Specific Questions

• Is this a secondary or passive or active display?
• What does distributing mean?
• What is the medical device? There are 6 separate open source projects, including this eCopy and the forums, all with separate maintainers and contributors. An assembled rig without the “cloud services” up and running does nothing.
• If listing source code on the Internet is widely considered “free speech” how does this relate to “distributing free speech?”
• Is there an API to upload data, relating to injuries or just for all therapy, to the FDA in order to aide in post-market surveillance?
  • Is there a way to prepare some kind of surveillance report, or observations of things we have found to the FDA outside of formal PMA/510k?
    • Should we build a “report to FDA” button into our UI to aide surveillance?
• Should we develop a risk assessment framework for Nightscout?
• Can we work on some framework to provide FDA with oversight for open source projects like Nightscout.
• How would this project be categorized, pending the current MDDS guidance
  • Is this a real-time or “active” monitoring application?
    • Does classifying this as Class III, “high risk” medical device make sense, empower the public to pursue safety in their own therapy?
  • How can open source methodology be integrated into FDA controls?
    • We want FDA to enforce protections allowing owners of devices to collect the data from those devices. We might propose some kind of explore “time in range” endpoint which indicates absence of harm due to therapy? Can we nullify the proprietary protections given to vendors if they have not provided satisfactory evidence that their device enables safe therapy?
    • Is there a De Novo classification process that would make sense, given the relative risk?
• Do any of the FDA certifications/approvals offer additional protection from liability, perhaps as outlined by Karen Sandler in “Killed by Code, Transparent Medical Devices?”