Clinical Trials and MedTech - Straight Talk with Susan: Key Issues in Medical Technology Regulation

The question is often asked: “Why don’t all new medical devices require clinical trials the same way for a new drug?” The simple answer is that they are not needed to determine the safety and effectiveness for the vast majority of devices.
Clinical trials are required for high-risk devices and those that are “really novel,” Dr. Susan Alpert explains, “where we don’t understand the safety or the benefits.”
But, as Alpert cautions, “No clinical trial should be done unless there’s something specific that needs to be known. You don’t enroll patients into research unless there’s a question that must be answered by clinical trial.”
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