FDA Stirs Debate over Plans To Regulate Laboratory-Developed Tests

摘要

Officials of the Food and Drug Administration (FDA) in July announced steps "to ensure that certain tests used by health care professionals to help diagnose and treat patients provide accurate, consistent, and reliable results." As' part of this effort, FDA plans to extend oversight to include laboratory-developed tests (LDTs), which are designed, manufactured, and used within single laboratories—a category of diagnostic procedures that more typically fall under jurisdiction of the Centers for Medicare & Medicaid Services (CMS) under the mandate of the Clinical Laboratory Improvement Amendments (CLIA).