Elizabeth Caruso

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FDA Targets April 2024 for Laboratory Developed Test (LDT) Final Rule

On December 6, 2023, the Office of Information and Regulatory Affairs (“OIRA”) released the Fall 2023 Unified Agenda of Regulatory and Deregulatory Actions (the “Agenda”), a semiannual compilation of information regarding...more

12/11/2023 / Clinical Laboratories , Diagnostic Tests , Final Rules , Food and Drug Administration (FDA) , Laboratory Developed Tests , Life Sciences , Medical Devices , OIRA

FDA’s Proposed Rule for Oversight of Laboratory Developed Tests: Part II: FDA’s Proposed Phaseout Policy - Key Considerations &...

After an over decade-long discourse amongst interested stakeholders, on October 3, 2023, FDA unveiled its proposed rule and policy to increase oversight over LDTs. If finalized as proposed, FDA would implement a new...more

10/13/2023 / Clinical Laboratories , Diagnostic Tests , Food and Drug Administration (FDA) , Laboratory Developed Tests , Life Sciences , Proposed Regulation , Proposed Rules

FDA’s Proposed Rule for Oversight of Laboratory Developed Tests: Part I: Underpinnings of FDA’s Proposed Rule

On October 3, 2023, the U.S. Food and Drug Administration (FDA) published its widely anticipated proposed rule on the regulation of laboratory developed tests (LDTs). The proposed rule and policy are the latest in an over...more

10/9/2023 / Clinical Laboratories , Comment Period , Diagnostic Tests , Food and Drug Administration (FDA) , Laboratory Developed Tests , Medical Devices , Proposed Rules , Regulatory History , Regulatory Oversight

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