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Utilizing GS1 Standards to Implement and Comply with FDA UDI Requirements
Utilizing GS1 Standards to Implement and Comply with FDA UDI Requirements


 
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Product Code: WB-7049
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About the Product
Contains video file.


In July of 2012, the FDA released drafted regulations that will require the implementation of a national unique device identification (UDI) system, aiming to improve safety and efficiency in US healthcare systems. The concept of this system has the potential to be effective only if UDI is captured, stored, integrated and exchanged by all stakeholders in the US and abroad. GS1 healthcare, a diversified global healthcare group which aims to develop and implement global standards by bringing together experts in healthcare to enhance patient safety and supply chain efficiencies, has applauded the FDA’s steps toward improving patient safety through UDI’s. Implementing this system on a global scale is sure to be quite complex for both manufacturers and regulators and becoming a member of a Standards Development Organization such as SG1 can assist in overcoming challenges. The following presentation discusses critical points within the UDI system and highlights how the GS1 system of standards is meeting them.
  • Status update and guidance on global UDI and traceability
  • Understanding the intricacies of the UDI system
    • Differentiating device and product indicators
    • UDID
    • AIDC
  • Allocation of UDI codes
    • Defining what products require UDI
    • Coding for product accessories/product packs
    • Delegating internal responsibilities for code maintenance
  • Label preparation
  • Strategies and methods for internal preparation
  • Potential UDI implementation timeline and compliance requirements

Speakers:
Géraldine Lissalde-Bonnet
Public Policy Manager
GS1

Ulrike Kreysa
Vice-President, Healthcare
GS1

Chuck Biss
Senior Director, AIDC Healthcare
GS1

Pete Alvarez
Senior Director, Industry Engagement, GDSN & GLN Service
GS1


Target Audience

  • Quality Assurance
  • Regulatory Affairs

Target Industry
  • Medical Device
  • Diagnostic


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