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="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> <a href="/advisory-committees/advisory-committee-calendar/november-20-21-2024-digital-health-advisory-committee-meeting-announcement-11202024" title="Digital Health Advisory Committee Meeting: Total Product Lifecycle Consideratio…"> <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/TPLC-AI-event-Novemer-2024.png?itok=SiWj_2Bp 380w" media="all and (max-width: 320px)" type="image/png" sizes="100vw" width="380" height="200"/> <source srcset="/files/styles/thunbnail_3/public/TPLC-AI-event-Novemer-2024.png?itok=SiWj_2Bp 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/TPLC-AI-event-Novemer-2024.png?itok=0BHBIFza 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/TPLC-AI-event-Novemer-2024.png?itok=0BHBIFza 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/TPLC-AI-event-Novemer-2024.png?itok=0BHBIFza 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/TPLC-AI-event-Novemer-2024.png?itok=0BHBIFza 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/TPLC-AI-event-Novemer-2024.png?itok=0BHBIFza" width="420" height="220" alt="Digital Health Advisory Committee Meeting. TPLC considerations for Generative AI-enabled Devices. November 20-21, 2024" class="img-responsive" /> </picture> </div> </div> <div class="lcds-card__body"> <h3 class="lcds-card__title">Digital Health Advisory Committee Meeting: Total Product Lifecycle Consideratio…</h3> <p class="lcds-card__text">FDA has established docket FDA-2024-N-3924 for public comment on this meeting. The docket will close on January 21, 2025.</p> </div> </article> </a> <a href="/medical-devices/recently-approved-devices/device-trial-participation-snapshots" title="Device Trial Participation Snapshots"> <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/device-trial-participation-snapshots.png?itok=l4QAL-ZE 380w" media="all and (max-width: 320px)" type="image/png" sizes="100vw" width="380" height="200"/> <source srcset="/files/styles/thunbnail_3/public/device-trial-participation-snapshots.png?itok=l4QAL-ZE 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/device-trial-participation-snapshots.png?itok=T9-QLd3N 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/device-trial-participation-snapshots.png?itok=T9-QLd3N 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/device-trial-participation-snapshots.png?itok=T9-QLd3N 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/device-trial-participation-snapshots.png?itok=T9-QLd3N 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/device-trial-participation-snapshots.png?itok=T9-QLd3N" width="420" height="220" alt="Device Trial Participation Snapshots" class="img-responsive" /> </picture> </div> </div> <div class="lcds-card__body"> <h3 class="lcds-card__title">Device Trial Participation Snapshots</h3> <p class="lcds-card__text">The Center for Devices and Radiological Health (CDRH) is piloting device trial participation snapshots to highlight certain information about the intended uses of the device, its benefits and risks, and the diversity of participants in clinical trials for certain new medical devices.</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 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/overview-device-regulation/device-labeling" title="Label a Device">Label a 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/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems" title="Submit Adverse Event and Problem Reports (MDR)">Submit Adverse Event and Problem Reports (MDR)</a></h3> <p class="lcds-card__text"></p> </article> <article 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