June 28, 2016 UDI Project Meeting

Agenda - Unique Device Identifier Implementation Guidance Project Meeting, June 28, 2016

Contents

1. Attendees
2. Meeting Minutes - Next meeting
3. Meeting Discussion

• Review Schedule for Summer/Fall leading to January 2017 Ballot Cycle
• Review Status DAM/Conceptual Model Ballot Document
• New Project Team member/author from the FDA
• UDI for Adverse Events

Meeting Minutes:

Last minutes ready later this week. Will review both next meeting

Meeting Discussion:

• Review Schedule:

• 6/30/2016 Add new primary author for DAM
• 7/26/2016 Next project meeting - Status DAM
• 8/30/2016 Project meeting - Status DAM, Any issues for WGM
• 9/17-23/2016 Baltimore WGM and Plenary
• 10/2/2016 Announcement of peer review which starts 10/23
• 10/23/2016-11/6/2016 2 week peer review
• 11/6/2016 Final Day for submission of peer review comments
• 11/8/2016 Project meeting, Reconciliation of peer review comments
• 11/13/2016 Ballot submission - initial content
• 11/15/2016 Possible project meeting if reconciliation not complete on 11/8
• 11/21/2016 Start of 2 weeks for changes to DAM doc to address reconciled issues from peer review
• 11/29/2016 Project Meeting - Final document approval
• 12/4/2016 Ballot submission – final content

• Review Status DAM/Conceptual Model Ballot Document

Not making tremendous progress. Turning over primary authorship on 6/30 after previous author completes current thoughts

• New Project Team member/author from the FDA

Not really a new member to the project team; he's been here for a number of weeks. However, turnover of primary authorship of DAM document from Patrick to Bob later this week (6/30/2016).

Parking Lot

• Add to Parking lot: how to fix an incorrect identifier
• Add to Parking lot: supply chain
• Add to Parking lot: directives in Europe to check identifier, before implantation

Next Meeting:

• Tuesday, July 26, 2016, Noon - 1:00PM EDT
• Phone: +1 770-657-9270, Passcode: 398652
• WebEx: https://fda.webex.com/fda/j.php?MTID=m40a6a072d9e4b354bb99222e7b0a04af
  • Meeting number: 741 298 577
  • Meeting password: 123456