ARUP Applauds Federal Court Decision Vacating the FDA's Final Rule Regulating Lab-Developed Tests

ADLM commends federal court's decision to vacate the FDA's final rule regulating laboratory developed tests

WASHINGTON, April 1, 2025 /PRNewswire/ -

Federal court 'vacates in its entirety' the FDA's costly and onerous lab test rule

RFK Jr. should accept the ruling and instruct the agency to immediately halt all efforts to regulate laboratory-developed and in vitro tests.

HealthTrackRx Applauds Court Ruling to Vacate FDA's Laboratory-Developed Test (LDT) Rule

DENTON, Texas, April 1, 2025 /PRNewswire/ -- HealthTrackRx, a leader in molecular diagnostics and named plaintiff in the lawsuit challenging the U.S. Food and Drug Administration's (FDA) regulation of laboratory-developed tests (LDTs) as medical devices, applauds the U.S. District Court…

ARUP Applauds Federal Court Decision Vacating the FDA's Final Rule Regulating Lab-Developed Tests

SALT LAKE CITY, March 31, 2025 /PRNewswire/ -- ARUP Laboratories applauded today's federal court ruling in favor of the American Clinical Laboratory Association (ACLA) and the Association for Molecular Pathology (AMP), vacating in its entirety the FDA's final rule to…

Texas judge strikes down FDA rule on lab-developed tests regulation

A federal judge in Texas ruled that the FDA overstepped its authority when it issued its Final Rule: Medical Devices; Laboratory Developed Tests in May of last year, which said laboratory-developed tests (LDTs) should be regulated as medical devices. In a 450-page lawsuit filed by the American Clinical Laboratory Association (ACLA), molecular testing laboratory for infectious diseases HealthTrackRx Indiana and HealthTrackRx, and others, the plai…

LDTs Are Not Devices Under the FDCA: Eastern District of Texas Vacates FDA Final Rule on LDTs

In our blog in December 2024, we provided an update on the U.S. Food and Drug Administration (FDA) final rule, revising the regulatory definition of an in vitro diagnostic (IVD) to explicitly capture IVDs manufactured by laboratories (known as laboratory developed tests or LDTs). We noted that two cases had been filed challenging the FDA’s authority to regulate LDTs. On March 31, 2025, the Eastern District of Texas granted the laboratory plainti…