FDA: Updated Pre-RFD Guidance for Combination Products
The U.S. FDA has released an updated final guidance on preparing a Pre-Request for Designation (Pre-RFD), replacing the previous 2018 version. The revised document provides new recommendations for interacting with the Office of Combination Products (OCP) and clarifies expectations for Pre-RFD submissions.
The Pre-RFD process is an informal pathway that allows sponsors to
obtain preliminary feedback on whether a medical product will be
regulated as a combination (drug and device) or non-combination product,
and which FDA Center will have primary oversight.
According to the FDA, the update aims to enhance transparency, consistency, and efficiency of the Pre-RFD program by clarifying required submission content and refining the overall process.
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