FDA Regulation of Medical Devices. 3 credits, 3 contact hours

Catalog description

Prerequisites: BME 301 . Restrictions: none. The course will teach the FDA regulatory process including design documentation and quality management system to attain FDA approval for medical devices. Statistical tests for the development of human randomized clinical trials and non-clinical bench testing of medical devices will be taught with safety standards for medical devices. A project will be assigned to teach students how to apply for FDA approval for a student-selected medical device.