Regulatory Affairs for Medical Devices

Catalog description

GR This course will introduce students to the history and mission of the Food and Drug Administration (FDA) and role in medical device design, testing, approval and sales. Students will learn core concepts for how products are regulated by the FDA, and the types of regulatory pathways and processes that are used for obtaining FDA marketing approval or clearance for biomedical products/devices. Topics related to quality systems regulations, good laboratory, manufacturing and clinical practices, post-market surveillance and sales and marketing will be included. Students led presentations and guest lectures will occur throughout the semester to cover current topics and events related to real-world application of FDA medical device regulations and decisions. Students will work in small teams on a semester long project to develop a mock device submission to simulate real-world applications of US FDA regulatory policies. Independent readings will come from handouts, assigned web-resources and selected chapters from optional textbooks