diff --git a/my/__init__.py b/my/__init__.py index 196b344..89121d5 100644 --- a/my/__init__.py +++ b/my/__init__.py @@ -1,5 +1,5 @@ -VERSION='1.0.1' +VERSION='2.0.0' RELEASE=VERSION __all__ = ['VERSION', 'RELEASE'] diff --git a/source/00-cover.rst b/source/00-cover.rst index 5f30b6d..568eaa5 100644 --- a/source/00-cover.rst +++ b/source/00-cover.rst @@ -19,14 +19,20 @@ following differences: * for security, a wet, inked signature is only provided on the hard copy, and absent in the digital and online versions of this eCopy - * An exact copy of this eCopy has been permanently archived in git - at tag ``1.0.0`` and `may be retrieved from the website`_. + * An exact copy of this eCopy has been permanently archived + at tag ``2.0.0`` and `may be retrieved from the website`_. -.. _may be retrieved from the website: https://github.com/nightscout/fda-presubmission/blob/1.0.0/nightscout-fda-presubmission.pdf?raw=true +.. _may be retrieved from the website: https://github.com/nightscout/fda-presubmission/blob/2.0.0/nightscout-fda-presubmission.pdf?raw=true -Nightscout sponsorship ----------------------- +Supplement to Q141084 +--------------------- + +This is supplemental update to Q141084. + + +Nightscout progress updates +--------------------------- To whom it may concern, Dr. Stayce Beck, et al. This premarket submission is to discuss open source projects and FDA diff --git a/source/01-description.rst b/source/01-description.rst index d44d12a..f6eac66 100644 --- a/source/01-description.rst +++ b/source/01-description.rst @@ -56,7 +56,7 @@ display of the Dexcom receiver. The web display works on most modern web browsers. android-uploader -############### +################ `android-uploader`_ is an Android application implemented in java. The application starts when a Dexcom receiver is detected using the diff --git a/source/02-proposed-use.rst b/source/02-proposed-use.rst index f69cc00..164a7f9 100644 --- a/source/02-proposed-use.rst +++ b/source/02-proposed-use.rst @@ -13,12 +13,6 @@ duplicate the display of the Dexcom. The best way to get an idea of how people use Nightscout is to peruse the `public testimonials`_ of use, or the `Facebook group`_. -.. image:: http://i.imgur.com/q9gWTAd.png -.. image:: http://i.imgur.com/y8V7SMW.png -.. image:: http://i.imgur.com/hopdq1X.png -.. image:: http://i.imgur.com/a1rRb3X.png - - .. _public testimonials: http://imgur.com/a/cxcGG/all .. _Facebook group: https://www.facebook.com/groups/cgminthecloud/ diff --git a/source/03-previous-work.rst b/source/03-previous-work.rst index 02da869..015d1d0 100644 --- a/source/03-previous-work.rst +++ b/source/03-previous-work.rst @@ -1,12 +1,32 @@ -Previous work -============= - -A number of informal discussions have taken place between the FDA and -the Nightscout contributors. The discussions have revealed a need to -establish a framework for open source authors and FDA to work -together in order to best protect and promote public safety. -We seek the FDA's guidance in finding similar frameworks from other -regulated or life-critical areas such as defense, aviation, and -automotive industries. +Process updates +=============== + +A brief synopsis of the Nightscout process is discussed here. For record +keeping, a more detailed look at each of the processes discussed is kept in +process-controls: + +* http://process-controls.readthedocs.org/en/latest/ +* https://github.com/nightscout/process-controls/tree/master/source + +These documents are to help follow up with the gap analysis requested in +October's meeting. When they reach 1.0.0 status, they will be provided to the +FDA through formal submission channels. + +High level overview +################### +A high level overview of our development process, contributing guidelines, how +documentation, issues, and updates are tracked using Github, Facebook, and +other social networking sites. + +The in depth analysis includes a description of the quality controls +http://process-controls.readthedocs.org/en/latest/controls/index.html and is modeled roughly around the quality systems regulations http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820 + +Audit log of operations +####################### + +A second, operations log +http://process-controls.readthedocs.org/en/latest/operations/index.html also +helps document specific and insightful examples of how processes have +influenced operations, or how growth and operations has effected processes. diff --git a/source/index.rst b/source/index.rst index bb82440..7d1b7b9 100644 --- a/source/index.rst +++ b/source/index.rst @@ -4,9 +4,7 @@ contain the root `toctree` directive. Nightscout FDA presubmission -=================================== - -Contents: +============================ .. toctree:: :maxdepth: 2 @@ -16,8 +14,6 @@ Contents: 02-proposed-use 03-previous-work 04-development-overview - 05-specific-questions - 06-feedback-methods 07-minutes