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FDA doesn't challenge LDT decision

Jun 3, 2025

The deadline has passed to appeal the court decision that nullified the FDA's oversight regulations over laboratory-developed tests (LDTs). 

Why it matters: The FDA will no longer defend the LDT rules, which pathologists and labs said threatened patient access to testing.

  • The CAP applauded the March 31 decision, saying that the regulation failed to target FDA oversight and would impede patient access to safe LDTs.
  • The FDA had until May 30 to appeal, but no appeal was filed.

Go deeper: Read the CAP's amicus brief in the case.

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