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Difference between revisions of "March 23, 2016 UDI Project Meeting"

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(Created page with "Minutes - Unique Device Identifier Implementation Guidance Project Meeting, March 23, 2016 =Contents= #Attendees #Meeting Minutes - Approve March 8, 2016, March 16, 2016 #M...")
 
 
(14 intermediate revisions by the same user not shown)
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#Action Items
 
#Action Items
 
##Finish Ballot
 
##Finish Ballot
 +
 +
=Attendees:=
 +
* Patrick
 +
* Marti
 +
* Steve
 +
* Beth Pumo
 +
* MaryKay McDaniel
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* Myron
 +
* Terrie
 +
* Nancy
 +
* Jose
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* Jan Wittenber
 +
 +
=Meeting Minutes:=
 +
* March 8, 2016, Marti/Steve to approve as distributed, vote for: 7, against: 0, abstain: 0
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* March 16, 2016, Marti/MaryKay to approve as corrected, and posted to the wiki, vote for: 7, against: 0, abstain: 0
 +
 +
=Meeting Discussion:=
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*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
 +
 +
*Scope: Jose to put together exclusion list
 +
*Marti will start open discussion about scope on listserv
 +
 +
=Action Items:=
 +
*Create parking lot, grab some items to use case spreadsheet (Patrick)
 +
*Start discussion scope limiting factors (Jose)
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*Submit outline for first content deadline (Patrick)
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*Complete ballot R1 (Patrick)
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 +
=Next Meeting:=
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*Tuesday, March 30, 2016, Noon - 1:00PM EDT
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*Phone: +1 770-657-9270, Passcode: 398652
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*WebEx: https://fda.webex.com/fda/j.php?MTID=m40a6a072d9e4b354bb99222e7b0a04af
 +
**Meeting number: 741 298 577
 +
**Meeting password: 123456

Latest revision as of 16:50, 22 March 2016

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
  • Scope: Jose to put together exclusion list
  • Marti will start open discussion about scope on listserv

Action Items:

  • Create parking lot, grab some items to use case spreadsheet (Patrick)
  • Start discussion scope limiting factors (Jose)
  • Submit outline for first content deadline (Patrick)
  • Complete ballot R1 (Patrick)

Next Meeting:

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