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Import Safety Tops FDA Device Center’s FY 2009 Priorities

This article was originally published in The Gray Sheet

Executive Summary

Creating and implementing an import safety strategy for medical devices tops CDRH's list of priorities for the coming year, center director Dan Schultz announced last week

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FDA Commissioner Margaret Hamburg and staff met with the commissioner of China's State Food and Drug Administration, Shao Mingli, Aug. 11 to review the progress made to date on the U.S.-China mutual agreement on device and drug safety, signed in 2007 (1"The Gray Sheet" Sept. 22, 2008). The commissioners also discussed ways to further strengthen cooperation on device and drug safety supervision, particularly in the areas of supply chain security and product quality and safety, according to an FDA spokeswoman

FDA/China talks

FDA Commissioner Margaret Hamburg and staff met with the commissioner of China's State Food and Drug Administration, Shao Mingli, Aug. 11 to review the progress made to date on the U.S.-China mutual agreement on device and drug safety, signed in 2007 (1"The Gray Sheet" Sept. 22, 2008). The commissioners also discussed ways to further strengthen cooperation on device and drug safety supervision, particularly in the areas of supply chain security and product quality and safety, according to an FDA spokeswoman

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The effects of FDA's effort to regulate certain software that interfaces with medical devices may not be as far-reaching as some manufacturers fear, the agency says

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