UCSC Extension, Regulation of Medical Devices and Diagnostics, Jan. 19 – April 13, 2010
Course Description
Medical devices encompass a broad array of products, ranging from the simple tongue depressor to surgically implanted stents and pacemakers. This course provides individuals from all backgrounds with a solid grounding in the laws, regulations and institutions that underlie the process of medical device and diagnostic product development and marketing.
Starting with the definition of medical devices, an overview of the medical device industry, and the historical roots of medical device regulation, the instructor lays a foundation for understanding the unique aspects of medical devices and the pathways through which various classes of products are moved into the U.S. marketplace.
Through lectures and case studies, students gain in-depth exposure to key routes to market, including 510(k) premarket notification and premarket approval applications (PMA). The instructor provides insight into the rationale and strategies for using each of these paths and others, including product development protocol (PDP) and reclassification. Also addressed are the pre-clinical and clinical testing of devices, as well as the investigational device exemption (IDE) application and process. There will be some coverage of international laws and regulations, particularly as they relate to the U.S. counterparts.
The instructor also details post-marketing issues, including recalls, corrections and removals, as well as medical device surveillance and reporting requirements. Finally, he highlights topics of current interest in the industry, including combination products.
Instructor: R. MICHAEL CROMPTON, J.D., M.P.H.
Dates and Times: Tue 6:00PM to 9:00PM
Jan 19, 2010 to Apr 13, 2010
Number of Sessions: 10
Tuition: $715 (Early Enrollment $643.50
See details at www.ucsc-extension.edu/biosciences
