BIOM 6806 - Regulatory Affairs of Medical Devices

Credit Hours: 3

Description This course is designed to provide engineering students with an introduction to the regulations that govern the design, testing, approval and sale of medical products. This course covers the history and mission of the Food and Drug Administration (FDA). Students will learn what products are regulated by the FDA, the types of regulatory pathways available for medical products, and the scientific data needed to support a successful approval decision from FDA. Quality systems regulations, good laboratory, manufacturing, and clinical practices will be covered as well as post-market surveillance and sales and marketing efforts. Over the course of the semester, student-led presentations and guest lectures will cover current events related to FDA regulatory decisions as well as real-world application of FDA oversight within local industries.