On Monday, March 31, a federal district court vacated FDA's final rule to regulate laboratory developed test services (LDTs) as medical devices. Federal Court Strikes Down FDA Rule on LDTs Federal Judge Vacates FDA's LDT Rule
FDA's Laboratory-Developed Test Rule Struck Down in Major Test of On March 31, 2025, the US District Court for the Eastern District of Texas vacated the FDA's Final Rule on laboratory-developed tests (LDTs). FDA's LDT Rule struck down – now what?
A recent decision finds that the FDA exceeded its statutory authority in attempting to regulate laboratory-developed tests as "devices." Federal District Court Vacates FDA's LDT Final Rule | Insights
Federal Court Vacates FDA Rule Regulating LDTs | AAMC Federal Court Vacates FDA's Final Rule on Laboratory-Developed US District Court Judge Sean D. Jordon has ruled that the US Food and Drug Administration (FDA) lacks the statutory authority to regulate laboratory developed
On March 31, 2025, the U.S. District Court for the Eastern District of Texas ruled that the Food and Drug Administration (FDA) lacks FDA vacates final rule regulating lab-developed tests as medical
In this webinar, we analyze the recent U.S. District Court ruling that vacated FDA's laboratory developed test (LDT) Final Rule, Federal District Court Vacates FDA's Laboratory Developed Tests Texas judge overturns FDA's lab developed test regulation, siding
On March 31, 2025, US District Judge Sean D. Jordan ordered that FDA's Laboratory Developed Tests (LDT) Final Rule be vacated and set aside, in its entirety. FDA's LDT Rule Struck Down by Federal District Court | Covington Federal Court Vacates FDA Rule on Laboratory Developed Testing
The parties cross-moved for summary judgment, and, on March 31, 2025, the court held that "FDA's final rule exceeds its authority and is The US District Court for the Eastern District of Texas has vacated the Final Rule in its entirety, holding that FDA's attempt to regulate professional
A Texas federal court on Monday struck down the Food and Drug Administration's new rule regulating laboratory developed tests as medical devices. A federal district court on March 31 vacated an FDA regulation of laboratory developed tests (LDTs) after two lawsuits. 18 that rescinds one from 2024 that applied medical device rules to laboratory-developed tests. The final rule is in response to a March 31