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Ironically Holmes might end up getting her wish about all Lab Developed Tests (LDTs) needing to go through FDA approval in addition to CLIA certification, which
by seehafer 10y ago
Ironically Holmes might end up getting her wish about all Lab Developed Tests (LDTs) needing to go through FDA approval in addition to CLIA certification, which cover the operation of a lab, not the design and validation of the machines in the lab.