JD Supra6h
District Court Vacates FDA LDT Rule; What’s Next for Regulation of Lab Testing?
Judge Sean D. Jordan of the U.S. District Court for the Eastern District of Texas issued an opinion and judgment in ...
Medical Device Network on MSN3d
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
The FDA finalized a rule to oversee lab-developed tests as if they were medical devices, prompting lawsuits. Opponents said ...
JD Supra10h
FDA’s LDT Final Rule Rejected by Federal District Court in Texas
As Wilson Sonsini previously reported,1 the U.S. Food and Drug Administration (FDA) had been preparing the industry to comply with the 2024 LDT ...
National Law Review2d
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 ...
Fierce Biotech3d
Federal judge blocks FDA's regulation of lab-developed tests
A federal judge in Texas has blocked the FDA’s plans to bring laboratory-developed tests under the same regulations it uses ...
American Hospital Association3d
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 ...
National Law Review5d
A Final Rule Bites the Dust: Federal Court Rules FDA Lacks Authority to Regulate LDTs
In May 2024, the U.S. Food & Drug Administration (“FDA” or the “Agency”) published its Final Rule establishing its regulatory ...
MedTech Dive3d
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 ...
360Dx3d
Future of LDT Oversight Unclear Following Court's Rejection of FDA Rule
The ruling makes clear that the FDA lacks the legal authority to regulate LDTs, and observers suggest it could also call into question its authority in other areas.
Yahoo Finance3d
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 ...