Master U.S. FDA device basics, regulatory strategy, and compliance from home
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).
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.
This class is offered in an online synchronous format. Students are expected to log into this course via Canvas at the start time of scheduled meetings and participate via Zoom, for the duration of each scheduled class meeting.
To see all meeting dates, click "Full Schedule" below.
You will be granted access in Canvas to your course site and course materials approximately 24 hours prior to the published start date of the course.
Recommended Text:
Fundamentals of Medical Device Regulations, 5th Ed., RAPS. ISBN: 978-1-947493-80-3
Note: REGL.X410 replaced REGL.X404 Regulation of Medical Devices and Diagnostics. If you have established candidacy using the former requirements, you will not need to take REGL.X410. If you are interested in establishing candidacy 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.
