Strategies for reducing regulatory barriers to focused ultrasound technology
نویسنده
چکیده
Background/introduction The U.S. Food and Drug Administration (FDA) has automatically classified focused ultrasound (FUS) devices Class III, which requires sponsors to demonstrate the safety and effectiveness of a device through clinical trials. This requirement adds significant time and cost to the device development process; reclassification to Class II would be highly beneficial for the future of FUS.
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عنوان ژورنال:
دوره 3 شماره
صفحات -
تاریخ انتشار 2015