Congressional Research Service Issues In Focus White Paper on FDA Regulation of Laboratory-Developed Tests
January 16, 2025
January 16, 2025
WASHINGTON, Jan. 16 (TNSrep) -- The Congressional Research Service issued the following In Focus white paper (No. IF11389) on Jan. 14, 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 . . .