March 31, 2025
A Texas federal judge on Monday vacated a new U.S. Food and Drug Administration rule that would have brought lab-developed tests under its regulatory authority as "medical devices," finding that the move exceeded the agency's statutory authority and defied "common sense."
September 04, 2024
A clinical-lab trade group and an infectious disease laboratory that sued the U.S. Food and Drug Administration over its new final rule on laboratory-developed tests are asking a federal court to vacate it, saying Congress didn't grant the agency such power.
May 29, 2024
A clinical lab trade group that has been highly critical of the U.S. Food and Drug Administration's new final rule on laboratory-developed tests filed a lawsuit late Wednesday, saying the agency doesn't have the authority to regulate the tests as medical devices.