A Sea-Change is Coming in How Laboratory-Developed Tests are Regulated – Is your Lab Ready?
By Inga Rose & and Aaron Schlum – On May 6, FDA published a final rule that will change the way laboratory-developed tests are regulated. The rule phases out the agency’s general policy of “enforcement discretion” and mandates that, across five stages within the next four years, LDTs will be beholden to the same regulatory requirements as in vitro diagnostics.
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