Congressional Research Service Issues In Focus White Paper on Regulation of Laboratory-Developed Tests - FDA's Proposed Rule
April 11, 2024
April 11, 2024
WASHINGTON, April 11 -- The Congressional Research Service issued the following In Focus white paper (No. IF12628) on April 8, 2024, by health policy specialist Amanda K. Sarata:
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Regulation of Laboratory-Developed Tests: FDA's Proposed Rule
The Food and Drug Administration (FDA) defines laboratory-developed tests (LDTs) as a class of in vitro diagnostic (IVD) device that is designed, manufactured, and used within a single clinical laboratory. LDTs are . . .
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Regulation of Laboratory-Developed Tests: FDA's Proposed Rule
The Food and Drug Administration (FDA) defines laboratory-developed tests (LDTs) as a class of in vitro diagnostic (IVD) device that is designed, manufactured, and used within a single clinical laboratory. LDTs are . . .