The American Clinical Laboratory Association (ACLA) and Association for Molecular Pathology (AMP) each filed closing briefs on Nov. 25 in the lawsuit against the U.S. Food and Drug Administration oversight of laboratory-developed tests (LDTs).
The plaintiffs filed the lawsuit against the FDA in the U.S. District Court for the Eastern District of Texas, challenging its regulation of LDTs as medical devices “as exceeding FDA’s statutory authority and as arbitrary and capricious in violation of the Administrative Procedure Act,” as stated in an Oct. 25 legal brief. Following the FDA filing a brief in defense of its position, the court denied the plaintiffs’ motion to vacate the final rule.
In their closing briefs, both plaintiffs reasserted that the court should vacate the final rule. The ACLA argued that FDA regulation of the development and performance of testing protocols as medical devices is objectionable. The AMP listed the ways in which the final rule conflicts with both the Food, Drug, and Cosmetics Act statutory language and the scope of the Clinical Laboratory Improvement Amendments of 1988.
The FDA is expected to file its closing brief by Dec. 23.
Sources:
https://www.cap.org/advocacy/latest-news-and-practice-data/november-26-2024
https://documents.cap.org/documents/acla-closing-brief2024.pdf
https://documents.cap.org/documents/amp-closing-brief2024.pdf
