2006N-0292
  

  
Unique Device Identification
  


  

  

  


  

  
FDA Comment Number : 
  

  
EC5
  



  

  
Submitter : 
  

  
Mr. Kevin Ham
  

  
Date & Time: 
  

  
08/18/2006 03:08:49
  



  

  
Organization : 
  

  
Directed Light
  



  

  
Category : 
  

  
Device Industry
  



  

  
Issue Areas/Comments 
  


  

  


  

  
 Developing a System of Unique Device Identifiers (UDI)

  


  

  


  

  



  

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


  

  



  

  
see above
  


  

  



  

  
Have you implemented some form of UDI in your product line? 
  


  

  



  

  
 At my last job we implementated a UDI on a CHF class III device using laser marked silicone ID tags overmolded into the structure of the device. The information was only a serial number but this could be used for full traceability.  

  


  

  


  

  


  

  
How should a unique device identification system be developed?
  


  

  



  

  
 Do what you are doing by reaching out to industry for answers. There are several technologies out there. See http://www.orbidcorp.com/ for an example.  

  


  

  


  

  


  

  
Should unique device identifiers be considered for all devices? 
  


  

  



  

  
 NO! Gloves were sited as an example in your article. Were you kidding? UDI's should only be required on implantable devices and/or those units that could cause death or serious injury if traceability would not otherwise be available.

  


  

  


  

  


  

  
What are the barriers for establishing unique device 
  


  

  



  

  
 Laser marking would be ideal for this application due to the ability to mark on a small sacle and avoid the use of inks which are often not durable enough for the human body. Unfortunately, these systems are a high cost item. 

  


  

  


  

  



  

  
What are the incentives for establishing a uniform, standardized 
  


  

  



  

  
Desire for patient safety would have to offset the high process cost of machinery to enable UDI implementation. 
  


  

  


  

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


  

  



  

  
 The FDA should develop the criteria defining what medical devices should have UDI's as well as exemption guidelines such as available footprint to mark (e.g: Class III larger than x.xx"). System may start out as voluntary and become mandatory at a later date?

  


  

  


  

  


  

  
What solutions have you developed or could be developed for 
  


  

  








  

  
see first response box