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The annual UDI Conference is the ONLY event dedicated to guidance and training for those impacted by the new UDI Regulation:

  • Medical device manufacturers
  • Health care distributors
  • Group purchasing organizations
  • Hospitals and health care providers
  • Health care industry professionals
The FDA UDI Regulation establishes a single device identification system that is consistent, unambiguous, standardized, and globally harmonized. All manufacturers of medical devices will be required to comply with the new UDI methodology.

Learn how device manufacturers, distributors, and hospitals will be able to facilitate the following with a UDI system:


  • Reduction of Medical Errors
  • Supply Chain management
  • Utilization of UPN and PDU data
  • Recall of Medical Devices
  • Improved Medical Device Reports (MDRs)
  • Preventing Allergic Reactions to Devices
  • Identification/Reduction of Product Counterfeiting
  • More Efficient Purchasing
  • Improved Inventory Control
  • Enhanced Medical Device Asset Utilization
  • Efficient Reimbursement
  • Identification of Compatibility Issues
  • Enhancements in Post-Market Surveillance

You can also explore the technology behind UDI in the exhibits area where you can learn about the solutions for your UDI implementation.


 

Important Announcements & Links

The Final FDA UDI Regulation was announced at the 2013 UDI Conference held in September 2013 in Baltimore, MD. To access the PDF version of the Final UDI Regulation, please visit: https://www.federalregister.gov/articles/2013/09/24/2013-23059/unique-device-identification-system

FDA Announces Three Accredited Issuing Agencies for assignment of UDIs according to the Final Rule:

GS1
http://www.gs1.org

Health Industry Business Communications Council (HIBCC)
http://www.hibcc.org

ICCBBA
http://www.iccbba.org

June 25, 2014 - FDA releases the Complete Global Unique Device Identification Database (GUDID): Guidance for Industry. Click here to view.

   
 
   
 
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