We will discuss the situation of the "sponsor/investigator," where a person doing research is sponsoring the research as well. This might be a physician who has designed a new instrument to be used in his practice, or an inventor doing a preliminary evaluation of his invention using human subjects. The situation in which a physician uses a legally-marketed device for a purpose other than that which it is intended will also be considered. The concept of "non significant risk鈥� is important in this context.
The Investigational Device Exemption: When is it Needed and How is it Obtained Most Easily - Webinar By GlobalCompliancePanel
28 September 2011, de, United States
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online training webinar
online training webinar, 1000 N West Street, Wilmington, Suite 1200, de, 19801, United States
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global compliance panel
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