Law360, New York ( August 4, 2014, 10:45 AM EDT) -- A couple of weeks ago the U.S. Food and Drug Administration issued draft guidance, the "Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)] with Different Technological Characteristics." This draft guidance seems based on the final guidance issued over a year ago, "Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications."...
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