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Medical Glove Quality Thresholds Targeted In FDA Proposed Rule

This article was originally published in The Gray Sheet

Executive Summary

More stringent acceptance criteria for medical examination and surgeons' gloves would be established under a 1March 31 proposed rule aligning FDA requirements with international consensus standards

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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...

Medical Glove Proposed Rule Requires Labeling Statement, Expiration Dating

Medical gloves containing natural rubber latex (NRL) and/or powder would be required to bear in labeling cautionary statements indicating the actual level of glove powder, according to a proposed rule published by FDA in the July 30 Federal Register.

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