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BMS 549 Regulation of Medical Devices

Prerequisites: BMS 545 and BMS 547. (Second semester/3 credits) 

This course offers an overview of the historical development as well as the current status of the laws, regulations and guidelines governing medical devices. The course focuses on key aspects of gaining regulatory approval for all classes of medical devices using various submission processes including the 510(k) Premarket Notification, the Premarket Approval Application and the Product Development Protocol.