RGA 6610 — Introduction to Food and Drug Administration Medical Device Regulation
3 semester hoursGraduateLecture
Presents an overview of the medical device engineering, development, and commercialization process and its regulation by the U.S. Food and Drug Administration. Studies 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 quality management system regulation as it relates to medical device development in the United States.