Fundamentals of US FDA Medical Device Submission Process

Name: Fundamentals of US FDA Medical Device Submission Process
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This free online course takes you to the path of medical device marketing in compliance with the US FDA regulations.

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Learning Outcomes

In this free course, you will learn how to:

Explain the global framework concerned with the regulations of medical devices
Describe the major steps required to market a medical device
Define the term "value proposition" in the context of medical device marketing
State the premarket requirements needed to be fulfilled before placing a medical device into the US market
Recognize the main similarities and differences between ISO 13485 and 21 CFR Part 820
Outline the necessary resources for manufacturers regarding premarket submission
Discuss the processions for a medical device manufacturer after submitting their medical device to the FDA
Identify the essential regulatory and product testing components in the US medical device marketing context
Indicate the different marketing pathways the FDA sets to help medical device manufacturers market their medical devices
Distinguish the medical devices according to the risks they pose to the FDA

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