NHLBI: Conquering the (Regulatory) Basics - Medical Device Classification

In this Hangout, we will discuss the basic concepts of medical device regulation in the U.S., what is considered significant risk versus non-significant risk, and how the level of risk factors into the regulation of new product development.


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  • Mike M.

    A nice introduction and overview to guidelines, definitions and principles that can serve as a foundation for further self-study. Thanks for providing these. As a person who wants to take the RAC Exam, I thought the information provided was on the same level as other introductions to Medical Devices. The key word--"basics"--is right in the title. It's a good starting point.

    September 10

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