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# LDT ‘Power Grab’ Suit Filed Against FDA
- URL: https://www.fdaweb.com/ldt-power-grab-suit-filed-against-fda/
- Published: 2024-08-20T12:00:00.000Z
- Updated: 2026-09-14T14:38:55.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5157615

The Association for Molecular Pathology and a doctor described as a “world-renowned clinical pathologist” who chairs the Department of Pathology at the University of Texas Medical Branch-Galveston, are suing FDA in a Texas federal court to block implementation of the agency’s final rule on laboratory-developed tests (LDTs). “This case challenges a historically unprecedented power grab that will jeopardize the health of hundreds of millions of Americans and, by defendant FDA’s own admission, impose tens of billions of dollars in new regulatory mandates on thousands of laboratories and laboratory professionals by subjecting their customized analytical processes (called laboratory-developed tests) to burdensome, duplicative, and unnecessary FDA regulation for the first time in American history,” the [suit](https://www.prnewswire.com/news-releases/association-for-molecular-pathology-files-lawsuit-against-fda-to-challenge-final-rule-on-regulation-for-laboratory-developed-testing-procedures-302226450.html?ref=fdaweb.com) declares.

It says that for nearly 50 years, Congress has drawn a sharp distinction between mass-produced medical devices that are commercially distributed for third-party use outside the manufacturer’s control, and highly customized LDTs that are developed and performed exclusively by highly-trained healthcare professionals working within a federally licensed or accredited facility.

“Some 40 years after Congress chose to subject LDTs to the Center for Medicare and Medicaid Services’ carefully tailored regulations under the Clinical Laboratory Improvement Act, and not FDA’s burdensome Medical Device Act-based requirements for tangible medical devices that are commercially distributed across the United States,” the association and doctor say, “FDA’s unelected bureaucrats now claim that Congress made the wrong choice. And after nearly 20 years of trying and failing to convince Congress to vest FDA with regulatory authority over LDTs, the agency now has seized that authority for itself by issuing a final rule that will subject LDTs to costly, duplicative, and highly intrusive FDA regulation for the first time ever.”

The suit charges that in its final rule, FDA is relying heavily on evidence that it admits is unverified and largely anecdotal. “FDA’s explicit rejection of Congress’ policy choices is neither appropriate nor lawful,” the filing says. “Under our Constitution, Congress writes legislation, the president signs it, and the administrative state is bound by these laws unless and until they are amended.”

The suit asks the court to:

- declare that the final rule is contrary to law; exceeds statutory jurisdiction, authority, or limitations; short of statutory right; arbitrary; capricious; and an abuse of discretion that must be vacated and set aside;
- enjoin FDA from taking any action to enforce the final rule;
- award the association and doctor their costs and attorney fees; and
- award the plaintiffs any other relief the court deems to be just and proper.