Trump’s Second Term Could Turn LDT Regulation on its Head

Submitted by admin on November 17, 2024 - 9:32pm

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Medical Devices and Diagnostics Industry

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Trump's new term could lead to the repeal of FDA's LDT rule, reverting it to previous regulations or alternative oversight.
FDA’s final rule treats LDTs as medical devices, imposing stricter requirements, and raising concerns in the lab industry.
The ACLA is challenging the FDA’s LDT rule, while the VALID Act proposes an alternative framework.

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