|FDA Finalizes Benefit-Risk Determination Methodology for Certain Medical Devices|
|Written by MWE.com|
|Monday, 30 April 2012 06:32|
In an attempt to improve the predictability, consistency and transparency of the medical device review process, the U.S. Food and Drug Administration (FDA) recently 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. In this newsletter, we provide a brief summary of the final guidance document and describe some of its implications.
Read the full article here.
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