FDA Guidances

Draft Guidance for Preparing a Pre-Request for Designation

On February 15, FDA issued a draft guidance on How to Prepare a Pre-Request for Designation (Pre-RFD). This guidance is intended to assist sponsors in obtaining a preliminary assessment from the FDA through the Pre-RFD process. Specifically, this guidance explains the Pre-RFD process at the Office of Combination Products (OCP) and helps a sponsor understand the type of information to provide in a Pre-RFD. The Pre-RFD process is available to provide informal, non-binding feedback regarding the regulatory identity or classification of a human medical product as a drug, device, biological product, or combination product. In addition, this informal process provides information about a non-combination or combination product’s assignment to the appropriate Agency such as CDER, CDRH, or CBER for premarket review and regulation.

Sponsors often seek OCP feedback on whether their medical product will be regulated as a drug, a device, a biologic, or a combination product, and which FDA medical product Center (CDER, CBER, or CDRH) will regulate it, if it is a non-combination product, or will have the primary jurisdiction for the premarket review and regulation of the product, if it is a combination product. There are two ways that a sponsor can receive such a feedback from OCP. One option is to submit an RFD to receive a formal, binding determination for the sponsor’s product with respect to classification and/or center assignment that may be changed under conditions specified in section 563 of the FD&C Act and 21 CFR 3.9 in the regulations. The RFD process is codified in 21 CFR Part 3, and OCP has issued a guidance about this process.

A second more flexible option is for a sponsor to submit an inquiry to OCP to receive a preliminary jurisdictional assessment, which is not binding. Many sponsors seek to utilize more flexible approachable ways to interact with OCP and the medical product Centers to obtain feedback from the Agency before submitting a marketing application to the Agency. Over time, these informal methods of obtaining feedback have become increasingly customary with sponsors, and for some, even preferable to the formal RFD process. Accordingly, FDA is enhancing the transparency and consistency of the process, which will now be called the Pre-RFD Program,” available through OCP. This guidance describes this structured process with clear recommendations for sponsors wishing to submit Pre-RFDs. It also provides the process for review of Pre-RFDs by FDA staff, the general timeframes for sponsors to receive feedback from OCP, and the process for scheduling teleconferences and meetings in relation to a Pre-RFD.

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