Medical Devices & Drugs: Regulatory Framework & Supply Chain Management in Emerging Economies
By: marketsandmarkets.com
Publishing Date: July 2012
Report Code: MD 1762
Recently, concerns have been raised, both within and outside of FDA, about whether the current 510(k) program optimally achieves its goals of fostering innovation while making safe and effective medical devices available to patients. In light of these concerns, and in keeping with the good government practice of periodically assessing the effectiveness of existing programs, FDA set about to identify problems and their root causes in a methodical manner. In September 2009, FDA launched a two-pronged, comprehensive assessment of the 510(k) process to determine whether changes should be made to the program so that it can better achieve its goals. Under the first part of the assessment, FDA created two staff working groups: one to review the 510(k) program and make recommendations to strengthen it; the other, to review how the Agency incorporates new science into its decision-making process, including our PMA program, and recommend how it can do so more predictably. The other part of this assessment is an independent evaluation by the Institute of Medicine (IOM), which is still underway.
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