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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.

Bioresearch Monitoring Inspections of In Vitro Diagnostic Devices
Internet:http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074893.htm
Origin/Publisher:FDA, ORA, CDRH, CBER
Content:The purpose of this document is to provide a written reference for FDA Investigators conducting bioresearch monitoring inspections involving in vitro diagnostic devices
Document Type:Guide to Inspections