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Updated the docs
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bewest committed Aug 15, 2014
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24 changes: 23 additions & 1 deletion 00-cover.html
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Expand Up @@ -51,10 +51,27 @@ <h3>Navigation</h3>

<div class="section" id="cover-letter">
<h1>Cover letter<a class="headerlink" href="#cover-letter" title="Permalink to this headline"></a></h1>
<div class="section" id="e-copy-statement">
<h2>E-Copy Statement<a class="headerlink" href="#e-copy-statement" title="Permalink to this headline"></a></h2>
<p>To the
| Food and Drug Administration
| Center for Devices and Radiological Health
| Document Control Center - WO66-G609
| 10903 New Hampshire Avenue
| Silver Spring, MD 20993-0002</p>
<p>The eCopy is an exact duplicate of the paper copy, except for the
following differences:</p>
<blockquote>
<div><ul class="simple">
<li>for security, a wet, inked signature is only provided on the hard
copy, and absent in the digital and online versions of this ecopy</li>
</ul>
</div></blockquote>
</div>
<div class="section" id="nightscout-sponsorship">
<h2>Nightscout sponsorship<a class="headerlink" href="#nightscout-sponsorship" title="Permalink to this headline"></a></h2>
<p>To whom it may concern, Dr. Stayce Beck, et al.</p>
<p>This presubmission is to discuss open source projects and FDA
<p>This premarket submission is to discuss open source projects and FDA
oversight. Specifically, this is to discuss the Nightscout project,
aka &#8220;CGM in the Cloud.&#8221;</p>
<p>The sponsor, collectively known as Nightscout contributors, may be
Expand All @@ -70,6 +87,10 @@ <h2>Nightscout sponsorship<a class="headerlink" href="#nightscout-sponsorship" t
<li><a class="reference external" href="https://groups.google.com/forum/?utm_medium=email&amp;utm_source=footer#!forum/nightscout-core-dev">https://groups.google.com/forum/?utm_medium=email&amp;utm_source=footer#!forum/nightscout-core-dev</a></li>
<li><a class="reference external" href="mailto:nightscout-core-dev&#37;&#52;&#48;googlegroups&#46;com">nightscout-core-dev<span>&#64;</span>googlegroups<span>&#46;</span>com</a></li>
</ul>
<p>We request a meeting to discuss the risks and safety Nightscout.
Please review the following discussion of the device description,
future plans, and questions.
We are happy to schedule meetings as needed.</p>
</div>
</div>

Expand All @@ -82,6 +103,7 @@ <h2>Nightscout sponsorship<a class="headerlink" href="#nightscout-sponsorship" t
<h3><a href="index.html">Table Of Contents</a></h3>
<ul>
<li><a class="reference internal" href="#">Cover letter</a><ul>
<li><a class="reference internal" href="#e-copy-statement">E-Copy Statement</a></li>
<li><a class="reference internal" href="#nightscout-sponsorship">Nightscout sponsorship</a></li>
</ul>
</li>
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23 changes: 22 additions & 1 deletion _sources/00-cover.txt
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Expand Up @@ -3,11 +3,27 @@
Cover letter
============

E-Copy Statement
----------------
To the
| Food and Drug Administration
| Center for Devices and Radiological Health
| Document Control Center - WO66-G609
| 10903 New Hampshire Avenue
| Silver Spring, MD 20993-0002

The eCopy is an exact duplicate of the paper copy, except for the
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



Nightscout sponsorship
----------------------
To whom it may concern, Dr. Stayce Beck, et al.

This presubmission is to discuss open source projects and FDA
This premarket submission is to discuss open source projects and FDA
oversight. Specifically, this is to discuss the Nightscout project,
aka "CGM in the Cloud."

Expand All @@ -24,3 +40,8 @@ project via an email list administered by Google groups:
* https://groups.google.com/forum/?utm_medium=email&utm_source=footer#!forum/nightscout-core-dev
* nightscout-core-dev@googlegroups.com

We request a meeting to discuss the risks and safety Nightscout.
Please review the following discussion of the device description,
future plans, and questions.
We are happy to schedule meetings as needed.

1 change: 1 addition & 0 deletions index.html
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Expand Up @@ -51,6 +51,7 @@ <h1>Nightscout FDA presubmission<a class="headerlink" href="#nightscout-fda-pres
<div class="toctree-wrapper compound">
<ul>
<li class="toctree-l1"><a class="reference internal" href="00-cover.html">Cover letter</a><ul>
<li class="toctree-l2"><a class="reference internal" href="00-cover.html#e-copy-statement">E-Copy Statement</a></li>
<li class="toctree-l2"><a class="reference internal" href="00-cover.html#nightscout-sponsorship">Nightscout sponsorship</a></li>
</ul>
</li>
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