Which organization would a company consult to verify the primary mode of action for a product with drug and device components?

The Office of Combination Products (OCP) is the appropriate organization for a company to consult when verifying the primary mode of action for a product that includes both drug and device components. This office within the FDA is specifically dedicated to products that fall into multiple categories, offering guidance in determining which regulatory pathway is most suitable. Its role is pivotal when addressing complex products that have attributes of both drugs and devices, ensuring that proper regulatory requirements are met.

When products encompass both drug and device components, identifying the primary mode of action is crucial, as it informs the regulatory approach and may dictate whether the product is regulated primarily as a drug or a device. The OCP assists companies by clarifying these regulatory distinctions, which is essential for compliance with relevant regulations.

Other organizations listed, while critical in their respective domains, focus on separate product types. The Center for Devices and Radiological Health (CDRH) primarily manages device-related products, the Center for Biologics Evaluation and Research (CBER) is focused on biological products, and the Center for Drug Evaluation and Research (CDER) oversees drug-related products. None of these centers specializes in the unique intersection of drugs and devices, making the OCP the best choice for consulting on the primary mode of action of