Firms Must Be Proactive About Live-Case Demo Plans For IDE Devices – FDA Draft Guidance

This article was originally published in The Gray Sheet

17 Apr 2014
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Executive Summary

FDA has released a draft guidance on the information that a device manufacturer should submit in an investigational device exemption application or supplement if it wants the device to be part of a live case demonstration.

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Firms Must Be Proactive About Live-Case Demo Plans For IDE Devices – FDA Draft Guidance

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