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Epic
Documentation of Requirements iAGC Special Controls
Unassigned
Raza Panjwani
None
Won't Do
Jul 22, 2020
Aug 7, 2020
Task
[To Do] Determine whether and how to include Patient Preference Information (PPI) documentation in support of Submission
Unassigned
Raza Panjwani
None
Done
Jul 15, 2020
Nov 5, 2020
Task
[Section 07] Draft Statement of Non-Class III Device
Unassigned
Raza Panjwani
None
Done
Apr 21, 2020
Nov 5, 2020
Task
[SC 4] Documentation of Measures to Record Critical Events
Unassigned
Raza Panjwani
None
Duplicate
Apr 21, 2020
Jun 24, 2020
Sub-task
Review proposed outline for documentation
Unassigned
Raza Panjwani
None
Done
Apr 10, 2020
Apr 21, 2020
Task
[Q-Sub] Draft April Q-Submission Cover Letter and Request for Feedback Questions
Unassigned
Raza Panjwani
None
Done
Apr 2, 2020
Jun 18, 2020
Task
[Q-Sub] Draft iCGM Sensitivity Analysis Plan
Unassigned
Raza Panjwani
High (4)
Done
Apr 2, 2020
Jun 18, 2020
Task
[Q-Sub] Draft Diabetes Metabolic Model
Unassigned
Raza Panjwani
High (4)
Done
Apr 2, 2020
Jun 18, 2020
Task
[Q-Sub] Draft iCGM Simulator Assumptions
Unassigned
Raza Panjwani
High (4)
Done
Apr 2, 2020
Jun 18, 2020
Task
[Q-Sub] Finalize Draft HF Testing Protocol with CoreHF
Unassigned
Raza Panjwani
High (4)
Done
Apr 2, 2020
Jun 18, 2020
Task
[Q-Sub] Draft Bolus Calculator Documentation
Unassigned
Raza Panjwani
High (4)
Done
Apr 2, 2020
Jun 18, 2020
Epic
June FDA Q-Submission
Unassigned
Raza Panjwani
None
Done
Apr 2, 2020
Jun 18, 2020
Task
Jaeb Center Executes Revised Tidepool Statistical Analysis Plan
Unassigned
Raza Panjwani
None
Done
Jan 29, 2020
May 27, 2020
Task
Draft Software Description
Unassigned
Raza Panjwani
None
Duplicate
Jan 29, 2020
Jun 24, 2020
Mar 31, 2020
Task
[Sections 14, 15, 19] Draft Statements of Non-Applicability
Unassigned
Raza Panjwani
None
Done
Jan 29, 2020
Nov 5, 2020
Task
Submission document that describes consolidation of Jaeb Data
Unassigned
Howard Look
Medium (3)
Done
Oct 9, 2019
Mar 3, 2020
Task
Prep Q-sub with additional demographic breakdowns from Jaeb Observational study
Unassigned
Howard Look
High (4)
Done
Sep 25, 2019
Mar 2, 2020
Task
Statement of SaMD
Unassigned
Janet Diehl
Done
Aug 5, 2019
Nov 5, 2020
Task
[Regulatory] Labeling / Intended Use
Unassigned
Janet Diehl
Won't Do
Aug 5, 2019
Aug 7, 2020
Story
[Regulatory] Document algorithm for Pre-Sub
Unassigned
Janet Diehl
Done
Aug 5, 2019
Mar 3, 2020
Story
[Regulatory] iController
Unassigned
Janet Diehl
Done
Aug 5, 2019
Mar 2, 2020
Story
Include both newbies and DIY users in a usability study
Unassigned
Janet Diehl
Done
Aug 5, 2019
Mar 3, 2020
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