What’s happening: In a final judgment filed March 31, the U.S. District Court for Eastern Texas ruled that the Food & Drug Administration (FDA) does not have the authority to regulate laboratory-developed tests, rendering a final rule issued May 6, 2024, null and void.
What else to know: This final rule phased out the FDA’s general enforcement discretion approach for most laboratory-developed tests to instead provide greater oversight.
During the proposed rule’s public comment period in late 2023, CHA expressed concerns to the FDA and urged the agency to continue enforcement discretion for hospital and health system laboratory-developed tests.
Megan Howard
