• Decrease
  • Normal
  • Increase
U.S. Department of Health and Human Services

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: DELAYED

Milestone DescriptionMilestone DateMilestone StatusMilestone 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

Completed 5/31/2013

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

Completed 5/31/2013

E. Complete Production-Ready UDI Database

4/15/2013

6/30/2013

Completed 7/15/2013

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

Completed 7/15/2013

F. Ongoing UDI Operations & Maintenance

12/31/2017

Life of the Project

On Track

1. CDRH Submission of Acquisition Package for Bilateral Contract Modification for UDI Operations & Maintenance

2/15/2013

Completed 3/19/2013

2. Modification Negotiation and Executed - Finalized by OAGS

4/15/2013

Completed 3/19/2013

3. Ongoing UDI Operations & Maintenance

12/31/2017

Life of the Project

On Track

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - 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.