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Expert Analysis

FDA: Show Us Your ISO Audit And We May Leave You Alone

Law360, New York (May 18, 2012, 1:21 PM EDT) -- Beginning June 5, 2012, the U.S. Food and Drug Administration (FDA) will allow medical device companies to participate in a pilot program that will allow firms to seek a one-year reprieve from FDA inspections by voluntarily submitting recent International Organization for Standardization (ISO) 13485 audit reports and additional data to the agency....

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