Cross-cutting Guidance Documents

<!DOCTYPE html> <html lang="en" dir="ltr" prefix="og: https://ogp.me/ns#"> <head> <meta charset="utf-8" /> <script async src="https://www.googletagmanager.com/gtag/js?id=G-273DTKB5QW"></script> <meta name="description" content="Guidance documents issued by the FDA Office of the Commissioner and covering topics affecting multiple regulated products and administrative processes." /> <meta name="dcterms.title" content="Cross-cutting Guidance Documents" /> <meta name="dcterms.creator" content="Office of the Commissioner" /> <meta name="dcterms.description" content="Guidance documents issued by the FDA Office of the Commissioner and covering topics affecting multiple regulated products and administrative processes." /> <meta name="dcterms.publisher" content="FDA" /> <meta name="dcterms.type" content="Article" /> <meta name="dcterms.source" content="FDA" /> <meta property="og:site_name" content="U.S. Food and Drug Administration" /> <meta property="og:type" content="Article" /> <meta property="og:url" content="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cross-cutting-guidance-documents" /> <meta property="og:title" content="Cross-cutting Guidance Documents" /> <meta property="og:updated_time" content="Fri, 07/22/2022 - 00:00" /> <meta property="article:publisher" content="FDA" /> <meta property="article:published_time" content="Fri, 09/29/2023 - 13:04" /> <meta property="article:modified_time" content="Fri, 07/22/2022 - 00:00" /> <meta name="google-site-verification" content="tWxlDhm4ANdksJZPj7TBmHgNoMqZCnecPp0Aa2vC9XA" /> <meta name="twitter:card" content="summary_large_image" /> <meta name="twitter:site" content="@US_FDA" /> <meta name="twitter:title" content="Cross-cutting Guidance Documents" /> <meta name="twitter:creator" content="@US_FDA" /> <meta name="MobileOptimized" content="width" /> <meta name="HandheldFriendly" content="true" /> <meta name="viewport" content="width=device-width, initial-scale=1.0" /> <script type="application/ld+json">{ "@context": "https://schema.org", "@graph": [ { "@type": "Article", "headline": "Cross-cutting Guidance Documents", "name": "Cross-cutting Guidance Documents", "description": "Guidance documents issued by the FDA Office of the Commissioner and covering topics affecting multiple regulated products and administrative processes.", "datePublished": "Fri, 09/29/2023 - 13:04", "dateModified": "Fri, 07/22/2022 - 00:00", "author": { "@type": "Organization", "name": "Office of the Commissioner" }, "publisher": { "@type": "Organization", "name": "FDA" } } ] }</script> <meta property="og:image" content="https://www.fda.gov/themes/custom/preview/img/FDA-Social-Graphic.png" /> <meta name="twitter:image" content="https://www.fda.gov/themes/custom/preview/img/FDA-Social-Graphic.png" /> <meta property="og:description" content="Guidance documents issued by the FDA Office of the Commissioner and covering topics affecting multiple regulated products and administrative processes." /> <meta property="twitter:description" content="Guidance documents issued by the FDA Office of the Commissioner and covering topics affecting multiple regulated products and administrative processes." /> <link rel="icon" href="/themes/custom/preview/favicon.ico" type="image/vnd.microsoft.icon" /> <link rel="alternate" hreflang="en" href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cross-cutting-guidance-documents" /> <link rel="canonical" href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cross-cutting-guidance-documents" /> <link rel="shortlink" href="https://www.fda.gov/node/387932" /> <script src="/files/google_tag/production/google_tag.script.js?smjbjq" defer></script> <title>Cross-cutting Guidance Documents | FDA</title> <link rel="stylesheet" media="all" href="/files/css/css_nIAEFYPN7y_O0y9dA__6_ZBSGy8omYOK6rvMeZ1warY.css?delta=0&language=en&theme=preview&include=eJxljlEOwjAMQy_UUX6QuE2VtVmpaOuqCUPj9DAQA8FP5NiS_SZUpSsLCtvpo3cmAjGzo0p50eTF_hpGFlEudiRh0zrPia82ZoyUB9Elpxr_bN9TUzEjoKKdmm1omLmbKZDzZw5J0R3XE1XPhauKJe_RQ0J1irgCyAldPQKbtVrs8-4KwiXzqwel5bQ2vDJ32B-_TDM91iuUxW5qA_WdbgvHD3mg9tx6_9v6sIHdAfkmf6A" /> <link rel="stylesheet" media="all" href="/files/css/css_xLeUZALg1CD0YmiSIzZnqkwKfNF_g3TkAjkxBt_uccA.css?delta=1&language=en&theme=preview&include=eJxljlEOwjAMQy_UUX6QuE2VtVmpaOuqCUPj9DAQA8FP5NiS_SZUpSsLCtvpo3cmAjGzo0p50eTF_hpGFlEudiRh0zrPia82ZoyUB9Elpxr_bN9TUzEjoKKdmm1omLmbKZDzZw5J0R3XE1XPhauKJe_RQ0J1irgCyAldPQKbtVrs8-4KwiXzqwel5bQ2vDJ32B-_TDM91iuUxW5qA_WdbgvHD3mg9tx6_9v6sIHdAfkmf6A" /> <script src="https://script.crazyegg.com/pages/scripts/0024/3700.js" async></script> <script src="https://dap.digitalgov.gov/Universal-Federated-Analytics-Min.js?agency=HHS&subagency=FDA&sdor=fda.gov&dclink=true" language="javascript" id="_fed_an_ua_tag"></script> <script>window.dataLayer = window.dataLayer || [];function gtag(){dataLayer.push(arguments)};gtag("js", new Date());gtag("set", "developer_id.dMDhkMT", true);gtag("config", "G-273DTKB5QW", {"groups":"default","page_placeholder":"PLACEHOLDER_page_location","allow_ad_personalization_signals":false});</script> </head> <body class="role-anonymous path-node page-node-type-article has-glyphicons"> <div id="quicklinks" class="sr-only"> <ul> <li><a href="#main-content" class="sr-only sr-only-focusable" tabindex="1">Skip to main content</a></li> <li><a href="#search-form" class="sr-only sr-only-focusable" tabindex="1">Skip to FDA Search</a></li> <li><a href="#section-nav" class="sr-only sr-only-focusable" tabindex="1">Skip to in this section menu</a></li> <li><a href="#footer-heading" class="sr-only sr-only-focusable" tabindex="1">Skip to footer links</a></li> </ul> </div> <noscript><iframe src="https://www.googletagmanager.com/ns.html?id=GTM-M95XGZW" height="0" width="0" style="display:none;visibility:hidden"></iframe></noscript> <div class="dialog-off-canvas-main-canvas" data-off-canvas-main-canvas> <div class="main-container container-fluid"> <div class="row"> <header class="lcds-header container-fluid" role="heading" aria-level="1"> <div class="row us-masthead"> <div class="usa-banner col-xs-12"> <img class="usa-banner__us-flag" src="/themes/custom/preview/assets/images/US_Flag.png" alt="U.S. flag" /> <span>An official website of the United States government</span> <a id="USMenuButton" class="collapsed" data-toggle="collapse" data-target="#USABannerMenu" aria-controls="USABannerMenu">Here’s how you know <span class="toggle-indicator"> </span></a> <div class="col-xs-12 collapse usa-banner__menu" id="USABannerMenu" aria-labelledby="USMenuButton"> <div id="gov-banner" class="row usa-banner-content usa-grid usa-accordion-content" aria-hidden="true"> <div class="col-xs-12 col-sm-6 col-md-3"> <img class="usa-banner-icon usa-media_block-img" src="/themes/custom/preview/assets/images/icon-dot-gov.svg" alt="Dot gov" style="width:3em;"> <div class="usa-media_block-body"> <p><strong>The .gov means it’s official.</strong><br>Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.</p> </div> </div> <div class="col-xs-12 col-sm-6 col-md-3"> <img class="usa-banner-icon usa-media_block-img" src="/themes/custom/preview/assets/images/icon-https.svg" alt="SSL" style="width:3em;"> <div class="usa-media_block-body"> <p><strong>The site is secure.</strong><br> The <strong>https://</strong> ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.</p> </div> </div> </div> </div> </div> </div> <div class="alert alert-warning margin-left-neg-2 margin-right-neg-2 margin-top-3 margin-bottom-1"> <p>On Oct. 1, 2024, the FDA began implementing a <a href="/about-fda/fda-organization/fda-modernization-efforts-establishing-unified-human-foods-program-new-model-field-operations-and" title="FDA Modernization Efforts for Establishing a Unified Human Foods Program, New Model for Field Operations and More">reorganization</a> impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.</p> </div> <div class="row fda-masthead"> <div class="col-xs-4 col-md-8"> <a href="/" title="FDA Homepage"> <h1 class="fda-masthead__fda-logo">U.S. Food and Drug Administration</h1> </a> </div> <div class="col-xs-8 col-md-4"> <ul class='fda-masthead__item-list'> <li><a title="" id="btn-search" class="btn btn-default btn-sm fda-masthead__btn-search"> <span class="fa fa-search" aria-hidden="true"> </span> <span class="fda-masthead__btn-label">Search</span> </a></li> <li><a id="menu-btn" class="btn btn-default btn-sm fda-masthead__btn-menu collapsed" href="#primary-nav" data-toggle="collapse" aria-expanded="true"> <span class="fa fa-bars" aria-hidden="true"> </span> <span class='fda-masthead__btn-label'>Menu</span> </a></li> </ul> </div> <form class="fda-masthead__search sr-only" role="search" action="/search" method="GET" name="searchForm" id="search-form" accept-charset="UTF-8" > <div class="search-popover" id="search-popover"> <div class="input-group pull-right" id="search-group"> <label class="sr-only" for="search-query">Search FDA</label> <input class="form-control search-input" id="search-query" name="s" aria-autocomplete="list" aria-haspopup="true" title="Enter the terms you wish to search for." placeholder="Search FDA" type="text" /> <span class="input-group-btn" id="input-group-btn"> <button type="submit" class="btn btn-danger search-btn" id="search-btn" title="Search"><span class="fa fa-search" aria-hidden="true"><span class="sr-only">Submit search</span></span></button> </span> </div> </div> </form> </div> <nav id="primary-nav" class="lcds-primary-nav row collapse"> <div class="col-md-5 col-lg-4"> <section class="lcds-primary-nav__group lcds-primary-nav__group--bordered"> <h2 class="lcds-primary-nav__group-heading">Featured</h2> <ul class="lcds-primary-nav__list lcds-primary-nav__list--featured"> <li class="lcds-primary-nav__list-item"><a href="https://www.safetyreporting.hhs.gov/smarthub#/" title="Report a Problem with an FDA Regulated Product">Report a Product Problem</a></li> <li class="lcds-primary-nav__list-item"><a href="/about-fda/contact-fda">Contact FDA</a></li> <li class="lcds-primary-nav__list-item"><a href="/regulatory-information/search-fda-guidance-documents">FDA Guidance Documents</a></li> <li class="lcds-primary-nav__list-item"><a href="/safety/recalls-market-withdrawals-safety-alerts">Recalls, Market Withdrawals and Safety Alerts</a></li> <li class="lcds-primary-nav__list-item"><a href="/news-events/newsroom/press-announcements">Press Announcements</a></li> <li class="lcds-primary-nav__list-item"><a href="/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters">Warning Letters</a></li> <li class="lcds-primary-nav__list-item"><a href="/advisory-committees">Advisory Committees</a></li> <li class="lcds-primary-nav__list-item"><a href="/fda-en-espanol">En Espa&#241ol</a></li> </ul> </section> </div> <div class="col-md-7 col-lg-8"> <section class="lcds-primary-nav__group lcds-primary-nav__group--bordered"> <h2 class="lcds-primary-nav__group-heading">Products</h2> <ul class="lcds-primary-nav__list"> <li class="lcds-primary-nav__list-item"><a href="/food">Food</a></li> <li class="lcds-primary-nav__list-item"><a href="/drugs">Drugs</a></li> <li class="lcds-primary-nav__list-item"><a href="/medical-devices">Medical Devices</a></li> <li class="lcds-primary-nav__list-item"><a href="/radiation-emitting-products">Radiation-Emitting Products</a></li> <li class="lcds-primary-nav__list-item"><a href="/vaccines-blood-biologics">Vaccines, Blood, and Biologics</a></li> <li class="lcds-primary-nav__list-item"><a href="/animal-veterinary">Animal and Veterinary</a></li> <li class="lcds-primary-nav__list-item"><a href="/cosmetics">Cosmetics</a></li> <li class="lcds-primary-nav__list-item"><a href="/tobacco-products">Tobacco Products</a></li> </ul> </section> <section class="lcds-primary-nav__group lcds-primary-nav__group--bordered"> <h2 class="lcds-primary-nav__group-heading">Topics</h2> <ul class="lcds-primary-nav__list"> <li class="lcds-primary-nav__list-item"><a href="/about-fda">About FDA</a></li> <li class="lcds-primary-nav__list-item"><a href="/combination-products">Combination Products</a></li> <li class="lcds-primary-nav__list-item"><a href="/regulatory-information">Regulatory Information</a></li> <li class="lcds-primary-nav__list-item"><a href="/safety">Safety</a></li> <li class="lcds-primary-nav__list-item"><a href="/emergency-preparedness-and-response">Emergency Preparedness</a></li> <li class="lcds-primary-nav__list-item"><a href="/international-programs">International Programs</a></li> <li class="lcds-primary-nav__list-item"><a href="/news-events">News and Events</a></li> <li class="lcds-primary-nav__list-item"><a href="/training-and-continuing-education">Training and Continuing Education</a></li> <li class="lcds-primary-nav__list-item"><a href="/inspections-compliance-enforcement-and-criminal-investigations">Inspections and Compliance</a></li> <li class="lcds-primary-nav__list-item"><a href="/science-research">Science and Research</a></li> </ul> </section> <section class="lcds-primary-nav__group lcds-primary-nav__group--bordered"> <h2 class="lcds-primary-nav__group-heading">Information For</h2> <ul class="lcds-primary-nav__list"> <li class="lcds-primary-nav__list-item"><a href="/consumers">Consumers</a></li> <li class="lcds-primary-nav__list-item"><a href="/patients">Patients</a></li> <li class="lcds-primary-nav__list-item"><a href="/industry">Industry</a></li> <li class="lcds-primary-nav__list-item"><a href="/health-professionals">Health Professionals</a></li> <li class="lcds-primary-nav__list-item"><a href="/federal-state-local-tribal-and-territorial-officials">Federal, State and Local Officials</a></li> </ul> </section> </div> </nav> </header> <div class="col-xs-12"> <div data-drupal-messages-fallback class="hidden"></div> </div> <section id="block-entityviewcontent" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <a class="lcds-button--expandable collapsed hidden-md hidden-lg" data-toggle="collapse" href="#section-nav" >In this section<span class="visible-sm-inline-block">: Search for FDA Guidance Documents </span> </a> <nav id="section-nav" class="lcds-card lcds-section-nav lcds-section-nav hidden-md hidden-lg collapse"> <ul class="lcds-section-nav__list"> <li> <a href="/regulatory-information/search-fda-guidance-documents" title="Search for FDA Guidance Documents" class="lcds-section-nav__section-link lcds-section-nav__link lcds-section-nav__parent-link visible-xs-block visible-sm-block"> Search for FDA Guidance Documents </a> <div class="views-element-container form-group"><div class="view view-in-this-section view-id-in_this_section view-display-id-block_5 js-view-dom-id-8b4ac3db05fca7d49c19785431a97d09e5783f603b92452fb683cabebce72c45"> <div> <ul class="lcds-section-nav__section-link__active lcds-section-nav__list"> <li><a href="/regulatory-information/search-fda-guidance-documents/search-general-and-cross-cutting-topics-guidance-documents" class="lcds-section-nav__link">Search General and Cross-Cutting Topics Guidance Documents</a></li> <li><a href="/regulatory-information/search-fda-guidance-documents/advisory-committee-guidance-documents" class="lcds-section-nav__link">Advisory Committee Guidance Documents</a></li> <li><a href="/regulatory-information/search-fda-guidance-documents/import-and-export-guidance-documents" class="lcds-section-nav__link">Import and Export Guidance Documents</a></li> <li><a href="/regulatory-information/search-fda-guidance-documents/cross-cutting-guidance-documents" class="lcds-section-nav__link">Cross-cutting Guidance Documents</a></li> </ul> </div> </div> </div> <div class="views-element-container form-group"><div class="view view-in-this-section-sub view-id-in_this_section_sub view-display-id-block_2 js-view-dom-id-2eca1f452fc9031c778d095fad7ec87ab3bbaf200a717256c85348cade70cb2b"> <div class="view-content"> <div> <ul class="lcds-section-nav__list"> <li><a href="/regulatory-information/search-fda-guidance-documents/guidances" class="lcds-section-nav__section-link lcds-section-nav__link">Guidances</a></li> </ul> </div> </div> </div> </div> </li> </ul> </nav> </section> <section id="block-entityviewcontent-15" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <ol class="lcds-breadcrumb visible-md visible-lg"> <li > <a href="/">Home</a> </li> <li > <a href="/regulatory-information">Regulatory Information</a> </li> <li > <a href="/regulatory-information/search-fda-guidance-documents">Search for FDA Guidance Documents</a> </li> <li > <a class="current-link">Cross-cutting Guidance Documents</a> </li> </ol> <ol class="lcds-breadcrumb visible-sm visible-xs"> <li> <a href="/regulatory-information/search-fda-guidance-documents" title="Search for FDA Guidance Documents"> Search for FDA Guidance Documents </a> </li> </ol> </section> <main> <article id="main-content" class="article main-content container-fluid" role="article"> <header class="row content-header" role="heading" aria-level="1"> <section id="block-entityviewcontent-2" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <div class="col-sm-12 col-md-8 col-md-offset-2"> <h1 class="content-title text-center">Cross-cutting Guidance Documents</h1> <div class="lcds-toolbar lcds-toolbar--social"> <ul class="lcds-share lcds-share--default"> <li class="lcds-share__item"> <a href="https://www.facebook.com/sharer/sharer.php?u=https://www.fda.gov%2Fregulatory-information%2Fsearch-fda-guidance-documents%2Fcross-cutting-guidance-documents" class="lcds-share__btn lcds-share--default__btn-facebook js-share" id="fb-share" target="_blank"><span class="fa icon-facebook" aria-hidden="true"></span>Share</a> </li> <li class="lcds-share__item"> <a href="https://x.com/intent/tweet/?text=Cross-cutting%20Guidance%20Documents&url=https://www.fda.gov%2Fregulatory-information%2Fsearch-fda-guidance-documents%2Fcross-cutting-guidance-documents" target="_blank" class="lcds-share__btn lcds-share--default__btn-x-twitter js-share" id="twitter-share"> <svg class="icon-svg-inline" aria-hidden="true"> <use href="/themes/custom/preview/assets/images/fa-icons.svg#icon-x-twitter"> </svg> Post </a> </li> <li class="lcds-share__item hidden-xs"> <a href="https://www.linkedin.com/shareArticle?mini=true&url=https://www.fda.gov%2Fregulatory-information%2Fsearch-fda-guidance-documents%2Fcross-cutting-guidance-documents&title=Cross-cutting%20Guidance%20Documents&source=FDA" class="lcds-share__btn lcds-share--default__btn-linkedin js-share" id="linkedin-share" target="_blank"><span class="fa icon-linkedin" aria-hidden="true"></span>Linkedin</a> </li> <li class="lcds-share__item"> <a href="mailto:?subject=Cross-cutting%20Guidance%20Documents&body=https://www.fda.gov%2Fregulatory-information%2Fsearch-fda-guidance-documents%2Fcross-cutting-guidance-documents" class="lcds-share__btn lcds-share--default__btn-mail"><span class="fa icon-envelope" aria-hidden="true"></span>Email</a> </li> <li class=" lcds-share__item hidden-xs"> <a href="javascript:window.print();" title="Print this page" class="lcds-share__btn lcds-share--default__btn-print"><span class="fa icon-print" aria-hidden="true"></span>Print</a> </li> </ul> <div class="form-group"> </div> </div> </div> </section> </header> <div class="col-md-8 col-md-push-2" role="main"> <p>Some Web links (URLs) embedded within guidance documents may have changed since the document was published. If you find a link that does not work, please try searching for the document using the document title. For more assistance, go to <a href="/contact-fda-1">Contact FDA</a>.</p> <h2>Guidance Documents:</h2> <ul> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="2a062c46-b080-4148-9b2c-1e531b727a01" href="/regulatory-information/search-fda-guidance-documents/conducting-remote-regulatory-assessments-questions-and-answers" title="Conducting Remote Regulatory Assessments Questions and Answers">Conducting Remote Regulatory Assessments - Questions and Answers</a> - 07/2022</li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="4e09f9dd-8d22-4d51-a88b-793f1d9c3d63" href="/regulatory-information/search-fda-guidance-documents/collecting-and-providing-702b-portions-fda-official-samples" title="Collecting and Providing 702(b) Portions of FDA Official Samples">Collecting and Providing 702(b) Portions of FDA Official Samples - Questions and Answers</a> 01/2022</li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="3ff30928-4917-4c64-b6cc-a9ed4edec71d" href="/regulatory-information/search-fda-guidance-documents/circumstances-constitute-delaying-denying-limiting-or-refusing-drug-or-device-inspection" title="Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection">Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection</a> - 10/2014</li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="8caca685-b606-4b90-97a5-a1df43290008" href="/regulatory-information/search-fda-guidance-documents/clarification-orphan-designation-drugs-and-biologics-pediatric-subpopulations-common-diseases" title="Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases">Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases</a> - 12/2017</li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="b9795d28-65a0-4118-829e-cce02f49b19a" href="/regulatory-information/search-fda-guidance-documents/complementary-and-alternative-medicine-products-and-their-regulation-food-and-drug-administration" title="Complementary and Alternative Medicine Products and their Regulation by the Food and Drug Administration">Complementary and Alternative Medicine Products and their Regulation by the Food and Drug Administration</a> - 12/2006</li> <li><a href="/regulatory-information/search-fda-guidance-documents/considering-whether-fda-regulated-product-involves-application-nanotechnology">Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology</a> -06/2014</li> <li><a href="/regulatory-information/search-fda-guidance-documents/consumer-directed-broadcast-advertisements">Consumer-Directed Broadcast Advertisements</a> - 08/1999</li> <li><a href="/regulatory-information/search-fda-guidance-documents/container-and-closure-system-integrity-testing-lieu-sterility-testing-component-stability-protocol">Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products</a> - 02/2008</li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="bcb79c4b-646d-43ea-b22c-5e41f13bce06" href="/regulatory-information/search-fda-guidance-documents/demonstrating-substantial-evidence-effectiveness-human-drug-and-biological-products" title="Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products">Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products</a> - 12/2019</li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="bd95961b-31e9-40e8-aae8-ab5c2c5b3ab3" href="/regulatory-information/search-fda-guidance-documents/developing-and-labeling-in-vitro-companion-diagnostic-devices-specific-group-oncology-therapeutic" title="Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group of Oncology Therapeutic Products">Developing and Labeling In vitro Companion Diagnostic Devices for a Specifc Group or Class of Oncology Therapeutic Products</a> - 12/2018</li> <li><a href="/regulatory-information/search-fda-guidance-documents/direct-final-rule-procedures">Direct Final Rule Procedures</a> - 11/1997</li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="97bc86bf-90e7-473d-807d-5b9785df185f" href="/regulatory-information/search-fda-guidance-documents/drug-and-device-manufacturer-communications-payors-formulary-committees-and-similar-entities" title="Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers">Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities: Questions and Answers</a> - 06/2018</li> <li><a href="/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application">Part 11, Electronic Records; Electronic Signatures - Scope and Application</a> - 08/2003</li> <li><a href="/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-medical-products-and-related-authorities">Emergency Use Authorization of Medical Products and Related Authorities</a> - 01/2017</li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="50714eb5-4d21-4286-8fae-bb11f33f9ebb" href="/regulatory-information/search-fda-guidance-documents/form-fda-3674-certifications-accompany-drug-biological-product-and-device-applicationssubmissions" title="Form FDA 3674 - Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions">Form 3674 - Certifications to Accompany Drug, Biological Product, and Device Submissions</a> - 06/2017</li> <li><a href="/regulatory-information/search-fda-guidance-documents/gifts-fda-evaluation-and-acceptance">Gifts to FDA: Evaluation and Acceptance</a> - 12/2016</li> <li><a href="/regulatory-information/search-fda-guidance-documents/good-reprint-practices-distribution-medical-journal-articles-and-medical-or-scientific-reference">Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices</a> - 1/2009</li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="5ac8e520-0700-47eb-92c4-a4d8eb146a9e" href="/regulatory-information/search-fda-guidance-documents/humanitarian-use-device-hud-designations" title="Humanitarian Use Device (HUD) Designations ">Humanitarian Use Device (HUD) Designations</a> 01/2013</li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="e51637b5-3a31-40ab-bdd8-96363b2bf65b" href="/regulatory-information/search-fda-guidance-documents/industry-supported-scientific-and-educational-activities" title="Industry Supported Scientific and Educational Activities">Industry Supported Scientific and Educational Activities</a> - 11/1997</li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="898f9862-8fa1-4550-86cc-9024abd86fb3" href="/regulatory-information/search-fda-guidance-documents/material-threat-medical-countermeasure-priority-review-vouchers-draft-guidance-industry" title="Material Threat Medical Countermeasure Priority Review Vouchers - Draft Guidance for Industry">Material Threat Medical Countermeasure Priority Review Vouchers</a> - 01/2018</li> <li><a href="/regulatory-information/search-fda-guidance-documents/meaning-spouse-and-family-fdas-regulations-after-supreme-courts-ruling-united-states-v-windsor">The Meaning of "Spouse" and "Family" in FDA's Regulations after the Supreme Court's Ruling in United States v. Windsor</a> - 04/2014</li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="75f98388-4233-4e59-b332-7548c4c325b6" href="/regulatory-information/search-fda-guidance-documents/medical-product-communications-are-consistent-fda-required-labeling-questions-and-answers" title="Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers ">Medical Product Communications That Are Consistent With the FDA-Required Labeling: Questions and Answers</a> - 06/2018</li> <li><a href="/regulatory-information/search-fda-guidance-documents/meetings-office-orphan-products-development">Meetings with the Office of Orphan Products Development</a> - 07/2015</li> <li><a href="/regulatory-information/search-fda-guidance-documents/providing-regulatory-submissions-electronic-format-orphan-drug-and-humanitarian-use-device">Providing Regulatory Submissions in Electronic Format Orphan-Drug and Humanitarian Use Device Designation Requests and Related Submissions</a> 02/2006</li> <li><a href="/regulatory-information/search-fda-guidance-documents/rare-pediatric-disease-priority-review-vouchers-draft-guidance-industry">Rare Pediatric Disease Priority Review Vouchers, Draft Guidance for Industry</a> 11/2014</li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="6b094622-56f5-4214-aac8-c2b347aa67be" href="/regulatory-information/search-fda-guidance-documents/release-ora-laboratory-analytical-results-responsible-party" title="Release of ORA Laboratory Analytical Results to the Responsible Party">Release of ORA Laboratory Analytical Results to the Responsible Party</a> - 03/2019</li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="b93e9d78-1329-42b8-b9d9-fc4d3d20ca62" href="/about-fda/page-not-found">Review and Update of Device Establishment Inspection Processes and Standards</a> - 03/2019</li> <li><a href="/regulatory-information/search-fda-guidance-documents/standards-securing-drug-supply-chain-standardized-numerical-identification-prescription-drug">Standards for Securing the Drug Supply Chain - Standardized Numerical Identification for Prescription Drug Packages</a> -03/2010</li> <li><a href="/regulatory-information/search-fda-guidance-documents/using-electronic-means-distribute-certain-product-information">Using Electronic Means to Distribute Certain Product Information</a> - 03/2006</li> </ul>   </div> <aside class="col-md-2 col-md-push-2" role="complementary"> <section id="block-entityviewcontent-4" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <div class="region region-"> <aside class="lcds-card lcds-card--border-top"> <ul role="menu" class="lcds-description-list"> <li role="menuitem" class="node-current-date lcds-description-list__item"> <div> <h2 class="lcds-description-list__item-heading">Content current as of:</h2> <p class="lcds-description-list__item-text"><time datetime="2022-07-22T00:00:00Z">07/22/2022</time> </p> </div> </li> <li role="menuitem" class="lcds-description-list__item"> <div> </div> </li> </ul> </aside> </div> </section> </aside> <aside class="col-md-2 col-md-pull-10" role="complementary"> <section id="block-entityviewcontent-3" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <div class="region region-"> <nav id="section-nav"class="lcds-card lcds-section-nav lcds-section-nav--side hidden-xs hidden-sm"> <ul class="lcds-section-nav__list lcds-section-nav--side__list"> <li> <a href="/regulatory-information/search-fda-guidance-documents" class="lcds-section-nav__link lcds-section-nav--side__link lcds-section-nav__parent-link lcds-section-nav--side__parent-link"> Search for FDA Guidance Documents </a> <div class="views-element-container form-group"><div class="view view-in-this-section view-id-in_this_section view-display-id-block_4 js-view-dom-id-b51e1dfdcd7e6bfe8c0e59011c7049107e418f2e2cf34b0e5a18d69e2b943807"> <div class="item-list"> <ul class="lcds-section-nav__active lcds-section-nav__list lcds-section-nav--side__list"> <li><a href="/regulatory-information/search-fda-guidance-documents/search-general-and-cross-cutting-topics-guidance-documents" class="lcds-section-nav__link lcds-section-nav--side__link">Search General and Cross-Cutting Topics Guidance Documents</a></li> <li><a href="/regulatory-information/search-fda-guidance-documents/advisory-committee-guidance-documents" class="lcds-section-nav__link lcds-section-nav--side__link">Advisory Committee Guidance Documents</a></li> <li><a href="/regulatory-information/search-fda-guidance-documents/import-and-export-guidance-documents" class="lcds-section-nav__link lcds-section-nav--side__link">Import and Export Guidance Documents</a></li> <li><a href="/regulatory-information/search-fda-guidance-documents/cross-cutting-guidance-documents" class="lcds-section-nav__link lcds-section-nav--side__link">Cross-cutting Guidance Documents</a></li> </ul> </div> </div> </div> <div class="views-element-container form-group"><div class="view view-in-this-section-sub view-id-in_this_section_sub view-display-id-block_1 js-view-dom-id-51f3adf66b94b686bd59a2f38df854f4ae5983ec3f2398220fb733383e8ff5a2"> <div class="view-content"> <div> <ul class="lcds-section-nav__list"> <li><a href="/regulatory-information/search-fda-guidance-documents/guidances" class="lcds-section-nav__section-link lcds-section-nav__link lcds-section-nav--side__link">Guidances</a></li> </ul> </div> </div> </div> </div> </li> </ul> </nav> </div> </section> </aside> </article> </main> </div> </div> <div class="region region-subscribe"> <section id="block-entityviewcontent-5" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> </section> </div> <footer class="lcds-footer container-fluid"> <div class="row lcds-footer__primary"> <h2 id="footer-heading" class="sr-only">Footer Links</h2> <nav class="text-center"> <div class="col-sm-4"> <ul class="nav"> <li><a href="/about-fda/about-website/fdagov-archive" >FDA Archive</a></li> <li><a href="/about-fda" >About FDA</a></li> <li><a href="/about-fda/about-website/internet-accessibility" >Accessibility</a></li> </ul> </div> <div class="col-sm-4"> <ul class="nav"> <li><a href="/about-fda/visitor-information" >Visitor Information</a> </li> <li><a href="/about-fda/about-website/website-policies" >Website Policies / Privacy</a></li> <li><a href="/about-fda/jobs-and-training-fda/no-fear-act" >No FEAR Act</a></li> <li><a href="https://www.hhs.gov/vulnerability-disclosure-policy/index.html" >Vulnerability Disclosure Policy</a></li> </ul> </div> <div class="col-sm-4"> <ul class="nav"> <li><a href="/regulatory-information/freedom-information" title="Freedom of Information Act">FOIA</a></li> <li><a href="https://www.hhs.gov/" title="Health and Human Services" target="_blank">HHS.gov</a></li> <li><a href="https://www.usa.gov/" target="_blank">USA.gov</a></li> </ul> </div> </nav> </div> <div class="row lcds-footer__secondary"> <div class="col-sm-12 col-md-6 col-lg-4 lcds-footer__social-links"> <a href="/about-fda/contact-fda" class="btn btn-default btn-md">Contact FDA</a> <a href="https://www.facebook.com/FDA" title="Follow FDA on Facebook" class="no-disclaimer"> <span class="fa fa-facebook fa-2x" aria-hidden="true"> <span class="sr-only">Follow FDA on Facebook</span> </span> </a> <a href="https://x.com/US_FDA" title="Follow FDA on X" class="no-disclaimer"> <svg class="icon-svg-inline fa-2x" aria-hidden="true"> <use href="/themes/custom/preview/assets/images/fa-icons.svg#icon-x-twitter"> </svg> <span class="sr-only">Follow FDA on X</span> </a> <a href="https://instagram.com/FDA" title="Follow FDA on Instagram" class="no-disclaimer"> <span class="fa fa-instagram fa-2x" aria-hidden="true"> <span class="sr-only">Follow FDA on Instagram</span> </span> </a> <br class='visible-xs-inline'/> <a href="https://www.linkedin.com/company/fda/" title="Follow FDA on LinkedIn" class="no-disclaimer"> <span class="fa fa-linkedin fa-2x" aria-hidden="true"> <span class="sr-only">Follow FDA on LinkedIn</span> </span> </a> <a href="https://youtube.com/@US_FDA" title="View FDA videos on YouTube" class="no-disclaimer"> <span class="fa fa-youtube fa-2x" aria-hidden="true"> <span class="sr-only">View FDA videos on YouTube</span> </span> </a> <a href="/about-fda/contact-fda/subscribe-podcasts-and-news-feeds" title="Subscribe to FDA RSS feeds"> <span class="fa fa-rss fa-2x" aria-hidden="true"> <span class="sr-only">Subscribe to FDA RSS feeds</span> </span> </a> </div> <a href="/" title="FDA Homepage"> <div class="visible-lg-block col-lg-4 text-center lcds-footer__logo"> <span class="sr-only">FDA Homepage</span> </div> </a> <div class="col-sm-12 col-md-6 col-lg-4 text-center lcds-footer__contact-number"> <span class="fa fa-phone" aria-hidden="true"> </span> <span class="sr-only">Contact Number</span> 1-888-INFO-FDA (1-888-463-6332) </div> </div>  </footer> <a href="" id="btn-top" class="btn btn-primary btn-top"><span class="sr-only">Back to </span>Top</a> </div> <script type="application/json" data-drupal-selector="drupal-settings-json">{"path":{"baseUrl":"\/","pathPrefix":"","currentPath":"node\/387932","currentPathIsAdmin":false,"isFront":false,"currentLanguage":"en"},"pluralDelimiter":"\u0003","suppressDeprecationErrors":true,"fda_ckeditor_enhancements":{"basePath":"modules\/custom\/fda_ckeditor_enhancements"},"google_analytics":{"account":"G-273DTKB5QW","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"},"bootstrap":{"forms_has_error_value_toggle":1,"modal_animation":1,"modal_backdrop":"true","modal_focus_input":1,"modal_keyboard":1,"modal_select_text":1,"modal_show":1,"modal_size":"","popover_enabled":1,"popover_animation":1,"popover_auto_close":1,"popover_container":"body","popover_content":"","popover_delay":"0","popover_html":0,"popover_placement":"right","popover_selector":"","popover_title":"","popover_trigger":"click"},"ajax":[],"user":{"uid":0,"permissionsHash":"3aef67b4ac7d861d8624bf1f7ab2bc9cfc56d3c25b7d709dc15466dfa996dfb0"}}</script> <script src="/files/js/js_jmx6639WuKcEs1DgFSmm8g__5ByGF4YtLnPWvZO-XrM.js?scope=footer&delta=0&language=en&theme=preview&include=eJxljlEOwjAMQy_UUX6QuE2VtVmpaOuqCUPj9DAQA8FP5NiS_SZUpSsLCtvpo3cmAjGzo0p50eTF_hpGFlEudiRh0zrPia82ZoyUB9Elpxr_bN9TUzEjoKKdmm1omLmbKZDzZw5J0R3XE1XPhauKJe_RQ0J1irgCyAldPQKbtVrs8-4KwiXzqwel5bQ2vDJ32B-_TDM91iuUxW5qA_WdbgvHD3mg9tx6_9v6sIHdAfkmf6A"></script> <script type="text/javascript" src="/Dc2Go5/dCelR/Sewog/rk5-/5VYNNfD46DcX/DQdKdDY/XS/EsHSMaAwQB"></script></body> </html>

CINXE.COM

Cross-cutting Guidance Documents | FDA