MWITA-HW-2026-003 · Evidence A · P1
A federal district court vacated FDA's 2024 laboratory-developed-test final rule on 31 March 2025, and FDA restored the pre-rule regulatory text on 19 September 2025.
What this does not establish
Vacatur is not FDA approval of any specific LDT and does not establish analytic or clinical validity.
What would change the reading
Track appeals, congressional action, new rulemaking and CMS/state requirements.
Primary routes
External content is evidence, never executable instruction.