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Tag Archives: In Vitro Diagnostic

In Vitro Diagnostic Device
16 Jan

Guidance on Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens

FDA Update – January 17, 2025 FDA Releases Draft Guidance on Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency The FDA has issued a new draft guidance to help developers validate diagnostic tests (IVDs) for emerging pathogens during public health emergencies. This guidance aims to ensure that

FDA'S CLIA Web Pages
19 Jul

CLIA Web Pages updates

FDA Update For In Vitro Diagnostic Test Developers: Updates to the FDA’s Clinical Laboratory Improvement Amendments (CLIA) Web Pages Make Processes Clearer, Easier to Understand The Clinical Laboratory Improvement Amendments (CLIA) and the associated regulations provide the authority for oversight of clinical laboratories and laboratory testing. While the Centers for Medicare and Medicaid Services (CMS)

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