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How the FDA Regulatory Team Assists | Office of Ethics and Compliance
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<a href="/">Home</a> </li> <li class="breadcrumb-item"> How The FDA Regulatory Team Assists </li> </ol> </nav> </div> <div class="layout-content"> <div data-drupal-messages-fallback class="hidden"></div> <div id="block-echo-page-title" class="block block-core block-page-title-block"> <div class="node-owner-group"> <h1 class="page-title"> How the FDA Regulatory Team Assists </h1> <p class="node-owner-group__info"> <span class="node-owner-group__subheading">Questions?</span> <span class="node-owner-group__link">Contact <a href="/teams/fda-regulatory-support">FDA Regulatory Support</a><span> </p> </div> </div> <div id="block-echo-content" class="block block-system block-system-main-block"> <article class="node node--type-knowledge-base node--view-mode-full knowledge-base"> <div class="l-basic l-container-offset "> <nav class="l-sidebar knowledge-base__sidebar" aria-label="Table of contents"> <input type="checkbox" id="check"> <label for="check" class="box-shadow knowledge-base__mobile-overview-toggle">In this article</label> <h2 class="l-sidebar knowledge-base__sidebar-title">In this article</h2> <ul class="knowledge-base__nav"> <li> <a href="#field-overview"> Overview </a> </li> <li> <a href="#paragraph-651"> How We Can Assist </a> </li> </ul> </nav> <div class="l-content"> <div class="box-shadow knowledge-base__content background-white"> <h2 id="field-overview">Overview</h2> <div class="node__overview"><p>The FDA Regulatory Support Team within the Office of Ethics and Compliance (OEC) supports the UCSF research community regarding compliance with Food and Drug Administration (FDA) regulations.</p> <p>To <strong>request a consultation</strong>, please submit a completed FDA <a href="https://ucsf.co1.qualtrics.com/jfe/form/SV_a96z3s2MMpbxc3j?Q_JFE=qdg">Regulatory Support Consultation Request Form</a>.</p> <p>All FDA regulatory compliance-related questions can be sent to <a href="/cdn-cgi/l/email-protection#1f595b5e7c70716c6a736b6c5f6a7c6c79317a7b6a"><span class="__cf_email__" data-cfemail="99dfddd8faf6f7eaecf5edead9ecfaeaffb7fcfdec">[email protected]</span></a>. </p> </div> <div class="section-panel paragraph paragraph--type--text-block paragraph--view-mode--default" id="paragraph-651"> <h2>How We Can Assist</h2> <div class="clearfix text-formatted field field--name-field-section-body field--type-text-long field--label-hidden field__item"><p>We provide consultations to investigators, study teams, and Institutional Review Board (IRB) staff regarding:</p> <ul> <li>Eligibility criteria for Investigational New Drug (IND) applications and exemptions</li> <li>Eligibility criteria for Investigational Device Exemption (IDE) applications and exemptions</li> <li>In-Vitro Diagnostics (IVD) and Assays</li> <li>Software as a Medical Device (SaMD), including Mobile Medical Applications</li> <li>Artificial Intelligence (AI)/Machine Learning Algorithms</li> <li>Clinical Decision Support Tools</li> <li>Related IRB determinations in the context of clinical research</li> <li> <p>FDA inspection support.</p> <p> </p> </li> </ul> <p><strong>FDA Regulatory Support Partners</strong></p> <p>Compliance with FDA regulations is a team effort across many different stakeholders. Charts outlining roles and responsibilities of the various stakeholders are provided below.</p> <p><a href="/sites/compliance.ucsf.edu/files/2024-07/FDA%20Regulatory%20Support%20Roles%20and%20Responsibilities.pdf" data-entity-type="media" data-entity-uuid="532b6c80-9f2f-4ea1-85fc-26b4382ca8da" data-entity-substitution="media" title="FDA Regulatory Support Roles and Responsibilities.pdf">Roles and Responsibilities for Compliance with FDA Regulations Pertaining to Clinical Research</a></p> <p><a href="/sites/compliance.ucsf.edu/files/2024-07/FDA%20Audit%20Roles%20and%20Responsibilities.pdf" data-entity-type="media" data-entity-uuid="45f7d347-0f15-4d2d-9c2d-15bc0a5c5482" data-entity-substitution="media" title="FDA Audit Roles and Responsibilities.pdf">Roles and Responsibilities of the Various Stakeholders during an FDA Audit of Clinical Research</a></p> </div> </div> </div> </div> </div> </article> </div> </div> </main> <footer class="footer"> <a href="/" rel="home" title="Office of Ethics and Compliance homepage" class="footer__logo"> <img src="/themes/custom/echo/images/logos/compliance.svg" alt="Office of Ethics and Compliance homepage" height="53" width="189"/> </a> <div class="footer__menus"> <nav aria-label="Footer" class="footer__columns"> </nav> </div><nav class="footer__legal" aria-label="Legal Information"> <p class="footer__copyright">漏 2024 The Regents of the University of California</p> <ul class="footer__legal-nav"> <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> </footer> </div> </div> <script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script><script type="application/json" data-drupal-selector="drupal-settings-json">{"path":{"baseUrl":"\/","pathPrefix":"","currentPath":"node\/256","currentPathIsAdmin":false,"isFront":false,"currentLanguage":"en"},"pluralDelimiter":"\u0003","suppressDeprecationErrors":true,"google_analytics":{"account":"UA-1557428-4","trackOutbound":true,"trackMailto":true,"trackTel":true,"trackDownload":true,"trackDownloadExtensions":"7z|aac|arc|arj|asf|asx|avi|bin|csv|doc(x|m)?|dot(x|m)?|exe|flv|gif|gz|gzip|hqx|jar|jpe?g|js|mp(2|3|4|e?g)|mov(ie)?|msi|msp|pdf|phps|png|ppt(x|m)?|pot(x|m)?|pps(x|m)?|ppam|sld(x|m)?|thmx|qtm?|ra(m|r)?|sea|sit|tar|tgz|torrent|txt|wav|wma|wmv|wpd|xls(x|m|b)?|xlt(x|m)|xlam|xml|z|zip"},"user":{"uid":0,"permissionsHash":"9029a057a0f22f07ee997045c90bda86ef38e1ceefd755b7cd4eb0b175995f71"}}</script> <script src="/sites/compliance.ucsf.edu/files/js/js_Aco2iilEAxNSDcEu_WOumNU4H6LnJPwo7xmDA9q-7kI.js?scope=footer&delta=0&language=en&theme=echo&include=eJxdjMEOwiAQBX-IlE8i2-2TYhaW8Ghi_XqNHmy8zcxhhMRMpd2h00dUclGv3Yo0RbqVBxiyezYkaWLnLMr4HwJPTtS4ChGgu1-ogpT8vnwsm69iQX0gNh9VrDwRugzJQ_rOuI2jiy2_shytH6sV7ti-j-YbXtE4R1Y"></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>