Digital Health Center of Excellence

<!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="Information about CDRH's Digital Health Program" /> <meta name="dcterms.title" content="Digital Health Center of Excellence" /> <meta name="dcterms.creator" content="Center for Devices and Radiological Health" /> <meta name="dcterms.description" content="Information about CDRH's Digital Health Program" /> <meta name="dcterms.publisher" content="FDA" /> <meta name="dcterms.source" content="FDA" /> <meta name="dcterms.audience" content="Health Care Provider" /> <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/medical-devices/digital-health-center-excellence" /> <meta property="og:title" content="Digital Health Center of Excellence" /> <meta property="og:description" content="Information about CDRH's Digital Health Program" /> <meta property="og:image" content="https://www.fda.gov/files/dhcoe%20page%20image.jpg" /> <meta property="og:updated_time" content="Thu, 09/26/2024 - 00:00" /> <meta property="article:published_time" content="Thu, 09/26/2024 - 13:02" /> <meta property="article:modified_time" content="Thu, 09/26/2024 - 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 property="twitter:description" content="Information about CDRH's Digital Health Program" /> <meta name="twitter:title" content="Digital Health Center of Excellence" /> <meta name="twitter:creator" content="@US_FDA" /> <meta name="twitter:image" content="https://www.fda.gov/files/dhcoe%20page%20image.jpg" /> <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": "Digital Health Center of Excellence", "name": "Digital Health Center of Excellence", "description": "Information about CDRH\u0027s Digital Health Program", "image": { "@type": "ImageObject", "representativeOfPage": "True", "url": "https://www.fda.gov/files/dhcoe%20page%20image.jpg" }, "datePublished": "Thu, 09/26/2024 - 13:02", "dateModified": "Thu, 09/26/2024 - 00:00", "author": { "@type": "Organization", "name": "Center for Devices and Radiological Health" }, "publisher": { "@type": "Organization", "name": "FDA" } } ] }</script> <link rel="icon" href="/themes/custom/preview/favicon.ico" type="image/vnd.microsoft.icon" /> <link rel="alternate" hreflang="en" href="https://www.fda.gov/medical-devices/digital-health-center-excellence" /> <link rel="canonical" href="https://www.fda.gov/medical-devices/digital-health-center-excellence" /> <link rel="shortlink" href="https://www.fda.gov/node/359753" /> <script src="/files/google_tag/production/google_tag.script.js?smjbjq" defer></script> <title>Digital Health Center of Excellence | FDA</title> <link rel="stylesheet" media="all" href="/files/css/css_pF_-QtQgT8ZN3eoadzEfql-KALI0XgOcCRIPM_0eEtw.css?delta=0&language=en&theme=preview&include=eJxlj1GOwjAMRC8UGn6Q9jaRm7hpRBJbtgvqnn4paFsEP9Z4LI3fTNQN7qjU0E-HHlwmyhUDdKirlaj-03C6qmHzIyg6FrwVvPtcaYR6Ultr6fnLjlLY1I1EpibAnonphuKmBCFeMRUjCdhn6BEbdlMPMZKkQj0Y5Q1AZxKLlNBt0eqfc2iUloqvHGpcy5bwuoXL-efNdAwC-fF8Vp9kYajD4QxL52WsRWdMbnpgdjJUv6u9URT4XTEfFRPwE-p_3zFPe4M_uG6P1A" /> <link rel="stylesheet" media="all" href="/files/css/css_xLeUZALg1CD0YmiSIzZnqkwKfNF_g3TkAjkxBt_uccA.css?delta=1&language=en&theme=preview&include=eJxlj1GOwjAMRC8UGn6Q9jaRm7hpRBJbtgvqnn4paFsEP9Z4LI3fTNQN7qjU0E-HHlwmyhUDdKirlaj-03C6qmHzIyg6FrwVvPtcaYR6Ultr6fnLjlLY1I1EpibAnonphuKmBCFeMRUjCdhn6BEbdlMPMZKkQj0Y5Q1AZxKLlNBt0eqfc2iUloqvHGpcy5bwuoXL-efNdAwC-fF8Vp9kYajD4QxL52WsRWdMbnpgdjJUv6u9URT4XTEfFRPwE-p_3zFPe4M_uG6P1A" /> <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-sub-section 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">: Medical Devices </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="/medical-devices/digital-health-center-excellence" class="lcds-section-nav__section-link lcds-section-nav__link lcds-section-nav__parent-link">Digital Health Center of Excellence</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-ee10e6a8d31eacc503c6f55ad064bf1286396167638d67b7e31fb13faf187f04"> <div> <ul class="lcds-section-nav__section-link__active lcds-section-nav__list"> <li><a href="/medical-devices/digital-health-center-excellence/cybersecurity-medical-devices-frequently-asked-questions-faqs" class="lcds-section-nav__link">Cybersecurity in Medical Devices Frequently Asked Questions (FAQs)</a></li> <li><a href="/medical-devices/digital-health-center-excellence/digital-health-frequently-asked-questions-faqs" class="lcds-section-nav__link">Digital Health Frequently Asked Questions (FAQs) </a></li> <li><a href="/medical-devices/digital-health-center-excellence/digital-health-center-excellence-services" class="lcds-section-nav__link">Digital Health Center of Excellence Services</a></li> <li><a href="/medical-devices/digital-health-center-excellence/about-digital-health-center-excellence" class="lcds-section-nav__link">About the Digital Health Center of Excellence</a></li> <li><a href="/medical-devices/digital-health-center-excellence/network-digital-health-experts" class="lcds-section-nav__link">Network of Digital Health Experts</a></li> <li><a href="/medical-devices/digital-health-center-excellence/what-digital-health" class="lcds-section-nav__link">What is Digital Health?</a></li> <li><a href="/medical-devices/digital-health-center-excellence/cybersecurity" class="lcds-section-nav__link">Cybersecurity</a></li> <li><a href="/medical-devices/digital-health-center-excellence/digital-health-terms" class="lcds-section-nav__link">Digital Health Terms</a></li> <li><a href="/medical-devices/digital-health-center-excellence/guidances-digital-health-content" class="lcds-section-nav__link">Guidances with Digital Health Content</a></li> <li><a href="/medical-devices/digital-health-center-excellence/digital-health-policy-navigator" class="lcds-section-nav__link">Digital Health Policy Navigator </a></li> <li><a href="/medical-devices/digital-health-center-excellence/digital-health-reports" class="lcds-section-nav__link">Digital Health Reports</a></li> <li><a href="/medical-devices/digital-health-center-excellence/fda-digital-health-advisory-committee" class="lcds-section-nav__link">FDA Digital Health Advisory Committee</a></li> <li><a href="/medical-devices/digital-health-center-excellence/medical-device-interoperability" class="lcds-section-nav__link">Medical Device Interoperability</a></li> <li><a href="/medical-devices/digital-health-center-excellence/digital-health-research-and-partnerships" class="lcds-section-nav__link">Digital Health Research and Partnerships </a></li> <li><a href="/medical-devices/digital-health-center-excellence/augmented-reality-and-virtual-reality-medical-devices" class="lcds-section-nav__link">Augmented Reality and Virtual Reality in Medical Devices</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-434e9c72fa8ea75805d9a07c79469d5d5e58d4f4decafeb752ad68ec34cd0b8b"> <div class="view-content"> <div> <ul class="lcds-section-nav__list"> <li><a href="/medical-devices/digital-health-center-excellence/diagnostic-data-program" class="lcds-section-nav__section-link lcds-section-nav__link">Diagnostic Data Program</a></li> <li><a href="/medical-devices/digital-health-center-excellence/software-medical-device-samd" class="lcds-section-nav__section-link lcds-section-nav__link">Software as a Medical Device (SaMD)</a></li> <li><a href="/medical-devices/digital-health-center-excellence/device-software-functions-including-mobile-medical-applications" class="lcds-section-nav__section-link lcds-section-nav__link">Device Software Functions Including Mobile Medical Applications</a></li> <li><a href="/medical-devices/digital-health-center-excellence/wireless-medical-devices" class="lcds-section-nav__section-link lcds-section-nav__link">Wireless Medical Devices</a></li> <li><a href="/medical-devices/digital-health-center-excellence/digital-health-software-precertification-pre-cert-pilot-program" class="lcds-section-nav__section-link lcds-section-nav__link">Digital Health Software Precertification (Pre-Cert) Pilot Program</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="/medical-devices">Medical Devices</a> </li> <li > <a class="current-link">Digital Health Center of Excellence</a> </li> </ol> <ol class="lcds-breadcrumb visible-sm visible-xs"> <li> <a href="/medical-devices" title="Medical Devices"> Medical Devices </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-14" 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">Digital Health Center of Excellence</h1> <div class="lcds-toolbar lcds-toolbar--social"> <a href="#subscribe" class="btn btn-sm btn-default header-button-subscribe">Subscribe to Email Updates</a> <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%2Fmedical-devices%2Fdigital-health-center-excellence" 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=Digital%20Health%20Center%20of%20Excellence&url=https://www.fda.gov%2Fmedical-devices%2Fdigital-health-center-excellence" 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%2Fmedical-devices%2Fdigital-health-center-excellence&title=Digital%20Health%20Center%20of%20Excellence&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=Digital%20Health%20Center%20of%20Excellence&body=https://www.fda.gov%2Fmedical-devices%2Fdigital-health-center-excellence" 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"> <figure> <div> <div class="field field--name-image field--type-image field--label-inline"> <div class="field--label">Image</div> <div class="field--item"> <picture> <source srcset="/files/styles/main_image_small/public/dhcoe%20page%20image.jpg?itok=yD-rguOm 1x" media="all and (max-width: 320px)" type="image/jpeg" width="320" height="180"/> <source srcset="/files/styles/main_image_medium/public/dhcoe%20page%20image.jpg?itok=DJM3rUZL 1x" media="all and (min-width: 321px) and (max-width: 480px)" type="image/jpeg" width="500" height="281"/> <source srcset="/files/styles/main_image_medium/public/dhcoe%20page%20image.jpg?itok=DJM3rUZL 1x" media="all and (min-width: 481px) and (max-width: 767px)" type="image/jpeg" width="500" height="281"/> <source srcset="/files/styles/main_image_medium/public/dhcoe%20page%20image.jpg?itok=DJM3rUZL 1x" media="all and (min-width: 768px) and (max-width: 992px)" type="image/jpeg" width="500" height="281"/> <source srcset="/files/styles/main_image_1/public/dhcoe%20page%20image.jpg?itok=hag0yBvI 1x" media="all and (min-width: 993px) and (max-width: 1200px)" type="image/jpeg" width="1020" height="574"/> <source srcset="/files/styles/main_image_1/public/dhcoe%20page%20image.jpg?itok=hag0yBvI 1x" media="all and (min-width: 1201px)" type="image/jpeg" width="1020" height="574"/> <img loading="eager" src="/files/styles/main_image_medium/public/dhcoe%20page%20image.jpg?itok=DJM3rUZL" width="500" height="281" alt="Digital Health Center of Excellence Feature Graphic" class="img-responsive" /> </picture> </div> </div> </div> </figure> <p><strong>Our goal: </strong>Empower stakeholders to advance health care by fostering responsible and high-quality digital health innovation.</p> <p><strong>Our objectives:</strong> The Digital Health Center of Excellence aims to:</p> <ul> <li><strong>Connect and build partnerships</strong> to accelerate digital health advancements.</li> <li><strong>Share knowledge</strong> to increase awareness and understanding, drive synergy, and advance best practices.</li> <li><strong>Innovate regulatory approaches</strong> to provide efficient and least burdensome oversight while meeting the FDA standards for safe and effective products.</li> </ul> <p class="text-align-center"><a class="btn btn-primary btn-lg" href="/medical-devices/digital-health/digital-health-center-excellence-services"><span class="text">Learn More About Our Services</span></a></p> <p><strong>Anticipated outcomes:</strong> Through fulfilling these objectives, we anticipate the following advancements across digital health:</p> <ul> <li>Strategically advance science and evidence for digital health technologies that meets the needs of stakeholders.</li> <li>Efficient access to a highly specialized expertise, knowledge, and tools to accelerate access to digital health technology.</li> <li>Aligned regulatory approach to harmonize international regulatory expectations and industry standards.</li> <li>Increased awareness and understanding of digital health trends.</li> <li>Consistent application of digital health technology policy and oversight approaches.</li> <li>Reimagined medical device regulatory paradigm tailored for digital health technologies.</li> </ul> <p class="text-align-center"><a class="btn btn-primary btn-lg" href="/medical-devices/digital-health/about-digital-health-center-excellence"><span class="text">About Our Evolution</span></a></p> <br> <div class="field field--name-field-sub-topic-paragraphs field--type-entity-reference-revisions field--label-above"> <div class="field--label">Sub-Topic Paragraphs</div> <div class="field--items"> <div class="field--item"> <section class="lcds-card-deck--promoted lcds-card-deck bg-lightest-gray"> <header class="lcds-card-deck__header"> <h2 class="lcds-card-deck__heading sr-only" >SPECIAL TOPICS IN MEDICAL DEVICES</h2> </header> <div class="lcds-card-deck__body"> <a href="/medical-devices/digital-health-center-excellence/blog-lifecycle-management-approach-toward-delivering-safe-effective-ai-enabled-health-care" title="Blog: A Lifecycle Management Approach toward Delivering Safe, Effective AI-enab…"> <article class="lcds-card lcds-card--promoted lcds-card--promoted-subtopic bg-white"> <div> <div class="field field--name-image field--type-image field--label-hidden field--item"> <picture> <source srcset="/files/styles/thunbnail_3/public/it-engineer-working-on-computer.png?itok=UG5rpBw3 380w" media="all and (max-width: 320px)" type="image/png" sizes="100vw" width="380" height="200"/> <source srcset="/files/styles/thunbnail_3/public/it-engineer-working-on-computer.png?itok=UG5rpBw3 380w" media="all and (min-width: 321px) and (max-width: 480px)" type="image/png" sizes="100vw" width="380" height="200"/> <source srcset="/files/styles/medium_3/public/it-engineer-working-on-computer.png?itok=v9l9s4I1 420w" media="all and (min-width: 481px) and (max-width: 767px)" type="image/png" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/it-engineer-working-on-computer.png?itok=v9l9s4I1 420w" media="all and (min-width: 768px) and (max-width: 992px)" type="image/png" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/it-engineer-working-on-computer.png?itok=v9l9s4I1 420w" media="all and (min-width: 993px) and (max-width: 1200px)" type="image/png" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/it-engineer-working-on-computer.png?itok=v9l9s4I1 420w" media="all and (min-width: 1201px)" type="image/png" sizes="100vw" width="420" height="220"/> <img loading="eager" src="/files/styles/medium_3/public/it-engineer-working-on-computer.png?itok=v9l9s4I1" width="420" height="220" alt="IT Engineer Working on Computer - Digital Health Feature" class="img-responsive" /> </picture> </div> </div> <div class="lcds-card__body"> <h3 class="lcds-card__title">Blog: A Lifecycle Management Approach toward Delivering Safe, Effective AI-enab…</h3> <p class="lcds-card__text"></p> </div> </article> </a> <a href="/science-research/artificial-intelligence-and-medical-products/fda-digital-health-and-artificial-intelligence-glossary-educational-resource" title="Digital Health and Artificial Intelligence Glossary – Educational Resource"> <article class="lcds-card lcds-card--promoted lcds-card--promoted-subtopic bg-white"> <div> <div class="field field--name-image field--type-image field--label-hidden field--item"> <picture> <source srcset="/files/styles/thunbnail_3/public/cdrh_ai_feature.png?itok=DmRklE5f 380w" media="all and (max-width: 320px)" type="image/png" sizes="100vw" width="380" height="200"/> <source srcset="/files/styles/thunbnail_3/public/cdrh_ai_feature.png?itok=DmRklE5f 380w" media="all and (min-width: 321px) and (max-width: 480px)" type="image/png" sizes="100vw" width="380" height="200"/> <source srcset="/files/styles/medium_3/public/cdrh_ai_feature.png?itok=goP4nFLr 420w" media="all and (min-width: 481px) and (max-width: 767px)" type="image/png" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/cdrh_ai_feature.png?itok=goP4nFLr 420w" media="all and (min-width: 768px) and (max-width: 992px)" type="image/png" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/cdrh_ai_feature.png?itok=goP4nFLr 420w" media="all and (min-width: 993px) and (max-width: 1200px)" type="image/png" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/cdrh_ai_feature.png?itok=goP4nFLr 420w" media="all and (min-width: 1201px)" type="image/png" sizes="100vw" width="420" height="220"/> <img loading="eager" src="/files/styles/medium_3/public/cdrh_ai_feature.png?itok=goP4nFLr" width="420" height="220" alt="Graphic representing Artificial Intelligence" class="img-responsive" /> </picture> </div> </div> <div class="lcds-card__body"> <h3 class="lcds-card__title">Digital Health and Artificial Intelligence Glossary – Educational Resource</h3> <p class="lcds-card__text"></p> </div> </article> </a> <a href="/medical-devices/software-medical-device-samd/transparency-machine-learning-enabled-medical-devices-guiding-principles" title="Transparency for Machine Learning-Enabled Medical Devices: Guiding Principles"> <article class="lcds-card lcds-card--promoted lcds-card--promoted-subtopic bg-white"> <div> <div class="field field--name-image field--type-image field--label-hidden field--item"> <picture> <source srcset="/files/styles/thunbnail_3/public/fda-canada-logo.jpg?itok=IG-fPCQn 380w" media="all and (max-width: 320px)" type="image/jpeg" sizes="100vw" width="380" height="200"/> <source srcset="/files/styles/thunbnail_3/public/fda-canada-logo.jpg?itok=IG-fPCQn 380w" media="all and (min-width: 321px) and (max-width: 480px)" type="image/jpeg" sizes="100vw" width="380" height="200"/> <source srcset="/files/styles/medium_3/public/fda-canada-logo.jpg?itok=ozuYfn2s 420w" media="all and (min-width: 481px) and (max-width: 767px)" type="image/jpeg" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/fda-canada-logo.jpg?itok=ozuYfn2s 420w" media="all and (min-width: 768px) and (max-width: 992px)" type="image/jpeg" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/fda-canada-logo.jpg?itok=ozuYfn2s 420w" media="all and (min-width: 993px) and (max-width: 1200px)" type="image/jpeg" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/fda-canada-logo.jpg?itok=ozuYfn2s 420w" media="all and (min-width: 1201px)" type="image/jpeg" sizes="100vw" width="420" height="220"/> <img loading="eager" src="/files/styles/medium_3/public/fda-canada-logo.jpg?itok=ozuYfn2s" width="420" height="220" alt="U.S. Food & Drug Administration and Health Canada logos" class="img-responsive" /> </picture> </div> </div> <div class="lcds-card__body"> <h3 class="lcds-card__title">Transparency for Machine Learning-Enabled Medical Devices: Guiding Principles</h3> <p class="lcds-card__text"></p> </div> </article> </a> <a href="https://precision.fda.gov/challenges/33" title="Digitally-Derived Endpoints for Freezing-of-Gait Detection (DEFoGD) Challenge"> <article class="lcds-card lcds-card--promoted lcds-card--promoted-subtopic bg-white"> <div> <div class="field field--name-image field--type-image field--label-hidden field--item"> <picture> <source srcset="/files/styles/thunbnail_3/public/gr-0215-3-01.png?itok=B7JmmJnL 380w" media="all and (max-width: 320px)" type="image/png" sizes="100vw" width="380" height="200"/> <source srcset="/files/styles/thunbnail_3/public/gr-0215-3-01.png?itok=B7JmmJnL 380w" media="all and (min-width: 321px) and (max-width: 480px)" type="image/png" sizes="100vw" width="380" height="200"/> <source srcset="/files/styles/medium_3/public/gr-0215-3-01.png?itok=cXnPaqR6 420w" media="all and (min-width: 481px) and (max-width: 767px)" type="image/png" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/gr-0215-3-01.png?itok=cXnPaqR6 420w" media="all and (min-width: 768px) and (max-width: 992px)" type="image/png" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/gr-0215-3-01.png?itok=cXnPaqR6 420w" media="all and (min-width: 993px) and (max-width: 1200px)" type="image/png" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/gr-0215-3-01.png?itok=cXnPaqR6 420w" media="all and (min-width: 1201px)" type="image/png" sizes="100vw" width="420" height="220"/> <img loading="eager" src="/files/styles/medium_3/public/gr-0215-3-01.png?itok=cXnPaqR6" width="420" height="220" alt="A female health care professional assists a senior man with walking in his home. Along with the image are the words: The Digitally-Derived Endpoints for Freezing-of-Gait Detection (DEFoGD) Challenge." class="img-responsive" /> </picture> </div> </div> <div class="lcds-card__body"> <h3 class="lcds-card__title">Digitally-Derived Endpoints for Freezing-of-Gait Detection (DEFoGD) Challenge</h3> <p class="lcds-card__text"></p> </div> </article> </a> <a href="/medical-devices/digital-health-center-excellence/digital-health-frequently-asked-questions-faqs" title="Digital Health Frequently Asked Questions"> <article class="lcds-card lcds-card--promoted lcds-card--promoted-subtopic bg-white"> <div> <div class="field field--name-image field--type-image field--label-hidden field--item"> <picture> <source srcset="/files/styles/thunbnail_3/public/Digital%20Health%20Frequently%20Asked%20Questions.png?itok=O0dOnjKV 380w" media="all and (max-width: 320px)" type="image/png" sizes="100vw" width="380" height="200"/> <source srcset="/files/styles/thunbnail_3/public/Digital%20Health%20Frequently%20Asked%20Questions.png?itok=O0dOnjKV 380w" media="all and (min-width: 321px) and (max-width: 480px)" type="image/png" sizes="100vw" width="380" height="200"/> <source srcset="/files/styles/medium_3/public/Digital%20Health%20Frequently%20Asked%20Questions.png?itok=PuxRaRmx 420w" media="all and (min-width: 481px) and (max-width: 767px)" type="image/png" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/Digital%20Health%20Frequently%20Asked%20Questions.png?itok=PuxRaRmx 420w" media="all and (min-width: 768px) and (max-width: 992px)" type="image/png" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/Digital%20Health%20Frequently%20Asked%20Questions.png?itok=PuxRaRmx 420w" media="all and (min-width: 993px) and (max-width: 1200px)" type="image/png" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/Digital%20Health%20Frequently%20Asked%20Questions.png?itok=PuxRaRmx 420w" media="all and (min-width: 1201px)" type="image/png" sizes="100vw" width="420" height="220"/> <img loading="eager" src="/files/styles/medium_3/public/Digital%20Health%20Frequently%20Asked%20Questions.png?itok=PuxRaRmx" width="420" height="220" alt="Digital Health Frequently Asked Questions" class="img-responsive" /> </picture> </div> </div> <div class="lcds-card__body"> <h3 class="lcds-card__title">Digital Health Frequently Asked Questions</h3> <p class="lcds-card__text"></p> </div> </article> </a> <a href="/medical-devices/digital-health-center-excellence/digital-health-policy-navigator" title="Interactive Overview of Digital Health Policies"> <article class="lcds-card lcds-card--promoted lcds-card--promoted-subtopic bg-white"> <div> <div class="field field--name-image field--type-image field--label-hidden field--item"> <picture> <source srcset="/files/styles/thunbnail_3/public/Policy%20Navigator%20drupal_final-01.png?itok=OkztFjox 380w" media="all and (max-width: 320px)" type="image/png" sizes="100vw" width="380" height="200"/> <source srcset="/files/styles/thunbnail_3/public/Policy%20Navigator%20drupal_final-01.png?itok=OkztFjox 380w" media="all and (min-width: 321px) and (max-width: 480px)" type="image/png" sizes="100vw" width="380" height="200"/> <source srcset="/files/styles/medium_3/public/Policy%20Navigator%20drupal_final-01.png?itok=pH0N8gO5 420w" media="all and (min-width: 481px) and (max-width: 767px)" type="image/png" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/Policy%20Navigator%20drupal_final-01.png?itok=pH0N8gO5 420w" media="all and (min-width: 768px) and (max-width: 992px)" type="image/png" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/Policy%20Navigator%20drupal_final-01.png?itok=pH0N8gO5 420w" media="all and (min-width: 993px) and (max-width: 1200px)" type="image/png" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/Policy%20Navigator%20drupal_final-01.png?itok=pH0N8gO5 420w" media="all and (min-width: 1201px)" type="image/png" sizes="100vw" width="420" height="220"/> <img loading="eager" src="/files/styles/medium_3/public/Policy%20Navigator%20drupal_final-01.png?itok=pH0N8gO5" width="420" height="220" alt="Digital Health Policy Navigator" class="img-responsive" /> </picture> </div> </div> <div class="lcds-card__body"> <h3 class="lcds-card__title">Interactive Overview of Digital Health Policies</h3> <p class="lcds-card__text"></p> </div> </article> </a> </div> </section></div> <div class="field--item"> <section class="lcds-card-deck--teaser lcds-card-deck txt-dark"> <header class="lcds-card-deck__header"> <h2 class="lcds-card-deck__heading" id="STRATEGIC PRIORITIES AND PROGRAMS">STRATEGIC PRIORITIES AND PROGRAMS</h2> </header> <div class="lcds-card-deck__body"> <article class="lcds-card lcds-card--border-top lcds-card--teaser lcds-card--teaser-subtopic"> <h3 class="lcds-card__title"><a href="/medical-devices/digital-health-center-excellence/cybersecurity">Cybersecurity</a></h3> <p class="lcds-card__text"></p> </article> <article class="lcds-card lcds-card--border-top lcds-card--teaser lcds-card--teaser-subtopic"> <h3 class="lcds-card__title"><a href="/medical-devices/digital-health-center-excellence/augmented-reality-and-virtual-reality-medical-devices">Augmented Reality and Virtual Reality in Medical Devices</a></h3> <p class="lcds-card__text"></p> </article> <article class="lcds-card lcds-card--border-top lcds-card--teaser lcds-card--teaser-subtopic"> <h3 class="lcds-card__title"><a href="/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-software-medical-device">Artificial Intelligence and Machine Learning in Software as a Medical Device</a></h3> <p class="lcds-card__text"></p> </article> <article class="lcds-card lcds-card--border-top lcds-card--teaser lcds-card--teaser-subtopic"> <h3 class="lcds-card__title"><a href="/medical-devices/digital-health-center-excellence/wireless-medical-devices">Wireless Medical Devices</a></h3> <p class="lcds-card__text"></p> </article> </div> </section> </div> <div class="field--item"> <section class="lcds-card-deck--teaser lcds-card-deck txt-dark"> <header class="lcds-card-deck__header"> <h2 class="lcds-card-deck__heading" >OUR KNOWLEDGE HUB</h2> </header> <div class="lcds-card-deck__body"> <article class="lcds-card lcds-card--border-top lcds-card--teaser lcds-card--teaser-subtopic"> <h3 class="lcds-card__title"><a href="/medical-devices/digital-health-center-excellence/software-medical-device-samd">Software as a Medical Device (SaMD)</a></h3> <p class="lcds-card__text"></p> </article> <article class="lcds-card lcds-card--border-top lcds-card--teaser lcds-card--teaser-subtopic"> <h3 class="lcds-card__title"><a href="/medical-devices/digital-health-center-excellence/guidances-digital-health-content">Guidances with Digital Health Content</a></h3> <p class="lcds-card__text"></p> </article> <article class="lcds-card lcds-card--border-top lcds-card--teaser lcds-card--teaser-subtopic"> <h3 class="lcds-card__title"><a href="/medical-devices/digital-health-center-excellence/device-software-functions-including-mobile-medical-applications">Device Software Functions Including Mobile Medical Applications</a></h3> <p class="lcds-card__text"></p> </article> <article class="lcds-card lcds-card--border-top lcds-card--teaser lcds-card--teaser-subtopic"> <h3 class="lcds-card__title"><a href="/about-fda/division-patient-centered-development/clinical-outcome-assessments-coas-medical-device-decision-making">Clinical Outcome Assessments (COAs) in Medical Device Decision Making</a></h3> <p class="lcds-card__text"></p> </article> <article class="lcds-card lcds-card--border-top lcds-card--teaser lcds-card--teaser-subtopic"> <h3 class="lcds-card__title"><a href="/medical-devices/digital-health-center-excellence/ask-question-about-digital-health-regulatory-policies"> Ask a Digital Health Question</a></h3> <p class="lcds-card__text"></p> </article> <article class="lcds-card lcds-card--border-top lcds-card--teaser lcds-card--teaser-subtopic"> <h3 class="lcds-card__title"><a href="/about-fda/center-devices-and-radiological-health/requesting-speakers-cdrh">Request a Speaker</a></h3> <p class="lcds-card__text"></p> </article> </div> </section> </div> <div class="field--item"> <section class="lcds-card-deck--teaser lcds-card-deck txt-dark"> <header class="lcds-card-deck__header"> <h2 class="lcds-card-deck__heading" >BUILD CONNECTIONS</h2> </header> <div class="lcds-card-deck__body"> <article class="lcds-card lcds-card--border-top lcds-card--teaser lcds-card--teaser-subtopic"> <h3 class="lcds-card__title"><a href="/medical-devices/digital-health-center-excellence/network-digital-health-experts">Network of Digital Health Experts</a></h3> <p class="lcds-card__text"></p> </article> <article class="lcds-card lcds-card--border-top lcds-card--teaser lcds-card--teaser-subtopic"> <h3 class="lcds-card__title"><a href="http://www.imdrf.org/index.asp">International Medical Device Regulators Forum (IMDRF)</a></h3> <p class="lcds-card__text"></p> </article> </div> </section> </div> </div> </div> <br> </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="2024-09-26T00:00:00Z">09/26/2024</time> </p> </div> </li> <li role="menuitem" class="lcds-description-list__item"> <div> <h2 class="lcds-description-list__item-heading">Regulated Product(s)</h2> <ul role="menu" class="lcds-metadata-list"> <li role="menuitem">Medical Devices</li> </ul> </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="/medical-devices/digital-health-center-excellence" class="lcds-section-nav__link lcds-section-nav--side__link lcds-section-nav__parent-link lcds-section-nav--side__parent-link">Digital Health Center of Excellence</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-ea03c2a3bbae5b84c8bf8dd7bd5699e2fc7528b54f6524b3d960470bc20b6522"> <div class="item-list"> <ul class="lcds-section-nav__active lcds-section-nav__list lcds-section-nav--side__list"> <li><a href="/medical-devices/digital-health-center-excellence/cybersecurity-medical-devices-frequently-asked-questions-faqs" class="lcds-section-nav__link lcds-section-nav--side__link">Cybersecurity in Medical Devices Frequently Asked Questions (FAQs)</a></li> <li><a href="/medical-devices/digital-health-center-excellence/digital-health-frequently-asked-questions-faqs" class="lcds-section-nav__link lcds-section-nav--side__link">Digital Health Frequently Asked Questions (FAQs) </a></li> <li><a href="/medical-devices/digital-health-center-excellence/digital-health-center-excellence-services" class="lcds-section-nav__link lcds-section-nav--side__link">Digital Health Center of Excellence Services</a></li> <li><a href="/medical-devices/digital-health-center-excellence/about-digital-health-center-excellence" class="lcds-section-nav__link lcds-section-nav--side__link">About the Digital Health Center of Excellence</a></li> <li><a href="/medical-devices/digital-health-center-excellence/network-digital-health-experts" class="lcds-section-nav__link lcds-section-nav--side__link">Network of Digital Health Experts</a></li> <li><a href="/medical-devices/digital-health-center-excellence/what-digital-health" class="lcds-section-nav__link lcds-section-nav--side__link">What is Digital Health?</a></li> <li><a href="/medical-devices/digital-health-center-excellence/cybersecurity" class="lcds-section-nav__link lcds-section-nav--side__link">Cybersecurity</a></li> <li><a href="/medical-devices/digital-health-center-excellence/digital-health-terms" class="lcds-section-nav__link lcds-section-nav--side__link">Digital Health Terms</a></li> <li><a href="/medical-devices/digital-health-center-excellence/guidances-digital-health-content" class="lcds-section-nav__link lcds-section-nav--side__link">Guidances with Digital Health Content</a></li> <li><a href="/medical-devices/digital-health-center-excellence/digital-health-policy-navigator" class="lcds-section-nav__link lcds-section-nav--side__link">Digital Health Policy Navigator </a></li> <li><a href="/medical-devices/digital-health-center-excellence/digital-health-reports" class="lcds-section-nav__link lcds-section-nav--side__link">Digital Health Reports</a></li> <li><a href="/medical-devices/digital-health-center-excellence/fda-digital-health-advisory-committee" class="lcds-section-nav__link lcds-section-nav--side__link">FDA Digital Health Advisory Committee</a></li> <li><a href="/medical-devices/digital-health-center-excellence/medical-device-interoperability" class="lcds-section-nav__link lcds-section-nav--side__link">Medical Device Interoperability</a></li> <li><a href="/medical-devices/digital-health-center-excellence/digital-health-research-and-partnerships" class="lcds-section-nav__link lcds-section-nav--side__link">Digital Health Research and Partnerships </a></li> <li><a href="/medical-devices/digital-health-center-excellence/augmented-reality-and-virtual-reality-medical-devices" class="lcds-section-nav__link lcds-section-nav--side__link">Augmented Reality and Virtual Reality in Medical Devices</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-d34d5120e3a1aa1f1b4e201c94be3091c4d9867863ae94b6e53e442008229499"> <div class="view-content"> <div> <ul class="lcds-section-nav__list"> <li><a href="/medical-devices/digital-health-center-excellence/diagnostic-data-program" class="lcds-section-nav__section-link lcds-section-nav__link lcds-section-nav--side__link">Diagnostic Data Program</a></li> <li><a href="/medical-devices/digital-health-center-excellence/software-medical-device-samd" class="lcds-section-nav__section-link lcds-section-nav__link lcds-section-nav--side__link">Software as a Medical Device (SaMD)</a></li> <li><a href="/medical-devices/digital-health-center-excellence/device-software-functions-including-mobile-medical-applications" class="lcds-section-nav__section-link lcds-section-nav__link lcds-section-nav--side__link">Device Software Functions Including Mobile Medical Applications</a></li> <li><a href="/medical-devices/digital-health-center-excellence/wireless-medical-devices" class="lcds-section-nav__section-link lcds-section-nav__link lcds-section-nav--side__link">Wireless Medical Devices</a></li> <li><a href="/medical-devices/digital-health-center-excellence/digital-health-software-precertification-pre-cert-pilot-program" class="lcds-section-nav__section-link lcds-section-nav__link lcds-section-nav--side__link">Digital Health Software Precertification (Pre-Cert) Pilot Program</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 class="lcds-subscribe" id="subscribe"> <div class="row"> <div class="col-sm-12 col-md-3 col-md-offset-3"> <h2>Digital Health</h2> <p>Sign up to receive email updates about Digital Health</p> </div> <div class="col-sm-12 col-md-3"> <form class="form-horizontal" id="GD-snippet-form" action="https://public.govdelivery.com/accounts/USFDA/subscribers/qualify" accept-charset="UTF-8" method="post"> <input name="utf8" type="hidden" value="✓"> <input type="hidden" name="authenticity_token" value="VJuyc1HyD63+xVCkN+K9qiH1bD9zSSJ+BfdR1d4LXjZ0BncrJ/u9dEw/e0U869OeCw6JxhyYXfnZCCGNF1oVkQ=="> <input type="hidden" name="topic_id" id="topic_id" value="USFDA_71"> <label class="sr-only" for="email">Enter your email address to subscribe:</label> <div class="input-group subscribe-group"> <input type="email" name="email" id="email" placeholder="Email Address" class="form-control"> <span class="input-group-btn"><input class="btn btn-primary" type="submit" name="commit" value="Subscribe"></span> </div> </form> </div> </div> </section> </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\/359753","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=eJxlj1GOwjAMRC8UGn6Q9jaRm7hpRBJbtgvqnn4paFsEP9Z4LI3fTNQN7qjU0E-HHlwmyhUDdKirlaj-03C6qmHzIyg6FrwVvPtcaYR6Ultr6fnLjlLY1I1EpibAnonphuKmBCFeMRUjCdhn6BEbdlMPMZKkQj0Y5Q1AZxKLlNBt0eqfc2iUloqvHGpcy5bwuoXL-efNdAwC-fF8Vp9kYajD4QxL52WsRWdMbnpgdjJUv6u9URT4XTEfFRPwE-p_3zFPe4M_uG6P1A"></script> <script type="text/javascript" src="/Glj4GCbp15rt1JYQ1bjdCY17/OOpiQpwDbfwtpO1S/LygGdz4/IiljWE0/wM2Y"></script></body> </html>

CINXE.COM

Digital Health Center of Excellence | FDA