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Current State of the Regulatory Trajectory for Whole Slide Imaging Devices in the USA
106
Zitationen
2
Autoren
2017
Jahr
Abstract
. This article reviews the past and emerging regulatory environment of WSI for clinical use in the USA. A WSI system with integrated subsystems is defined in the context of medical device regulations. The FDA technical performance assessment guideline is also discussed as well as parameters involved in analytical testing and clinical studies to demonstrate that WSI devices are safe and effective for clinical use.
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