RGAF 6000 - Introduction to Regulatory Affairs

Credits: (3)
Typically Taught Fall Semester: 1st Block Online
Description: This course is designed to present an introduction to the regulations, documents and processes necessary for FDA approval of new medical products. The course covers an overview of critical scientific, technical, engineering design, manufacturing, and operational drivers for national and global regulatory compliance. This course also discusses the historical context in which the FDA evolved, its structure and relationship with other US regulatory agencies. The course will provide an overview of market clearance pathways for various medical products and devices that ensure the development and delivery of safe and effective healthcare products to consumers.