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Foundations in Medical Devices: Developing Premarket U.S. Regulatory Strategies and Working in a Regulated Environment | REGL.X410

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 end of the course, students should be able to

  • Discuss FDA’s jurisdiction and the reason for food, drug, and cosmetic laws
  • Define the various regulatory pathways available for the various biopharmaceutical products
  • Understand individual roles/responsibilities in regulatory affairs
  • Understand the basic technical data elements required in biopharmaceutical product development

REGL.x410 replaced REGL.x404 Regulation of Medical Devices and Diagnostics. If you have declared candidacy using the former requirements, you will not need to take REGL.x410. If you are interested in declaring 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.
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Call (408) 861-3860