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Submissions for Sponsor-Investigators</h1> <div class="content-top"> </div> <div id="main-wrapper"> <div id="main" class="clearfix"> <div id="content" class="column"> <div class="inside"> <a id="main-content"></a> <div class="tabs"></div> <div class="region region-content"> <div id="block-system-main" class="block block-system"> <div class="content"> <div id="node-1511" class="node node-page slider-secondary clearfix" about="/ide-development-process" typeof="sioc:Item foaf:Document"> <span property="dc:title" content="Investigational Device Exemption (IDE) Submissions for Sponsor-Investigators" class="rdf-meta element-hidden"></span><span property="sioc:num_replies" content="0" datatype="xsd:integer" class="rdf-meta element-hidden"></span> <div class="content"> <div class="field field-name-field-last-revised field-type-datetime field-label-inline inline"><div class="field-label">Last revised<span class="colon">:</span> </div><div class="field-items"><div class="field-item even"><span property="dc:date" datatype="xsd:dateTime" content="2018-02-14T00:00:00-08:00" class="date-display-single">02/14/2018</span></div></div></div><div class="field field-name-field-body field-type-text-long field-label-hidden"><div class="field-items"><div class="field-item even"><h2>IDE Overview</h2> <p>Confused about the need to file an IDE? Think your study may be exempt? Not sure where to start? You are not alone. This website will help faculty navigate the process of developing a Sponsor-Investigator IDE. The information provided pertains to Class III and some Class II devices, that is, devices with the greatest risk or those that have a new intended use or employ a new, unique technology. </p> <p>The sponsor of a <a href="http://www.research.ucsf.edu/chr/guide/chr12D_FDA.asp">Significant Risk (SR)</a> device study is required to submit an IDE application to the FDA. The IDE allows the investigational device to be used in a clinical study in order to collect the safety and effectiveness data required to support a marketing application.</p> <p>Use the <a href="http://irb.ucsf.edu/sites/hrpp.ucsf.edu/files/device-checklist.pdf">Investigator Checklist for IDE Exempt, Non-Significant Risk,or Significant Risk Device Studies</a> to <strong>help you</strong> determine if an IDE is required. While the first step is a self-assesement of whether an IDE is needed, the IRB serves as a first-level review as designated by FDA. FDA makes the ultimate decision, if needed.</p> <p>Need assistance or have regulatory questions? Please contact <a href="http://ctsi.ucsf.edu/consult">CTSI Consultation Services</a></p> <h3>New:</h3> <p>The FDA has issued guidance on “<a href="http://www.fda.gov/downloads/MedicalDevices/.../UCM263366.pdf">Mobile Medical Applications</a>” to clarify the subset of mobile apps to which the FDA intends to apply its authority. Guidance is also now available for "‘<a href="/sites/g/files/tkssra261/f/IDE Early Feasibility.pdf">Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies</a>."<span> </span></p> <p>On June 20, 2014 the FDA issued draft guidance regarding <a href="http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM401996.pdf">Medical Device Data Systems (MDDS), Medical Image Storage Devices, and Medical Image Communication Devices</a>. The draft guidance also contains some edits to the 2013 Mobile Medical Applications Guidance to conform to its draft guidance here.</p> <p><a href="http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/ucm370879.htm"><span>eCopy Program for Medical Device Submissions</span></a></p> <p> </p> </div></div></div> </div> </div> </div> </div> </div> </div> </div> <div id="sidebar" class="column"> <div class="sidebar"> <div class="section"> <div class="region region-sidebar"> <div id="block-menu-block-3" class="block block-menu-block"> <h3><a href="/ide-development-process" class="active-trail active">IDE Development Process</a></h3> <div class="content"> <div class="menu-block-wrapper menu-block-3 menu-name-main-menu parent-mlid-0 menu-level-3"> <ul class="menu"><li class="first leaf menu-mlid-2331"><a href="/pre-ide-process">The Pre-IDE Process</a></li> <li class="leaf menu-mlid-2396"><a href="/ide-study-protocol">IDE Preparation</a></li> <li class="leaf menu-mlid-2496"><a href="/file-ide">File the IDE</a></li> <li class="leaf menu-mlid-2121"><a href="/maintain-ide">Maintain the IDE</a></li> <li class="last leaf menu-mlid-2191"><a href="/ide-resources">IDE Templates, Education & Useful Links</a></li> </ul></div> </div> </div> </div> </div> </div> </div> </div></div> <div id="footer"> <div class="section"> <div class="region region-footer"> <div id="block-block-6" class="block block-block"> <div class="content"> <style type="text/css"> <![CDATA[/* ><!]]>*/ </style> <div class="quickref"> <h2 style="color:#000;font-size:22px;margin:0;padding: 0 0 6px;">Quick Reference</h2> <div class="wysiwyg_threecols layout--33-33-33"> <div class="wysiwyg_threecols--first"> <ul> <li><a href="http://policies.ucsf.edu/" target="_blank">Campus Policies</a></li> <li><a href="http://cancer.ucsf.edu/" target="_blank">Cancer Center (HDFCCC)</a></li> <li><a href="http://accelerate.ucsf.edu/research/crs" target="_blank">Clinical Research Services</a></li> <li><a href="http://ctsi.ucsf.edu" target="_blank">Clinical & Translational Science Institute (CTSI)</a></li> </ul> </div> <div class="wysiwyg_threecols--second"> <ul> <li><a href="http://coi.ucsf.edu/" target="_blank">Conflicts of Interest (COI)</a></li> <li><a href="http://accelerate.ucsf.edu/consult" target="_blank">Consultation Services</a></li> <li><a href="http://accelerate.ucsf.edu/cores/" target="_blank">Cores Search</a></li> <li><a href="https://ehs.ucsf.edu/" target="_blank">Environment, Health and Safety</a></li> <li><a href="http://compliance.ucsf.edu/" target="_blank">Ethics & Compliance</a></li> </ul> </div> <div class="wysiwyg_threecols--third"> <ul> <li><a href="http://globalhealthsciences.ucsf.edu/" target="_blank">Global Health Sciences</a></li> <li><a href="http://ita.ucsf.edu/" target="_blank">Innovation, Technology & Alliances</a></li> <li><a href="http://irb.ucsf.edu" target="_blank">IRB / Human Research Protection Program</a></li> <li><a href="https://osr.ucsf.edu/" target="_blank">Office of Sponsored Research</a></li> <li><a href="http://profiles.ucsf.edu" target="_blank">UCSF Profiles</a></li> </ul> </div> </div> </div> <p style="float: right; margin: 1.2em 30px -1.5em; text-align: right; width: 6em;"><a href="/cdn-cgi/l/email-protection#2169746361544252470f444554" style="color:#FFF"><span class="__cf_email__" data-cfemail="d9918c9b99acbaaabff7bcbdac">[email protected]</span></a></p> </div> </div> </div> <div class="footer-bottom"> <nav aria-label="Footer Navigation" class="footer--navigation"> <ul> <li><a href="/cdn-cgi/l/email-protection#276f7265675244544109424352">Contact Us</a></li> <li><a href="https://www.ucsf.edu/accessibility-resources">Accessibility</a></li> <li><a href="https://www.ucsf.edu/website-privacy-policy">Privacy Policy</a></li> <li><a href="https://websites.ucsf.edu/website-terms-use">Terms of Use </a></li> <li><a href="https://websites.ucsf.edu/azlist">A-Z Website List</a></li> </ul> </nav> <div class="footer--copyright"> <p>© 2024 The Regents of the University of California</p> </div> </div> </div> </div> </div> </div> <script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script><script type="text/javascript"> /*<![CDATA[*/ (function() { var sz = document.createElement('script'); sz.type = 'text/javascript'; sz.async = true; sz.src = '//siteimproveanalytics.com/js/siteanalyze_8343.js'; var s = document.getElementsByTagName('script')[0]; s.parentNode.insertBefore(sz, s); })(); /*]]>*/ </script> </body> </html>