The Office of In Vitro Diagnostic evaluation and Safety (OIVD) is holding a public meeting on In Vitro Diagnostic Multivariate Index Assays. The meeting is intended to provide a public forum during which OIVD will hear presentations and comments from interested stakeholders regarding the draft guidance entitled, “Draft Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays.” This draft guidance is intended to provide clarification on FDA’s approach to regulation of in vitro diagnostic multivariate index assays.
The public meeting will be held on February 8, 2007, from 8:00 a.m. to 5:00 p.m. at the Grand Ballroom of the Hilton Washington DC/Gaithersburg Hotel located at 620 Perry Parkway, Gaithersburg, Maryland, 20877.
