Updates to CDRH Customer Service

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Battery CtQ Pilot Report

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PMA Final Decisions for August 2015

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Added Presentations to Public Workshop – Non

The Food and Drug Administration (FDA) announced a Public Workshop entitled “Non-Microbial Biomarkers of Infection for In Vitro Diagnostic Device Use.” The purpose of this workshop was to receive input from stakeholders and discuss approaches to establish the performance of non-microbial biomarker assays for differentiating viral from bacterial infections and for diagnosis and assessment of sepsis….