Is the FDA's response to a 513(g) request legally binding?

No, the FDA's response is non-binding. It provides the agency's current thinking but does not commit the FDA to that position in future regulatory actions.

When should a manufacturer consider submitting a 513(g) request?

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.

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RegulatoryRegulated Pathways Global Markets513(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 CyberLast reviewed September 19, 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. Anyone can make the request in writing under section 513(g) of the FD&C Act, and FDA aims to respond within 60 days. The answer does not clear the device, but it often settles whether a product is a device, which product code applies and whether a 510(k), De Novo or PMA is likely. A user fee applies.

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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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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Tier 2Regulator guidance and consensus· 3

Link health: 3 verified· last checked 2026-06-20

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Category: Regulatory
Acronym: 513(g)
Sources: 3
Updated: 9/19/2026

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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.
·Anyone can make the request in writing under section 513(g) of the FD&C Act, and FDA aims to respond within 60 days.

Remember this

Watch out: Misinterpreting the non-binding nature of the FDA's response, leading to inappropriate regulatory strategies.

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