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.

Learning Outcomes

At the conclusion of the course, you should be able to

• Discuss the U.S. medical device industry and how FDA gained authority to regulate it.
• Discuss FDA's jurisdiction in the design, testing, marketing and post-marketing of medical devices.
• Explain the risk-based method for classification of devices and understand how to create strategies to gain access to the US market.
• Define substantial equivalence, and how it is employed in evaluating medical devices.
• Understand how medical devices gain access to the market.
• Discuss when and how clinical data is needed to support a medical device marketing applications and basic clinical requirements.
• Discuss the effects of OUS regulation of medical devices and its effect on the US device industry.
• Use the FDA website and other internet-based tools to assist in the development of regulatory strategies.

Topics Include

• 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

Necessary Knowledge

• To be successful in this class all students should have working knowledge of Google Workspace or Microsoft Office, proper email etiquette, and an essential understanding of Canvas.

Additional Information

This course will provide students with a general understanding of medical devices and diagnostics. Topics will include a review of FDA and the medical device regulatory framework, agency law, the device classification system, routes to market, pre-market submissions, and post-market requirements and interaction with FDA. The course will also touch on the requirements for human studies of medical devices.

The course will be interactive, with student participation required, and will consist of lectures and case studies/examples, with two exams and a brief paper with references that the student will then present to class on a relevant topic of the student’s choice (approved in advance by the instructor).

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.