No Appeal of LDT/FDA Lawsuit

No Appeal of LDT/FDA Lawsuit

The FDA had until May 30 to appeal U.S. District Court Judge Sean D. Jordan's decision to vacate the agency's Final Rule seeking to regulate laboratory developed tests (LDTs). The federal government declined to appeal the judge's decision meaning the Texas District Court's decision to vacate, in its entirety, the FDA's attempt to regulate LDTs as medical devices stands.

Read ACLA’s full lawsuit.

Read the Final Judgment.

 

Congressional Problem Solvers Caucus Endorses RESULTS Act

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Senate HELP Committee Votes to Advance Price Transparency Legislation

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The Rise of CLIA-Related Rejections: What Labs Should Review

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