The Long and Winding Road to FDA Regulation of LDTs

Over the years, FDA’s regulation of in vitro diagnostics (lVDs) has raised many policy issues. Some are short-lived and quickly resolved, such as the creation of the Analyte Specific Reagent (ASR) regulation, and the subsequent guidance which curtailed the distribution of ASRs. Other policy issues have remained open for decades. The regulation of laboratory developed tests (LOTs) falls into the latter category.

FDA first asserted it could regulate LDTs in 1992. That assertion was controversial then, and is at least as controversial today. During this 21-year period, there have been prolonged lulis, where the issue remains unresolved but simply docs not receive much attention. At other times, the issue flares up.