Business · 07/09/2006

FDA Releases Draft Guidance on In Vitro Diagnostic Multivariate Index Assays

The Food and Drug Administration (FDA) has published a draft guidance document outlining the regulatory status and requirements for In Vitro Diagnostic Multivariate Index Assays (IVDMIAs), which are used to diagnose diseases or conditions, and will provide clarity on premarket and postmarket requirements for these devices.