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CDRH matrix team likely to be scrapped

This article was originally published in The Silver Sheet

Executive Summary

Two years after going live, CDRH's matrix team - a structure of network leaders tasked with keeping pre- and post-market offices communicating - is likely on its way out. "We did an internal assessment of the matrix structure and concluded it is probably not the best organization [for us] right now," CDRH Director Jeffrey Shuren said at a June 22 FDA "town hall" meeting in Woburn, Mass., noting that the matrix "is very challenging to maintain." CDRH plans to issue a report soon that will explore alternative organizational options, he said. The matrix brings together pre-market reviewers, adverse event analysts, scientific researchers and others to evaluate safety risks for different device types ("The Silver Sheet" September 2009). Although the matrix may not be the answer, Shuren affirmed that the goal of breaking down barriers between "siloed" groups within the center is correct. He cited the recent creation of two new deputy director positions in the Office of the Center Director, one for science and one for policy, as a step toward greater alignment on those issues throughout CDRH's various offices. Those posts have yet to be filled, however

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