FDA medical device regulation and informed consent.

New medical devices are subject to a regulatory scheme designed to ensure safety and effectiveness that is administered by the United States Food and Drug Administration (FDA). Gaining approval to market a device for a specific clinical indication may be time-consuming and costly, particularly for one that poses a potentially unreasonable risk of patient injury and represents genuinely new medical technology. The difficulty of gaining FDA approval has led to the use of devices for indications other than those approved by the FDA and to the clinical use of products that lack any formal FDA appr1oval. Such nonFDA approved uses raise the question of what patients subjected to these products should be told as part of the informed consent process.