Meeting Minutes

What follows are minutes of the first Nightscout FDA Pre-submission Meeting which took place on October 8, 2014.

Summary

  • FDA expressed interest in a continuing conversation related to the NightScout project
  • While Medical Device regulations are applicable to the NightScout project, how these regulations can be met will be an ongoing discussion with the agency
  • Areas to be discussed – is there one responsible party? -
  • How are design controls met during software development?
  • How to fulfill post market requirements?
  • Are there any product claims made?
  • How are data security and privacy handled?
  • FDA and NightScout project members discussed performing a gap analysis regarding the regulations for the next discussion. Meeting time TBD.

Attendees

Participant introductions of attendees:

John Costik, Ping Fang, Ben West, and Scott Leibrand: CGM in the Cloud / Nightscout Bennet Dunlap: Your Diabetes May Vary Mark O’Donnell: Medtronic

Beth Stephen, Dan St. Pierre, Robert Sauer, Stayce Beck, Courtney Lias, Katherine Serrano, Suzanne Schwartz, and Ariel Seeley: FDA

Discussion Topics

Introduction: background on Nightscout software and project, history, open-source development methodology, and some existing controls.

Discussion of FDA’s questions around Nightscout’s control of what goes out to general users of Nightscout. Description of how core developers maintain the main community version, review and test any new features before they are incorporated or distributed to end users.

Discussion of the FDA’s and Nightscout’s shared goal of safety. The FDA hears the demand from patients for devices like Nightscout to exist, and doesn’t have a particular problem with this kind of device coming to market. In fact, they want to make this happen faster, so we don’t have to ask, “why isn’t this happening yet?” The FDA also recognizes the need for device interoperability in order to fix a lot of things, along the lines of what Tidepool is working on. They noted recent progress on interoperability from CGM makers, but not so much yet from pump makers. Subsequent to this meeting, the FDA would like to hear from our community to help make sure interoperability moves forward.

Discussion of FDA’s desire that there be a single responsible party to ensure that nothing falls through the cracks. They want to make sure there is a mechanism to handle, triage, and prioritize the response to complaints that might affect safety, to ensure that fixes can be distributed to people using the system, and to make sure that Nightscout is preventing unexpected complications from modifications. The FDA recognizes that many of Nightscout’s existing methods and processes, while informal, address many of these concerns, but would like to see further documentation of how Nightscout is doing so, and wants to ensure that there is someone ultimately responsible.

Discussion of how Nightscout might be able to provide the FDA with better visibility into any events that affect patient safety. The FDA would welcome submissions from Nightscout to MedWatch, especially if they can include as much detail as possible to see what was really going on. Such processes will help Nightscout make decisions on how to improve the system.

Nightscout can begin working on a gap analysis to document what is already being covered, and which areas require improvements. The FDA and Nightscout would both like to meet again, definitely sooner than 6 months from now.