STAT+: Texas judge strikes down FDA’s plan to regulate lab-developed tests
The FDA has long believed it has the power to regulate lab-developed tests, but it only put out the rules under former President Biden.
WASHINGTON — A federal judge in Texas squashed the Food and Drug Administration’s plan to regulate lab-developed tests on Monday, ruling in favor of lab trade groups that said the agency was overstepping its bounds.
“The Court VACATES and SETS ASIDE, in its entirety, the FDA’s Final Rule titled Medical Devices; Laboratory Developed Tests,” the ruling reads. “The Court remands this matter to the Secretary of Health and Human Services for further consideration.”
The FDA has always believed it has the power to regulate lab-developed tests as medical devices, but it has not exercised that authority historically. It was only under President Biden that the agency announced its plans to actively regulate the tests, giving labs until 2028 to comply. The move came after Congress tried and failed to give FDA more explicit authority in 2022.
