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March 23, 2016 UDI Project Meeting
Minutes - Unique Device Identifier Implementation Guidance Project Meeting, March 23, 2016
Contents
Contents
- Attendees
- Meeting Minutes - Approve March 8, 2016, March 16, 2016
- Meeting Discussion
- Review Technical Artifacts to be created for ballot
- Review DAM/Conceptual Model Ballot Outline
- Action Items
- Finish Ballot
Attendees:
- Patrick
- Marti
- Steve
- Beth Pumo
- MaryKay McDaniel
- Myron
- Terrie
- Nancy
- Jose
- Jan Wittenber
Meeting Minutes:
- March 8, 2016, Marti/Steve to approve as distributed, vote for: 7, against: 0, abstain: 0
- March 16, 2016, Marti/MaryKay to approve as corrected, and posted to the wiki, vote for: 7, against: 0, abstain: 0
Meeting Discussion:
- Structured Documents call to discuss CCDA, UDI components and/or mods next week 3/31, 10AM EDT, get links
- Scope: exclude devices
- Scope: not explantation
- Scope: verbiage about replacement - specifically implantation, updates, the implantion part of the explantation with or *Scope: without replacement
- Scope: not include wrong identifier
- Scope: no catalog of products
- 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
Action Items:
- Submit outline for first content deadline (Patrick)
- Complete ballot R1 (Patrick)
Next Meeting:
- Tuesday, March 30, 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