FDA Bioresearch Monitoring Inspections of In Vitro Diagnostic Devices

Title:
FDA Bioresearch Monitoring Inspections of In Vitro Diagnostic Devices

https://www.gmp-compliance.org/files/guidemgr/2016_Bioresarch_Monitoring_2.pdf

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

Go back