HealthIT Answers September 18, 2024
Inga Rose, Founder & CEO, Reference Medicine
Aaron Schlum, Head of Operational Development
On May 6, FDA published a final rule that will change the way laboratory-developed tests (LDTs) 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 (IVDs).
While FDA has long defined LDTs as IVDs that are intended for clinical use and are designed, manufactured, and used within laboratories (and as such, devices), LDTs have traditionally been regulated by agencies such as Clinical Laboratory Improvement...
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