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Obtaining an FDA Investigational Device Exemption - Webinar By GlobalCompliancePanel

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Overview: Clinical testing and studies of effectiveness are often needed to demonstrate that new medical devices are reasonably safe and effective. The participation of human subjects in these studies often implies some degree of risk and outcomes which are necessarily unpredictable. It is essential, therefore, that the rights, safety, and welfare of the subjects be protected. The instrument by which this is accomplished is the Investigational Device Exemption (IDE). We will discuss here the conditions under which this protection is necessary, the means by which the IDE rules can be met while considering the degree of risk involved, and the means by which an approved IDE can be obtained. Interpretation of the IDE rules requires a precise knowledge of the terminology used, such as "medical device," "intended use," "Institutional Review Board (IRB)," "sponsor," "investigator," and "informed consent." We will define these terms and explain how subtleties of the definitions affect the interpretation of the rules.

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