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.

The basic concept is that if the FDA is comfortable that the manufacturing site meets ISO quality standards, it can “leverage” — the FDA’s term — off of those audits and allow the agency...
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