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. ON TRACK ON TRACK A. Complete Detailed Business Requirements and Alternative Analysis 6/30/2011 Completed 6/30/2011 sub 1. CDRH Submission of Acquisition Package for Development of Detailed Business Requirements and Alternative Analysis 11/15/2010 Completed 11/15/2010 sub 2. Modification Negotiated and Executed - Finalized by OAGS 2/28/2011 Completed 3/31/2011 sub 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 sub 1. CDRH Submission of Acquisition Package for the Development of the UDI Database and Internal User Testing 3/15/2011 Completed 3/15/2011 sub 2. Modification Negotiated and Executed - Finalized by OAGS 9/1/2011 Completed 9/1/2011 sub 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 <i>(10/13/2012)</i> Completed 10/13/2012 sub 1. CDRH Submission of Acquisition Package for Bilateral Contract Modification for External User Testing 3/15/2011 Completed 3/15/2011 sub 2. Modification Negotiated and Executed - Finalized by OAGS 4/15/2012 Completed 4/1/2012 sub 3. Completion of External User Testing 7/15/2012 <i>(10/31/2012<i> Completed 10/13/2012 D. Complete Application Bug Fixes and Enhancements 1/15/2013 <i>5/31/2013</i> On Track sub 1. CDRH Submission of Acquisition Package for Bilateral Contract Modification for Bug Fixes and Enhancements 3/15/2011 Completed 3/15/2011 sub 2. Modification Negotiated and Executed - Finalized by OAGS 7/15/2012 Completed 4/1/2012 sub 3. Completion of Bug Fixes and Enhancements 1/15/2013 <i>5/31/2013</i> Not Yet Started Complete Production-Ready UDI Database 4/15/2013 <i>6/30/2013</i> On Track sub 1. CDRH Submission of Acquisition Package for Bilateral Contract Modification for UDI Final Implementation 3/15/2011 Completed 3/15/2011 sub 2. Modification Negotiation and Executed - Finalized by OAGS 1/15/2013 Completed 4/1/2012 sub 3. Complete Production-Ready UDI Database 4/15/2013 <i>6/30/2013</i> Not Yet Started F. Ongoing UDI Operations & Maintenance 12/31/2017 <i>Life of the Project</i> Not Yet Started sub 1. CDRH Submission of Acquisition Package for Bilateral Contract Modification for UDI Operations & Maintenance 2/15/2013 Not Yet Started sub 2. Modification Negotiation and Executed - Finalized by OAGS 4/15/2013 Not Yet Started sub 3. Ongoing UDI Operations & Maintenance 12/31/2017 <i>Life of the Project</i> Not Yet Started http://www.fda.gov/AboutFDA/Transparency/track/ucm203038.htm FDA-TRACK CDRH Dashboard ਍††਍਍਍਍਍਍਍