One question that product sponsors often ask the U.S. Food and Drug Administration (FDA) is whether their medical product will be regulated as a drug, a device, a biologic, or as a combination product—and in the case of the latter, which FDA component will regulate it.

One way sponsors may determine how their product will be classified is to submit a Request for Designation (RFD) to the Office of Combination Products (OCP). This request requires the FDA to provide a written determination of product classification and/or which agency component will regulate the product if it’s a combination product. Sponsors have also been able to obtain less formal feedback regarding product classification through communications with the OCP.

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