Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. FDA expects to receive large numbers of combination products for review as technological advances continue to merge product types and blur the historical lines of separation between FDA’s medical product centers, which are made up of the Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), and the Center for Devices and Radiological Health (CDRH). Because combination products involve components that would normally be regulated under different types of regulatory authorities, and frequently by different FDA Centers, they raise challenging regulatory, policy, and review management challenges. Differences in regulatory pathways for each component can impact the regulatory processes for all aspects of product development and management, including preclinical testing, clinical investigation, marketing applications, manufacturing and quality control, adverse event reporting, promotion and advertising, and post-approval modifications.
Many products that the U.S. Food and Drug Administration (FDA) regulates are not just drugs, devices, or biological products, but rather, are a combination of these regulated products. The FDA’s Office of Combination Products (OCP) is responsible for assigning an FDA Center to evaluate and review combination products. This assignment may mean the difference between having the product evaluated as a new drug to be submitted through the New Drug Application (NDA) process, or require a medical device 510(k) clearance. Appropriately identifying the product designation at the beginning of the submission process and filing the appropriate application can avoid significant delays and costs to a corporation that is looking to get their product into the marketplace.