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JD Supra5d
The LDT Final Rule Bites the Dust: Examining the Repercussions of the Federal Court’s Vacatur and What the Future May Hold
Judge Sean D. Jordan of the U.S. District Court for the Eastern District of Texas ruled that the Food and Drug Administration ...
National Law Review12d
Texas Court Vacates FDA’s Laboratory Developed Test (LDT) Final Rule
A Texas judge for the U.S. District Court for the Eastern District of Texas issued a ruling on March 31, 2025, to vacate and ...
JD Supra7d
FDA's LDT Rule Struck Down by Court: FDA Has Lost the Battle, But Is the War Over?
A court has struck down the Food and Drug Administration’s attempt to extend its regulatory authority to clinical laboratory testing services.
Medical Device Network on MSN13d
FDA’s LDT rule struck down in Texas court
Published in 2024, the FDA’s ‘Final Rule’ outlined plans to subject lab-developed tests to the same requirements as medical ...
Judge foils FDA plan to regulate lab-developed tests
Folks with cancer that has gene variants or rare diseases often need laboratory-developed tests for information that could ...
The National Law Review7d
LDT Final Rule Series: Part 4 – Rule Overturned by Federal District Court
We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation ...
American Hospital Association12d
Court strikes down FDA rule on regulating lab-developed tests
The U.S. District Court for the Eastern District of Texas March 31 ruled that the Food and Drug Administration does not have the authority to regulate laboratory-developed tests.
MedTech Dive12d
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 ...
STAT12d
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 ...
FDA Lacks Authority to Regulate Laboratory Tests, Judge Rules
A federal judge ruled Monday that the FDA doesn’t have the legal authority to regulate lab-developed tests, dealing a blow to ...
KSL7d
Judge foils FDA plan to regulate lab-developed tests
"The LDT final rule would have stifled medical innovation and dramatically increased regulatory burden and costs for both hospitals and the federal government." Karcher said that the now-dismissed ...
Yahoo Finance13d
FDA’s LDT rule struck down in Texas court
A Texas judge has ruled against the US Food and Drug Administration (FDA) in a court case that challenged the agency’s plans to regulate laboratory-developed tests (LDTs) – defined as in vitro ...