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<h1>Selected FDA regulations, guidance documents and articles</h1>
Selected references from FDA are listed below. These are available from
<a href="http://www.fda.gov/MedicalDevices/default.htm" target="blank" >FDA.gov</a> or you can click on a document below to download a PDF version. <br/><br/>
<span class="bold">Regulations </span><br/><br/>
<ul class="indent_white">
<li><a href="images/QSR.pdf">21 CFR 820, Current GMP, Final Rule, October 7, 1996 FDA.</a> </li>
<li class="white_bullet"></li>
<li><a href="images/Part11.pdf">21 CFR Part 11, Electronic Records Electronic Signatures, Final Rule, March 20, 1997 FDA.</a></li>
<li class="white_bullet"></li>
<li><a href="images/EUMDR.pdf">EU Medical Device Regulation, May 2017</a></li>
<li class="white_bullet"></li>
<li><a href="images/EUIVDR.pdf">EU In-vitro Diagnostic Regulation, May 2017</a></li>
</ul><br/>
<span class="bold">Guidance Documents</span><br/><br/>
<ul class="indent_white">
<li><a href="images/premarket.pdf">Guidance for the Content of Premarket Submission for Software Contained in Medical Devices,
May 11, 2005 </a></li>
<li class="white_bullet"></li>
<li><a href="images/GPSV.pdf">General Principles of Software Validation, Jan 2002 </a></li>
<li class="white_bullet"></li>
<li><a href="images/ots.pdf">Guidance for Off-the-Shelf Software Use in Medical Devices, Draft Guidance, Sept 2019 </a></li>
<li class="white_bullet"></li>
<li><a href="images/cyberpre.pdf">Guidance for Content of Premarket Submissions for Management of Cybersecurity, Oct 2014 </a></li>
<li class="white_bullet"></li>
<li><a href="images/cyberpost.pdf">Guidance for Postmarket Management of Cybersecurity, Dec 2016 </a></li>
<li class="white_bullet"></li>
<li><a href="images/when.pdf">Guidance on When to Submit 510(k) for Changes to Software, Oct 2017 </a></li>
<li class="white_bullet"></li>
<li><a href="images/mobile.pdf">Guidance for Multiple Function Device Products, Apr 2018 </a></li>
<li class="white_bullet"></li>
</ul><br/>
<span class="bold">Articles </span><br/><br/>
<ul class="indent_white">
<li><a href="images/Networked.pdf">"Networked Medical Devices: Essential Collaboration for Improved Safety"</a>,
by Steven R. Rakitin, AAMI BI&T, Vol. 43, No. 4, July-Aug 2009, p.332-338. </li>
<li class="white_bullet"></li>
<li><a href="images/Coping.pdf">"Coping with Defective Software in Medical Devices"</a>, by Steven R. Rakitin,
IEEE Computer, April 2006. </li>
<li class="white_bullet"></li>
<li><a href="images/Therac25.pdf">"An Investigation of the Therac-25 Accidents"</a>, by Nancy Leveson and
Clark Turner, IEEE Computer, July 1993. </li>
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