From 026a4645e140325f54ed84b884a59dfb1fe7b280 Mon Sep 17 00:00:00 2001 From: Ben West Date: Thu, 15 Jan 2015 11:08:02 -0800 Subject: [PATCH 1/8] restructure for versioning --- source/00-cover.rst | 10 +++++----- source/02-proposed-use.rst | 6 ------ source/03-previous-work.rst | 29 +++++++++++++++++++---------- source/index.rst | 2 -- 4 files changed, 24 insertions(+), 23 deletions(-) diff --git a/source/00-cover.rst b/source/00-cover.rst index 5f30b6d..62d45d0 100644 --- a/source/00-cover.rst +++ b/source/00-cover.rst @@ -19,14 +19,14 @@ 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 ----------------------- +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/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..96c9b37 100644 --- a/source/03-previous-work.rst +++ b/source/03-previous-work.rst @@ -1,12 +1,21 @@ -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 + +The in depth analysis includes a description of the quality controls +http://process-controls.readthedocs.org/en/latest/controls/index.html As well +as log of +http://process-controls.readthedocs.org/en/latest/operations/index.html +operations and how the process has influenced or changed in response. + +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. diff --git a/source/index.rst b/source/index.rst index bb82440..95b674f 100644 --- a/source/index.rst +++ b/source/index.rst @@ -16,8 +16,6 @@ Contents: 02-proposed-use 03-previous-work 04-development-overview - 05-specific-questions - 06-feedback-methods 07-minutes From c85e1807d8fbd2b68518775ae07a71ed433e541b Mon Sep 17 00:00:00 2001 From: Ben West Date: Thu, 15 Jan 2015 11:08:39 -0800 Subject: [PATCH 2/8] version bump --- my/__init__.py | 2 +- 1 file changed, 1 insertion(+), 1 deletion(-) diff --git a/my/__init__.py b/my/__init__.py index 196b344..a1ef977 100644 --- a/my/__init__.py +++ b/my/__init__.py @@ -1,5 +1,5 @@ -VERSION='1.0.1' +VERSION='1.1.0' RELEASE=VERSION __all__ = ['VERSION', 'RELEASE'] From 7463315923d9a538aa776627a80721cdc92a08b5 Mon Sep 17 00:00:00 2001 From: Ben West Date: Thu, 15 Jan 2015 11:50:33 -0800 Subject: [PATCH 3/8] tweak cover letter --- source/00-cover.rst | 5 +++++ 1 file changed, 5 insertions(+) diff --git a/source/00-cover.rst b/source/00-cover.rst index 62d45d0..c156557 100644 --- a/source/00-cover.rst +++ b/source/00-cover.rst @@ -25,6 +25,11 @@ following differences: .. _may be retrieved from the website: https://github.com/nightscout/fda-presubmission/blob/2.0.0/nightscout-fda-presubmission.pdf?raw=true +Supplement to Q141084 +--------------------- + +This is supplemental update to Q141084. + Nightscout progress updates --------------------------- To whom it may concern, Dr. Stayce Beck, et al. From 57a7928926fd597a75d72aa7d21a3a7d6124ab95 Mon Sep 17 00:00:00 2001 From: Ben West Date: Thu, 15 Jan 2015 11:51:02 -0800 Subject: [PATCH 4/8] bump version --- my/__init__.py | 2 +- 1 file changed, 1 insertion(+), 1 deletion(-) diff --git a/my/__init__.py b/my/__init__.py index a1ef977..89121d5 100644 --- a/my/__init__.py +++ b/my/__init__.py @@ -1,5 +1,5 @@ -VERSION='1.1.0' +VERSION='2.0.0' RELEASE=VERSION __all__ = ['VERSION', 'RELEASE'] From be5a30ade0823f1f78acd15105272f09505e1f22 Mon Sep 17 00:00:00 2001 From: Ben West Date: Thu, 15 Jan 2015 12:39:09 -0800 Subject: [PATCH 5/8] tweak title --- source/00-cover.rst | 1 + source/index.rst | 2 +- 2 files changed, 2 insertions(+), 1 deletion(-) diff --git a/source/00-cover.rst b/source/00-cover.rst index c156557..568eaa5 100644 --- a/source/00-cover.rst +++ b/source/00-cover.rst @@ -30,6 +30,7 @@ Supplement to Q141084 This is supplemental update to Q141084. + Nightscout progress updates --------------------------- To whom it may concern, Dr. Stayce Beck, et al. diff --git a/source/index.rst b/source/index.rst index 95b674f..fa614fb 100644 --- a/source/index.rst +++ b/source/index.rst @@ -4,7 +4,7 @@ contain the root `toctree` directive. Nightscout FDA presubmission -=================================== +============================ Contents: From 39f539a2084c4fe978b5c21f02b27a1ca249942b Mon Sep 17 00:00:00 2001 From: Ben West Date: Thu, 15 Jan 2015 12:52:36 -0800 Subject: [PATCH 6/8] explain the process document idea a bit more --- source/03-previous-work.rst | 23 +++++++++++++++++------ 1 file changed, 17 insertions(+), 6 deletions(-) diff --git a/source/03-previous-work.rst b/source/03-previous-work.rst index 96c9b37..015d1d0 100644 --- a/source/03-previous-work.rst +++ b/source/03-previous-work.rst @@ -9,13 +9,24 @@ process-controls: * http://process-controls.readthedocs.org/en/latest/ * https://github.com/nightscout/process-controls/tree/master/source -The in depth analysis includes a description of the quality controls -http://process-controls.readthedocs.org/en/latest/controls/index.html As well -as log of -http://process-controls.readthedocs.org/en/latest/operations/index.html -operations and how the process has influenced or changed in response. - 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. + From 8077af518037cf19817d202dacde740b22267e61 Mon Sep 17 00:00:00 2001 From: Ben West Date: Thu, 15 Jan 2015 12:53:50 -0800 Subject: [PATCH 7/8] tweak title underline --- source/01-description.rst | 2 +- 1 file changed, 1 insertion(+), 1 deletion(-) 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 From 5401ac0121e0c98044ccca83415c4959d5066ec1 Mon Sep 17 00:00:00 2001 From: Ben West Date: Thu, 15 Jan 2015 12:59:12 -0800 Subject: [PATCH 8/8] tweak index file --- source/index.rst | 2 -- 1 file changed, 2 deletions(-) diff --git a/source/index.rst b/source/index.rst index fa614fb..7d1b7b9 100644 --- a/source/index.rst +++ b/source/index.rst @@ -6,8 +6,6 @@ Nightscout FDA presubmission ============================ -Contents: - .. toctree:: :maxdepth: 2