USA/FDA – FDA issues long-awaited LDT final rule

After years of jostling with industry, failed legislative efforts, and some false starts, the US Food and Drug Administration (FDA) has unveiled its plan to bring laboratory developed tests (LDTs) into its regulatory fold over the next four years. The much-anticipated final rule amends the agency’s regulations to explicitly treat in vitro diagnostics (IVDs), including tests made by laboratories, as medical devices and offers a phased approach to regulating such tests. More information on the...