Statement from The Coalition for 21st Century Medicine Regarding the FDA’s Proposed Rule for Regulating Lab-Developed Tests as Medical Devices
The Food and Drug Administration (FDA) announced today that it intends to regulate Laboratory Developed Tests (LDTs) furnished by clinical laboratories as medical devices and outlined a plan to end enforcement discretion for all LDTs over the next 4 years. These proposed new FDA regulatory requirements would be in addition to the comprehensive regulations applicable to LDTs and laboratories under the Clinical Laboratory Improvement Amendments (CLIA).