FDA Bioresearch Monitoring Inspections of In Vitro Diagnostic Devices
Title:
FDA Bioresearch Monitoring Inspections of In Vitro Diagnostic Devices
Origin/Publisher:
FDA, ORA, CDRH, CBER
Document Type:
Guide to Inspections
Content:
The purpose of this document is to provide a written reference for FDA Investigators conducting bioresearch monitoring inspections involving in vitro diagnostic devices