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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 CyberLast 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
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.
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510(k) Premarket Notification(510(k))
FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.
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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.
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Abbreviated 510(k)
510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards.
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Accreditation Scheme for Conformity Assessment(ASCA)
FDA voluntary program in which accredited testing labs perform standards-based testing accepted with reduced FDA scrutiny.
Primary references
3 sourcesLink health: 3 verified· last checked 2026-06-20
FDA·1European Commission·1IMDRF·1
- 1
FDA - Medical DevicesVerifiedFDAfda.gov
- 2
European Commission - Medical DevicesVerifiedEuropean Commissionhealth.ec.europa.eu
- 3
IMDRF DocumentsVerifiedIMDRFimdrf.org
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