Carol Hogan

Carol Hogan

Jones Day

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Industry Anticipates Impending FDA Proposed Regulation Addressing Laboratory Developed Tests

Stakeholders prepare for the U.S. Food and Drug Administration's ("FDA") rulemaking effort to "make explicit" that laboratory developed tests ("LDTs") are devices subject to the agency's oversight, reigniting outstanding...more

8/31/2023  /  Clinical Laboratory Testing , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Draft Guidance , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Medical Devices , OIRA , Proposed Regulation , Proposed Rules
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