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November 15, 2008 (Vol. 28, No. 20)

Adroit Crafting of “Intended Use” Critical

Regulatory Fate of a New IVD May Well Depend on a Few Dozen Words

  • In vitro diagnostic (IVD) devices are comprehensively regulated by the FDA. The FDA, however, does not regulate just the physical materials and software comprising an IVD. When developing a new assay, IVD companies tend to focus on key physical aspects: the composition of the assay, what it detects ...

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