UDI Process Overview
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).
FDA UDI Process
1. The UDI is created through a new FDA 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 FDA UDI submission.
▪ Set the FDA UDI submission to a Failed state.
▪ Set the FDA UDI submission to a Closed state.
◦ Failed FDA UDI submission: If the FDA UDI 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. |
UDI Super Set
1. The UDI Super Set is created through a new UDI.
2. A user in the UDI Creator role receives a task to edit the UDI Super Set data as needed.
3. After the UDI Creator completes the edits and clicks Finish, the system validates the UDI. 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 state when complete. Reviewers approve UDI Super Sets individually or in bulk.
5. After the reviewer approves the UDI Super Set, it moves to the Closed state.
