Introduction to Food and Drug Administration (FDA) Medical Device Regulation

Catalog description

Offers an overview of the medical device engineering, development, and commercialization process and its regulation by the U.S. Food and Drug Administration (FDA). Through course work and didactic technical instruction, offers students an opportunity to develop an understanding of fundamental medical device regulatory affairs from a U.S.-centric perspective. Reviews the historical development of significant U.S. medical device legislation, including the Medical Device Amendments of 1976. Introduces the subject of quality system regulation (QSR) as it relates to device product design, clinical development, operations management, and compliance.