Public comment response gc3

Connecting the Real World to the Digital World Developing a System of Unique Device Identifiers FDA Docket 2006N-0292 November 8, 2006 Background InfoGlyph USA Inc. is a provider of a closed system used for the identification, authen-tication and tracking of items. We connect the real world to the digital world through the technology. Our customers use the technology in various fields and applications, includ-ing automated pathology applications, automotive marking and tracking and security applications with an emphasis on authentication. The technology is robust and provides users with many features, permitting them to achieve key business objectives. The technology can be deployed via a wide range of delivery systems from direct printing to laser, the latter including both engraving and the use of laser marking materials. The recovery operation can be based on an inexpensive web camera and various hand held devices. To enable global deployment we have developed Internet based operations which only require a web camera and Internet access. 1. How should a unique device identification system be developed? What attrib-utes or elements of a device should be used to create the UDI? Careful consideration must be given to the system and the identifiers to insure that the multiple dimensions of the system architecture are fully considered. Fu-ture growth in new devices can be added to the system without causing problems for the system or its ...