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FDA’s LDT rule, CDS guidance combine to complicate regulatory life

Feb. 26, 2025
By Mark McCarty
The routine use of software to interpret the results of lab-developed tests (LDTs) leaves clinical labs in a complicated spot in 2025 thanks in no small part to an ongoing lawsuit over the U.S. FDA’s final rule for LDTs.
BioWorld MedTech Regulatory Diagnostics Digital health U.S. FDA Policy