--- title: "Device Reclassification Petition, Definition | MedTech Terms" description: "Formal request to FDA to move a device type from one classification (I, II, or III) to another, either down-classifying or up-classifying." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/reclassification-petition#term", "name": "Device Reclassification Petition", "alternateName": [ "513(e) petition", "513(f)(3) petition" ], "description": "A reclassification petition is a formal submission asking FDA to change the regulatory classification of a generic type of device. Section 513(e) of the FD&C Act authorizes FDA-initiated reclassification; Section 513(f)(3) authorizes manufacturer-initiated petitions. 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[Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Regulatory](/terms?cat=Regulatory) 6. / 7. Device Reclassification Petition [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways)[Global Markets](/ecosystems/global-markets) # Device Reclassification Petition Formal request to FDA to move a device type from one classification (I, II, or III) to another, either down-classifying or up-classifying. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed June 20, 2026 ## Definition A reclassification petition is a formal submission asking FDA to change the regulatory classification of a generic type of device. Section 513(e) of the FD&C Act authorizes FDA-initiated reclassification; Section 513(f)(3) authorizes manufacturer-initiated petitions. Petitions must include valid scientific evidence showing that the device type warrants a different classification, typically that risks can be adequately controlled by general or [special controls](/terms/special-controls) (down-classification from III to II) or that existing controls are insufficient (up-classification). What the regulation says FD&C Act §513(e) and §513(f)(3); 21 CFR 860.130 (FDA-initiated) and 21 CFR 860.132 (manufacturer-initiated). FDA published the 'Reclassification of Medical Devices' guidance in 2019. ## What this means in practice Reclassification is uncommon but strategically powerful. Down-classifying a [Class III device](/terms/class-iii) type to Class II eliminates the [PMA](/terms/pma) burden for the entire device class, affecting every competitor. FDA periodically reclassifies device types based on accumulated post-market evidence (e.g., reclassification of certain external defibrillators, some surgical staplers). Manufacturer-initiated petitions typically come from industry consortia rather than individual companies because the benefits accrue to all competitors. Common pitfalls - • Treating a reclassification petition as a substitute for a 510(k) or De Novo, petitions reclassify the entire generic type, not individual products. - • Underestimating the evidence bar, FDA requires comprehensive scientific evidence about the device type's risk profile across the market. - • Ignoring the public comment and Federal Register process, reclassifications go through formal rulemaking. ## 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 Class III Device FDA's highest-risk device class, generally requiring PMA. ](/terms/class-iii)[ Regulatory De Novo Classification Request(De Novo) Pathway to classify novel low- to moderate-risk devices that lack a predicate. ](/terms/de-novo)[ Regulatory General Controls Baseline FDA requirements that apply to all medical devices regardless of class. ](/terms/general-controls) ### More in Regulatory · Same category [ Regulatory Premarket Approval(PMA) FDA's most stringent device marketing application, required for high-risk Class III devices. ](/terms/pma)[ Regulatory Special Controls Device-type-specific FDA requirements (often performance standards, labeling, or post-market surveillance) that apply on top of General Controls. ](/terms/special-controls)[ Regulatory 510(k) Summary vs 510(k) Statement Two alternative disclosure mechanisms in a 510(k) submission, a Summary is public on FDA's website; a Statement promises to share Safety & Effectiveness info on request. ](/terms/510k-summary-vs-statement)[ Regulatory 513(g) Request for Information(513(g)) Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification. ](/terms/513g) Cited by Where this term appears across MedTech Terms. Ecosystems (2) - [Regulated Pathways](/ecosystems/regulated-pathways) - [Global Markets](/ecosystems/global-markets) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 FDA· 1 eCFR· 1 IMDRF· 1 1. [1 Reclassification of Medical Devices Guidance Verified FDA · fda.gov ](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/reclassification-medical-devices-frequently-asked-questions) 2. [2 21 CFR Part 860 Subpart C Verified eCFR · ecfr.gov ](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-860/subpart-C) 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 6/20/2026 [Compare with another term](/compare?a=reclassification-petition) Learn in 60 seconds Card Lesson Quiz Formal request to FDA to move a device type from one classification (I, II, or III) to another, either down-classifying or up-classifying. - · Reclassification is uncommon but strategically powerful. - · Down-classifying a Class III device type to Class II eliminates the PMA burden for the entire device class, affecting every competitor. - · FDA periodically reclassifies device types based on accumulated post-market evidence (e.g., reclassification of certain external defibrillators, some surgical staplers). Remember this Watch out: Treating a reclassification petition as a substitute for a 510(k) or De Novo, petitions reclassify the entire generic type, not individual products. Related terms - [Premarket Approval(PMA) ](/terms/pma) - [510(k) Premarket Notification(510(k)) ](/terms/510k) - [De Novo Classification Request(De Novo) ](/terms/de-novo) - [Class III Device ](/terms/class-iii) - [General Controls ](/terms/general-controls) - [Special Controls ](/terms/special-controls) You may also need Auto-suggested from Regulatory and shared keywords. - [513(g) Request for Information(513(g)) ](/terms/513g) - [510(k) Summary vs 510(k) Statement ](/terms/510k-summary-vs-statement) - [Q-Submission (Pre-Submission)(Q-Sub / Pre-Sub) ](/terms/q-sub) - [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) [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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