FDA Details Approach To Expedited Medical Device Reviews

Law360, New York (May 17, 2013, 4:30 PM EDT) -- The U.S. Food and Drug Administration on Friday laid out its criteria for medical devices that qualify for speedier approval, saying technology must address life-threatening or irreversibly debilitating conditions and represent a leap forward in health care.

In a guidance document, the FDA said it will grant so-called priority review to devices intended to tackle the most serious medical ailments if they represent breakthrough technology, would be the first treatment or diagnostic tool of their kind, improve significantly on existing devices, or provide benefits that would...
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