Medical Devices

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class="lcds-section-nav__section-link lcds-section-nav__link">Medical Device Safety</a></li> <li><a href="/medical-devices/medical-devices-news-and-events" class="lcds-section-nav__section-link lcds-section-nav__link">Medical Devices News and Events</a></li> <li><a href="/medical-devices/products-and-medical-procedures" class="lcds-section-nav__section-link lcds-section-nav__link">Products and Medical Procedures</a></li> <li><a href="/medical-devices/resources-you-medical-devices" class="lcds-section-nav__section-link lcds-section-nav__link">Resources for You (Medical Devices)</a></li> <li><a href="/medical-devices/science-and-research-medical-devices" class="lcds-section-nav__section-link lcds-section-nav__link">Science and Research | Medical Devices</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"> <li> <a href="/" title="Home">Home</a> </li> </ol> </section> <main> <div id="main-content"> <header class='content-header' role="heading" aria-level="1"> <section id="block-entityviewcontent-16" 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">Medical Devices</h1> </div> </section> </header> <div class="field field--name-field-topic-paragraphs field--type-entity-reference-revisions field--label-above"> <div class="field--label">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">Medical Device Updates</h2> </header> <div class="lcds-card-deck__body"> <a href="/medical-devices/home-health-care-hub/idea-lab" title="Imagine Home as a Health Care Hub through the Idea Lab"> <article class="lcds-card lcds-card--promoted 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/The%20Idea%20Lab%20-%20banner%20v13-01.png?itok=V3uGG8c4 380w" media="all and (max-width: 320px)" type="image/png" sizes="100vw" width="380" height="200"/> <source srcset="/files/styles/thunbnail_3/public/The%20Idea%20Lab%20-%20banner%20v13-01.png?itok=V3uGG8c4 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/The%20Idea%20Lab%20-%20banner%20v13-01.png?itok=nbOJ1tn0 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/The%20Idea%20Lab%20-%20banner%20v13-01.png?itok=nbOJ1tn0 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/The%20Idea%20Lab%20-%20banner%20v13-01.png?itok=nbOJ1tn0 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/The%20Idea%20Lab%20-%20banner%20v13-01.png?itok=nbOJ1tn0 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/The%20Idea%20Lab%20-%20banner%20v13-01.png?itok=nbOJ1tn0" width="420" height="220" alt="Image Home as a Health care through The Idea Lab" class="img-responsive" /> </picture> </div> </div> <div class="lcds-card__body"> <h3 class="lcds-card__title">Imagine Home as a Health Care Hub through the Idea Lab</h3> <p class="lcds-card__text">Helping innovators, providers, and patients reimagine the home as an integral part of the health care system.</p> </div> </article> </a> <a href="/medical-devices/medical-devices-news-and-events/cdrh-announces-communications-pilot-enhance-medical-device-recall-program" title="Communications Pilot to Enhance Medical Device Recall Program"> <article class="lcds-card lcds-card--promoted 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-early-alert-communications-pilot.png?itok=Vm12N2oF 380w" media="all and (max-width: 320px)" type="image/png" sizes="100vw" width="380" height="200"/> <source srcset="/files/styles/thunbnail_3/public/cdrh-early-alert-communications-pilot.png?itok=Vm12N2oF 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-early-alert-communications-pilot.png?itok=KuAXf5_J 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-early-alert-communications-pilot.png?itok=KuAXf5_J 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-early-alert-communications-pilot.png?itok=KuAXf5_J 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-early-alert-communications-pilot.png?itok=KuAXf5_J 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-early-alert-communications-pilot.png?itok=KuAXf5_J" width="420" height="220" alt="Early Alert - Communications Pilot to Enhance Medical Device Recalls" class="img-responsive" /> </picture> </div> </div> <div class="lcds-card__body"> <h3 class="lcds-card__title">Communications Pilot to Enhance Medical Device Recall Program</h3> <p class="lcds-card__text">The pilot aims to minimize the time between the FDA’s initial awareness of and public notification of potentially high-risk medical device removals or corrections.</p> </div> </article> </a> <a href="https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/home-otc-covid-19-diagnostic-tests#list" title="Before throwing out at-home COVID-19 tests, check the FDA’s website to confirm …"> <article class="lcds-card lcds-card--promoted 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_covid_tests_extended_expiration.png?itok=JYXQDapG 380w" media="all and (max-width: 320px)" type="image/png" sizes="100vw" width="380" height="200"/> <source srcset="/files/styles/thunbnail_3/public/cdrh_covid_tests_extended_expiration.png?itok=JYXQDapG 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_covid_tests_extended_expiration.png?itok=2IsyYAPZ 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_covid_tests_extended_expiration.png?itok=2IsyYAPZ 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_covid_tests_extended_expiration.png?itok=2IsyYAPZ 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_covid_tests_extended_expiration.png?itok=2IsyYAPZ 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_covid_tests_extended_expiration.png?itok=2IsyYAPZ" width="420" height="220" alt="Externed expiration dates for OTC COVID-19 tests" class="img-responsive" /> </picture> </div> </div> <div class="lcds-card__body"> <h3 class="lcds-card__title">Before throwing out at-home COVID-19 tests, check the FDA’s website to confirm …</h3> <p class="lcds-card__text">Did you know that there are several over-the-counter (OTC) COVID-19 tests that have extended expiration dates? If you have at-home OTC COVID-19 tests with extended expiration dates, they can be used beyond the expiration date that is printed on the box.</p> </div> </article> </a> </div> </section> </div> <div class="field--item"> <section class="lcds-card-deck--audience lcds-card-deck bg-dark-gray txt-light"> <div class="lcds-card-deck__body lcds-card-deck__body--audience"> <a href="/medical-devices/medical-devices-news-and-events" title="CDRH News and Events" class="lcds-card--audience">CDRH News and Events</a> <a href="/medical-devices/medical-device-safety" title="Medical Device Safety" class="lcds-card--audience">Medical Device Safety</a> <a href="/medical-devices/device-advice-comprehensive-regulatory-assistance" title="Device Advice" class="lcds-card--audience">Device Advice</a> <a href="/regulatory-information/search-fda-guidance-documents" title="Search for FDA Guidance Documents" class="lcds-card--audience">Search for FDA Guidance Documents</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">Navigate the Medical Device Section</h2> </header> <div class="lcds-card-deck__body"> <article class="lcds-card lcds-card--border-top lcds-card--teaser"> <h3 class="lcds-card__title"><a href="/medical-devices/medical-devices-news-and-events/cdrhnew-news-and-updates" title="CDRHNew">CDRHNew</a></h3> <p class="lcds-card__text">Comprehensive List of Latest CDRH Updates</p> </article> <article class="lcds-card lcds-card--border-top lcds-card--teaser"> <h3 class="lcds-card__title"><a href="/medical-devices/products-and-medical-procedures" title="Products and Medical Procedures">Products and Medical Procedures</a></h3> <p class="lcds-card__text">Approvals and clearances, information on medical devices by type</p> </article> <article class="lcds-card lcds-card--border-top lcds-card--teaser"> <h3 class="lcds-card__title"><a href="/medical-devices/digital-health-center-excellence" title="Digital Health Center of Excellence">Digital Health Center of Excellence</a></h3> <p class="lcds-card__text">Cybersecurity, mobile medical apps, wireless medical devices, AI/ML in Software as a Medical Device (SaMD), Interoperability</p> </article> <article class="lcds-card lcds-card--border-top lcds-card--teaser"> <h3 class="lcds-card__title"><a href="/medical-devices/science-and-research-medical-devices" title="Science and Research">Science and Research</a></h3> <p class="lcds-card__text">CDRH research programs, epidemiology, medical device development tools (MDDT)</p> </article> <article class="lcds-card lcds-card--border-top lcds-card--teaser"> <h3 class="lcds-card__title"><a href="/medical-devices/emergency-situations-medical-devices/coronavirus-covid-19-and-medical-devices" title="COVID-19 and Medical Devices">COVID-19 and Medical Devices</a></h3> <p class="lcds-card__text">Stay up to date with information about COVID-19 and medical devices</p> </article> <article class="lcds-card lcds-card--border-top lcds-card--teaser"> <h3 class="lcds-card__title"><a href="/medical-devices/cdrh-international-affairs" title="International Affairs">International Affairs</a></h3> <p class="lcds-card__text">International Medical Device Regulators Forum, Medical Device Single Audit Program (MDSAP)</p> </article> <article class="lcds-card lcds-card--border-top lcds-card--teaser"> <h3 class="lcds-card__title"><a href="/medical-devices/resources-you-medical-devices" title="Resources for You">Resources for You</a></h3> <p class="lcds-card__text">Information for consumers and health care providers, letters to industry</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">Search Medical Device Databases</h2> </header> <div class="lcds-card-deck__body"> <article class="lcds-card lcds-card--border-top lcds-card--teaser"> <h3 class="lcds-card__title"><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm" title=" 510(k) Premarket Notification Database"> 510(k) Premarket Notification Database</a></h3> <p class="lcds-card__text"></p> </article> <article class="lcds-card lcds-card--border-top lcds-card--teaser"> <h3 class="lcds-card__title"><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm" title="Device Registration and Listing Database">Device Registration and Listing Database</a></h3> <p class="lcds-card__text"></p> </article> <article class="lcds-card lcds-card--border-top lcds-card--teaser"> <h3 class="lcds-card__title"><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/PCDSimpleSearch.cfm" title="Product Code Classification Database">Product Code Classification Database</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 sr-only">more: Search Medical Device Databases</h2> </header> <div class="lcds-card-deck__body"> <article class="lcds-card lcds-card--border-top lcds-card--teaser"> <h3 class="lcds-card__title"><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM" title="MAUDE (Manufacturer and User Facility Device Experience) Database"> MAUDE (Manufacturer and User Facility Device Experience) Database</a></h3> <p class="lcds-card__text"></p> </article> <article class="lcds-card lcds-card--border-top lcds-card--teaser"> <h3 class="lcds-card__title"><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm" title="Premarket Approvals (PMA) Database">Premarket Approvals (PMA) Database</a></h3> <p class="lcds-card__text"></p> </article> <article class="lcds-card lcds-card--border-top lcds-card--teaser"> <h3 class="lcds-card__title"><a href="/medical-devices/device-advice-comprehensive-regulatory-assistance/medical-device-databases" title="All Medical Device Databases">All Medical Device Databases</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">How Do I </h2> </header> <div class="lcds-card-deck__body"> <article class="lcds-card lcds-card--border-top lcds-card--teaser"> <h3 class="lcds-card__title"><a href="/medical-devices/overview-device-regulation/classify-your-medical-device" title="Classify a Medical Device"> Classify a Medical Device</a></h3> <p class="lcds-card__text"></p> </article> <article class="lcds-card lcds-card--border-top lcds-card--teaser"> <h3 class="lcds-card__title"><a href="/medical-devices/device-registration-and-listing/how-register-and-list" title="Register and List a Device">Register and List a 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