Food and Drug Administration


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Regulatory Considerations: A patient is faced with decision making related to a cutting edge surgical device. They seek to gain additional information about the device and navigate to the FDA website. 1/ In one to two sentences – in your own words, please – no direct quotes. Who is the FDA and what role do they play in approval of devices and helping to ensure quality outcomes? 2/Identify and discuss one device quality link and provides additional information about the device. 3/Then provide a short justification for why you selected that link. Consider linking to professional association/society websites and other audio/video resources that enlighten the conversation. For instance, you might add a YouTube video that adds a multimedia illumination of this issue.

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