--- title: "SE, Substantial Equivalence | MedTech Terms" description: "The legal standard a 510(k) device must meet versus a predicate. 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[Terms](/terms) 4. / 5. [Regulatory](/terms?cat=Regulatory) 6. / 7. Substantial Equivalence [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways)SE # Substantial Equivalence The legal standard a 510(k) device must meet versus a predicate. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition A device is substantially equivalent if it has the same [intended use](/terms/intended-use) as the predicate and either the same technological characteristics, or different technological characteristics that do not raise different questions of safety and effectiveness, with performance data demonstrating equivalent safety and effectiveness. What the regulation says The FDA defines substantial equivalence in 21 CFR 807.100. This is the primary criterion for clearing medical devices through the [510(k) premarket notification](/terms/510k) pathway. Manufacturers must demonstrate that their new device is as [safe](/terms/safe-note) and effective as a legally marketed [predicate device](/terms/predicate-device), as outlined in FDA guidance documents on the 510(k) program. ## What this means in practice Substantial equivalence is the legal foundation of the 510(k) pathway. FDA decisions hinge on careful predicate selection and side-by-side comparisons of indications, technology, and performance. ## Examples - A manufacturer submits a 510(k) for a new surgical instrument, demonstrating its substantial equivalence to an existing, legally marketed surgical instrument by comparing materials, dimensions, and sterilization methods. - A company develops a new in vitro diagnostic device and compares its performance characteristics, such as sensitivity and specificity, to a predicate device already cleared for the same intended use. - A medical device company adds a new feature to an existing cleared device and provides data to show that this change does not raise new questions of safety or effectiveness, thus maintaining substantial equivalence to its own predicate device. Common pitfalls - • Failing to select an appropriate predicate device can lead to significant delays or rejection of a 510(k) submission. - • Claiming substantial equivalence without robust side-by-side comparison data will result in FDA deficiencies. - • Assuming that minor technological differences will automatically be considered substantially equivalent without justification is a common mistake. - • Not adequately addressing new questions of safety and effectiveness raised by technological differences will prevent 510(k) clearance. ## Frequently asked questions What is a 'predicate device'? A [predicate device](/terms/predicate-device) is a legally marketed device to which a new device is compared to establish substantial equivalence. It must be a device that was cleared through the 510(k) process, preamendment, or reclassified. Can a device have different technological characteristics and still be substantially equivalent? What kind of data is typically required to demonstrate substantial equivalence? ## Cross-references ### Used by Things that build on this term. - [ 510(k) Premarket Notification(510(k)) ](/terms/510k) ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Regulatory Predicate Device A legally marketed device used as the comparator in a 510(k) submission. ](/terms/predicate-device)[ Regulatory 510(k) Premarket Notification(510(k)) FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate. ](/terms/510k) ### 510(k) Fundamentals · From this learning path [ Regulatory Intended Use The objective intent of the manufacturer regarding the use of the device. Adjacent lesson ](/terms/intended-use?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 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 Refuse to Accept(RTA) FDA administrative decision that a submission is incomplete and won't be substantively reviewed. ](/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 Premarket Approval(PMA) FDA's most stringent device marketing application, required for high-risk Class III devices. ](/terms/pma?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) Cited by Where this term appears across MedTech Terms. Learning paths (2) - [510(k) Fundamentals](/paths/510k-fundamentals)Lesson 3 of 7 - [De Novo & Breakthrough Pathways](/paths/de-novo-and-breakthrough)Lesson 8 of 11 Ecosystems (1) - [Regulated Pathways](/ecosystems/regulated-pathways) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 FDA· 1 European Commission· 1 IMDRF· 1 1. [1 The 510(k) Program Guidance Verified FDA · fda.gov ](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-program-evaluating-substantial-equivalence-premarket-notifications-510k) 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 Acronym SE Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=substantial-equivalence) Learn in 60 seconds Card Lesson Quiz The legal standard a 510(k) device must meet versus a predicate. - · Substantial equivalence is the legal foundation of the 510(k) pathway. - · FDA decisions hinge on careful predicate selection and side-by-side comparisons of indications, technology, and performance. Remember this Watch out: Failing to select an appropriate predicate device can lead to significant delays or rejection of a 510(k) submission. Related terms - [510(k) Premarket Notification(510(k)) ](/terms/510k) - [Predicate Device ](/terms/predicate-device) You may also need Auto-suggested from Regulatory and shared keywords. - [De Novo Classification Request(De Novo) ](/terms/de-novo) - [510(k) Summary vs 510(k) Statement ](/terms/510k-summary-vs-statement) - [Common Specifications (IVDR)(CS) ](/terms/ivdr-common-specifications) - [General Safety and Performance Requirements(GSPRs) ](/terms/gspr) - [General Safety and Performance Requirements (IVDR)(GSPR) ](/terms/ivdr-gspr) - [Real-Time PMA Supplement Review ](/terms/pma-real-time-review) [All Regulatory terms](/terms?cat=Regulatory) From the Blue Goat network Related resources and services on this topic. - [ MedTech Truths Common misconceptions about medical device development - debunked. ](https://mdcmisconceptions.com) - [ 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 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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