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Alias Born 09/09/2010

Re: None

Saturday, 09/11/2010 5:56:42 PM

Saturday, September 11, 2010 5:56:42 PM

Post# of 59551
"FDA does not do pre-clearance audits"...last paragraph of "Introduction". Overall facility audit in relation to previous clearance? Overall capability/compliance??
http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/premarketnotification510k/default.htm