AG/FDA Blog

Medical Device “Top 5” for 2016

The opening days of a new year are, to some, an apropos time to look back and reflect on the year that is now “one for the books.” Unable to resist the urge to do so ourselves, we have compiled our “Top-5” list for medical device regulation i… Read More
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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On October 3 of this year, the Food and Drug Administration (FDA) published draft guidance documents that, when finalized, will mark a “game changer” for clinical laboratories.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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