Posts tagged Safe Medical Device Act.
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Upon learning that FDA had lost another round in its battle to classify Diphoterine® Skin Wash (DSW) as a combination product with a drug primary mode of action and that Prevor, DSW's manufacturer, was still fighting this issue nearly six years after it submitted its initial premarket notification for DSW, I turned into a five-year-old and kept asking why?
- Why does FDA insists that a skin wash intended to "help prevent and minimize accidental chemical burn injuries" must be regulated as a drug but a drug-coated stent intended to improves arterial diameter is regulated as a device?
- Why ...
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