BE-GY 9763 Regulatory Issues Surrounding Medical Devices

3 Credits

Medical devices are developed, manufactured, and distributed in a highly regulated environment. This course primarily concerns the processes for obtaining FDA marketing approval or clearance for biomedical devices. Prior to marketing a medical device in the United States, a specific governmental approval or clearance is required depending on the type of device and the risk associated with the device.

Prerequisite(s): Instructor and advisor’s approval.