March 23, 2016 UDI Project Meeting

Minutes - Unique Device Identifier Implementation Guidance Project Meeting, March 23, 2016

Contents

1. Attendees
2. Meeting Minutes - Approve March 8, 2016, March 16, 2016
3. Meeting Discussion
   1. Review Technical Artifacts to be created for ballot
   2. Review DAM/Conceptual Model Ballot Outline
4. Action Items
   1. 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