2006N-0292
  

  
Unique Device Identification
  


  

  

  


  

  
FDA Comment Number : 
  

  
EC2
  



  

  
Submitter : 
  

  
Mr. Sanford Brown
  

  
Date & Time: 
  

  
08/15/2006 03:08:39
  



  

  
Organization : 
  

  
Oridion medical 1987 Ltd.
  



  

  
Category : 
  

  
Device Industry
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 Early this year we questioned the FDA about requirements for adding RFID as a UDI to our products. Their answer was that a new 510k would be required. This answer before they have really studied and understood the subject imposes a heavy burden on device manufacturers who want to adopt the RFID technology. Getting this block to adoption out of the way should be one of the goals.