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CLIA Corner: FDA Moves to Boost CLIA Waiver Transparency

by | Nov 30, 2017

The CLIA standards that a lab must meet are based on the complexity of the in vitro diagnostic tests it performs. The FDA’s primary role in the CLIA system is to categorize IVDs. Test Category Get CLIA Certificate Meet Quality Standards Submit to Routine Inspections Moderate complexity √ √ √ High complexity √ √ √ […]

The CLIA standards that a lab must meet are based on the complexity of the in vitro diagnostic tests it performs. The FDA’s primary role in the CLIA system is to categorize IVDs. Test Category Get CLIA Certificate Meet Quality Standards Submit to Routine Inspections Moderate complexity √ √ √ High complexity √ √ √ […]

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