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 ...
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 ...
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, ...
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 ...
Historically, developing a molecular test within a clinical laboratory has been perceived as a complicated and laborious process. In this webinar, we aim to dispel common misconceptions of laboratory ...
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Future of Lab-Developed Tests Still Taking Shape
As the new Congress and a new administration start up, the fate of FDA-issued regulations on laboratory-developed tests (LDTs) is one of many issues that health advocates and lobbyists will be ...
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Judge foils FDA plan to regulate lab-developed tests
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 ...
These tests are typically not advertised or sold as kits to other testing facilities. The only labs that are allowed to perform laboratory developed tests are those that are considered high-complexity ...
A federal judge in Texas has blocked the FDA’s plans to bring laboratory-developed tests under the same regulations it uses to oversee other in vitro diagnostics and medical devices—saying the agency ...
WASHINGTON, Feb. 19, 2025 /PRNewswire/ -- Laboratory developed tests play an essential role in diagnosing and treating many of the conditions that affect pediatric patients. Join the Association for ...
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 ...
In a guidance document issued by the Association for Diagnostics & Laboratory Medicine, updated recommendations are presented ...
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