How, and When, Will FDA Regulate LDTs?July 15, 2013
Over the years, FDA’s regulation of IVDs 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 that curtailed the distribution of ASRs. Other policy issues remain open for decades. The regulation of laboratory-developed tests (LDTs) falls into the latter category.
Additional information available here.