Working with Unique Device Identification
The Unique Device Identification (UDI) module allows users to comply with the Part 830 medical device regulation for the UDI submission process. Users can electronically submit unique device identifiers for their medical devices and device packages to the Food and Drug Administration (FDA) Global Unique Device Identification Database (GUDID).
The UDI feature in Windchill allows users to do the following:
• Create, edit, and review their UDIs
• Generate Health Level 7 (HL7) documents populated with UDI information
• Submit UDIs to the FDA GUDID database through an electronic gateway
• Manage and monitor UDI electronic submissions, including history and follow-ups
Creating UDIs
UDIs can be added to Windchill in two ways:
• Created in Windchill
• Imported from a spreadsheet
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• A UDI submission can be created independently, without being associated with a part.
• A submission can only be linked to one part in Windchill; however, a single part can be associated with multiple submissions.
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UDI Process Overview
1. The UDI is created through a new UDI submission or by importing it from a spreadsheet.
2. A user in the UDI Creator role receives a task to edit the UDI and edits the UDI data as needed.
3. After the UDI Creator completes the edits and clicks Finish, the system validates the submission against published FDA UDI rules. The system then sends the UDI package to a user in the UDI Approver role.
4. The UDI Approver opens the task and the attached report for review. After approval, the UDI advances to the next reviewer or the Submission state when complete. Reviewers approve the UDI using an e-signature.
5. After the reviewer approves the UDI, the system submits the HL7 document to the FDA using the Electronic Submissions Gateway (ESG).
◦ Successful submissions: After the system receives three successful acknowledgements from the FDA, the UDI task moves to the Closed state. Users can then create a follow-up version of a closed UDI task.
◦ Delayed submissions: If the submission is delayed, a user in the Library Manager role receives a task to do one of the following:
▪ Wait for four hours
▪ Resubmit the UDI submission
▪ Set the submission to a Failed state
▪ Set the submission to a Closed state
◦ Failed submissions: If the submission fails, a user in the UDI Creator role receives a task to resolve the submission by editing the document and resubmitting it for approval.
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The FDA system can take up to four hours before sending acknowledgement #2 or #3. If you do not receive a response within that time, send an email to the FDA at guidsupport@fda.hhs.gov with the Primary Device Identifier. Do not resubmit the UDI until the submission fails or the FDA instructs you. For instructions, see Resolving Delayed UDI Submissions. |
