Combination Products

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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-23ac1677f05e3a65ee4a6a526053cdc358c12341873b184407d04a3f7a0dcc15"> <div class="view-content"> <div> <ul class="lcds-section-nav__list"> <li><a href="/combination-products/about-combination-products" class="lcds-section-nav__section-link lcds-section-nav__link">About Combination Products</a></li> <li><a href="/combination-products/meetings-conferences-workshops" class="lcds-section-nav__section-link lcds-section-nav__link">Combination Products Meetings, Conferences, & Workshops</a></li> <li><a href="/combination-products/feedback-combination-products" class="lcds-section-nav__section-link lcds-section-nav__link">Feedback on Combination Products</a></li> <li><a href="/combination-products/guidance-regulatory-information" class="lcds-section-nav__section-link lcds-section-nav__link">Guidance & Regulatory Information</a></li> <li><a href="/combination-products/jurisdictional-information" class="lcds-section-nav__section-link lcds-section-nav__link">Jurisdictional Information</a></li> <li><a href="/combination-products/rfd-process" class="lcds-section-nav__section-link lcds-section-nav__link">RFD Process</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">Combination Products</h1> <h2 class="topic-subtitle text-center">Therapeutic and diagnostic products that combine drugs, devices, and/or biological products.</h2> </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-cta bg-blue txt-light"> <div class="lcds-cta__media"> <div> <div class="field field--name-image field--type-image field--label-hidden field--item"> <picture> <source srcset="/files/styles/call_to_action_480x270/public/generic-auto-injector.jpg?itok=Eh_4c0li 480w" media="all and (max-width: 320px)" type="image/jpeg" sizes="100vw" width="480" height="270"/> <source srcset="/files/styles/call_to_action_480x270/public/generic-auto-injector.jpg?itok=Eh_4c0li 480w" media="all and (min-width: 321px) and (max-width: 480px)" type="image/jpeg" sizes="100vw" width="480" height="270"/> <source srcset="/files/styles/call_to_action_992x558/public/generic-auto-injector.jpg?itok=XbMr4IKa 992w" media="all and (min-width: 481px) and (max-width: 767px)" type="image/jpeg" sizes="100vw" width="992" height="558"/> <source srcset="/files/styles/call_to_action_992x558/public/generic-auto-injector.jpg?itok=XbMr4IKa 992w" media="all and (min-width: 768px) and (max-width: 992px)" type="image/jpeg" sizes="100vw" width="992" height="558"/> <source srcset="/files/styles/call_to_action_992x558/public/generic-auto-injector.jpg?itok=XbMr4IKa 992w" media="all and (min-width: 993px) and (max-width: 1200px)" type="image/jpeg" sizes="100vw" width="992" height="558"/> <source srcset="/files/styles/call_to_action_992x558/public/generic-auto-injector.jpg?itok=XbMr4IKa 992w" media="all and (min-width: 1201px)" type="image/jpeg" sizes="100vw" width="992" height="558"/> <img loading="eager" src="/files/styles/call_to_action_992x558/public/generic-auto-injector.jpg?itok=XbMr4IKa" width="992" height="558" alt="A person prepares to use a generic auto-injector to give themself a drug dose" class="img-responsive" /> </picture> </div> </div> </div> <div class="lcds-cta__body"> <h2 class="lcds-cta__title"> About Combination Products </h2> <p class="lcds-cta__text"> Combination product definition, reports, examples and common questions. </p> <a href="/combination-products/about-combination-products" title="Learn More" class="btn btn-default"> Learn More </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 Combination Products 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="/combination-products/guidance-regulatory-information" title="Guidance & Regulatory Information"> Guidance & Regulatory Information</a></h3> <p class="lcds-card__text">Combination products rules, regulations, and guidance documents.</p> </article> <article class="lcds-card lcds-card--border-top lcds-card--teaser"> <h3 class="lcds-card__title"><a href="/combination-products/jurisdictional-information" title="Classification and Jurisdictional Information">Classification and Jurisdictional Information</a></h3> <p class="lcds-card__text">Jurisdictional information for human medical products.</p> </article> <article class="lcds-card lcds-card--border-top lcds-card--teaser"> <h3 class="lcds-card__title"><a href="/combination-products/feedback-combination-products" title="Feedback on Combination Products">Feedback on Combination Products</a></h3> <p class="lcds-card__text">Details on how to leave feedback with the Office of Combination Products.</p> </article> <article class="lcds-card lcds-card--border-top lcds-card--teaser"> <h3 class="lcds-card__title"><a href="/combination-products/meetings-conferences-workshops" title="Meetings, Conferences, & Workshops">Meetings, Conferences, & Workshops</a></h3> <p class="lcds-card__text">Presentations, articles and information about combination product meetings.</p> </article> </div> </section> </div> <div class="field--item"> <section class="lcds-card-deck bg-dark-gray txt-light"> <header class="lcds-card-deck__header"> <h2 class="lcds-card-deck__heading">Industry Resources and Key Topics</h2> </header> <div class="lcds-card-deck__body"> <p></p> </div> <div> <a href="/combination-products/guidance-regulatory-information/combination-products-guidance-documents" title="Combination Products Guidance Documents" class="btn btn-default">Combination Products Guidance Documents</a> <a href="/combination-products/rfd-process" title="Informaton on the RFD Process" class="btn btn-default">Informaton on the RFD Process</a> </div> </section> </div> <div class="field--item"> <section class="lcds-card-deck--teaser lcds-card-deck bg-dark-gray txt-light"> <header class="lcds-card-deck__header"> <h2 class="lcds-card-deck__heading sr-only">More Industry Resources and Key Topics</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="/regulatory-information/search-fda-guidance-documents/current-good-manufacturing-practice-requirements-combination-products" title="Current Good Manufacturing Practice Requirements for Combination Products"> Current Good Manufacturing Practice Requirements for Combination Products</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="/regulatory-information/search-fda-guidance-documents/classification-products-drugs-and-devices-and-additional-product-classification-issues" title="Classification of Products as Drugs and Devices and Additional Product Classifi…">Classification of Products as Drugs and Devices and Additional Product Classifi…</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="/regulatory-information/search-fda-guidance-documents/how-prepare-pre-request-designation-pre-rfd" title="How to Prepare a Pre-Request for Designation (Pre-RFD)">How to Prepare a Pre-Request for Designation (Pre-RFD)</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="/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products" title="Postmarketing Safety Reporting for Combination Products">Postmarketing Safety Reporting for Combination Products</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">Resources for You</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="/combination-products/about-combination-products/frequently-asked-questions-about-combination-products" title="Frequently Asked Questions About Combination Products"> Frequently Asked Questions About Combination Products</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="/about-fda/office-chief-medical-officer/office-combination-products" title="Information About the Office of Combination Products">Information About the Office of Combination Products</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="/combination-products/about-combination-products/combination-product-definition-combination-product-types" title="Combination Product Definition and Combination Product Types">Combination Product Definition and Combination Product Types</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="/combination-products/jurisdictional-information/combination-product-contacts" title="Combination Product Contacts">Combination Product Contacts</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="/about-fda/reports/combination-products-performance-reports" title="Combination Products Performance Reports">Combination Products Performance Reports</a></h3> <p class="lcds-card__text"></p> </article> <article class="lcds-card lcds-card--border-top lcds-card--teaser"> <h3 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