RFD and Pre-RFD Submission for Medical Devices

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. The FDA’s Office of Combination Products (OCP) aids the manufacturers in identifying the applicable center and addresses any queries related to the product.

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 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 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 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:

*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.