Lab Trade Group Urges Court to Vacate FDA Test Regulation

The FDA can’t justify its regulation classifying laboratory-developed tests as medical devices because Congress never granted them that authority, a leading lab industry group told a federal court.

The Food and Drug Administration’s new regulation over laboratory-developed tests (LDTs) is arbitrary and capricious and in violation of the Administrative Procedure Act, the American Clinical Laboratory Association and HealthTrackRx wrote Tuesday in a motion for summary judgment in the US District Court for the Eastern District of Texas.

The motion comes after ACLA in May filed a lawsuit against the agency’s May 6 final rule, which seeks to regulate LDTs as ...