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.

Draft Guidance for Industry, Clinical Laboratories, and FDA Staff In Vitro Diagnostic Multivariate Index Assays DRAFT GUIDANCE
Internet:	http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm071455.pdf
Origin/Publisher:	Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, http://www.fda.gov/
Content:	This draft guidance addresses the definition and regulatory status of a class of In Vitro Diagnostic Devices referred to as In Vitro Diagnostic Multivariate Index Assays (IVDMIAs).
Document Type:	Guidance for Industry DRAFT