How can I appeal FDA’s designation of the primary review process for my combination product?
FDA’s Office of Combination Products (OCP) assigns the review responsibility for a combination product based on the product’s “primary mode of action.” Section 503(g)(1). You may obtain an FDA determination concerning your combination product’s primary mode of action by submitting a “Request for Designation” (RFD) to OCP. OCP will make a determination within 60 days. The RFD process is outlined in 21 C.F.R. Part 3; 21 C.F.R. § 3.7 outlines the information we require in your RFD submission. When OCP determines the primary mode of action of your product, that action will also determine how FDA will review and regulate your product. For example, when OCP determines that primary mode of action results from a drug component, that product will be reviewed and regulated as a drug by the Center for Drug Evaluation and Research. The primary review process may be subject to a user fee, either under MDUFMA or the Prescription Drug User Fee Act (PDUFA). PDUFA fees are higher than fees under MDUFMA
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