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.

Inspections of Medical Device Manufacturers
Internet:	http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM244277.pdf
Origin/Publisher:	FDA
Content:	This guide was prepared to address concerns about consistency and uniformity of inspection between the domestic and foreign inspection programs. Consistency and uniformity of inspection and enforcement represent high priority goals for the Office of Regulatory Affairs (ORA). This guide sets forth clear instructions regarding the approach to the foreign inspection.
Status:	Compliance Guide
Document Type:	Compliance Guide