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Medical Device Regulation Regulation

Firms Must Be Proactive About Live-Case Demo Plans For IDE Devices – FDA Draft Guidance

This article was originally published in The Gray Sheet

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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FDA has released a draft guidance on the information that a device manufacturer should submit in an investigational device exemption application or supplement if it wants the device to be part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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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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