Medical devices are different from drugs and biologics in their regulation and paths to market. Effective clinical trials design and management for devices requires a solid understanding of these issues. This course defines medical devices and explains routes to market, regulatory pathways, successful investigational device exemption (IDE) and PMA submissions to the FDA. You'll also learn how to get devices effectively to market, manage and report adverse device events (MDRs) and other post-market FDA surveillance tools and get a glimpse into the future of device regulations.
- The FDA’s role in the American medical device industry
- Risk-based classification of devices
- Regulatory pathways for medical devices
- Uses of clinical data and clinical studies including the IDE program
- 522s, medical device reports (MDRs), and recalls
Note(s): Students pursuing the Clinical Trials Certificate who are also interested in the Regulatory Affairs Certificate may take "Regulation of Medical Devices and Diagnostics" to fulfill the "Medical Devices: Regulatory Strategies and Marketing Pathways" requirement in the Clinical Trials Program. You can use the extra 1.5 units towards meeting the elective requirement for the Clinical Trials Design and Management Certificate program.
Professional Credit: CA BRN/LVN Credit - Provider #CEP13114.