical device cybersecurity. ](https://medtechcyberstandards.com) - [ MedTech Cybersecurity Crosswalk International crosswalk of medical device cybersecurity requirements across regulators. ](https://mdccrosswalk.com) - [ MedTech Truths Common misconceptions about medical device development - debunked. ](https://mdcmisconceptions.com) - [ 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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