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BioWorld - Saturday, May 23, 2026
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Home » ACLA files suit against US FDA over lab-developed test final rule
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ACLA files suit against US FDA over lab-developed test final rule

May 29, 2024
By Mark McCarty
The American Clinical Laboratory Association has followed through on its promise to file suit against the U.S. FDA over the agency’s final rule for lab-developed tests. The lawsuit will be heard in the U.S. District Court for the Eastern District of Texas, which is also the venue for litigation against another federal government agency, the Federal Trade Commission, suggesting that litigants expect a favorable review of their case in this court.
Medical technology Regulatory Diagnostics U.S. FDA

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