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.