Lab Orgs Call for CLIA Modernization to Handle LDT Oversight, but CMS Appears to Oppose Idea

With the VALID Act — which would formally give the FDA authority over LDTs — facing an uncertain future, there is perhaps an opening for alternative approaches to LDT regulation. However, Reynolds Salerno, director of the division of laboratory systems at the US Centers for Disease Control and Prevention and designated federal official of the US Clinical Laboratory Improvement Advisory Committee (CLIAC), indicated that CMS has little interest in regulating LDTs under CLIA and believes these tests should fall under the FDA’s authority.

Source: https://www.360dx.com/clinical-lab-management/lab-orgs-call-clia-modernization-handle-ldt-oversight-cms-appears-oppose#.Y0WOcHbMKUk