--- title: "Intended Use, Definition | MedTech Terms" description: "The objective intent of the manufacturer regarding the use of the device. 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Device classification dictates the regulatory controls and pre-market submission requirements, impacting the entire product development lifecycle." } }, { "@type": "Question", "name": "Can the intended use of a device change after market approval?", "acceptedAnswer": { "@type": "Answer", "text": "Yes, changes to a device's intended use after market approval typically require a new regulatory submission. This is because a change in intended use can alter the device's classification, risks, and required evidence of safety and effectiveness." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Regulatory](/terms?cat=Regulatory) 6. / 7. Intended Use [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways) # Intended Use The objective intent of the manufacturer regarding the use of the device. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition Intended use is the use for which a product is intended according to the data supplied by the manufacturer in [labeling](/terms/labeling), advertising, and promotional materials. What the regulation says Under the US FDA, intended use refers to the objective intent of the persons legally responsible for the [labeling](/terms/labeling) of devices (21 CFR 801.4). This objective intent is determined by the expressions of the manufacturer or their authorized representative, including labeling claims, advertising, and promotional materials. Similarly, the EU [MDR](/terms/mdr-reporting) (Regulation (EU) 2017/745) defines intended purpose as the use for which a device is intended according to the data supplied by the manufacturer in the labeling, [instructions for use](/terms/ifu), or promotional materials. ## What this means in practice Intended use defines the device, drives classification, and is the anchor for risk analysis and [labeling](/terms/labeling). Off-label promotion is a regulatory violation. ## Examples - A manufacturer states their software is intended to assist clinicians in diagnosing melanoma from dermatoscopic images, which defines its intended use. - A blood glucose meter is marketed for self-monitoring by individuals with diabetes, establishing its intended use for patient management of a chronic condition. - An orthopedic implant Common pitfalls - • A poorly defined intended use can lead to incorrect device classification, impacting regulatory pathway and submission requirements. - • Failing to clearly articulate the intended use can result in inadequate risk management activities, as potential hazards may be overlooked. - • Marketing or promoting a device for uses outside its stated intended use constitutes off-label promotion, which is a regulatory violation. - • Modifying the intended use of a device without proper regulatory notification or submission can lead to non-compliance and enforcement actions. - • Overly broad or vague intended use statements can create ambiguity and make it difficult to demonstrate conformity with essential requirements or safety and performance principles. ## Frequently asked questions How does intended use differ from indications for use? Intended use describes the general purpose of the device (e.g., to diagnose a condition), while [indications for use](/terms/indications-for-use) specify the particular disease or condition the device will diagnose, treat, or prevent, and often include patient populations or anatomical sites. Why is intended use critical for device classification? Can the intended use of a device change after market approval? ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Regulatory Indications for Use(IFU (statement)) Description of the disease or condition the device will diagnose, treat, prevent, cure, or mitigate. ](/terms/indications-for-use)[ Regulatory Labeling All written, printed, or graphic matter on or accompanying a device. ](/terms/labeling) ### 510(k) Fundamentals · From this learning path [ Regulatory Substantial Equivalence(SE) The legal standard a 510(k) device must meet versus a predicate. Adjacent lesson ](/terms/substantial-equivalence?from=510k-fundamentals)[ Regulatory 510(k) Premarket Notification(510(k)) FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate. ](/terms/510k?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 Predicate Device A legally marketed device used as the comparator in a 510(k) submission. ](/terms/predicate-device?from=510k-fundamentals) ### De Novo & Breakthrough Pathways · From this learning path [ Regulatory Q-Submission (Pre-Submission)(Q-Sub / Pre-Sub) Voluntary mechanism to obtain FDA feedback before a formal premarket submission. Adjacent lesson ](/terms/q-sub?from=de-novo-and-breakthrough)[ 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 Premarket Approval(PMA) FDA's most stringent device marketing application, required for high-risk Class III devices. ](/terms/pma?from=de-novo-and-breakthrough) Cited by Where this term appears across MedTech Terms. Learning paths (2) - [510(k) Fundamentals](/paths/510k-fundamentals)Lesson 4 of 7 - [De Novo & Breakthrough Pathways](/paths/de-novo-and-breakthrough)Lesson 5 of 11 Ecosystems (1) - [Regulated Pathways](/ecosystems/regulated-pathways) ## Mentioned in recent activity 2 entries Recalls (1)PubMed (1) [LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241, 99577-001255, 99577-001219, 99577-001957, 99577-001935, 99577-001964, 99577-001955, 99577-001956, 99577-001588, 99577-001958, 99577-001950, 99577-001962, 99577-002178, 99577-001372, 99577-001938, 99577-000045; LIFEPAK 1000, REF: 99425-000025, 99425-000023, 99425-000096; LIFEPAK 35, REF: 99335-000013, 99335-000031; LIFEPAK 20e, REF: 99507-000122 ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=Z-2065-2026) Class II · 2026-04-13 ## Latest in MedTech [View all](/latest?term=intended-use) Recent regulatory actions, publications, and trials matched to this term. Updated daily. - PubMed 2026-06-11 [B1+rms for Implants: A Review of Intended Use. ](https://pubmed.ncbi.nlm.nih.gov/42281234/) Journal of magnetic resonance imaging : JMRI - Recall 2026-04-13 [LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241, 99577-001255, 99577-001219, 99577-001957, 99577-001935, 99577-001964, 99577-001955, 99577-001956, 99577-001588, 99577-001958, 99577-001950, 99577-001962, 99577-002178, 99577-001372, 99577-001938, 99577-000045; LIFEPAK 1000, REF: 99425-000025, 99425-000023, 99425-000096; LIFEPAK 35, REF: 99335-000013, 99335-000031; LIFEPAK 20e, REF: 99507-000122 ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=Z-2065-2026) Class II · Physio-Control, Inc. ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 eCFR· 1 European Commission· 1 IMDRF· 1 1. [1 21 CFR 801.4 Verified eCFR · ecfr.gov ](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-801/subpart-A/section-801.4) 2. [2 European Commission - Medical Devices Verified European Commission · health.ec.europa.eu ](https://health.ec.europa.eu/medical-devices-sector_en) 3. [3 IMDRF Documents Verified IMDRF · imdrf.org ](https://www.imdrf.org/documents) 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 Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=intended-use) Learn in 60 seconds Card Lesson Quiz The objective intent of the manufacturer regarding the use of the device. - · Intended use defines the device, drives classification, and is the anchor for risk analysis and labeling. - · Off-label promotion is a regulatory violation. Remember this Watch out: A poorly defined intended use can lead to incorrect device classification, impacting regulatory pathway and submission requirements. Related terms - [Indications for Use(IFU (statement)) ](/terms/indications-for-use) - [Labeling ](/terms/labeling) You may also need Auto-suggested from Regulatory and shared keywords. - [Device Master File(MAF) ](/terms/device-master-file) - [General Safety and Performance Requirements (IVDR)(GSPR) ](/terms/ivdr-gspr) - [Instructions for Use(IFU) ](/terms/ifu) - [IVDR Legacy Device ](/terms/ivdr-legacy-device) - [Modular PMA ](/terms/pma-modular) - [Post-Market Performance Follow-Up (IVDR)(PMPF) ](/terms/ivdr-pmpf) [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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