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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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