The U.S. trade group representing laboratory companies and test manufacturers is suing to block the FDA from increasing its oversight of lab-developed tests, saying the agency overstepped its ...
On March 31, 2025, Judge Sean D. Jordan of the U.S. District Court for the Eastern District of Texas issued an opinion and judgment in American Clinical Laboratory Association v. FDA (“ACLA v. FDA”), ...
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, ...
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 ...
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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 ...
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 ...
A group representing clinical labs across the country sued the Food and Drug Administration on Wednesday over the agency’s plan to actively regulate lab-developed tests. The suit, filed in a Texas ...
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 ...
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