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 ...
JD Supra

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 set aside, in its entirety, the U.S. Food and Drug Administration’s (FDA) ...
Tyler Morning Telegraph

HealthTrackRx Applauds Court Ruling to Vacate FDA’s Laboratory-Developed Test (LDT) Rule

“This ruling affirms what we and our colleagues across the industry have long maintained: the FDA lacks the legal authority to regulate LDTs,” said Martin Price, Executive Chairman & CEO of ...
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 ...
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 ...
Morningstar

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

Most laboratory developed tests are created because there is not already a Food and Drug Administration-approved test available, and they are often used to diagnose rare conditions, such as inherited ...
Healthcare Dive

5 steps to navigate the FDA’s new lab developed test rule

Laboratories are just beginning to assess the magnitude of operational changes needed to comply with a new federal rule expanding regulatory oversight of lab developed tests (LDTs). In a major shift, ...

Gene Solutions and Pangea Laboratory Establish Strategic Collaboration to Validate Laboratory Developed ctDNA Tests for Precision Screening and Cancer Care in the …

Gene Solutions and Pangea Laboratory Establish Strategic Collaboration to Validate Laboratory Developed ctDNA Tests for ...
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 ...
The National Law Review

FDA Sued Over Laboratory Developed Tests Final Rule

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 ...
abc27

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 ...