--- title: "De Novo, De Novo Classification Request | MedTech Terms" description: "Pathway to classify novel low- to moderate-risk devices that lack a predicate. Plain-English Regulatory definition for MedTech teams, with examples and related" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/de-novo#term", "name": "De Novo Classification Request", "alternateName": "De Novo", "description": "The De Novo classification process provides a marketing pathway to classify novel medical devices for which general controls alone, or general and special controls, provide a reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate device.", "url": "https://medtechterms.com/terms/de-novo", "termCode": "de-novo", "inDefinedTermSet": { "@type": "DefinedTermSet", "name": "MedTech Terms", "url": "https://medtechterms.com/terms" } }, { "@type": "Article", "@id": "https://medtechterms.com/terms/de-novo#article", "headline": "De Novo, De Novo Classification Request", "description": "Pathway to classify novel low- to moderate-risk devices that lack a predicate.", "url": "https://medtechterms.com/terms/de-novo", "mainEntityOfPage": { "@type": "WebPage", "@id": "https://medtechterms.com/terms/de-novo" }, "about": { "@id": "https://medtechterms.com/terms/de-novo#term" }, "articleSection": "Regulatory", "inLanguage": "en", "keywords": "De Novo Classification Request, De Novo, 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": "De Novo Classification Request", "url": "https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/de-novo-classification-request", "publisher": { "@type": "Organization", "name": "FDA" } }, { "@type": "CreativeWork", "name": "Acceptance Review for De Novo Classification Requests", "url": "https://www.fda.gov/regulatory-information/search-fda-guidance-documents/acceptance-review-de-novo-classification-requests", "publisher": { "@type": "Organization", "name": "FDA" } }, { "@type": "CreativeWork", "name": "IMDRF Documents", "url": "https://www.imdrf.org/documents", "publisher": { "@type": "Organization", "name": "IMDRF" } } ], "mentions": [ { "@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/predicate-device#term", "name": "Predicate Device", "url": "https://medtechterms.com/terms/predicate-device" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/pma#term", "name": "Premarket Approval", "alternateName": "PMA", "url": "https://medtechterms.com/terms/pma" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/substantial-equivalence#term", "name": "Substantial Equivalence", "alternateName": "SE", "url": "https://medtechterms.com/terms/substantial-equivalence" } ] }, { "@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": "De Novo Classification Request", "item": "https://medtechterms.com/terms/de-novo" } ] }, { "@type": "FAQPage", "@id": "https://medtechterms.com/terms/de-novo#faq", "mainEntity": [ { "@type": "Question", "name": "When should I use De Novo instead of 510(k) or PMA?", "acceptedAnswer": { "@type": "Answer", "text": "De Novo fits novel low- to moderate-risk devices with no legally marketed predicate. 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Once granted, the De Novo creates a classification order that any subsequent 510(k) can cite as a predicate, subject to the special controls FDA established for the device type." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Regulatory](/terms?cat=Regulatory) 6. / 7. De Novo Classification Request [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways)[Quality System](/ecosystems/quality-system)[Global Markets](/ecosystems/global-markets)De Novo # De Novo Classification Request Pathway to classify novel low- to moderate-risk devices that lack a predicate. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition The De Novo classification process provides a marketing pathway to classify novel medical devices for which [general controls](/terms/general-controls) alone, or general and [special controls](/terms/special-controls), provide a reasonable assurance of safety and effectiveness for the [intended use](/terms/intended-use), but for which there is no legally marketed [predicate device](/terms/predicate-device). ## What this means in practice Granting a De Novo creates a new device classification (Class I or Class II with [special controls](/terms/special-controls)) and can serve as a predicate for future 510(k) submissions, shaping the regulatory framework for an entire device category. It is intended for novel devices where risk is low to moderate but no legally marketed predicate exists. ## Examples - The first cleared AI-based diabetic retinopathy screening software, which established a new device type and enabled subsequent 510(k) submissions. - A novel low-risk digital therapeutic classified into a newly created Class II product code with special controls. ## Use cases 1 scenario 1 ### First-of-kind continuous glucose-trend wearable Regulatory strategist A wearable measures interstitial glucose trends but doesn't fit any existing product code. The sponsor receives a Not Substantially Equivalent decision on a 510(k), then files a De Novo with risk-based [special controls](/terms/special-controls). Outcome FDA grants De Novo classification as Class II and creates a new product code, which becomes a predicate for future entrants. Common pitfalls - • Filing a De Novo when a plausible predicate exists. FDA may redirect the submission to a 510(k), losing months. - • Underestimating the special controls FDA may impose, which become binding on the applicant and future 510(k) followers. - • Skipping a Pre-Submission (Q-Sub) meeting to confirm De Novo is the correct pathway. ## Frequently asked questions When should I use De Novo instead of 510(k) or PMA? De Novo fits novel low- to moderate-risk devices with no legally marketed predicate. If a predicate exists, use 510(k). If the device is high risk (Class III), use [PMA](/terms/pma). How long does a De Novo take? Does a De Novo require clinical data? Can others use my De Novo as a predicate? ## Cross-references ### Often confused with Distinct concept frequently mistaken for this one. - [ 510(k) Premarket Notification(510(k)) De Novo is for novel devices lacking a predicate. ](/terms/510k) ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ 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)[ Regulatory Predicate Device A legally marketed device used as the comparator in a 510(k) submission. ](/terms/predicate-device)[ Regulatory Substantial Equivalence(SE) The legal standard a 510(k) device must meet versus a predicate. ](/terms/substantial-equivalence) ### 510(k) Fundamentals · From this learning path [ 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?from=510k-fundamentals)[ Regulatory Intended Use The objective intent of the manufacturer regarding the use of the device. ](/terms/intended-use?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. Adjacent lesson ](/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) ### Founder & Investor Primer · From this learning path [ Investment & Finance Capitalization Table(Cap Table) Ledger of all securities issued by a company and who owns them. ](/terms/cap-table?from=founder-and-investor-primer)[ Investment & Finance Convertible Note Short-term debt that converts into equity at a future financing round. ](/terms/convertible-note?from=founder-and-investor-primer)[ Investment & Finance Due Diligence Investigation of a company before an investment, financing, or acquisition. ](/terms/due-diligence?from=founder-and-investor-primer)[ Investment & Finance Exit Multiple Valuation ratio applied at exit, e.g., enterprise value to revenue. ](/terms/exit-multiple?from=founder-and-investor-primer) Cited by Where this term appears across MedTech Terms. Learning paths (3) - [510(k) Fundamentals](/paths/510k-fundamentals)Lesson 7 of 7 - [De Novo & Breakthrough Pathways](/paths/de-novo-and-breakthrough)Lesson 1 of 11 - [Founder & Investor Primer](/paths/founder-and-investor-primer)Lesson 4 of 16 Ecosystems (3) - [Regulated Pathways](/ecosystems/regulated-pathways) - [Quality System](/ecosystems/quality-system) - [Global Markets](/ecosystems/global-markets) ## Primary references 3 sources Link health: 2 verified 1 unchecked · last checked 2026-06-20 FDA· 2 IMDRF· 1 1. [1 De Novo Classification Request Verified FDA · fda.gov ](https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/de-novo-classification-request) 2. [2 Acceptance Review for De Novo Classification Requests Unchecked FDA · fda.gov ](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/acceptance-review-de-novo-classification-requests) 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 Acronym De Novo Sources 3 Use cases 1 Updated 5/5/2026 [Compare with another term](/compare?a=de-novo) Learn in 60 seconds Card Lesson Quiz Pathway to classify novel low- to moderate-risk devices that lack a predicate. - · It is intended for novel devices where risk is low to moderate but no legally marketed predicate exists. Remember this Watch out: Filing a De Novo when a plausible predicate exists. FDA may redirect the submission to a 510(k), losing months. Related terms - [510(k) Premarket Notification(510(k)) ](/terms/510k) - [Predicate Device ](/terms/predicate-device) - [Premarket Approval(PMA) ](/terms/pma) - [Substantial Equivalence(SE) ](/terms/substantial-equivalence) You may also need Auto-suggested from Regulatory and shared keywords. - [Device Reclassification Petition ](/terms/reclassification-petition) - [510(k) Summary vs 510(k) Statement ](/terms/510k-summary-vs-statement) - [Humanitarian Device Exemption(HDE) ](/terms/hde) - [MDR Article 117 ](/terms/mdr-article-117) - [PMA Supplement Types ](/terms/pma-supplement-types) - [Special 510(k)(Special 510(k)) ](/terms/special-510k) [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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