--- title: "513(g), 513(g) Request for Information | MedTech Terms" description: "Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification. Plain-English Regulatory definition for MedTech teams, with exa" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/513g#term", "name": "513(g) Request for Information", "alternateName": "513(g)", "description": "A 513(g) submission asks CDRH for FDA's opinion on the classification and regulatory requirements applicable to a specific product. 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It provides the agency's current thinking but does not commit the FDA to that position in future regulatory actions." } }, { "@type": "Question", "name": "When should a manufacturer consider submitting a 513(g) request?", "acceptedAnswer": { "@type": "Answer", "text": "A manufacturer should consider a 513(g) request when they are uncertain about their product's classification, intended use, or the specific regulatory requirements that apply, particularly for innovative or complex devices." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Regulatory](/terms?cat=Regulatory) 6. / 7. 513(g) Request for Information [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways)[Global Markets](/ecosystems/global-markets)513(g) # 513(g) Request for Information Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition A 513(g) submission asks CDRH for FDA's opinion on the classification and regulatory requirements applicable to a specific product. Responses are non-binding but heavily relied upon by sponsors of borderline products. What the regulation says The FDA, under section 513(g) of the Federal Food, Drug, and Cosmetic Act, offers this mechanism for manufacturers to obtain non-binding information regarding the classification and regulatory requirements for a device. This request is particularly useful for novel devices or those with unclear regulatory pathways, as it provides the agency's current thinking without committing the manufacturer to a specific regulatory path. ## What this means in practice Useful for software-only products, combination products, and wellness devices where the 'is-it-a-device?' answer drives the entire regulatory plan. ## Examples - A software developer creates an application that uses AI to analyze health data and wants to know if it's considered a medical device by the FDA. - A company develops a novel combination product, integrating a drug and a device, and seeks clarification on whether the device component falls under FDA device regulations. - A manufacturer of a wellness product that offers health monitoring features wants to confirm with the FDA if their product requires premarket submission or if it's exempt from device regulations. Common pitfalls - • Misinterpreting the non-binding nature of the FDA's response, leading to inappropriate regulatory strategies. - • Failing to provide sufficient detail about the device in the 513(g) submission, resulting in an unhelpful or generic FDA response. - • Delaying critical regulatory activities waiting for a 513(g) response, which is advisory and not a prerequisite for other submissions. - • Confusing a 513(g) submission with a Pre-Submission (Q-Submission), which has a different purpose and interaction model with the FDA. - • Assuming a 513(g) response guarantees market clearance or approval; it only provides information regarding classification and requirements. ## Frequently asked questions What is the primary purpose of a 513(g) submission? The primary purpose is to receive the FDA's informal opinion on the classification and regulatory requirements applicable to a specific medical device, especially for novel or borderline products. Is the FDA's response to a 513(g) request legally binding? When should a manufacturer consider submitting a 513(g) request? ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Regulatory Intended Use The objective intent of the manufacturer regarding the use of the device. ](/terms/intended-use)[ Regulatory Request for Designation(RFD) Formal mechanism to obtain a binding FDA decision on which Center will regulate a product. ](/terms/rfd) ### More in Regulatory · Same category [ Regulatory 510(k) Premarket Notification(510(k)) FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate. ](/terms/510k)[ 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 Abbreviated 510(k) 510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards. ](/terms/abbreviated-510k)[ Regulatory Accreditation Scheme for Conformity Assessment(ASCA) FDA voluntary program in which accredited testing labs perform standards-based testing accepted with reduced FDA scrutiny. ](/terms/asca) 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 European Commission· 1 IMDRF· 1 1. [1 FDA - Medical Devices Verified FDA · fda.gov ](https://www.fda.gov/medical-devices) 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 513(g) Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=513g) Learn in 60 seconds Card Lesson Quiz Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification. - · Useful for software-only products, combination products, and wellness devices where the 'is-it-a-device?' answer drives the entire regulatory plan. - · Responses are non-binding but heavily relied upon by sponsors of borderline products. Remember this Watch out: Misinterpreting the non-binding nature of the FDA's response, leading to inappropriate regulatory strategies. Related terms - [Request for Designation(RFD) ](/terms/rfd) - [Intended Use ](/terms/intended-use) You may also need Auto-suggested from Regulatory and shared keywords. - [Q-Submission (Pre-Submission)(Q-Sub / Pre-Sub) ](/terms/q-sub) - [Device Reclassification Petition ](/terms/reclassification-petition) - [510(k) Summary vs 510(k) Statement ](/terms/510k-summary-vs-statement) - [Self-Test and Near-Patient Testing (IVDR) ](/terms/ivdr-self-test) - [Special Controls ](/terms/special-controls) - [Pre-Submission Meeting(Q-Sub) ](/terms/pre-submission) [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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