Texas judge overturns FDA’s lab developed test regulation, siding with industry groups

The judge vacated the FDA’s final rule, which was strongly opposed by the laboratory industry, and remanded the matter to HHS Secretary Robert F. Kennedy Jr.

A Texas federal court on Monday struck down the Food and Drug Administration’s new rule regulating laboratory developed tests as medical devices in a victory for the clinical lab industry.

Judge Sean Jordan, for the U.S. District Court for the Eastern District of Texas, vacated the FDA’s final rule in its entirety. The court remanded the matter to newly confirmed Health and Human Services Secretary Robert F. Kennedy Jr.

The FDA’s final rule was vehemently opposed by the laboratory industry, which argued it would slow development of critical diagnostics and force labs to scale back the number of tests they could perform, decreasing patient access to care. Trade groups have argued that LDTs are already successfully regulated under the Centers for Medicare and Medicaid Services’ Clinical Laboratory Improvement Amendments statutory framework.

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