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Texas Judge Rules FDA Can't Regulate Lab Tests

4/1/2025

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Summary

Story summary

In a landmark ruling, a Texas federal judge declared that the FDA cannot regulate laboratory-developed tests (LDTs) as medical devices, striking down a controversial new rule. Judge Sean Jordan's decision champions the clinical lab industry, emphasizing the need for innovation and accessibility in vital diagnostics. The case now returns to Health and Human Services Secretary Robert F. Kennedy Jr. for further action.

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Story summary

In a landmark ruling, a Texas federal judge declared that the FDA cannot regulate laboratory-developed tests (LDTs) as medical devices, striking down a controversial new rule. Judge Sean Jordan's decision champions the clinical lab industry, emphasizing the need for innovation and accessibility in vital diagnostics. The case now returns to Health and Human Services Secretary Robert F. Kennedy Jr. for further action.