What is the recommended regulatory pathway for a medical device company developing a product with drug, biologic, and device components?

The recommended regulatory pathway for a medical device company developing a product with drug, biologic, and device components involves sending a Request for Designation (RFD) to the Office of Combination Products. This is correct because the Office of Combination Products is specifically designed to handle products that contain multiple components from different regulatory categories, including drugs, devices, and biologics.

When a product consists of components that fall under different regulatory jurisdictions, the Office can provide guidance on how the product should be classified and regulated, determining which FDA center will have primary jurisdiction. This ensures that the company is addressing all regulatory requirements appropriately for each component of the product. The RFD process helps in clarifying the necessary regulatory submissions and streamlining the development process.

The other options represent different regulatory pathways but do not specifically address the complexities involved with a combination product. For example, submitting an Investigational Device Exemption (IDE) and Pre-market Approval (PMA) to the Center for Devices and Radiological Health (CDRH) would not be suitable for addressing drug or biologic components, while submitting an Investigational New Drug (IND) and New Drug Application (NDA) to the Center for Biologics Evaluation and Research (CBER) ignores the device aspect. Sub