2006N-0292
  

  
Unique Device Identification
  


  

  

  


  

  
FDA Comment Number : 
  

  
EC1
  



  

  
Submitter : 
  

  
Dr. Jonathan Black
  

  
Date & Time: 
  

  
08/15/2006 03:08:23
  



  

  
Organization : 
  

  
Clemson University, Clemson, SC
  



  

  
Category : 
  

  
Academia
  



  

  
Issue Areas/Comments 
  


  

  


  

  
 Developing a System of Unique Device Identifiers (UDI)

  


  

  


  

  



  

  
At what level of packaging (that is, unit of use) should UDIs be 
  


  

  



  

  
 UDIs should appear on the device and in a label form that may be inserted into a patient's permanent medical record.  In regard to the latter form, both optical and electronically readable forms should be considered

  


  

  


  

  



  

  
Should unique device identifiers be considered for all devices? 
  


  

  



  

  
 UDIs should be developed through a public/private consensus process and should be mandatory for all devices intended to be used for periods exceeding 30 days.

  


  

  


  

  


  

  
What are the incentives for establishing a uniform, standardized 
  


  

  



  

  
 One of the biggest defects in the US medical (non-) system is the absence of long-term use and outcomes data for chronic (greater than 30 days) medical device usage.  The implementation of UDIs would be a great enabler to the further development of reliable device data bases.

  


  

  


  

  



  

  
What should be the role, if any, of FDA in the development and 
  


  

  



  

  
Mandatory for all devices expected to be used for more than 30 days; voluntary for all others.