Significant risk studies of medical devices require an investigational device exemption (IDE), which allows the device to be used in a clinical study to collect data on its safety and effectiveness.1 Often, device developers wonder whether—and how—the cost of those...
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An investigational device exemption (IDE) allows an investigational device to be used in a clinical study to collect data on its safety and effectiveness.1 This exemption applies to the conduct of trials necessary for developing new medical devices. Most often,...