2006N-0292
  

  
Unique Device Identification
  


  

  

  


  

  
FDA Comment Number : 
  

  
EC29
  



  

  
Submitter : 
  

  
Mr. David Mrak
  

  
Date & Time: 
  

  
10/25/2006 08:10:43
  



  

  
Organization : 
  

  
BioPro
  



  

  
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 
  


  

  



  

  
If you use the HIBC format, that is taken into consideration with the barcode already.
  


  

  



  

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


  

  



  

  
We use the HIBC standard, we supply the unique company identifier, the item number, qty, serial number and sterilization date.
  


  

  



  

  
How should a unique device identification system be developed?
  


  

  



  

  
 In the absence of any regulatory requirements, many have used the "Health industry bar code"  HIBC.   This format contains most of the proposed information.   In keeping with this format, little change would be required for most already participating with the HIBC format.

  


  

  


  

  


  

  
Should unique device identifiers be considered for all devices? 
  


  

  



  

  
 The identifier should be the companies product number.   Having to register a product number to a requlatory agency to receive a unique identifier number for your product will be burdensome, cost money and delay release of innovative product.   And like all regulatory processes, there will eventually be a charge for the service, which is not welcome.

  


  

  


  

  


  

  



  

  
What are the barriers for establishing unique device 
  


  

  



  

  
 Regulations that burden small business.   Requirements developed by large corporations that make it harder for smaller companies to comply, or make it convenient for larger companies, but not so convenient for smaller companies.

  


  

  


  

  


  

  
What are the incentives for establishing a uniform, standardized 
  


  

  



  

  
 We do not need an incentive.  I think the industry is waiting for a uniform standard, the HIBC is proof of that.   However, a disincentive is allowing large corporations to dictate the format.

  


  

  


  

  



  

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


  

  



  

  
The system should be voluntary.   Hospital use and industry will force companies to comply.
  


  

  


  

  
What solutions have you developed or could be developed for 
  


  

  








  

  
 Standard equipment already exist.  The largest issue is with the hospitals.  Many are not prepared for read the barcode or RFID.   Industry could be forced to add the UDI, yet most hospitals would not be able to take advantage.