Apr 1 2025
Thanks to PBI’s Dean Willett for his heads-up about the March 31, 2025 ruling, “FDA‘s LDT Rule Struck Down in Texas Court.” The US FDA‘s 2024 “Final Rule” outlined plans to subject lab-developed tests to the same requirements as medical devices. The Texas ruling illustrates the US struggle to achieve a realistic approach to validation and clinical application of LDTs.
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