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CLIA Guidance Draws Industry Criticism On User Comparability Studies

This article was originally published in The Gray Sheet

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Executive Summary

Manufacturers seeking waived status for diagnostic tests should be able to choose a statistically appropriate sample for user comparability tests, according to comments submitted by industry on FDA's March 1 draft guidance on criteria for CLIA waiver applications.
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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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