FDA Request for Designation (RFD) & Pre-RFD Submissions

The United States Food and Drug Administration (US FDA)'s Request for Designation (RFD) and pre-RFD submissions are crucial for determining the appropriate Regulatory pathway(s) for combination products. Freyr's seasoned medical device consultants help manufacturers compile the necessary information, prepare and review applications, and liaise with the US FDA, providing reliable support for navigating the complex Regulatory requirements.

FDA Request for Designation (RFD) & Pre-RFD Submissions Overview

US FDA is a highly organized Regulatory Agency with various divisions and demarcated Regulatory responsibilities. The CDER, CBER, and CDRH are the centers that oversee the regulations of Drugs, Biologics, and Medical Devices. The products which are a combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, a device, and a biological product are commonly called combination products, and they have a defined Regulatory purview for each of these divisions. However, despite having set such clear boundaries, certain borderline products still create confusion on which the center would be in charge of reviewing the application. As such, manufacturers can seek clarification by submitting an FDA Request for Designation submission (RFD submission) or opting for Pre-RFD submissions. These processes help facilitate the determination of the appropriate regulatory pathway and ensure efficient communication with the FDA's Office of Combination Products (OCP).

The sponsor can approach the FDA Office of Combination Products (OCP) to clarify on the classification of a product as a drug/device/biological or combination product and on which medicinal product center the application needs to be filed. The manufacturers may opt for any of the following two ways:
Request for Designation (RFD)- Formal/binding submission application. The RFD process is codified in 21 CFR Part 3. The FDA RFD application must not exceed 15 pages. The sponsor must provide an analysis of a product’s classification, a Primary Mode of Action (PMOA) analysis, and a recommendation regarding Agency Center assignment during the FDA Request for Designation (RFD) submission.

Pre- Request for Designation (Pre-RFD)- Simpler, informal, and non-binding process. No length requirement exists for Pre-RFD submissions. Requirements like analysis of a product’s classification, a Primary Mode of Action (PMOA) analysis, and a recommendation regarding the Agency are optional in the Pre-RFD process. The FDA will conduct a PMOA analysis even if the sponsor has provided the information.

When Should an RFD and Pre-RFD be Submitted?
Sponsors can submit the FDA Request for Designation before filing any investigational/marketing application and with all the sufficient information available for the FDA to decide on the classification or assignment. A Pre-RFD may be submitted at any point during medical product development.
Timeline for OCP’s Decision on the Submitted RFD and Pre-RFD
The timeline for OCP’s decision on the submitted RFD and Pre-RFD is Sixty (60) calendar days.
Information to be included in the RFD and Pre-RFD Application
Information to be included in the RFD and Pre-RFD is as follows:

Information	Request for Designation	Pre- Request for Designation
Product Details	Yes	Yes
Proposed Use/Indication of Use	Yes	Yes
Manufacturing Details	Yes	Optional
Supportive Data/Studies	Yes	Optional
Description of How a Product Achieves its Intended Therapeutic/Diagnostic Effects	Yes	Yes
Analysis of Classification, Primary Mode of Action (PMOA), if it is a Combination Product and Jurisdictional Assignment.	Yes	Optional
Description of Related Products	Yes	Optional
Sponsor Recommendation	Yes	Optional
Page Limit	Yes	No

*US FDA guidance

With expertise in handling RFD and Pre-RFD submissions, Freyr can identify and compile the information and assist in preparing and reviewing the application.