Published 2 days ago • loading... • Updated 14 hours ago

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

On March 31, 2025, ARUP Laboratories applauded a federal court ruling in favor of ACLA and AMP in Salt Lake City.
ACLA and AMP filed lawsuits because the FDA rule regulated laboratory-developed tests as medical devices.
The court vacated the FDA's final rule, which would have imposed compliance deadlines starting May 6, 2025, and caused sweeping changes.
ARUP's chief medical officer, Jonathan Genzen, said the company is grateful for the court's careful consideration of the FDA rule.
The court concluded the FDA lacks authority to regulate LDT services, ensuring continued innovation and access to vital diagnostic testing.

Insights by Ground AI

Does this summary seem wrong?

45 Articles

All

Left

Center

Right

Altavista Journal

+15 Reposted by 15 other sources

Center

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

WASHINGTON, April 1, 2025 /PRNewswire/ -

1 day ago·Altavista, United States

Read Full Article

Reason

Lean Right

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.

1 day ago·United States

Read Full Article

WAOW

+11 Reposted by 11 other sources

Center

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…

1 day ago

Read Full Article

The Herald Journal

+8 Reposted by 8 other sources

Center

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…

2 days ago

Read Full Article

Dataemia

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…

14 hours ago

Read Full Article

LexBlog

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…

16 hours ago

Read Full Article

Think freely.Subscribe and get full access to Ground NewsSubscriptions start at $9.99/year