For a medical product with mixed components, what is the best approach to determine the regulatory pathway?

The best approach to determine the regulatory pathway for a medical product with mixed components is to send a Request for Designation (RFD) to the Office of Combination Products (OCP) at the FDA. This is because the OCP is specifically designed to handle products that fall into multiple categories or have components that could be considered as different types of medical products—such as drugs, devices, and biological products.

Submitting an RFD allows the sponsor to clarify how the product should be regulated based on its primary mode of action (PMOA), which is crucial in determining the appropriate regulatory pathway. By seeking formal guidance from the OCP, the sponsor can ensure that the product is evaluated correctly for its intended use and characteristics, which helps in understanding the requirements for approval and bringing the product to market efficiently.

In cases where options focus on submitting specific applications like an Investigational Device Exemption (IDE) or a Premarket Approval (PMA) to the Center for Devices and Radiological Health (CDRH), they may not adequately address products that have both drug and device components or those that primarily function as biological products. Similarly, submitting an Investigational New Drug (IND) and New Drug Application (NDA) to the Center for Biologics Evaluation