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LDTs Are Not Devices Under the FDCA: Eastern District of Texas Vacates FDA Final Rule on LDTs

April 2, 2025

FDA LDT Final Rule Litigation — Status and What May Happen Next

December 4, 2024
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The Convergence of Life Sciences and Artificial Intelligence: Seizing Opportunities While Managing Risk

November 13, 2024

What you need to know about the FDA Laboratory Developed Test Final Rule

May 8, 2024

FDA issues final rule to more closely align with ISO 13485

February 8, 2024

Harmonisation of international rules on medical device quality management systems

April 7, 2022

FDA Guidance on Clinical Investigators Signing Form FDA 1572 and Practical Challenges Outside the US

October 29, 2021
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