Draft Guidance for Industry and Food and Drug Administration Staff; In Vitro Diagnostic Multivariate Index Assays; Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance entitled "In Vitro Diagnostic Multivariate Index Assays." FDA is issuing this revised draft guidance to address the definition and regulatory status of a class of In Vitro Diagnostic Devices referred to as In Vitro Diagnostic Multivariate Index Assays (IVDMIAs). The revised draft guidance also addresses premarket and postmarket requirements with respect to IVDMIAs. The initial draft of this guidance was issued September 7, 2006.