ADLM Commends Federal Court鈥檚 Decision to Vacate the FDA鈥檚 Final Rule Regulating Laboratory Developed Tests
Association for Diagnostic and Laboratory Medicine (ADLM (formerly AACC))鈥淎DLM applauds the U.S. District Court for the Eastern District of Texas for issuing a decision to vacate the Food and Drug Administration鈥檚 (FDA鈥檚) final rule to regulate laboratory developed tests as medical devices. The court found that the FDA rule would have negatively impacted testing on which patients and clinicians depend, and that the rule also went against Congress鈥 intent, which is for laboratory services to be regulated under the current framework administered by the Centers for Medicare & Medicaid Services (CMS).