ABSTRACT
Medical devices are an important part of health care. Yet they are an extraordinarily heterogeneous category of products. The term “medical device” includes such technologically simple articles as ice bags and tongue depressors on one end of the continuum and very sophisticated articles such as pacemakers and surgical lasers on the other end. Perhaps it is this diversity of products coupled with the sheer number of different devices that makes the development of an effective and efficient regulatory scheme a unique challenge for domestic and international regulatory bodies.
