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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