Course Description

410.721 - In Vitro Diagnostic Regulation

This course provides a comprehensive overview of in vitro diagnostic (IVD) devices and how they are regulated by the U.S. Food and Drug Administration (FDA) and internationally, including the European Union (E.U.). Topics that will be covered include: (1) a summary of the U.S. and international laws, regulations, and policies that govern IVD devices, (2) administrative and legal requirements and resources for IVD devices throughout the full product life-cycle, (3) types of IVD devices, (4) coverage and reimbursement of laboratory tests, and (5) current issues and developments. Upon completion of this course, the student will have a working knowledge of the requirements and policies of the regulation of IVD devices.