About FDA
Unique Device Identification Database (UDID)
Description: The creation of a UDID system will improve medical device safety by providing a mechanism for regulated entities subject to UDI to submit a core set of device-related identification information to the database. The contents of the database will provide a public, standard data source of consistent, unambiguous device product information. The establishment of the database, its operation and maintenance, and ongoing administration will require a coordinated effort between CDRH, the Office of Information Management (OIM), and the Office of Acquisitions & Grants Services (OAGS). This project will monitor the development of the UDI supporting database.
Briefing Status: ON TRACK
Prior Briefing Status: ON TRACK
| Milestone Description | Milestone Date | Milestone Status | Milestone Completion Date |
|---|---|---|---|
|
A. Complete Detailed Business Requirements and Alternative Analysis |
6/30/2011 |
Completed | 6/30/2011 |
|
1. CDRH Submission of Acquisition Package for Development of Detailed Business Requirements and Alternative Analysis |
11/15/2010 |
Completed | 11/15/2010 |
|
2. Modification Negotiated and Executed - Finalized by OAGS |
2/28/2011 |
Completed | 3/31/2011 |
|
3. Completion of Detailed Business Requirements and Alternative Analysis Phase |
7/29/2011 |
Completed | 7/29/2011 |
|
B. Complete UDI Database Development and Internal User Testing |
4/15/2012 |
Completed | 7/15/2012 |
|
1. CDRH Submission of Acquisition Package for the Development of the UDI Database and Internal User Testing |
3/15/2011 |
Completed | 3/15/2011 |
|
2. Modification Negotiated and Executed - Finalized by OAGS |
9/1/2011 |
Completed | 9/1/2011 |
|
3. Completion of Development of UDI Database and Testing |
4/15/2012 |
Completed | 7/15/2012 |
|
C. Complete External (industry) User Testing |
7/15/2012 (10/13/2012) |
Completed | 10/13/2012 |
|
1. CDRH Submission of Acquisition Package for Bilateral Contract Modification for External User Testing |
3/15/2011 |
Completed | 3/15/2011 |
|
2. Modification Negotiated and Executed - Finalized by OAGS |
4/15/2012 |
Completed | 4/1/2012 |
|
3. Completion of External User Testing |
7/15/2012 (10/31/2012 |
Completed | 10/13/2012 |
|
D. Complete Application Bug Fixes and Enhancements |
1/15/2013 5/31/2013 |
On Track | |
|
1. CDRH Submission of Acquisition Package for Bilateral Contract Modification for Bug Fixes and Enhancements |
3/15/2011 |
Completed | 3/15/2011 |
|
2. Modification Negotiated and Executed - Finalized by OAGS |
7/15/2012 |
Completed | 4/1/2012 |
|
3. Completion of Bug Fixes and Enhancements |
1/15/2013 5/31/2013 |
Not Yet Started | |
|
Complete Production-Ready UDI Database |
4/15/2013 6/30/2013 |
On Track | |
|
1. CDRH Submission of Acquisition Package for Bilateral Contract Modification for UDI Final Implementation |
3/15/2011 |
Completed | 3/15/2011 |
|
2. Modification Negotiation and Executed - Finalized by OAGS |
1/15/2013 |
Completed | 4/1/2012 |
|
3. Complete Production-Ready UDI Database |
4/15/2013 6/30/2013 |
Not Yet Started | |
|
F. Ongoing UDI Operations & Maintenance |
12/31/2017 Life of the Project |
Not Yet Started | |
|
1. CDRH Submission of Acquisition Package for Bilateral Contract Modification for UDI Operations & Maintenance |
2/15/2013 |
Not Yet Started | |
|
2. Modification Negotiation and Executed - Finalized by OAGS |
4/15/2013 |
Not Yet Started | |
|
3. Ongoing UDI Operations & Maintenance |
12/31/2017 Life of the Project |
Not Yet Started |
Key Projects Legend
| Milestone Status | Definition |
|---|---|
| Not Yet Started | Work for specific milestone has not yet been started. |
| Completed | Milestone and/or overall project is completed. |
| On Track | Milestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status. |
| On Hold | Milestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status. |
| Delayed | Milestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status. |
Glossary
Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.
