Nightscout FDA presubmission

• Cover letter
  • E-Copy Statement
  • Supplement to Q141084
  • Nightscout progress updates
• Nightscout
  • Device Description
    • Nightscout project
      • cgm-remote-monitor
      • android-uploader
      • cgm-pebble
    • Development
    • Assembly and guides
• Proposed Use
  • Nightscout
    • Communicating recent therapy
    • Glanceable interface
  • Reliance on preexisting work
    • Uses of Nightscout
    • Requirements
      • Nightscout uploader device
• Process updates
  • High level overview
  • Audit log of operations
• Overview of Product Development
  • Community based, social technical development
    • Nightscout begins
    • Open source methodology
    • Known issues
  • Future plans
    • Oversight
    • Integration
    • Operational metadata
    • Access controls
    • Support/Commercialization
• Meeting Minutes
  • Summary
  • Attendees
    • CGM in the Cloud / Nightscout
      • Your Diabetes May Vary
      • Invited guests
    • FDA
  • Discussion Topics

About

In open source fashion, this document’s raw source, pdf version and an html rendering is available online. The purpose is to create a framework for having a discussion with the FDA.

Indices and tables

• Index
• Module Index
• Search Page