2006D-0347 Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
FDA Comment Number : EC5
Submitter : Dr. Roland Stoughton Date & Time: 10/18/2006 10:10:41
Organization : GHC Technologies, Inc.
Category : Device Industry
Issue Areas/Comments
In the second of the three characteristics listed as defining IVDMIAs, is the word "proprietary" essential? In other words, if all the information were publicly published, but the other criteria were met, would the assay still be an IVDMIA?