2006D-0347 Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
FDA Comment Number : EC6
Submitter : Dr. Jon Rosenblatt Date & Time: 10/25/2006 08:10:37
Organization : Dr. Jon Rosenblatt
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
Pleas provide a definition of "proprietary". Please provide specific examples of "assays" that would be covered. Would the IVDMIA almost always be computer generated? Would "interpretations" on lab reports and printed or on-line "interpretive guides" be included?, What is the difference between a laboratorian derived "consultative" report and the algorithm discussed in the draft? Please be aware that individual laboratories may not have the resources to conduct large scale clinical studies which might be required to validate in-house developed IVDMIAs as required by the FDA.