Issues
 | Documentation of Requirements iAGC Special Controls | Unassigned | Raza Panjwani |  | Won't Do | Jul 22, 2020 | Aug 7, 2020 | ||||
| [To Do] Determine whether and how to include Patient Preference Information (PPI) documentation in support of Submission | Unassigned | Raza Panjwani | | Done | Jul 15, 2020 | Nov 5, 2020 | |||||
| [Section 07] Draft Statement of Non-Class III Device | Unassigned | Raza Panjwani | | Done | Apr 21, 2020 | Nov 5, 2020 | |||||
| [SC 4] Documentation of Measures to Record Critical Events | Unassigned | Raza Panjwani | | Duplicate | Apr 21, 2020 | Jun 24, 2020 | |||||
| Review proposed outline for documentation | Unassigned | Raza Panjwani | | Done | Apr 10, 2020 | Apr 21, 2020 | |||||
| [Q-Sub] Draft April Q-Submission Cover Letter and Request for Feedback Questions | Unassigned | Raza Panjwani | | Done | Apr 2, 2020 | Jun 18, 2020 | |||||
| [Q-Sub] Draft iCGM Sensitivity Analysis Plan | Unassigned | Raza Panjwani |  | Done | Apr 2, 2020 | Jun 18, 2020 | |||||
| [Q-Sub] Draft Diabetes Metabolic Model | Unassigned | Raza Panjwani | | Done | Apr 2, 2020 | Jun 18, 2020 | |||||
| [Q-Sub] Draft iCGM Simulator Assumptions | Unassigned | Raza Panjwani | | Done | Apr 2, 2020 | Jun 18, 2020 | |||||
| [Q-Sub] Finalize Draft HF Testing Protocol with CoreHF | Unassigned | Raza Panjwani | | Done | Apr 2, 2020 | Jun 18, 2020 | |||||
| [Q-Sub] Draft Bolus Calculator Documentation | Unassigned | Raza Panjwani | | Done | Apr 2, 2020 | Jun 18, 2020 | |||||
| June FDA Q-Submission | Unassigned | Raza Panjwani | | Done | Apr 2, 2020 | Jun 18, 2020 | ||||
| Jaeb Center Executes Revised Tidepool Statistical Analysis Plan | Unassigned | Raza Panjwani | | Done | Jan 29, 2020 | May 27, 2020 | |||||
| Draft Software Description | Unassigned | Raza Panjwani | | Duplicate | Jan 29, 2020 | Jun 24, 2020 | Mar 31, 2020 | ||||
| [Sections 14, 15, 19] Draft Statements of Non-Applicability | Unassigned | Raza Panjwani | | Done | Jan 29, 2020 | Nov 5, 2020 | |||||
| Submission document that describes consolidation of Jaeb Data | Unassigned | Howard Look |  | Done | Oct 9, 2019 | Mar 3, 2020 | |||||
| Prep Q-sub with additional demographic breakdowns from Jaeb Observational study | Unassigned | Howard Look | | Done | Sep 25, 2019 | Mar 2, 2020 | |||||
| Statement of SaMD | Unassigned | Janet Diehl | Done | Aug 5, 2019 | Nov 5, 2020 | ||||||
| [Regulatory] Labeling / Intended Use | Unassigned | Janet Diehl | Won't Do | Aug 5, 2019 | Aug 7, 2020 | ||||||
| [Regulatory] Document algorithm for Pre-Sub | Unassigned | Janet Diehl | Done | Aug 5, 2019 | Mar 3, 2020 | ||||||
| [Regulatory] iController | Unassigned | Janet Diehl | Done | Aug 5, 2019 | Mar 2, 2020 | ||||||
| Include both newbies and DIY users in a usability study | Unassigned | Janet Diehl | Done | Aug 5, 2019 | Mar 3, 2020 |
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