In October, 2014, Nightscout contributors met with FDA to discuss Nightscout, aka “CGM in the Cloud.” This meeting is to follow up on questions remaining open for discussions during the last meeting.

Those questions centered around describing a variety of processes, known as controls, and discussed in http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820

  • Design controls
  • Document controls
  • Change controls
  • Testing, support
  • Distribution controls
  • Traceability
  • Nonconformance

We’ve created a document to track each of these controls separately. What follows is a report on how those controls have played out in the past months.