FDA’s Regulation of Combination Products: The Road Ahead

The Food and Drug Administration (FDA) applies different regulatory requirements to products depending upon whether they are medical devices, drugs or biologics. The agency has established different centers to handle these different types of products: for drugs, the Center for Drug Evaluation

and Research (CDER); for devices, the Center for Devices and Radiological Health; for biologics, the Center for Biologics Evaluation and Research (CBER). Some products, however, combine products across jurisdictional lines, and these “combination products” have always posed a regulatory challenge

for FDA.