1997N-0484T
  

  
 Human Cells, Tissues, and Cellular and Tissue-Based Products; Donor Screening and Testing, and Related Labeling

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC1
  



  

  
Submitter : 
  

  
Miss. DAWN Hunt
  

  
Date & Time: 
  

  
08/03/2005 02:08:02
  



  

  
Organization : 
  

  
Fertility Alternatives, Inc
  



  

  
Category : 
  

  
Other Organization
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 There is no indication in your documents with regards to curable infectious diseases for tissue donors, such as Chlamydia (for oocyte donors). If a donor tests positive for a bacterial infection that can be cured by antibiotics, it should state that donors can qualify after treatment and they retest negative.