ABSTRACT
The last three decades have seen a vast increase in the number of new therapeutic products that 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 such as insulin pumps) and drug-impregnated devices (in which drug delivery is an adjunct to the device function such as drug-eluting cardiovascular stents). Congress rst acknowledged the need for specic regulation of such combination products in the 1990 Safe Medical Device Act.
