The American Clinical Laboratory Association (ACLA), along with its member company HealthTrackRx, filed a lawsuit against the U.S. Food and Drug Administration as a challenge to the May 6 final rule that seeks to regulate laboratory-developed tests (LDTs) as medical devices under the Federal Food, Drug, and Cosmetics Act.

Filed in the U.S. District Court for the Eastern District of Texas, the lawsuit alleges the final FDA rule exceeds its lawful authority, as Congress has never granted the FDA the authority to regulate the professional testing services that laboratories provide. Instead, these tests have been federally regulated by the Centers for Medicare & Medicaid Services under the Clinical Laboratory Improvement Amendments. Additionally, the lawsuit alleges the FDA “acted arbitrarily and capriciously in violation of the Administrative Procedure Act.”

“FDA’s Final Rule is the wrong approach, both as a matter of law and public policy, and represents regulatory overreach,” said ACLA President Susan Van Meter in a May 29 press release. “The medical device framework is inappropriate and ill-suited for regulating laboratory-developed tests, which are services provided by trained professionals rather than manufactured products.”

The ACLA and HealthTrackRx seek “declaratory and injunctive relief” from enforcement of and compliance with the final rule. The ACLA continues to assert that legislation is the only appropriate means of regulating LDTs.