JD Supra

Laboratory-Developed Tests (LDTs) Do Not Qualify as ‘Devices’ Under the Food, Drug and Cosmetic Act

On March 31, 2025, in the U.S. District Court for the Eastern District of Texas vacated the Food and Drug Administration’s (FDA) final rule, in which FDA attempted to assert regulatory authority over ...
MobiHealthNews

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 ...
JD Supra

FDA to rescind laboratory developed test rule

The U.S. Food and Drug Administration (FDA) plans to rescind its laboratory developed test (LDT) rule dated May 6, 2024. The rule would have regulated LDTs as in vitro diagnostic products (IVDs) and ...
STAT

A court decision on lab-developed tests sets a dangerous precedent

Kadakia is a medical student at Harvard Medical School. Ross and Ramachandran are physicians and professors at the Yale School of Medicine. They submitted an amicus brief in support of the FDA in ACLA ...
The National Law Review

In Landmark Ruling, Eastern District of Texas Strikes Down FDA’s Final Rule Regulating Laboratory Developed Tests

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 and ...
KSL

Judge foils FDA plan to regulate lab-developed tests

SALT LAKE CITY — Folks with cancer that has gene variants or rare diseases often need laboratory-developed tests for information that could guide their treatment when commercial tests don't exist or ...
Healthcare Dive

Texas judge overturns FDA’s lab developed test regulation, siding with industry groups

A Texas federal court on Monday struck down the Food and Drug Administration’s new rule regulating laboratory developed tests as medical devices in a victory for the clinical lab industry. Judge Sean ...
Tyler Morning Telegraph

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 ...
Becker's Hospital Review

FDA wants to crack down on lab-developed tests: 3 things to know

The Food and Drug Administration aims next year to toughen up regulations on the lab-developed testing industry, according to an article in The Wall Street Journal. Here are three things to know about ...
Healthcare Dive

Could the FDA take an indirect approach to regulate LDTs?

When the deadline to appeal the court decision that blocked the Food and Drug Administration’s final rule regulating laboratory developed tests as medical devices slipped by in May without a word from ...