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Clinical Performance Studies For Ivd
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MLN006270 – CLIA Program & Medicare Lab Services
www.cms.govThe Clinical Laboratory Improvement Amendments (CLIA) Program regulates labs testing human ... Monitors lab Proficiency Testing (PT) performance and approves PT programs Develops, implements, and publishes CLIA rules and regulations FDA Categorizes tests based on complexity Reviews In Vitro Diagnostic (IVD) applications for marketing devices
COMMUNICATION FROM THE COMMISSION Guidelines on …
ec.europa.euperformance, i.e. how well it is able to achieve that purpose. This document provides guidance on these aspects. It outlines the regulatory context of COVID-19-related in vitro diagnostic testing devices in the EU and gives an overview of different types of tests and their purposes. It includes considerations on device performance