AG/FDA Blog

Ask Not for Whom the Bell Tolls, it Tolls for Your LDT (Part II)

In our prior posting, we provided a brief overview of the notification and adverse event reporting requirements that will apply to the vast majority of a subset of in vitro diagnostic devices known as Laboratory Developed Tests (LDTs), most likely in… Read More
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Ask Not for Whom the Bell Tolls, it Tolls for Your LDT (Part I)

On October 3 of this year, the Food and Drug Administration (FDA) published draft guidance documents that, when finalized, will mark a “game changer” for clinical laboratories. Specifically, these guidances call for the active regulation of a sub… Read More
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