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 ...

Laboratory Developed Tests (LDTs) are critical for diagnosing rare diseases and addressing unmet clinical needs. They are developed, manufactured, and used within a single licensed clinical laboratory ...

In May 2024, FDA finalized a rule regarding LDTs, which purported to amend the 21 CFR 809.3(a) definition of "in vitro diagnostic products" to specify that such definition "[includes] when the ...

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 ...

Many doctors and laboratories don't have the resources to comply with the Food and Drug Administration’s final rule on the regulation of laboratory developed tests and will likely scale back the ...

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 aren’t precise ...

WASHINGTON, Sept. 5, 2024 /PRNewswire/ -- Today, the Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC) released the latest results from an ongoing survey that ADLM has been ...

The US Food and Drug Administration (FDA) plans to scrutinize the safety and efficacy of lab-developed tests — those designed, manufactured, and used in a single laboratory — far more thoroughly in ...

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 ...

The Food and Drug Administration will wait until members of the next White House administration and Congress take office before finalizing guidance on laboratory developed tests. LDTs are in vitro ...