Tidepool documents and disclosures

Tidepool Loop, Clearance Received January 23, 2023

• Substantial Equivalence Notification (PDF)
• 510(k) Summary (PDF)
• Indications for Use (PDF)
• An Observational Study of Individuals with Type 1 Diabetes Using the Loop System for Automated Insulin Delivery - Public Dataset, JAEB Center for Health Research

FDA Q-Submission Meeting, Submitted June 12, 2020

• Tidepool Human Factors Bolus Calculator iCGM RFF (Public Google Doc)
• Tidepool Loop Background for Human Factors Reviewers (Public Google Doc)
• Tidepool Loop Human Factors Protocol Draft (Public Google Doc)
• Tidepool Loop Use-related Risk Analysis (PDF)
• Tidepool Loop Bolus Recommendation Tool (Public Google Doc)
• Plan for Assessing Loops Decision Making under iCGM Constraints v2 (Public Google Doc)
• Assumptions Underlying the iCGM Sensor Simulator (Public Google Doc)
• Details of Simple Diabetes Metabolism Model Insulin and Carb Only (PDF)
• Documents Tidepool Intends to Submit in Support of Tidepool Loop 510k Pre-market Notification (Public Google Doc)
• Written feedback from FDA, received August 21, 2020 (PDF)
• Meeting Minutes from August 27 call. Submitted to the FDA on September 11, 2020. Approved on October 14, 2020. (PDF)
• Response to Tidepool Loop Human Factors Protocol Feedback (Public Google Doc)

FDA Q-Submission Meeting, February 13, 2020

• Proposed Teleconference Meeting Agenda (Public Google Doc)
• Exposure time in the Loop Study - Updated February 10, 2020 (PDF)
• Teleconference Meeting Minutes — Submitted to FDA, Approved April 15, 2020 (Public Google Doc)

JAEB Observational Study of DIY Loop users, 6 month readout — ATTD 2020 Shared with permission from the JAEB Center for Health Research, first shared on February 21, 2020

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FDA Q-Submission Supplement, Submitted December 11, 2019

• Request for Information: Tidepool Loop Observational Study Exposure Targets (PDF)
• Exposure Time in the Loop Observational Study (PDF)
• Written feedback from FDA, received Feburary 7, 2020

FDA Pre-submission Meeting, June 17, 2019

• Proposed In-person Meeting Agenda and Misc Questions (Public Google Doc) (PDF)
• Plan for Demonstrating Safety of Tidepool Loop 1.0 (Public Google Doc) (PDF)
• Tidepool Loop Statistical Analysis Plan (Public Google Doc) (PDF)
• Jaeb Loop Statistical Analysis Plan (PDF)
• Plan for Assessing Loop’s Decision Making under iCGM Constraints (Public Google Doc) (PDF)
• Human Factors and Usability Testing Outline for Tidepool Loop 1.0 (Public Google Doc) (PDF)
• Tidepool Loop 1.0: Anticipated Changes to DIY Loop (Public Google Doc) (PDF)
• Analysis of DIY Loop GitHub Issues and Resolutions (Public Google Doc) (PDF)
• Proposal for Ongoing Beta Test Program for Tidepool Loop (Public Google Doc) (PDF)
• Tidepool Loop Quality Assurance Strategy (Public Google Doc) (PDF)
• Tidepool Approach to Online Documentation and Training (Public Google Doc) (PDF)
• Cybersecurity Strategy for Tidepool Loop 1.0 (Public Google Doc) (PDF)
• Wireless Test Strategy for Tidepool Loop 1.0 (Public Google Doc) (PDF)
• Meeting Minutes. Submitted to the FDA on July 2, 2019. Approved by FDA. (Public Google Doc) (PDF)

Jaeb Observational Study Protocol, November 29, 2018

• Observational Study Protocol, v2.0 (PDF)

FDA Pre-submission Meeting, January 10, 2019

• In-person agenda (PDF)
• Tidepool and DIY Loop Functionality Narrative (Public Google Doc) (PDF)
• Tidepool Loop: Proposed iController Definition and Special Controls (Public Google Doc) (PDF)
• Loop Algorithm Documentation (Public Google Doc) (PDF)
• Approved Meeting Minutes from January 10 In-Person Meeting (PDF)

FDA Pre-submission Meeting, August 27, 2018

• Observational Study Protocol Meeting (Public Google Doc)
• Approved Meeting Minutes (PDF)

FDA Pre-submission Meeting, May 4, 2018

• In-person agenda (Public Google Doc) (PDF)
• Approved Meeting Minutes (PDF)

Regarding Tidepool Project

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Tidepool Public Comment on Federal Register 2023-14624, issued July 13, 2023 CMS Proposed Rules (PDF)

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Tidepool Public Comments on FDA Cybersecurity Draft Guidance, July 6, 2022 (Public Google Doc)

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FDA Workshop, November 13, 2014

• Presentation from FDA Workshop on Diabetes Software and Interoperability (PDF)

FDA Pre-submission Meeting, March 3, 2016

• Pre-submission Informational Meeting Full Presentation about Tidepool Project updates (PDF)
• Approved Meeting Minutes (PDF)

FDA Pre-submission Meeting, June 2, 2015

• Pre-submission Informational Meeting Full Presentation about Regulatory Quality System (PDF)
• Approved Meeting Minutes (PDF)

FDA Pre-submission Meeting, October 14, 2014

• Pre-submission Cover Letter and agenda (PDF)
• Pre-submission Informational Meeting Full Presentation (PDF)
• Approved Meeting Minutes (PDF)

More information about our Regulatory Quality System can be found here.

• FDA Registration
• FDA Listing: Tidepool Data Platform
• FDA Listing: Tidepool Uploader
• Tidepool Quality System Index