1WorldSync Obligations

1WorldSync will assist Suppliers in complying with the FDA’s requirements of submitting content to the FDA GUIDID system. This service assists the healthcare supplier with education, guidance and testing support to successfully connect the FDA GUIDID electronically, leveraging their GDSN content.

Client Obligations

• – Provide medical Device information.
• – Submit an FDA Helpdesk. It is the client to submit a test scenario certification. Issues with DUNs, Third Party submitter DUNS or other information pertaining to the GUDID account.

Scope/Tasks

• – Connecting GDSN content to the FDA GUIDID system
• – UDI Attribute Mapping Document
• – Education & Training- 3 hours
• – FDA GUIDID Account Setup & Testing Support
• – User Acceptance Testing Support- up to 10 hours
• – Post Go-Live Support- 2 hours support