How, and When, Will FDA Regulate LDTs?

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.

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