Statement from The Coalition for 21st Century Medicine Regarding the FDA’s Draft Guidance Framework for Regulating Lab-Developed Tests

Laboratory developed tests (LDTs) are currently subject to comprehensive regulations under the Clinical Laboratory Improvement Amendments (CLIA). The Food and Drug Administration (FDA) announced that it intends to regulate LDTs as medical devices and outlined the structure of a regulatory framework that the agency intends to implement once a Guidance Document is finalized.