FDA Regulation of Laboratory-Developed Tests Topic of White Paper From CRS
December 20, 2025
December 20, 2025
WASHINGTON, Dec. 20 (TNSLrpt) -- The Congressional Research Service issued the following In Focus white paper (No. IF11389) on Dec. 19, 2025, by health policy specialist Amanda K. Sarata:
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FDA Regulation of Laboratory-Developed Tests (LDTs)
Laboratory-developed tests (LDTs) are a class of in vitro diagnostic (IVD) device that is designed, manufactured, and used within a single laboratory. LDTs may be used in the context of identifying evolving diseases . . .
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FDA Regulation of Laboratory-Developed Tests (LDTs)
Laboratory-developed tests (LDTs) are a class of in vitro diagnostic (IVD) device that is designed, manufactured, and used within a single laboratory. LDTs may be used in the context of identifying evolving diseases . . .