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Guideline

The following guideline can be ordered through the address listed in the "Source/Publisher"-category.
In cases in which you can order through the Internet we have established a hyperlink.

Guide to Bioresearch Monitoring Inspections of in vitro Diagnostic Devices
Internet:http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074893.htm
Origin/Publisher:FDA
Content:The purpose of this guide is do describe that bioresearch monitoring inspections is to ensure that data and information contained in premarket applications are scientifically valid and accurate.
Status:Guide
Document Type:Guide