North America
By Priya Bhutani — Obtaining market approval for a medical device from the US FDA seems arduous and frightening and most manufacturers do not know where to even begin. Medical devices are subject to general controls of the Federal Food Drug & Cosmetic...
North America
By Michael Rugnetta– After a few years of ambiguity, discussion, meetings, and conferences, the FDA has finally begun to take some small but definite steps into new territories for test regulation. It was barely a year ago (November 22, 2013) that the Food and...
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