In a March blog white paper, the Institute for Critical Infrastructure Technology suggested tougher FDA action.
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Two Big Moves at FDA(3)
http://www.xkssw.com 时间:2016-11-28 16:10来源:互联网
(1) eliminate “essential clinical performance” from the document and instead focus on maintaining device functionality and safety," (2) provide more information about Information Sharing and Analysis Organizations, and (3) "continue to rely on consensus standards" such as the National Institute for Standards and Technology’s framework for improving clinical infrastructure.