ABSTRACT
The medical device industry in the United States and worldwide is immense in its economic impact (sales in 2006 were $220 billion worldwide and $114 billion in the United States, $60 billion in the European Community and $32 billion in Japan), scope (between 92,000 and 145,000 different devices are produced in the U.S. by ~12,000 different manufacturers employing some 370,000 people; it is believed that ~2,100 of these manufacturers are development stage companies without products yet on the market) and importance to the health of the world’s citizens (The Wilkerson Group, 2006). The assessment of the safety to patients using the multitude of items produced by this industry is dependent on schemes and methods which are largely particular to these kinds of products, not as rigorous as those employed for foods, drugs, and pesticides, and which are in a state of flux. Regulation of such devices is, in fact, relatively new. It is only with the Medical Device Amendments (to the Food, Drug and Cosmetic Act) of 1976 that devices have come to be explicitly regulated at all. And with the Safe Medical Devices Act of 1990, the Medical Device Amendments of 1992 and subsequent laws that the regulation of devices for biocompatibility became rigorous.
