Acts, Rules and Regulations

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The following are some of the provisions focused specifically on these topics.</p><p><strong>Statutory provisions</strong></p><ul><li><a target="_blank" href="http://docs.house.gov/billsthisweek/20161128/CPRT-114-HPRT-RU00-SAHR34.pdf">21st Century Cures Act, Section 3038. Combination Product Innovation, December 13, 2016</a></li><li><a target="_blank" href="http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360bbb-2&num=0&edition=prelim">21 USC 360bbb-2</a> - Statutory provisions pertaining to classification and assignment of medical products can be found in section 563 of the Federal Food, Drug, and Cosmetic Act</li><li><a target="_blank" href="http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section353&num=0&edition=prelim">21 USC 353(g)</a> - Statutory provisions relating to the assignment of combination products to Agency components, to their premarket and postmarket regulation, and to associated responsibilities of Agency components including the Office of Combination Products can be found at section 503(g) of the Federal Food, Drug, and Cosmetic Act Statutory definitions <ul><li><a target="_blank" href="http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim">42 U.S.C. 262(i) </a>and <a target="_blank" href="https://www.ecfr.gov/cgi-bin/text-idx?SID=71cbfe8ad4cf801cb7fe161140109bdb&mc=true&node=se21.7.600_13&rgn=div8">21 CFR 600.3(h)</a> - Biological product – section 351(a) of the Public Health Service Act</li><li><a target="_blank" href="http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section321&num=0&edition=prelim">21 U.S.C. 321(g)</a> - Drug - section 201(g) of the Federal Food, Drug, and Cosmetic Act</li><li><a target="_blank" href="http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section321&num=0&edition=prelim">21 U.S.C. 321(h)</a> - Device - section 201(h) of the Federal Food, Drug, and Cosmetic Act</li><li><a target="_blank" href="http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section353&num=0&edition=prelim">21 U.S.C 353 (g)</a> - Combination product - section 503(g) of the Federal Food, Drug, and Cosmetic Act</li></ul></li></ul><p><strong>Regulations</strong></p><ul><li><a target="_blank" href="https://www.ecfr.gov/cgi-bin/text-idx?SID=71cbfe8ad4cf801cb7fe161140109bdb&mc=true&tpl=/ecfrbrowse/Title21/21cfr4_main_02.tpl">21 CFR Part 4</a> – the regulations pertaining to current good manufacturing practices and postmarket safety reporting requirements for combination products <ul><li><a target="_blank" href="https://www.federalregister.gov/documents/2016/12/20/2016-30485/postmarketing-safety-reporting-for-combination-products">Final rule on postmarketing safety requirements for combination products</a>, December 20, 2016</li><li><a target="_blank" href="https://www.federalregister.gov/documents/2013/01/22/2013-01068/current-good-manufacturing-practice-requirements-for-combination-products">Final rule on current good manufacturing practice requirements for combination products</a>, January 22, 2013</li></ul></li></ul><ul><li><a target="_blank" href="https://www.ecfr.gov/cgi-bin/text-idx?SID=71cbfe8ad4cf801cb7fe161140109bdb&mc=true&tpl=/ecfrbrowse/Title21/21cfr3_main_02.tpl">21 CFR Part 3</a> - the regulations pertaining to the classification of medical products as drugs, devices, biological products, or combination products and their assignment to FDA components for premarket review and regulation <ul><li><a target="_blank" href="https://www.ecfr.gov/cgi-bin/text-idx?SID=71cbfe8ad4cf801cb7fe161140109bdb&mc=true&node=se21.1.3_12&rgn=div8">21 CFR 3.2(e)</a> – Definition of a combination product</li><li><a target="_blank" href="https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&SID=71cbfe8ad4cf801cb7fe161140109bdb&mc=true&n=sp21.1.3.a&r=SUBPART&ty=HTML#se21.1.3_17">21 CFR 3.7</a> – requirements for RFD submissions</li><li><a target="_blank" href="https://www.federalregister.gov/documents/2005/08/25/05-16527/definition-of-primary-mode-of-action-of-a-combination-product">Final rule to define “mode of action” (MOA) and “primary mode of action” (PMOA)</a>, August 25, 2005</li></ul></li></ul><ul><li><a target="_blank" href="https://www.federalregister.gov/documents/2018/05/15/2018-10321/product-jurisdiction">Proposed rule to amend regulations concerning the classification of products as biological products, devices, drugs, or combination products, and their assignment to Agency components for premarket review and regulation.</a> May 15, 2018</li></ul><p> </p>   </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="2018-05-25T10:28:00Z">05/25/2018</time> </p> </div> </li> <li role="menuitem" class="lcds-description-list__item"> <div> </div> </li> </ul> </aside> </div> </section> </aside> <aside class="col-md-2 col-md-pull-10" role="complementary"> <section id="block-entityviewcontent-3" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <div class="region region-"> <nav id="section-nav"class="lcds-card lcds-section-nav lcds-section-nav--side hidden-xs hidden-sm"> <ul class="lcds-section-nav__list lcds-section-nav--side__list"> <li> <a href="/combination-products/guidance-regulatory-information" class="lcds-section-nav__link lcds-section-nav--side__link lcds-section-nav__parent-link lcds-section-nav--side__parent-link"> Guidance & Regulatory Information </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-41b7597947870360f7bf9af5a5d810a24282cedcc0b3ab90462db39766cb2202"> <div class="item-list"> <ul class="lcds-section-nav__active lcds-section-nav__list lcds-section-nav--side__list"> <li><a href="/combination-products/guidance-regulatory-information/acts-rules-and-regulations" class="lcds-section-nav__link lcds-section-nav--side__link">Acts, Rules and Regulations</a></li> <li><a href="/combination-products/guidance-regulatory-information/combination-products-guidance-documents" class="lcds-section-nav__link lcds-section-nav--side__link">Combination Products Guidance Documents</a></li> <li><a href="/combination-products/guidance-regulatory-information/intercenter-consultative-collaborative-review-process" class="lcds-section-nav__link lcds-section-nav--side__link">Intercenter Consultative/ Collaborative Review Process</a></li> <li><a href="/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products" class="lcds-section-nav__link lcds-section-nav--side__link">Postmarketing Safety Reporting for Combination Products</a></li> <li><a href="/combination-products/guidance-regulatory-information/genus-v-fda-dc-circuit-court-decision-and-transition-drugs-devices" class="lcds-section-nav__link lcds-section-nav--side__link">Genus v. 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