NILA and AAB File an Amicus Brief in Support of the ACLA and AMP Lawsuit Against FDA’s LDT Rule
The National Independent Laboratory Association (NILA) and the American Association of Bioanalysts (AAB) filed an Amicus Brief in support of the American Clinical Laboratory Association (ACLA) and Association for Molecular Pathology (AMP) in their lawsuits against the Food and Drug Administration’s (FDA's) Final Rule on Laboratory Developed Tests (LDTs).
NILA and AAB, along with the American Society for Clinical Pathology, the American Society for Microbiology, the Association for Diagnostics & Laboratory Medicine, and the Infectious Disease Society of America submitted an Amicus Brief on October 7, 2024.
NILA and AAB assert that the FDA Final Rule is unreasonable on several grounds. Among NILA's and AAB’s arguments is that Congress has not authorized the FDA to regulate LDTs; rather, Congress established the Clinical Laboratory Improvement Amendments (CLIA) to regulate LDTs. NILA and AAB argue that the FDA is overstepping its authority through this Final Rule. See the NILA/AAB press release for more information.