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Import safety strategy paramount for CDRH in '09

This article was originally published in The Silver Sheet

Executive Summary

Creating and implementing an import safety strategy for medical devices tops CDRH's list of priorities for the current 2009 fiscal year, center director Dan Schultz says. Last November, the Bush administration unveiled a national import safety action plan with broad recommendations, along with some short- and long-term steps to address mounting concerns about the safety of food and medical and consumer products coming from overseas, particularly China. So far, the Department of Health and Human Services has signed two memoranda of agreement with China to enhance the safety of a wide variety of medical devices, drugs, food and feed traded between the two nations, while Congress attempts to tackle import safety through legislation. "I think it's relatively obvious why that has to be done, and obviously it's something that we're doing in conjunction with the rest of the agency," Schultz said Sept. 15 at the Regulatory Affairs Professionals Society (RAPS) annual meeting in Boston
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