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Test Makers Have One Year To Comply With New ASR Guidelines

This article was originally published in The Gray Sheet

Executive Summary

Diagnostic test makers will have until September 2008 to comply with newly clarified FDA policies for analyte specific reagents

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FDA expects to send out multiple warning letters to firms for illegally selling diagnostic products as 510(k)-exempt analyte specific reagents instead of as test kits, which are more heavily regulated

FDA Diagnostics Chief Predicts Multiple Warning Letters For ASR Violations

FDA expects to send out multiple warning letters to firms for illegally selling diagnostic products as 510(k)-exempt analyte specific reagents instead of as test kits, which are more heavily regulated

Contracting Out Gives Laboratories An In With Diagnostics Manufacturers

Manufacturers and laboratories have until September to begin complying with FDA's analyte specific reagent policy, clarified in 2007 guidelines. But some labs, particularly those specializing in molecular diagnostics, are scrambling to fill what could be a gap in needed supplies

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