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Medical Devices

The Approval Process for New Medical Devices

About the Course

This course gives an overall view of the development regulatory process for legally marketing a new medical device in the U.S. The mission of FDA is the protection of public health and safety. Medical devices are under FDA regulation, and these regulations are in place to ensure that only medical devices that are safe and effective can be marketed. The development process that a new medical device has to follow must also be designed to ensure this end. After completing this eLearning course, you will be able to list the major steps in new device development and the required regulatory process for the U.S. market. This online course will also teach you how to define a 510(k), an IDE, and a PMA. You will also be able to identify the purpose and requirements of clinical studies. In addition, this training program will teach you to recognize key information about the classification of medical devices and the role of FDA in the approval of medical devices for the marketplace.