| | Revise Loop Algorithm Documentation for Submission | | | | | Unresolved | Mar 3, 2020 | Apr 2, 2022 | | |
| | Draft iCGM Sensitivity Analysis Methods and Results Summary | | | | | Unresolved | Nov 6, 2020 | Apr 2, 2022 | | |
| | [SC 1.vii] Draft Proposed Assignment of Post-Market Responsibility and Complaint Handling | | | | | Unresolved | Mar 3, 2020 | Mar 12, 2022 | | |
| | Documented Process for Adverse Event investigations and MDRs | | | | | Unresolved | Mar 4, 2020 | Mar 12, 2022 | | |
| | [To Do] Document Functional Requirements for Tidepool Loop (Jira Review) | | | | | Unresolved | Mar 11, 2020 | Nov 20, 2021 | | |
| | Draft Tidepool Loop Maintenance Plan | | | | | Unresolved | Nov 6, 2020 | Jun 25, 2021 | | |
| | [SC 7] Draft "Training Plan for Tidepool Loop for Users and HCPs" summary for inclusion in 510(k) | | | | | Unresolved | Nov 10, 2020 | Mar 4, 2021 | | |
| | [SC 7/8] Draft User-facing Training Materials | | | | | Unresolved | Mar 3, 2020 | Mar 4, 2021 | | |
| | [SC 7/8] Draft HCP Training Materials (Summary) | | | | | Unresolved | Mar 3, 2020 | Mar 4, 2021 | | |
| | Draft Summary and Rationale of Changes from DIY Loop to Tidepool Loop
| | | | | Unresolved | Apr 2, 2020 | Jan 8, 2021 | | |
| | [SC 1.v] Draft Device Qualification Plan for Controller Devices | | | | | Unresolved | Apr 5, 2020 | Nov 18, 2020 | | |
| | [SC 1.iv] Draft Device Qualification Plan for Representative ACE Pumps | | | | | Unresolved | Apr 3, 2020 | Nov 18, 2020 | | |
| | [SC 1.iv] Draft Device Qualification Plan for Representative iCGM | | | | | Unresolved | Apr 3, 2020 | Nov 18, 2020 | | |
| | [SC 1.iv] Draft Functional Requirements for Compatible ACE Pump | | | | | Unresolved | Mar 3, 2020 | Nov 12, 2020 | | |
| | [SC 1.iv] Draft Functional Requirements for Compatible iCGM | | | | | Unresolved | Mar 3, 2020 | Nov 11, 2020 | | |
| | Draft Iterative development plan | | | | | Unresolved | Mar 2, 2020 | Nov 10, 2020 | | |
| | Tidepool Loop 510(k) Submission | | | | | Unresolved | Mar 3, 2020 | Nov 10, 2020 | | |
| | [Section 16.j] Output of open bugs in Jira | | | | | Unresolved | Jun 23, 2020 | Nov 10, 2020 | | |
| | [To Do] Draft Verification Test Plan for Tidepool Loop | | | | | Unresolved | Mar 3, 2020 | Nov 10, 2020 | | |
| | [Section 20] Draft Summary of Clinical Study Report Data | | | | | Unresolved | Apr 21, 2020 | Nov 9, 2020 | | |
| | [Section 16.d] Create Architecture Design Charts | | | | | Unresolved | Jun 23, 2020 | Nov 9, 2020 | | |
| | Observational Study Adverse Event Summary and Reports | | | | | Unresolved | Sep 3, 2020 | Nov 6, 2020 | | |
| | [Section 16.a+d] Draft Software Description and Design and Architecture Overview | | | | | Unresolved | Mar 2, 2020 | Nov 6, 2020 | | |
| | [Section 16.g] Include copy of Tidepool Software Life Cycle Management Plan | | | | | Unresolved | Mar 2, 2020 | Nov 6, 2020 | | |
| | Hazard Analysis Table | | | | | Unresolved | Mar 2, 2020 | Nov 6, 2020 | | |
| | [SC 1.iii] Documentation of Measures to Ensure Reliability and Security of Connected Device Communications | | | | | Unresolved | Apr 21, 2020 | Nov 6, 2020 | | |
| | Clinical Study Report (Covance) | | | | | Unresolved | Jan 29, 2020 | Nov 6, 2020 | | |
| | Draft Post-Market Study Plan | | | | | Unresolved | Nov 6, 2020 | Nov 6, 2020 | | |
| | Create Tidepool Loop Full Demo Video | | | | | Unresolved | Nov 6, 2020 | Nov 6, 2020 | | |
| | [Section 18] Draft Summary of Bench Testing | | | | | Unresolved | Apr 21, 2020 | Nov 5, 2020 | | |
| | Draft Patient Testimonial Summary | | | | | Unresolved | Nov 5, 2020 | Nov 5, 2020 | | |
| | [To Do] Determine whether and how to include Patient Preference Information (PPI) documentation in support of Submission | | | | | Done | Jul 15, 2020 | Nov 5, 2020 | | |
| | [Section 13] Draft Summary of Proposed Labeling | | | | | Unresolved | Jan 29, 2020 | Nov 5, 2020 | | |
| | Statement of SaMD | | | | | Done | Aug 5, 2019 | Nov 5, 2020 | | |
| | [Sections 14, 15, 19] Draft Statements of Non-Applicability | | | | | Done | Jan 29, 2020 | Nov 5, 2020 | | |
| | [Section 04] Fill FDA Form 3881 - Indications for Use Statement | | | | | Unresolved | Jan 29, 2020 | Nov 5, 2020 | | |
| | [Section 03] Draft 510(k) Cover Letter | | | | | Unresolved | Jan 29, 2020 | Nov 5, 2020 | | |
| | [Section 09] Declarations of Conformity and Summary Reports | | | | | Unresolved | Jan 29, 2020 | Nov 5, 2020 | | |
| | [Section 08] Draft Financial Certification or Disclosure | | | | | Unresolved | Jan 29, 2020 | Nov 5, 2020 | | |
| | [Section 06] Execute Truthful and Accuracy Statement | | | | | Unresolved | Jan 29, 2020 | Nov 5, 2020 | | |
| | [Section 16.h] Draft Summary of Verification and Validation Outputs | | | | | Unresolved | Apr 22, 2020 | Nov 5, 2020 | | |
| | [Section 05] Draft 510(k) Summary | | | | | Unresolved | Jan 29, 2020 | Nov 5, 2020 | | |
| | [Section 12] Draft Substantial Equivalence Discussion | | | | | Unresolved | Jan 29, 2020 | Nov 5, 2020 | | |
| | [Section 11] Draft Executive Summary | | | | | Unresolved | Jan 29, 2020 | Nov 5, 2020 | | |
| | [Section 10] Draft Device Description | | | | | Unresolved | Jan 29, 2020 | Nov 5, 2020 | | |
| | Draft Summary Report of iAGC Special Controls Compliance | | | | | Unresolved | Jan 29, 2020 | Nov 5, 2020 | | |
| | [SC 5/6] Documentation of Tidepool Loop Restricting Compatibility to only iCGMs, ACE Pumps, and other devices deemed appropriate by FDA | | | | | Unresolved | Apr 21, 2020 | Nov 5, 2020 | | |
| | [SC 1.vi] Documentation of Measures to Ensure Safety During Loss of Connected Device Communications | | | | | Unresolved | Apr 21, 2020 | Nov 5, 2020 | | |
| | [Section 01] Pay Medical Device User Fee and attach Cover Sheet to submission | | | | | Unresolved | Jan 29, 2020 | Nov 5, 2020 | | |
| | [Section 16] Draft Statement of Major Level of Concern | | | | | Unresolved | Apr 21, 2020 | Nov 5, 2020 | | |
