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FDA Will Not Meet Proposed PMA Review Goal; Industry Expresses Frustration

This article was originally published in The Gray Sheet

Executive Summary

CDRH says it cannot meet MDUFMA's so-called "PMA stretch" goal for fiscal year 2007, which requires the agency to issue approvable decisions for at least 50% of premarket applications within 180 days

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Regulatory News In Brief

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...

Regulatory News In Brief

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...

Industry Favors Predictability Over Speed In Next Round Of MDUFMA

Senior device industry staffers are more interested in improving the predictability of FDA's premarket review process than pushing the agency to accelerate its performance, an FDA 1report suggests

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