ABSTRACT
Recent years have seen a vast increase in the number of new therapeutic products which are not purely drug, device, or biologic, but rather a combination of two or more of these. Classical examples are implanted drug delivery systems (whose primary function is drug delivery) and drug impregnated devices (in which drug delivery is an adjunct to the device function). Congress first acknowledged the need for specific regulation of such combination products in the 1990 Safe Medical Device Act.
