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Difference between revisions of "June 28, 2016 UDI Project Meeting"
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*Review Status DAM/Conceptual Model Ballot Document | *Review Status DAM/Conceptual Model Ballot Document | ||
*New Project Team member/author from the FDA | *New Project Team member/author from the FDA | ||
| + | *UDI for Adverse Events | ||
=Attendees:= | =Attendees:= | ||
Revision as of 15:57, 28 June 2016
Agenda - Unique Device Identifier Implementation Guidance Project Meeting, June 28, 2016
Contents
Contents
- Attendees
- Meeting Minutes - Next meeting
- 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
Attendees:
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:
- 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
