Heather Pearson

Heather Pearson

Bass, Berry & Sims PLC

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The End of an Era? FDA Finalizes LDT Rule But Grandfathers Many Existing LDTs

On May 6, 2024, the Food and Drug Administration (FDA) published its final rule for laboratory developed tests (LDTs). The final rule cemented the agency’s forecasted decision to increase the FDA’s regulatory oversight of...more

5/7/2024  /  Clinical Laboratory Testing , Final Rules , Food and Drug Administration (FDA) , Laboratory Developed Tests , Life Sciences , Pharmaceutical Industry , Proposed Rules , Regulatory Oversight , Regulatory Requirements

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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