ABSTRACT
In the United States, combination products comprise two or more different types of medical products, either a biological product (or biologic) and device, biologic and drug, device and drug, or all three combined.1 These different types of medical products are regulated under distinct regulatory programs by different components of the US Food and Drug Administration (FDA). As a consequence, combination products raise particular regulatory questions and challenges, for example, with regard to regulatory standards and procedures, as well as coordination within the Agency and between the Agency and sponsors.
