ABSTRACT
This chapter addresses the regulation of combination products in the United States. The Food and Drug Administration (FDA) has three components, called "Centers," that regulate medical products for humans: the Center for Biologics Evaluation and Research; the Center for Devices and Radiological Health; and the Center for Drugs Evaluation and Research. Section 503 of the Federal Food, Drug, and Cosmetic Act (FD&C) requires that the determination as to which of these Centers will have primary responsibility for the regulation of a combination product be based upon the "primary mode of action" of the combination product. Section 563 FD&C Act provides that a request for designation may be submitted to obtain a formal, binding determination from the FDA as to the classification or Center assignment for a product. As in the premarket context, various staff from Centers other than the lead Center and from other FDA components may participate in post-market regulatory activities for combination products.
