New to the industry? Or maybe you need a basic understanding of the U.S. FD&C Act and U.S. FDA regulations? Maybe you have a medical device that you’d like to commercialize in the U.S.? Maybe you just want some practical regulatory advice for working in the industry or how to do remote work? This online synchronous-lecture course will give you the medical device industry basics all from the comfort of your home. The course will answer your questions such as: how to work in a regulated environment, what are the roles available to you, and what are the differences between regulatory affairs, quality assurance, quality control, compliance, and quality engineering. This course will also help you create or be a part of producing a regulatory strategy for your medical device, IVD, stand-alone software, or combination product. Live discussions, class group games, etc. will be used to help you in navigating through the US FDA regulations including California’s FDB requirements. You’ll learn about the various US FDA device classifications, including the various regulatory pathways 510(k), De Novo, PMA, and HDE. You’ll also learn about the different programs such as Q-submissions, Investigational Device Exemptions (IDE), Breakthrough Designation, Pilot Programs, and more. Including the medical device program enacted by FDA during emergency situations such as the COVID-19 pandemic: Emergency Use Authorization (EUA).

Learning Outcomes

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

• Discuss FDA’s jurisdiction and the reason for food, drug, and cosmetic laws
• Define the various regulatory pathways available for medical devices, including requirements for combination products, IVDs, and stand-alone software
• Understand individual roles/responsibilities and how the medical device industry works in general

Topics Include

• Regulatory Writing
• Federal vs State level requirements: FD&C Act, FDA’s CDRH, and California’s FDB
• US Product Classifications I, II, III and Regulatory Pathways 510(k), De Novo, PMA, HDE
• Submission Considerations: Breakthrough Designation, Emergency Use Authorization, Sterility, Biocompatibility, Labeling, Pilot Programs, etc.

Additional Information

REGL.x410 replaced REGL.X404 Regulation of Medical Devices and Diagnostics. If you have enrolled into the program using the former requirements, you will not need to take REGL.X410. If you are interested in establishing candidacy & enrolling into the program using the new requirements, please contact student services. Student services will guide you on the steps needed to request REGL.X404 earned credits to count towards the updated program requirements.

The student is responsible for ensuring pertinent emails and Canvas notifications do not go to spam as well as completing all assignments by the due date. There are no late submissions accepted.

The modules in Canvas are set up as the roadmap for each class lecture week.