Bringing a new medical device to market is a complex process that is quite different from that required for new drugs. In the United States it is the rule, rather than the exception, for a medical device not to have been studied in patients prior to its being marketed. It is also possible for a device, such as a urinary catheter, to be studied without the Food and Drug Administration being aware of the study. Thus, it is not surprising that device-related complications, particularly infections, may occur for many different reasons. The following discussion highlights some of the most important issues related to new medical devices.
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