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This course provides a comprehensive overview of medical device and combination product (drug-device, drug-biologic) regulation. The primary focus will be how medical devices and combination products are regulated by the U.S. Food and Drug Administration (FDA). Topics that will be covered include: (1) FDA's organizational structure, responsibilities, and resources for medical device and combination product regulation; (2) an overview of the laws, regulations, and regulatory processes that govern medical devices and combination products; (3) regulatory and administrative requirements for medical devices throughout the full product life-cycle, including premarket review, postmarket requirements, and enforcement programs.

College/Department: COM School of Biomedical Sciences Professional Studies
Repeat Status: Not repeatable for credit