Court strikes down FDA rule on regulating lab-developed tests

The U.S. District Court for the Eastern District of Texas March 31 ruled that the Food and Drug Administration does not have the authority to regulate laboratory-developed tests.

The FDA last April issued a final rule that would have phased out its general enforcement discretion approach for most lab-developed tests over four years. The phase-out deadlines set in the final rule are no longer in effect.

The AHA previously expressed concerns about the proposed rule and urged the FDA not to apply the rule to hospital and health system lab-developed tests.

“This ruling ensures that hospital-based labs are able to continue to develop innovative and high-quality tests that provide physicians with important clinical information to help diagnose and treat patients,” said Jason Kleinman, AHA director of federal relations. “The LDT final rule would have stifled medical innovation and dramatically increased regulatory burden and costs for both hospitals and the federal government.”