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 ...
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 ...
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 ...
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 ...
MD&M East

Regulatory Reversal: Federal Court Rules FDA Cannot Oversee LDTs

After nearly a year’s worth of trepidation about how laboratory-developed tests (LDTs) could be regulated, there appears to be no path for FDA to assume its oversight. The vacating of the final rule ...
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

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 ...
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 ...
Becker's Hospital Review

HHS reinstates FDA review of lab-developed COVID-19 tests

HHS is withdrawing a 2020 policy that limited the FDA’s review process of certain lab tests, including some COVID-19 tests, the agency said Nov. 15. The policy was originally put in place to help labs ...