When should an RFD be submitted?

An RFD should ideally be submitted early in the product development lifecycle, especially for novel or complex products, to establish a clear regulatory pathway and avoid potential issues later on.

What information is typically included in an RFD submission?

An RFD submission typically includes a detailed description of the product, its intended use, the proposed primary mode of action, and supporting scientific rationale for the requested classification.

What is the outcome of an RFD submission?

The outcome of an RFD submission is a designation letter from the FDA's Office of Combination Products, which formally classifies the product and identifies the lead FDA Center.

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RegulatoryRegulated Pathways Global MarketsRFD

Request for Designation

Formal mechanism to obtain a binding FDA decision on which Center will regulate a product.

Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed September 19, 2026

Definition

An RFD is submitted to the Office of Combination Products to determine the classification of a product (drug, device, biologic, or combination) and assign the lead FDA Center based on primary mode of action. Sponsors file one when a product's classification or lead center is unclear or disputed. FDA must issue a designation letter within 60 days, or the sponsor's own recommendation becomes the designation. A less formal Pre-RFD gives preliminary, non-binding feedback, and the process is set out in 21 CFR Part 3.

What the regulation says

The FDA, under 21 CFR Part 3, outlines the process for submitting a Request for Designation (RFD) to the Office of Combination Products (OCP). This submission helps determine the regulatory classification of a medical product, such as a drug, device, biologic, or combination product, and designates the lead FDA Center for its review based on its primary mode of action. The OCP then issues a designation letter that clarifies the regulatory pathway and applicable requirements.

What this means in practice

Often used early in development for novel combination products to remove ambiguity about the regulatory pathway and applicable cGMP requirements.

Examples

A company developing a drug-eluting stent submits an RFD to confirm it will be regulated as a device with a drug component, with CDRH as the lead center.
A manufacturer of a diagnostic test that also delivers a therapeutic agent files an RFD to determine if it is considered a combination product and which FDA centers will be involved.
A startup with a novel biologic delivered via a specialized injector submits an RFD to ensure proper classification and to identify the correct regulatory pathway under CDER or CBER.

Common pitfalls

•A common pitfall is submitting an RFD too late in the development process, which can lead to costly delays if the product is misclassified.
•Failing to provide a clear and well-supported primary mode of action in the RFD can result in an unfavorable or delayed designation.
•Assuming an RFD is only for novel combination products is a mistake, as it can also be beneficial for products with unclear classifications.
•Not thoroughly understanding the distinctions between drug, device, and biologic classifications can lead to an inaccurate RFD submission.

Frequently asked questions

The primary purpose of an RFD is to obtain a formal FDA determination of a medical product's regulatory classification and the assignment of the lead FDA Center responsible for its premarket review and regulation.

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Combination Product

Product comprised of two or more regulated components - e.g., drug-device, biologic-device.

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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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513(g) Request for Information(513(g))

Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification.

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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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Category: Regulatory
Acronym: RFD
Sources: 3
Updated: 9/19/2026

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Formal mechanism to obtain a binding FDA decision on which Center will regulate a product.

·Often used early in development for novel combination products to remove ambiguity about the regulatory pathway and applicable cGMP requirements.
·Sponsors file one when a product's classification or lead center is unclear or disputed.
·FDA must issue a designation letter within 60 days, or the sponsor's own recommendation becomes the designation.

Remember this

Watch out: A common pitfall is submitting an RFD too late in the development process, which can lead to costly delays if the product is misclassified.

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Combination Product

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