Heather Pearson

Heather Pearson

Bass, Berry & Sims PLC

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FDA Takes Definitive Step Toward the Regulation of LDTs

On October 3, the U.S. Food & Drug Administration (FDA) published a highly anticipated proposed rule (Proposed Rule) to regulate laboratory-developed tests (LDTs) as medical devices. LDTs are tests that are developed and...more

10/4/2023  /  Clinical Laboratories , Comment Period , Enforcement , Food and Drug Administration (FDA) , Laboratory Developed Tests , Medical Devices , Proposed Rules , Regulatory Reform , Regulatory Requirements
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