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 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 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?