--- title: "Regulatory Terms - MedTech Terms" description: "FDA, EU MDR/IVDR, and global pathways for getting devices to market. 99 vendor-neutral definitions with primary-source citations." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTermSet", "@id": "https://medtechterms.com/categories/regulatory#set", "name": "Regulatory - MedTech Terms", "description": "FDA, EU MDR/IVDR, and global pathways for getting devices to market.", "url": "https://medtechterms.com/categories/regulatory", "hasDefinedTerm": [ { "@type": "DefinedTerm", "name": "510(k) Premarket Notification", "alternateName": "510(k)", "url": "https://medtechterms.com/terms/510k", "termCode": "510k" }, { "@type": "DefinedTerm", "name": "510(k) Summary vs 510(k) Statement", "url": "https://medtechterms.com/terms/510k-summary-vs-statement", "termCode": "510k-summary-vs-statement" }, { "@type": "DefinedTerm", "name": "513(g) Request for Information", "alternateName": "513(g)", "url": 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Device Identification", "alternateName": "UDI", "url": "https://medtechterms.com/terms/udi", "termCode": "udi" }, { "@type": "DefinedTerm", "name": "WHO Prequalification (Diagnostics)", "alternateName": "WHO PQ Dx", "url": "https://medtechterms.com/terms/who-pq-dx", "termCode": "who-pq-dx" } ] }, { "@type": "BreadcrumbList", "itemListElement": [ { "@type": "ListItem", "position": 1, "name": "Home", "item": "https://medtechterms.com/" }, { "@type": "ListItem", "position": 2, "name": "Categories", "item": "https://medtechterms.com/categories" }, { "@type": "ListItem", "position": 3, "name": "Regulatory", "item": "https://medtechterms.com/categories/regulatory" } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About [All categories](/categories)Category # Regulatory FDA, EU MDR/IVDR, and global pathways for getting devices to market. 99 terms [Filter in glossary](/terms?cat=Regulatory) ## Popular regulatory terms [ 510(k) Premarket Notification(510(k)) FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate. ](/terms/510k)[ Breakthrough Device Designation(BDD) FDA program providing expedited review for devices that treat life-threatening or irreversibly debilitating conditions. ](/terms/breakthrough-device)[ De Novo Classification Request(De Novo) Pathway to classify novel low- to moderate-risk devices that lack a predicate. ](/terms/de-novo)[ eSTAR FDA's interactive PDF template for preparing and submitting 510(k) and De Novo submissions. ](/terms/estar)[ EU In Vitro Diagnostic Regulation(IVDR) Regulation (EU) 2017/746 governing in vitro diagnostic medical devices in the EU. ](/terms/ivdr)[ EU Medical Device Regulation(MDR) Regulation (EU) 2017/745 governing medical devices in the European Union. ](/terms/mdr) ## All Regulatory terms - [510(k) Premarket Notification(510(k)) ](/terms/510k) - [510(k) Summary vs 510(k) Statement ](/terms/510k-summary-vs-statement) - [513(g) Request for Information(513(g)) ](/terms/513g) - [Abbreviated 510(k) ](/terms/abbreviated-510k) - [Accreditation Scheme for Conformity Assessment(ASCA) ](/terms/asca) - [Additional Condition for Nonprescription Use(ACNU) ](/terms/acnu) - [AI Act Conformity Assessment (Medical Devices) ](/terms/ai-act-conformity-assessment) - [AI Act Post-Market Monitoring ](/terms/ai-act-post-market-monitoring) - [AI Act Prohibited Practices ](/terms/ai-act-prohibited-practices) - [AI Act Serious Incident Reporting ](/terms/ai-act-serious-incident-reporting) - [AI Act Technical Documentation (Annex IV) ](/terms/ai-act-technical-documentation) - [AI Act Transparency Obligations ](/terms/ai-act-transparency-obligations) - [Analytical Performance (IVDR) ](/terms/ivdr-analytical-performance) - [ANVISA(ANVISA) ](/terms/anvisa) - [Authorized Representative (EU)(EC REP) ](/terms/ec-rep) - [Benefit-Risk Determination ](/terms/benefit-risk) - [Breakthrough Device Designation(BDD) ](/terms/breakthrough-device) - [CE Mark ](/terms/ce-mark) - [Class D Batch Verification (IVDR) ](/terms/ivdr-class-d-batch-verification) - [Class III Device ](/terms/class-iii) - [Clinical Performance (IVDR) ](/terms/ivdr-clinical-performance) - [Combination Product ](/terms/combination-product) - [Common Specifications(CS) ](/terms/common-specifications) - [Common Specifications (IVDR)(CS) ](/terms/ivdr-common-specifications) - [Companion Diagnostic (IVDR)(CDx) ](/terms/ivdr-companion-diagnostic) - [De Novo Classification Request(De Novo) ](/terms/de-novo) - [Device Master File(MAF) ](/terms/device-master-file) - [Device Reclassification Petition ](/terms/reclassification-petition) - [Electronic Instructions for Use(eIFU) ](/terms/eifu) - [Emergency Use Authorization(EUA) ](/terms/eua) - [eSTAR ](/terms/estar) - [EU In Vitro Diagnostic Regulation(IVDR) ](/terms/ivdr) - [EU Medical Device Regulation(MDR) ](/terms/mdr) - [EU Reference Laboratory (EURL)(EURL) ](/terms/ivdr-eu-reference-laboratory) - [EUDAMED ](/terms/eudamed) - [FDA Recognized Consensus Standards ](/terms/recognized-standards) - [Fundamental Rights Impact Assessment(FRIA) ](/terms/ai-act-fria) - [General Controls ](/terms/general-controls) - [General Safety and Performance Requirements(GSPRs) ](/terms/gspr) - [General Safety and Performance Requirements (IVDR)(GSPR) ](/terms/ivdr-gspr) - [General-Purpose AI Model(GPAI) ](/terms/ai-act-gpai) - [Genetic Testing Requirements (IVDR Article 4) ](/terms/ivdr-genetic-testing) - [Health Canada Medical Device Licence(MDL) ](/terms/health-canada-mdl) - [High-Risk AI System (EU AI Act) ](/terms/ai-act-high-risk-system) - [Humanitarian Device Exemption(HDE) ](/terms/hde) - [IMDRF ](/terms/imdrf) - [Importer and Distributor Obligations (EU) ](/terms/importer-distributor) - [In-House IVDs (Article 5(5)) ](/terms/ivdr-in-house-devices) - [Indications for Use(IFU (statement)) ](/terms/indications-for-use) - [Instructions for Use(IFU) ](/terms/ifu) - [Intended Use ](/terms/intended-use) - [ISO 20916 ](/terms/iso-20916) - [IVDR Conformity Assessment Routes ](/terms/ivdr-conformity-assessment-routes) - [IVDR Legacy Device ](/terms/ivdr-legacy-device) - [IVDR Performance Evaluation ](/terms/ivdr-performance-evaluation) - [IVDR Risk Classes A–D ](/terms/ivdr-classes) - [IVDR Transitional Provisions ](/terms/ivdr-transitional-provisions) - [Labeling ](/terms/labeling) - [Letter to File(LTF) ](/terms/letter-to-file) - [MDR Article 117 ](/terms/mdr-article-117) - [Medical Device Coordination Group Guidance(MDCG) ](/terms/mdcg) - [Medical Device User Fee Amendments(MDUFA) ](/terms/mdufa) - [Metrological Traceability (IVDR) ](/terms/ivdr-metrological-traceability) - [MHRA / UKCA Marking(MHRA / UKCA) ](/terms/mhra-ukca) - [Ministry of Food and Drug Safety (Korea)(MFDS) ](/terms/mfds) - [Modular PMA ](/terms/pma-modular) - [National Medical Products Administration(NMPA) ](/terms/nmpa) - [NMPA Innovative Medical Device Pathway ](/terms/nmpa-innovation) - [Notified Body(NB) ](/terms/notified-body) - [Notified Body Scrutiny (IVDR Class D) ](/terms/ivdr-notified-body-scrutiny) - [Performance Study Application (IVDR) ](/terms/ivdr-performance-study-application) - [Person Responsible for Regulatory Compliance(PRRC) ](/terms/prrc) - [Pharmaceuticals and Medical Devices Agency(PMDA) ](/terms/pmda) - [PMA Supplement Types ](/terms/pma-supplement-types) - [Post-Market Performance Follow-Up (IVDR)(PMPF) ](/terms/ivdr-pmpf) - [Post-Market Surveillance Plan (IVDR) ](/terms/ivdr-pms-plan) - [Predicate Device ](/terms/predicate-device) - [Premarket Approval(PMA) ](/terms/pma) - [Provider and Deployer (EU AI Act) ](/terms/ai-act-provider-deployer) - [Q-Submission (Pre-Submission)(Q-Sub / Pre-Sub) ](/terms/q-sub) - [Real-Time PMA Supplement Review ](/terms/pma-real-time-review) - [Refuse to Accept(RTA) ](/terms/rta) - [Request for Designation(RFD) ](/terms/rfd) - [Safer Technologies Program(STeP) ](/terms/step) - [Saudi Food and Drug Authority(SFDA) ](/terms/sfda) - 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