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HUG Regulatory/Government Affairs Team
Jackie Elkin, Medtronic June 20, 2005
Objectives
Organize the Industry Around a Single Position to Influence Future Regulations
Work with Existing Healthcare Industry Organizations in Delivering the Position of HUG
AdvaMedMedical AlleyOthers
Scope
Standard Product Auto-
Identification
Medical Devices and
Pharmaceuticals
International, National, Regional
Laws, Regulations, Standards
DeliverablesProvide Baseline of Applicable Laws, Regulations, Standards
Development of One Global GS1 Standard as the Industry Response
Provide guidance on current baseline
Organize the Education and Lobbying around the Preferred Single Solution to Regulatory Agencies
Provide guidance on Healthcare organizations to approach
Timeline
August – Identify Industry Focus Groups to Approach
September – Provide Baseline Set of Applicable Laws, Regulations, Standards