This course will present the principles and fundamentals of medical device and in vitro diagnostic regulation. The course will cover the history of the FDA and the regulations around food, drug and cosmetic products. An overview of regulatory pathways, clinical trials, good manufacturing practices and quality system design will be covered. Comparisons between US, EU and other international regulatory bodies will also be discussed. The course will culminate with students developing a clinical trial and regulatory strategy for a new hypothetical medical device.