united-states open-source-software health medical regulations
How can I discover what regulations a biomedical device needs to meet?
<p><strong>Please note:</strong> the contextual jurisdiction of this question is primarily the United States, but could be extended to European and Asian countries as well.</p>

<p>The <a href="http://www.openbci.com" rel="nofollow">OpenBCI</a> is a recently-funded startup that will provide open source hardware (that is, open for any derivation but requiring attribution) capable of reading biodata such as "brain waves" (EEG), as well as heart (EKG) and muscle movement (EMG) data. It is clear from their site that this is <em>not</em> meant to be used as a medical and/or clinic/diagnostic tool, and is just a (high quality) hobbyist toy.</p>

<p><strong>However</strong>, because it is a high quality "hobbyist tool", there's no reason why someone couldn't come along and build a commercial hardware device on top of its design (it's open source, afterall). This is actually pretty common in the electronics industry. You take an open source design (to save yourself the hardship of designing your own circuit/system from scratch) and then extend its capabilities to suit your commercial/proprietary interests.</p>

<hr>

<p>I am interested in doing this, however the commercial device that I plan on building <em>would</em> be used in a biomedical/clinical setting. As such, there will be legal medical standards I need to ensure the hardware/firmware/software live up to. I <em>believe</em> this would be:</p>

<ul>
<li><a href="https://en.wikipedia.org/wiki/IEC_60601" rel="nofollow">IEC 6061</a>; and</li>
<li><a href="https://en.wikipedia.org/wiki/Title_21_CFR_Part_11" rel="nofollow">FDA CRA 21</a></li>
<li><a href="https://en.wikipedia.org/wiki/Health_Insurance_Portability_and_Accountability_Act" rel="nofollow">HIPAA (?)</a></li>
</ul>

<p>However I am not sure if this is a comprehensive list or not.</p>

<p>What I'm asking here is: how do I know what standards I <em>must</em> design my device (hardware + software) to live up to, for its intended purpose, inside the intended jurisdictions (which like I said are primarily USA, but might also be Europe and Asia)? Are there agencies I can call? Websites I can turn to? Places like <a href="https://en.wikipedia.org/wiki/UL_(safety_organization)" rel="nofollow">Underwriters Laboratory ("UL")</a> that I can consult?</p>

<p>To make a safe, legally-compliant and industry-compliant biomedical device, one must build that device to a certain set of standards. <strong>How do I find out what those standards even are?</strong></p>

<blockquote>
  <p>To make a safe, legally-compliant and industry-compliant biomedical
  device, one must build that device to a certain set of standards. How
  do I find out what those standards even are?</p>
</blockquote>

<p>For one, start reading: <a href="http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm" rel="nofollow">http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm</a></p>

<p>The FDA is one of the primary regulatory bodies that you will work with in terms of the development and potential marketing of a device. There are many documents and contact links, such as for information on standards, inspections, third-party reviews, existing device databases, workshops, etc.</p>

<p>Especially relevant from the Division of Industry and Consumer Education (DICE):</p>

<blockquote>
  <p><em>The Division of Industry and Consumer Education (DICE) answers
  questions (by phone and email) from the medical device industry ....
  In addition, DICE develops educational resources for the FDA
  website to help the medical device industry understand FDA regulations
  and policies.</em></p>
</blockquote>

<p>Your conclusions and decisions may lead you to other government bodies, such as the Small Business Administration, the US Patent Office, and similar offices in other countries if you go that route.</p>

<p>And, because you are potentially entering into a field and endeavor that has huge liability for yourself and your business and possible investors, it's not a good idea to trust the judgement of the general public on a site like LSE; there are many private medical and legal consultants available by Google that could act as as consultants and leads for such a project.</p>
