FDA TO HOLD MEETING ON IN VITRO DIAGNOSTIC MULTIVARIATE INDEX ASSAYS

The FDA will hold a public meeting Feb. 8 on in vitro diagnostic multivariate index assays (IVDMIAs). The agency will hear presentations and comments regarding the "Draft Guidance for Industry, Clinical Laboratories and FDA Staff on In Vitro Diagnostic Multivariate Index Assays."

The draft guidance addresses the definition and regulatory status of IVDMIAs. It also addresses premarket and postmarket requirements with respect to IVDMIAs.

The comment period on the guidance closes March 5. Electronic comments on the draft guidance can be submitted to www.fda.gov/dockets/ecomments (http://www.fda.gov/dockets/ecomments).

The meeting will be held at the Hilton Washington D.C./Gaithersburg Hotel in Gaithersburg, Md. For more information, contact CDRH's Sousan Altaie at the following email address: Sousan.Altaie@fda.hhs.gov.