2006D-0347
  

  
 Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC8
  



  

  
Submitter : 
  

  
Dr. Steven Linke
  

  
Date & Time: 
  

  
11/14/2006 08:11:21
  



  

  
Organization : 
  

  
Prediction Sciences
  



  

  
Category : 
  

  
Device Industry
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
See Attachment
  


  

  



  

  
2006D-0347-EC8-Attach-1.PDF