The instructor first defines medical devices, provides an overview of the medical device industry and the historical roots of medical device regulation. You'll learn the unique aspects of medical devices and the pathways through which various classes of product are moved into the U.S. marketplace with a brief comparison to OUS approval processes.
Through lectures and case studies, you'll 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. You’ll also learn the pre-clinical and clinical testing of devices, the investigational device exemption (IDE) application and process, and international laws and regulations 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. The course also highlights current industry issues such as stand-alone software, IVDs, combination products, distribution of off-label information, physician payments, and more.
Note(s): Individuals who have taken "Introduction to Medical Device Regulation” or "Medical Devices: Regulatory Strategies and Marketing Pathways" at UCSC Extension within the past three years can use it to partially satisfy the requirement for "Regulation of Medical Devices and Diagnostics" in the Regulatory Affairs Certificate Program. Rather than taking the complete "Regulation of Medical Devices and Diagnostics" course, these students can enroll in "Medical Device and Diagnostics Bridge. Please contact email@example.com for enrollment information.
Individuals who are pursuing the Medical Devices Certificate Program who have already completed the "Introduction to Medical Device Regulation,” do not need to retake the "Regulation of Medical Devices and Diagnostics" course.