2006N-0292
  

  
Unique Device Identification
  


  

  

  


  

  
FDA Comment Number : 
  

  
EC27
  



  

  
Submitter : 
  

  
Mr. Gregor Stock
  

  
Date & Time: 
  

  
10/19/2006 02:10:15
  



  

  
Organization : 
  

  
VDDI Association of German Dental Industry
  



  

  
Category : 
  

  
Device Association
  



  

  
Issue Areas/Comments 
  


  

  


  

  
 Developing a System of Unique Device Identifiers (UDI)

  


  

  


  

  



  

  
How should a unique device identification system be developed?
  


  

  



  

  
 The attributes of an UDI are ideally those from existing national and international standards, accepted world wide already. 1)The key standard for "Unique Identifiers" ISO/IEC 15459 is being under maintenance for extension global uniqueness for ITEMS, PRODUCTS, TRANSPORT UNITS, RETURNABLE UNITS and GROUPS of ENTITIES. Issuing Agencies as HIBCC/EHIBCC, GS1, Dun & Bradstreet and about 20 others supply unique Company and Labeler Identifications Codes for acheaving unique UDI's. This UDI specification ISO/IEC 15459 ise useful for a) Barcode b) 2-dimensional symbols c) RFID (ISO/IEC 18000 series) 2) In addition to it ISO/IEC 15418 GS1 Application Identifiers and ASC MH 10 Data Identifiers is the relevant attribut for identifying the data elements and its content. 3) DOD "UID strategy" includes same attributes (Department of Defense Guide to Uniquely Identifying Items, version 1.5, June 7, 2005.) 

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  



  

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


  

  



  

  
 FDA should refer to the ISO and ISO/IEC standards covering UID because ANSI and the other national bodies achieved world wide operability for it. FDA should take a voluntary role supplying guidance how to use the full scope of the ISO standards where GS1, HIBC and ASC structures are included, relevant for Health Care.