ABSTRACT
This chapter represents the views of the authors in their personal capacities. It addresses the regulation of combination products in the United States. In the United States, the term “combination product” is a product comprising any combination of a drug and a device; a device and a biological product; a biological product and a drug; or a drug, a device, and a biological product. A principal consideration for combination products is to ensure that product development and testing addresses all relevant considerations relating to each constituent part and their interactions. Strong, clear business arrangements between regulated entities can be important to obtaining marketing authorization. The US Food and Drug Administration works with foreign counterpart agencies on regulatory issues relating to combination products and has expressed interest in working with foreign counterparts to promote convergence and coordination of activities with respect to combination products.
