Friday, April 20, 2012

FDA Finalizes Benefit-Risk Determination Methodology for Certain Medical Devices

In the News...


FDA Finalizes Benefit-Risk Determination Methodology for Certain Medical DevicesIn an attempt to improve the predictability, consistency and transparency of the medical device review process, the U.S. Food and Drug Administration (FDA) released final guidance describing the principal factors the agency will consider when making benefit-risk determinations during the premarket approval and de novo classification processes, respectively.
 
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