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40:(FDA). Clinical studies are most often conducted to support a PMA. Only a small percentage of 510(k)'s require clinical data to support the application. Investigational use also includes clinical evaluation of certain modifications or new intended uses of legally marketed devices. All clinical evaluations of investigational devices, unless exempt, must have an approved IDE before the study is initiated.
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believe that the risks to human subjects from the proposed investigation are outweighed by the anticipated benefits to subjects and the importance of the knowledge to be gained, that the investigation is scientifically sound, and that there is reason to believe that the device as proposed for use will be effective.
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A commercial sponsor of a significant risk device study must submit a complete IDE application to FDA. There are no preprinted forms for an IDE application; however, an IDE application must include certain required information. The sponsor must demonstrate in the application that there is reason to
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that would apply to devices in commercial distribution. Sponsors need not submit a PMA or premarket notification, register their establishment, or list the device while the device is under investigation. Sponsors of IDEs are also exempt from the
Quality System (QS) Regulation except for the
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An approved IDE permits a device to be shipped lawfully for the purpose of conducting investigations of the device without complying with other requirements of the
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55:(IRB). If the study involves a significant risk device, the IDE must also be approved by FDA
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Clinical evaluation of devices that have not been cleared for
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