Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
Industry and FDA prioritize 180-day PMA goal: FDA will prioritize its goal of making a decision within 180 days on 50% of PMAs and panel-track PMA supplements received in fiscal 2007, even if that means not meeting its 150-day cycle goal for PMAs, under a recent agreement with AdvaMed, the Medical Device Manufacturers Association and National Electrical Manufacturers Association. The 1agreement stems from a May 22 public hearing - mandated by MDUFMA - during which FDA indicated that it likely would not be able to reach its PMA stretch goal (i.e. the 180-day goal) in 2007 due to the time required to meet the major deficiency letter goal (i.e. the 150-day goal) (2"The Gray Sheet" May 29, 2006, p. 3). The agreement only relates to the review of non-expedited original PMAs, according to FDA...
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