2005D-0330
  

  
 Guidance for Industry and FDA Review Staff on Collection of Platelets by Automated Methods

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC1
  



  

  
Submitter : 
  

  
Mr. Robert Currie
  

  
Date & Time: 
  

  
12/05/2005 05:12:35
  



  

  
Organization : 
  

  
Scott 
  



  

  
Category : 
  

  
Health Care Association
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 We collect double units from many of our donors.  We are concerned that the proposed limitation of 24 products per annum would cause a serious shortage of platelets.  We would rather that the current industry standard be followed and donors be allowed to donate 24 times per annum.  There is no evidence to indicate that this is a risk to the donor.