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June 28, 2016 UDI Project Meeting

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


  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


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).

Action Items:

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: