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href="/training-and-continuing-education" title="Training and Continuing Education"> Training and Continuing Education </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">CDRH Learn</h1> <div class="lcds-toolbar lcds-toolbar--social"> <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%2Ftraining-and-continuing-education%2Fcdrh-learn" 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 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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"> <p>Welcome to CDRH Learn! CDRH Learn is our multi-media educational resource, featuring learning modules that address medical device and radiation emitting product laws, regulations, guidances, and policies, across the entire product life cycle. These modules provide industry with information that is comprehensive, interactive, and easily accessible. Modules are provided in various formats, including videos, audio recordings, and slide presentations. </p> <div class="callout"> <p><strong>Tips for Viewing Modules</strong><br> Modules should be compatible with most devices (computers, tablets, smart phones). We recommend you use Mozilla Firefox or Google Chrome to view modules. If you encounter a viewing error, we suggest you try another browser.</p> </div> <div class="panel-group" id="accordion"> <div class="panel panel-default"> <div class="panel-heading"> <h4 class="panel-title"><a class="toggle collapsed" data-parent="#accordion" data-toggle="collapse" href="#collapseOne">Start Here/The Basics! (<em>Updated 10/29/2024</em>) </a></h4> <a class="toggle collapsed" data-parent="#accordion" data-toggle="collapse" href="#collapseOne"><em>MDUFA Small Business Program, Registration and Listing</em> </a></div> <div class="panel-collapse collapse" id="collapseOne"> <div class="panel-body"> <p><a class="toggle collapsed" data-parent="#accordion" data-toggle="collapse" href="#collapseOne">An Introduction to FDA's Regulation of Medical Devices </a><br> <a href="http://fda.yorkcast.com/webcast/Play/884aea9662174dea8ef4df68988b86981d">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="37f7072f-b499-41bc-aa53-e2772149a77c" href="/media/123602/download?attachment" title="An Introduction to FDA’s Regulation of Medical Devices - Slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="13b57946-f85b-4f96-bf98-20de28be1408" href="/media/123603/download?attachment" title="An Introduction to FDA’s Regulation of Medical Devices - Transcript">Transcript</a></p> <p>How is CDRH Structured?<br> <a href="http://fda.yorkcast.com/webcast/Play/07d061bc1b204888aafa4baf36c86be71d">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="04ae04e7-9da0-47d7-878a-3873552afaea" href="/media/131267/download?attachment" title="How is CDRH Structured - slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="66e52a83-c481-4379-a855-876c84ba39bd" href="/media/131292/download?attachment" title="How is CDRH Structured - transcript">Transcript</a></p> <p>Is My Product a Medical Device?<br> <a href="http://fda.yorkcast.com/webcast/Play/e0eec5f6ee3d4947a70fcedef32993f71d">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="584c5bf1-c0f2-4938-8f90-5a1ebefa68d9" href="/media/131268/download?attachment" title="Is My Product a Medical Device - slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="fdba3a2e-aea6-4d98-a1d2-10bb687d5153" href="/media/131269/download?attachment" title="Is My Product a Medical Device - Transcript">Transcript</a></p> <p>An Introduction to the Medical Device User Fee Program: MDUFA V<br> <a href="https://fda.yorkcast.com/webcast/Play/d5fd6a45a6394a2b8f69066e05b78e061d">Presentation</a>  <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="9fa0fef5-abe5-4907-a5c1-ef1e36b94d97" href="/media/170403/download?attachment" title="Slides CDRH Learn Introduction MDUFA V">Printable Slides</a>  <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="fc2382a0-f4df-47bd-9280-b005fa3d2618" href="/media/170399/download?attachment" title="Transcript: CDRH Learn MDUFA V User Fee Program">Transcript</a></p> <hr> <p><strong>MDUFA Small Business Program</strong></p> <p>For information about submissions to the Small Business Determination (SBD) program, please reference "<a href="https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/reduced-medical-device-user-fees-small-business-determination-sbd-program#application">How to submit a Small Business Certification Request</a>".</p> <p>How to Complete Form FDA 3602: MDUFA Small Business Qualification and Certification for a Business Headquartered in the United States. </p> <p><a href="http://www.accessdata.fda.gov/cdrh_docs/presentations/how-to-complete-form-fda-3602/story.html">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="12e5cb2b-0bd4-4942-bbef-542ea04d3f43" href="/media/119714/download?attachment" title="How to Complete Form FDA 3602: MDUFA Small Business Qualification and Certification for a Business Headquartered in the United States - Transcript">Transcript</a></p> <p>How to Complete Form FDA 3602A: MDUFA Foreign Small Business Certification Request for a Business Headquartered Outside the United States. </p> <p><a href="http://www.accessdata.fda.gov/cdrh_docs/presentations/how-to-complete-form-fda-3602a/story.html">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="7e985117-2973-47cc-9214-446ea2f88e1d" href="/media/121860/download?attachment" title="How to Complete Form FDA 3602A: MDUFA Foreign Small Business Certification Request For a Business Headquartered Outside the United States - Transcript">Transcript</a></p> <hr> <p><strong>Registration and Listing</strong></p> <p>Device Registration and Listing: An Introduction – Part 1<br> <a href="https://fda.yorkcast.com/webcast/Play/0d11c844da704628a6ea85b06b1dbe8b1d">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="d9f067c4-f55e-4602-b6b5-a891337d7ac6" href="/media/170332/download?attachment" title="Slides CDRH Learn Registration and Listing Introduction Part 1">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="98acafce-4b4f-468c-b631-654dccc02921" href="/media/170330/download?attachment" title="Transcript CDRH Learn Registration and Listing Introduction Part 1">Transcript</a></p> <p>Device Registration and Listing: An Introduction – Part 2<br> <a href="https://fda.yorkcast.com/webcast/Play/764ece0cf29b47b48ac5c2e6cd765a0b1d">Presentation</a>   <a href="/media/170333/download">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="d85ce357-38fb-4c67-a3f7-9ef6f0bd1fb4" href="/media/170331/download?attachment" title="Transcript CDRH Learn Registration and Listing Introduction Part 2">Transcript</a></p> <p>Paying the Annual Registration User Fee via the Device Facility User Fee (DFUF) Website<br> <a href="http://www.accessdata.fda.gov/cdrh_docs/presentations/AnnualFee/index.html">Presentation</a>   <a href="/media/87326/download">Printable Slides</a></p> <p>FURLS Device Registration and Listing Module for Annual Registration<br> <a href="/media/107672/download" target>Presentation</a></p> <p>FURLS Device Registration and Listing Module for Initial Registration<br> <a href="https://www.accessdata.fda.gov/cdrh_docs/presentations/FURLS/story.html">Presentatio</a></p> </div> </div> </div> <div class="panel panel-default"> <div class="panel-heading"> <h4 class="panel-title"><a class="toggle collapsed" data-parent="#accordion" data-toggle="collapse" href="#collapseTwo">How to Study and Market Your Device -<em> (New module 10/18/24)</em></a></h4> <em>510k, De Novo, IDE, PMA, HUD/HDE, Q-Submissions, Standards, Classification</em></div> <div class="panel-collapse collapse" id="collapseTwo"> <div class="panel-body"> <p><strong>Premarket Notification (510k)</strong></p> <p>The 510(k) Program<br> <a href="http://fda.yorkcast.com/webcast/Play/d91af554691c4260b5eca0b2a28e636b1d" target="_blank">Presentation</a>   <a href="/media/89869/download" target>Printable Slides</a>   <a href="/training-and-continuing-education/cdrhlearn/510k-program-transcript" target>Transcript</a></p> <p>CDRH's New Draft Guidances to Continue to Modernize the 510(k) Program</p> <p><a href="https://youtu.be/eIZGb9mx4gk" target="_blank">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="b42a0c63-ca5e-4ea3-acf3-4247255a5977" href="/media/173332/download?attachment" title="Webinar - CDRH's New Draft Guidances to Continue to Modernize the 510(k) Program - Slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="9dba690e-eb60-443e-8921-54802c8b652a" href="/media/173607/download?attachment" title="Transcript CDRH Webinar New Draft Guidances to Continue to Modernize the 510(k) Program">Transcript</a></p> <p>The Special 510(k) Program: Final Guidance<br> <a href="https://www.youtube.com/watch_popup?v=C-CBFllw0vU">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="6789e82a-a716-4f35-bae2-8f9b1e1f4f8b" href="/media/132151/download?attachment" title="The Special 510(k) Program: Final Guidance - slides ">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="4eabcd8b-2ad7-4213-ab85-3509a301f8ce" href="/media/132460/download?attachment" title="The Special 510(k) Program: Final Guidance - Transcript">Transcript</a></p> <p>Safety and Performance Based Pathway Criteria for Certain Device Types Final Guidances<br> <a href="https://www.youtube.com/watch?v=SEdNLlifg5w">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="a5d5fa64-2782-4e46-935e-988a928b0209" href="/media/142410/download?attachment" title="Webinar - Safety and Performance Based Pathway Criteria for Certain Device Types Final Guidances - Slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="d621c8fc-b2ed-4469-a0ef-4e8edfb2d0d5" href="/media/142580/download?attachment" title="Webinar - Safety and Performance Based Pathway Criteria for Certain Device Types Final Guidances - Transcript">Transcript</a></p> <p>Safety and Performance Based Pathway Performance Criteria<br> <a href="https://www.youtube.com/watch_popup?v=ZkLhZwXGkKY">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="27fc17cb-030c-4f80-8ebe-f462804e2251" href="/media/132363/download?attachment" title="Safety and Performance Based Pathway Performance Criteria - Slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="2dbb8de5-ff14-420f-b9d7-529ae5b92a25" href="/media/132679/download?attachment" title="Safety and Performance Based Pathway Performance Criteria - Transcript">Transcript</a></p> <p>Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics<br> <a href="https://www.youtube.com/watch_popup?v=H1qE70UTwA0">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="277e07ab-2084-45c3-a9ea-fe62d8b50c45" href="/media/118211/download?attachment" title="Benefit-Risk Factors to Consider - Slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="9ffc1148-76fb-434a-b663-f34c12e5c3a4" href="/media/118212/download?attachment" title="Benefit-Risk Factors to Consider - Transcript">Transcript</a><br> <br> Final Guidances on "Deciding When to Submit a 510(k) for a Change to an Existing Device" and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" <br> <a href="https://www.youtube.com/watch_popup?v=X_4v2UpBVbw" target="_blank">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="7cae52ac-9897-4544-b7ca-8642d678bb34" href="/media/108995/download?attachment" target title="Final Guidances on "Deciding When to Submit a 510(k) for a Change to an Existing Device” and “Deciding When to Submit a 510(k) for a Software Change to an Existing Device" - Slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="f59373fa-7d23-4f38-8c2c-63eec8655114" href="/media/109450/download?attachment" target title="Final Guidances on "Deciding When to Submit a 510(k) for a Change to an Existing Device” and “Deciding When to Submit a 510(k) for a Software Change to an Existing Device" - Transcript">Transcript</a></p> <hr> <p><strong>De Novo</strong></p> <p>De Novo Final Rule: Overview and Guidance Updates<br> <a href="https://youtu.be/uK8igWjzjyk">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="c30bf9b6-d798-4a85-a21a-659cbb51a612" href="/media/155111/download?attachment" title="CDRH Learn Slides De Novo Final Rule Overview and Guidance Updates ">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="d66dfca5-f939-4781-8f70-38ed334c442e" href="/media/155110/download?attachment" title="CDRH Learn De Novo Final Rule: Overview and Guidance Updates">Transcript</a></p> <p>De Novo Program<br> <a href="http://fda.yorkcast.com/webcast/Play/9058dda0731f4cbdaf8ee37be10a9eb51d" target="_blank">Presentation</a>   <a href="/media/89875/download" target>Printable Slides</a>   <a href="https://public4.pagefreezer.com/browse/FDA/01-01-2022T01:12/https://www.fda.gov/training-and-continuing-education/cdrhlearn/de-novo-program-transcript" target>Transcript</a></p> <hr> <p><strong>Clinical Studies/Investigational Device Exemption (IDE)</strong></p> <p>IDE Basics<br> <a href="http://fda.yorkcast.com/webcast/Play/696d857b34334d5389364ed8c2db3ded1d" target="_blank">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="dfc79936-f499-4335-9dad-b37092bb189a" href="/media/127955/download?attachment" target title="IDE Basics - Slides">Printable Slides</a>   <a href="/training-and-continuing-education/cdrhlearn/ide-basics-transcript" target>Transcript</a></p> <p>Implementation of Final Rule on Human Subject Protection: Acceptance of Data from Clinical Investigations for Medical Devices<br> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="69ef5dde-d55e-4a26-a6d2-163b5f65690a" href="/media/121365/download?attachment" title="Implementation of Final Rule on Human Subject Protection: Acceptance of Data from Clinical Investigations for Medical Devices - Slides ">Printable Slides</a>    <a href="https://www.research.net/r/CDRHWebinar03192019">Survey</a></p> <p>Final Guidance on Adaptive Designs for Medical Device Clinical Studies<br> <a href="https://www.youtube.com/watch_popup?v=STYb8ZOUb5U" target="_blank">Presentation</a>   <a href="/media/100415/download" target>Printable Slides</a>   <a href="/media/100701/download" target>Transcript</a></p> <p>An Update on the FDA's Medical Device Clinical Trials Program<br> <a href="https://www.youtube.com/watch_popup?v=YiXT3bbTQ1M" target="_blank">Presentation</a>    Printable Slides (<a href="/media/99388/download" target>Full</a>, <a href="/media/99393/download" target>Part 1</a>, <a href="/media/99397/download" target>Part 2</a>)    <a href="/media/99234/download" target>Transcript</a></p> <p>Breakthrough Devices Program, Updated Final Guidance [2023]<br> <a href="https://youtu.be/Z6k-PM12ZOk">Presentation</a>     <a href="/media/173763/download">Printable Slides</a>    <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="f8adac53-c127-4b8b-aa5c-5382095eee28" href="/media/174041/download?attachment" title="Transcript CDRH Webinar Breakthrough Devices Program Updates Nov 2023">Transcript</a></p> <p>Breakthrough Devices Program [2019]<br> <a href="https://youtu.be/rZ7eESNdyPk">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="835f2c35-aef2-412b-bdf4-b10e89d47d99" href="/media/119742/download?attachment" title="Breakthrough Devices Program - Slides ">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="9c0427af-1ff6-4834-84cd-9a9fdd46ab5d" href="/media/119804/download?attachment" title="Breakthrough Devices Program - Transcript ">Transcript</a></p> <p>Strengthening the Medical Device Clinical Trial Enterprise<br> <a href="https://www.youtube.com/watch_popup?v=s1-e77TQdLM" target="_blank">Presentation</a>   <a href="/media/90581/download" target>Printable Slides</a>   <a href="/media/90682/download" target>Transcript</a></p> <p>IDEs for Early Feasibility Medical Device Clinical Studies, Including First in Human (FIH) Studies<br> <a href="https://www.accessdata.fda.gov/cdrh_docs/presentations/video/ide-early-feasibility.mp3" target="_blank">Presentation</a>   <a href="/media/86975/download">Printable Slides</a>   <a href="/training-and-continuing-education/cdrhlearn/transcript-ides-early-feasibility-medical-device-clinical-studies-including-first-human-fih-studies">Transcript</a></p> <p>FDA Guidance: Design Considerations for Pivotal Clinical Investigations for Medical Devices<br> <a href="https://www.accessdata.fda.gov/cdrh_docs/presentations/video/pivotal-webinar.mp3" target="_blank">Presentation</a>   <a href="/media/87225/download">Printable Slides</a>   <a href="/training-and-continuing-education/cdrhlearn/transcript-design-considerations-pivotal-clinical-investigations-medical-devices">Transcript</a></p> <p>Final Guidance on "Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies"<br> <a href="https://www.youtube.com/watch_popup?v=JlJjfdz43hQ" target="_blank">Presentation</a>   <a href="/media/109014/download" target>Printable Slides</a>   <a href="/media/108780/download" target>Transcript</a></p> <p>Evaluation of Sex-Specific Data in Medical Device Clinical Studies<br> <a href="https://www.youtube.com/watch_popup?v=VnnZ1qI_nBQ" target="_blank">Presentation</a>   <a href="/media/89450/download" target>Printable Slides</a>   <a href="/media/89817/download" target>Transcript</a></p> <p>FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations<br> <a href="https://www.youtube.com/watch_popup?v=PwkakQPj0-8" target="_blank">Presentation</a>   <a href="/media/86317/download">Printable Slides</a>   <a href="/media/89866/download" target>Transcript</a></p> <p>Clinical Studies/IDE  <br> <a href="https://www.youtube.com/watch_popup?v=c9VLs_G2BUw" target="_blank">Presentation</a>   <a href="/media/103325/download" target>Printable Slides</a>   <a href="/media/103484/download" target>Transcript</a></p> <p>Post-Approval Study Requirements and Postmarket Surveillance under Section 522 of the Federal Food, Drug, and Cosmetic Act, Final Guidances<br> <a href="https://youtu.be/fo6sJmCkuCs">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="30361325-a47b-4788-88d5-76819e76d938" href="/media/163624/download?attachment" title="Webinar: Postmarket Mandated Studies Programs: Overview and Final Guidance Updates - Printable Slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="d2007942-1406-4435-a482-6116dfb3c0e4" href="/media/163940/download?attachment" title="Post-Approval Study Requirements and Postmarket Surveillance under Section 522 of the Federal Food, Drug, and Cosmetic Act, Final Guidances - Transcript">Transcript</a></p> <p>FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions<br> <a href="https://www.youtube.com/watch_popup?v=InxTWFUXIJ0" target="_blank">Presentation</a>   <a href="/media/110254/download" target>Printable Slides</a>   <a href="/media/110602/download" target>Transcript</a></p> <hr> <p><strong>Premarket Approval Application (PMA)</strong></p> <p>Introduction to the Premarket Approval Application (PMA) Program<br> <a href="http://fda.yorkcast.com/webcast/Play/97aec4c92a9b433c8342618d19fa9c9e1d">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="70b56bbf-fe47-42d0-a4e3-c6af4a932c60" href="/media/131254/download?attachment" title="Introduction to the Premarket Approval Application (PMA) Program - slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="0d1379b2-852e-4b32-bc8d-d1470d36ccae" href="/media/131255/download?attachment" title="Introduction to the Premarket Approval Application (PMA) Program - transcript">Transcript</a></p> <p>Premarket Approval Application (PMA) Program: Postapproval Requirements<br> <a href="http://fda.yorkcast.com/webcast/Play/4d593b3a081c48e8a249d6b0d71588281d">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="5b608268-c977-42fa-b2a1-f7f608d97c67" href="/media/131249/download?attachment" title="Premarket Approval Application (PMA) Program: Postapproval Requirements">Printable Slides</a>   <a href="http://wayback.archive-it.org/7993/20191212161048/https://www.fda.gov/media/131251/download">Transcript</a></p> <hr> <p><strong>Humanitarian Use Device (HUD)/Humanitarian Device Exemption (HDE) </strong></p> <p>Module 1: Office of Orphan Products Development<br> <a href="http://fda.yorkcast.com/webcast/Play/5801ca9c8713492bb28ed262be0368531d" target="_blank">Presentation</a>   <a href="/media/99921/download" target>Printable Slides</a>   <a href="/media/99926/download" target>Transcript</a></p> <p>Module 2: Humanitarian Use Device (HUD): Program Overview<br> <a href="http://fda.yorkcast.com/webcast/Play/06f527183f2a41ee8c10e0bceeb9746f1d" target="_blank">Presentation</a>   <a href="/media/99933/download" target>Printable Slides</a>   <a href="/media/99940/download" target>Transcript</a></p> <p>Module 3: Humanitarian Device Exemption (HDE): Program Overview and Pre-approval Activities<br> <a href="http://fda.yorkcast.com/webcast/Play/58ccd9e3581e4fb59ae267f0dcaa43871d" target="_blank">Presentation</a>   <a href="/media/99947/download" target>Printable Slides</a>   <a href="/media/99955/download" target>Transcript</a></p> <p>Module 4: Humanitarian Device Exemption (HDE): Post-approval Activities<br> <a href="http://fda.yorkcast.com/webcast/Play/5d544b03a0c247a9842ea072042f1f0a1d" target="_blank">Presentation</a>   <a href="/media/99962/download" target>Printable Slides</a>   <a href="/media/99966/download" target>Transcript</a></p> <p>Humanitarian Device Exemption Program<br> <a href="https://www.youtube.com/watch_popup?v=w0UIrbAzkmw">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="6b24a2f7-1179-411c-aec4-f118e7c18fa8" href="/media/131886/download?attachment" title="Humanitarian Device Exemption Program - slides ">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="ecfe611d-b87a-4d40-93e5-c3f742fd55cd" href="/media/132219/download?attachment" title="Humanitarian Device Exemption Program - Transcript ">Transcript</a></p> <hr> <p><strong>Q-Submissions</strong></p> <p>Q-Submission Program for Medical Device Submissions<br> <a href="https://youtu.be/WwXk02CAeO4">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="ee452aac-a2b4-424b-a55a-8dc0827adbf6" href="/media/127856/download?attachment" title="Q-Submission Program for Medical Device Submissions - Slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="f52649b4-02ed-4f6f-8f36-10dfda6feff5" href="/media/128149/download?attachment" title="Transcript - Q-Submission Program for Medical Device Submissions - June 11, 2019">Transcript</a></p> <p>Requests for Feedback: The Pre-Submission Program and Meetings with FDA Staff<br> <a href="http://fda.yorkcast.com/webcast/Play/854abe570f0a4000a90931767e12d6191d">Presentation</a>   <a href="/media/93740/download" target>Printable Slides</a>   <a href="/media/93744/download" target>Transcript</a></p> <hr> <p><strong>Standards </strong></p> <p>Module 1: Standards Overview<br> <a href="http://fda.yorkcast.com/webcast/Play/19fb4aaf3db5441898df39fe5af7d1b11d" target="_blank">Presentation</a>   <a href="/media/93752/download" target>Printable Slides</a>   <a href="/media/93763/download" target>Transcript</a></p> <p>Module 2: Standards Resources and Premarket Use<br> <a href="http://fda.yorkcast.com/webcast/Play/bd69ac738f0d418eb27923fb967906b31d" target="_blank">Presentation</a>   <a href="/media/93774/download" target>Printable Slides</a>   <a href="/media/93781/download" target>Transcript</a></p> <p>Module 3: CDRH Standards Recognition Process<br> <a href="http://fda.yorkcast.com/webcast/Play/8866483d519d4e4f9d94d5ee20b8e9ae1d" target="_blank">Presentation</a>   <a href="/media/93791/download" target>Printable Slides</a>   <a href="/media/93799/download" target>Transcript</a></p> <p>Module 4: How to Use Consensus Standards in Premarket Submissions<br> <a href="https://fda.yorkcast.com/webcast/Play/9e73a97e01dd4edbaf51c46df7b42b771d">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="10d3908c-fd81-4ac4-b5a7-a64a1d545e89" href="/media/147787/download?attachment" title="How to Use Consensus Standards in Premarket Submissions - Slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="d38df106-d831-4e50-bfa5-93e5d0dc0c6e" href="/media/147788/download?attachment" title="How to Use Consensus Standards in Premarket Submissions - Transcript">Transcript</a></p> <p>Module 5: The ASCA Pilot: Streamlining Conformity Assessment in Device Submissions <br> <a href="https://fda.yorkcast.com/webcast/Play/49e588824faa4d9bada64af0037b75971d">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="e07b5bde-6d47-4a82-b1dd-a0828d49fc68" href="/media/147789/download?attachment" title="The ASCA Pilot: Streamlining Conformity Assessment in Device Submissions - Slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="1d36b4d8-69c4-443f-9d8b-32a2d4333a64" href="/media/147790/download?attachment" title="The ASCA Pilot: Streamlining Conformity Assessment in Device Submissions - Transcript">Transcript</a></p> <p>Webinar - ASCA Pilot: Streamlining Conformity Assessment in Device Submissions<br> <a href="https://www.youtube.com/watch?v=aNOWJvU1NlQ">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="f5547795-6f62-4ad0-ad9f-b625b59d23b7" href="/media/148865/download?attachment" title="Webinar - ASCA Pilot: Streamlining Conformity Assessment in Device Submissions - Slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="d7d7623c-bc5e-457f-917c-0b39a729bcca" href="/media/149661/download?attachment" title="Webinar - ASCA Pilot: Streamlining Conformity Assessment in Device Submissions - Transcript">Transcript</a></p> <p>Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program - Final Guidances<br> <a href="https://www.youtube.com/watch?v=-N7iqrybnro">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="c62afcbd-73bf-41e2-929d-ba60c53c242c" href="/media/143170/download?attachment" title="Webinar - Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program - Final Guidances - Slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="8520b18a-a8ff-4904-9751-ade70be22e1d" href="/media/143728/download?attachment" title="Webinar - Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program - Final Guidances - Transcript">Transcript</a></p> <p>Appropriate Use of Voluntary Consensus Standards<br> <a href="https://www.youtube.com/watch_popup?v=3f66KBy7yh8">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="e7593762-e9d2-4dfa-91c0-136246a15075" href="/media/117223/download?attachment" title="Appropriate Use of Voluntary Consensus Standards - Slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="b526c09d-f711-431f-941c-9d64e184cdc2" href="/media/119006/download?attachment" title="Appropriate Use Webinar - Transcript">Transcript</a></p> <p>Recognition and Withdrawal of Voluntary Consensus Standards - Final Guidance<br> <a href="https://www.youtube.com/watch?v=_1gVftKWwsA">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="19fa79b4-dae4-41b1-9940-0346f78de460" href="/media/142961/download?attachment" title="Webinar - Recognition and Withdrawal of Voluntary Consensus Standards - Final Guidance - Slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="263bbb55-6aa0-4025-9f3c-7f23679db4c3" href="/media/143197/download?attachment" title="Webinar - Recognition and Withdrawal of Voluntary Consensus Standards - Final Guidance - Transcript">Transcript</a></p> <hr> <p><strong>Cross-Cutting Premarket Policy</strong></p> <p>CDRH Portal Overview and Feature Walkthrough<br> <a href="https://youtu.be/883NXd94Aog">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="5ec02773-f5b2-4a39-aa5f-7bf29f060840" href="/media/172575/download?attachment" title="CDRH Portal Overview and Feature Walkthrough - Printable Slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="e3b84d8c-b65a-4001-a467-6258324c8b26" href="/media/172576/download?attachment" title="CDRH Portal Overview and Feature Walkthrough - Transcript">Transcript</a></p> <p>Combination Product Updates for "Acceptance and Filing Reviews for Premarket Approval Applications" and "Refuse to Accept Policy for 510(k)s" <br> <a href="https://www.youtube.com/embed/m2diHN04fmk">Presentation</a>   <a href="/media/111710/download" target>Printable Slides</a>   <a href="/media/112670/download" target>Transcript</a></p> <p>Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions<br> <a href="https://www.youtube.com/watch_popup?v=KXUMDQDSPMk">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="5fbefe80-e2ca-456a-8238-2b704118bc5b" href="/media/131762/download?attachment" title="Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions - slides ">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="4e60d6b9-5486-44a7-ad9a-c910fa0227b5" href="/media/131930/download?attachment" title="Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions - transcript (Unpublished)">Transcript</a></p> <p>Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications<br> <a href="http://fda.yorkcast.com/webcast/Viewer/?peid=bac3f2698df14fa98388409da5cba6831d" target="_blank">Presentation</a>   <a href="/media/83377/download">Printable Slides</a>   <a href="/media/83387/download">Transcript</a></p> <p>Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle, Draft Guidance <em>(Updated 10/18/2024)</em><br> <a href="https://youtu.be/YdoUMECSS-A">Presentation</a>  <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="cad087d4-9859-40d6-9797-123aedc8dd18" href="/media/182631/download?attachment" title="Slides - Draft Guidance: Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="16a264ad-8d79-48ac-9507-8efbb2f073f3" href="/media/182844/download?attachment" title="Transcript: Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle, October 15, 2024">Transcript</a></p> <p>The Least Burdensome Provisions: Concept and Principles Final Guidance<br> <a href="https://www.youtube.com/watch_popup?v=iUZmlAblY3Y">Presentation</a><strong><em>   </em></strong><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="4ecbc317-c864-4ca9-a578-d46cc33a3382" href="/media/121002/download?attachment" title="The Least Burdensome Provisions: Concept and Principles Final Guidance - Slides ">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="a17ce4ea-464b-4300-b14a-0ffd9c684d25" href="/media/121948/download?attachment" title="The Least Burdensome Provisions: Concept and Principles Final Guidance - Transcript ">Transcript</a></p> <p>Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices<br> <a href="https://www.youtube.com/watch_popup?v=MxZBUhhYKbQ" target="_blank">Presentation</a>   <a href="/media/99829/download" target>Printable Slides</a>   <a href="/media/99501/download" target>Transcript</a></p> <p>Multiple Function Device Products: Policy and Considerations<br> <a href="https://www.youtube.com/watch?v=xdGSNNEwQrU">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="99aefaba-0bdd-4057-8f34-3b14b56cbf84" href="/media/141929/download?attachment" title="Webinar - Multiple Function Device Products: Policy and Considerations - Slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="c3bf3950-b990-46ac-9c2d-98b0ad51dd13" href="/media/142238/download?attachment" title="Webinar - Multiple Function Device Products: Policy and Considerations - Transcript">Transcript</a></p> <p>Patient Preference Information <br> <a href="https://www.youtube.com/watch_popup?v=WSHQ4SAVzKQ" target="_blank">Presentation</a>   <a href="/media/100112/download" target>Printable Slides</a>   <a href="/media/100380/download" target>Transcript</a></p> <p>Predetermined Change Control Plans for Medical Devices, Draft Guidance <em><strong>(Updated 9/11/24)</strong></em><br> <a href="https://youtu.be/AYFQhvDQEsA">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="fccd2803-2618-49fb-80a5-6336e45ecc70" href="/media/181394/download?attachment" title="Webinar – Draft Guidance: Predetermined Change Control Plans for Medical Devices - Slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="876f909a-e4ea-42d4-b1be-fa6dbeaba484" href="/media/181710/download?attachment" title="Transcript for Webinar - Draft Guidance: Predetermined Change Control Plans for Medical Devices">Transcript</a></p> <p>Safer Technologies Program: Draft Guidance<br> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="46a125e6-f6e2-47ea-88c4-f2cc3895dce0" href="/media/145541/download?attachment" title="Webinar - Safer Technologies Program: Final Guidance - Slides">Printable Slides</a></p> <p>Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices<br> <a href="https://www.youtube.com/watch_popup?v=WGrIUsGVuvU" target="_blank">Presentation</a>   <a href="/media/108039/download" target>Printable Slides</a>   <a href="/media/108477/download" target>Transcript</a></p> <hr> <p><strong>Classification</strong></p> <p>How is My Medical Device Classified?<br> <a href="http://fda.yorkcast.com/webcast/Play/17792840509f49f0875806b6e9a1be471d">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="f3cda574-ac16-401f-951a-ca3fa72f6c9c" href="/media/131270/download?attachment" title="How is My Medical Device Classified - slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="b4dcd74b-3d4d-4c69-b715-e75de61e7ed4" href="/media/131271/download?attachment" title="How is My Medical Device Classified - transcript">Transcript</a></p> <p>Case Study: How is My Medical Device Classified?<br> <a href="http://fda.yorkcast.com/webcast/Play/b2ac233bb624462b9750bf0552018daa1d">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="107ca5fe-5b1e-4dc1-9355-9c03286c50ec" href="/media/131272/download?attachment" title="Case Study: How is My Medical Device Classified - slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="33a51c03-fb66-451c-a945-a10921d884ce" href="/media/131273/download?attachment" title="Case Study: How is My Medical Device Classified - transcript">Transcript</a></p> <p>513(g) Requests for Information<br> <a href="http://fda.yorkcast.com/webcast/Play/01b9a71491b54a2c9603f01443a477d61d">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="be1dfa6f-4480-4198-b4a0-609d135f956c" href="/media/133229/download?attachment" title="513(g) Requests for Information - Slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="c2630e61-2217-45f0-8020-297c96dfa42d" href="/media/133226/download?attachment" title="513(g) Requests for Information - Transcript">Transcript</a></p> <p>Final Guidance on Medical Device Accessories: Describing Accessories and Classification Pathway for New Accessory Types <br> <a href="https://www.youtube.com/watch_popup?v=mHqW54fdQp0" target="_blank">Presentation</a>   <a href="/media/102770/download" target>Printable Slides</a>   <a href="/media/102761/download" target>Transcript</a></p> <hr> <p><strong>Bioresearch Monitoring (BIMO)</strong></p> <p>BIMO Part 1 - Introduction to the Bioresearch Monitoring Program<br> <a href="http://fda.yorkcast.com/webcast/Viewer/?peid=96f1ee7896ee4a70876b601f533b4a9c" target="_blank">Presentation</a>   <a href="/media/77438/download" target>Printable Slides</a></p> <p>BIMO Part 3a - Institutional Review Board: Responsibilities in Making the Significant Risk and Non-significant Risk Device Determination<br> <a href="http://fda.yorkcast.com/webcast/Viewer/?peid=389cda9506134988a1ac3cc5a725ce87" target="_blank">Presentation</a>   <a href="/media/77480/download" target>Printable Slides</a></p> <p>BIMO Part 3b - Institutional Review Board: Humanitarian Use Devices (HUDs)<br> <a href="http://fda.yorkcast.com/webcast/Viewer/?peid=679dff2747964a5c90c7274a7313255f" target="_blank">Presentation</a>   <a href="/media/77468/download" target>Printable Slides</a></p> <p>BIMO Part 4c - Preparing for an FDA Institutional Review Board Inspection<br> <a href="http://fda.yorkcast.com/webcast/Viewer/?peid=a805008fd1ab4a9c9c2e87641e95a86a" target="_blank">Presentation</a>   <a href="/media/77487/download" target>Printable Slides</a></p> <p>BIMO Part 5a - Strategies for Sponsors to Build Quality into Device Research<br> <a href="http://fda.yorkcast.com/webcast/Viewer/?peid=225ed5f7301b474196b16c8d9b9a20a5" target="_blank">Presentation</a>   <a href="/media/77245/download" target>Printable Slides</a></p> <p>BIMO Part 5b - Strategies For Clinical Investigators to Build Quality into Device Research<br> <a href="http://fda.yorkcast.com/webcast/Viewer/?peid=b618186c8c9c488f8d951013adf0b635" target="_blank">Presentation</a>   <a href="/media/77493/download" target>Printable Slides</a></p> </div> </div> </div> <div class="panel panel-default"> <div class="panel-heading"> <h4 class="panel-title"><a class="toggle collapsed" data-parent="#accordion" data-toggle="collapse" href="#collapseThree">Postmarket Activities <em>(Updated module 10/16/24)</em></a></h4> <em>Quality System, QMSR, Exporting, Device Recalls, MDR, Inspection - Global Harmonization</em></div> <div class="panel-collapse collapse" id="collapseThree"> <div class="panel-body"> <p><strong>Overview of the Quality System </strong></p> <p><strong>Start Here!</strong> Overview of the Quality System<br> <a href="http://fda.yorkcast.com/webcast/Play/4abbbeeb0f76423998cab8c782c3e4181d">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="989ea95f-a9aa-4679-a9ea-2784028b3f8e" href="/media/118197/download?attachment" title="Overview of the Quality System - Slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="73a095e5-5802-4349-84f6-69187f1c7abe" href="/media/118198/download?attachment" title="Overview of the Quality System - Transcript">Transcript</a></p> <p>Production and Process Controls<br> <a href="http://fda.yorkcast.com/webcast/Play/c996037bfee443e4904ff2080833603a1d">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="21c1fb6c-c8a0-43f3-80c4-f51726c1fbfd" href="/media/118200/download?attachment" title="Production and Process Controls - Slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="f568d2fe-e7f8-4ad1-8ad9-1a598830d174" href="/media/118201/download?attachment" title="Production and Process Controls - Transcript">Transcript</a></p> <p>Production and Process Controls, Part 2<br> <a href="http://fda.yorkcast.com/webcast/Play/a2350a316b774c918baa21230d36b6dd1d">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="54ef6c88-7693-4b6a-9277-90afb1a696d8" href="/media/134138/download?attachment" title="Production and Process Controls, Part 2 - Slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="b6c17964-0948-452a-bcbe-c53745bb7d54" href="/media/134139/download?attachment" title="Production and Process Controls, Part 2 - Transcript">Transcript</a></p> <p>Documents, Change Control, and Records<br> <a href="http://fda.yorkcast.com/webcast/Play/3833c9464d2148fd8f258238725f9f871d">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="92dcdb10-fc60-4050-95ed-d0c249988694" href="/media/118202/download?attachment" title="Documents, Change Control, and Records - Slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="029cdbd0-3d7c-4982-bfc3-2fefcf7b5840" href="/media/118203/download?attachment" title="Documents, Change Control, and Records - Transcript">Transcript</a></p> <p>Design Controls <br> <a href="http://fda.yorkcast.com/webcast/Play/a12e1a3b9faa40ae96225b236de6d1a51d" target="_blank">Presentation</a>   <a href="/media/116762/download" target>Printable Slides</a>   <a href="/media/101501/download" target>Transcript</a></p> <p>Risk Basics for Medical Devices <br> <a href="https://fda.yorkcast.com/webcast/Play/69a2920f1a284ac2be3b33f1aa5497b81d">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="dd7f930d-8c01-4c8e-810e-669db71a3c34" href="/media/163912/download?attachment" title="CDRH Learn Presentation - Risk Basics for Medical Devices">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="612a77e0-b8f9-40f6-87d5-c5ed9cc007e7" href="/media/163914/download?attachment" title="CDRH Learn Transcript - Risk Basics for Medical Devices">Transcript</a></p> <p>Application of Risk Management Principles for Medical Devices <br> <a href="https://fda.yorkcast.com/webcast/Play/2f3dce7e06d140c4a769666418af58e91d">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="47bd943b-8860-4907-86f9-032ab01a95ad" href="/media/163915/download?attachment" title="CDRH Learn Presentation - Application of Risk Management Principles for Medical Devices">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="ebc3b745-d04f-4862-9e1e-bf97e3200b32" href="/media/163913/download?attachment" title="CDRH Learn Transcript - Application of Risk Management Principles for Medical Devices">Transcript</a></p> <p>Management Controls <br> <a href="http://fda.yorkcast.com/webcast/Play/5812f1d8ab474dafb200cd55bfbaac361d" target="_blank">Presentation</a>   <a href="/media/101512/download" target>Printable Slides</a>   <a href="/media/101520/download" target>Transcript</a></p> <p>Purchasing Controls<br> <a href="http://fda.yorkcast.com/webcast/Play/083de1ef7cfb40169e2451492a32ed1e1d" target="_blank">Presentation</a>   <a href="/media/94743/download" target>Printable Slides</a>   <a href="/media/109665/download" target>Transcript</a></p> <p>Process Validation<br> <a href="http://fda.yorkcast.com/webcast/Play/090c4052bc2b4f90ba94245204e745061d" target="_blank">Presentation</a>   <a href="/media/109539/download" target>Printable Slides</a>   <a href="/media/109544/download" target>Transcript</a></p> <p>Corrective and Preventive Actions<br> <a href="http://fda.yorkcast.com/webcast/Play/c78cfebf72774163a59f8f6f197435451d" target="_blank">Presentation</a>   <a href="/media/89883/download" target>Printable Slides</a>   <a href="/training-and-continuing-education/cdrhlearn/corrective-and-preventive-actions-transcript" target>Transcript</a></p> <p>Nonconforming Product<br> <a href="http://fda.yorkcast.com/webcast/Play/1c9f57f8b762476bbb692fdf6d23851d1d" target="_blank">Presentation</a>   <a href="/media/109408/download" target>Printable Slides</a>   <a href="/media/109420/download" target>Transcript</a></p> <p>Complaint Files<br> <a href="http://fda.yorkcast.com/webcast/Play/1980e8ad35064bc5b0f8cbc75b99793d1d" target="_blank">Presentation</a>   <a href="/media/109411/download" target>Printable Slides</a>   <a href="/media/109415/download" target>Transcript</a></p> <hr> <p><strong>Quality Management System Regulation <em>(New section)</em></strong></p> <p>Overview of Quality Management System Regulation <strong><em>(New 8/30/24)</em></strong><br> <a href="https://youtu.be/Na-OF3OkqEg">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="511e290a-2fc0-4ee9-8250-73db46c5cd5a" href="/media/181434/download?attachment" title="Overview of the Quality Management System Regulation - Slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="7311c6ed-d424-4b00-ac1f-b931e7fbf343" href="/media/181426/download?attachment" title="Overview of the Quality Management System Regulation - Transcript">Transcript</a></p> <p>Navigating the Quality Management System Regulation <strong><em>(New 8/30/24)</em></strong><br> <a href="https://youtu.be/CMnJw6G4hKo">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="5f987e98-d41b-41db-a31c-22855c0e5d55" href="/media/181437/download?attachment" title="Navigating the Quality Management System Regulation - Slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="0348a50d-b8c2-475b-9db4-f87a213f8c4f" href="/media/181427/download?attachment" title="Navigating the Quality Management System Regulation - Transcript">Transcript</a></p> <hr> <p><strong>Exports and Imports</strong></p> <p>Exporting Medical Devices<br> <a href="http://fda.yorkcast.com/webcast/Play/e7f8611bd06b40e890d6031ea1b1ee3a1d">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="30cd5b69-947a-496a-ad23-921ab0dca80e" href="/media/122215/download?attachment" title="Exporting Medical Devices - Slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="0d0c7945-9184-4a8f-966d-431a6c6ba020" href="/media/122216/download?attachment" title="Exporting Medical Devices - Transcript">Transcript</a></p> <p>Importing Medical Devices Into the United States<br> <a href="http://fda.yorkcast.com/webcast/Play/ffc9033bddb84fbe9e6f660290d707b11d">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="171a9985-b8b7-47da-b92f-ac1e5c0cb9b1" href="/media/134140/download?attachment" title="Importing Medical Devices Into the United States - Slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="bb8d2581-bbd7-4cb8-978c-3acb6cabea00" href="/media/134141/download?attachment" title="Importing Medical Devices Into the United States - Transcript">Transcript</a></p> <hr> <p><strong>General Policy</strong></p> <p>Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act During the COVID-19 Public Health Emergency<br> <a href="https://www.youtube.com/watch?v=mr07TboyypI">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="e6f0d817-81c1-4f10-8303-29227a61e07e" href="/media/137905/download?attachment" title="Webinar - Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act During the COVID-19 Public Health Emergency - Slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="bb0fe2bb-c118-4757-b851-ff4b824f14ab" href="/media/138241/download?attachment" title="Webinar - Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act During the COVID-19 Public Health Emergency - Transcript">Transcript</a></p> <p>Final Guidance: Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance and Enforcement Decisions<br> <a href="https://www.youtube.com/watch_popup?v=6qGuTXbWia8" target="_blank">Presentation</a>   <a href="/media/102923/download" target>Printable Slides</a>   <a href="/media/103183/download" target>Transcript</a></p> <p>Remanufacturing of Medical Devices, Final Guidance <em><strong>(Updated 9/17/24)</strong></em><br> <a href="https://youtu.be/cZx6AdUdlvs">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="c802adc0-02f0-4c4c-8180-1b3d23806d9c" href="/media/181629/download?attachment" title="Webinar – Final Guidance: Remanufacturing of Medical Devices - Slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="6ab8b4fd-97c8-4118-b433-5783bf25c67f" href="/media/181931/download?attachment" title="Transcript CDRH Webinar: Remanufacturing Final Guidance 09-10-2024">Transcript</a></p> <p>Computer Software Assurance for Production and Quality System Software, Draft Guidance<br> <a href="https://youtu.be/g6z0MuKHKeE">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="e6cd8657-d1d0-4b1a-b800-3380d230d855" href="/media/162627/download?attachment" title="Webinar - Draft Guidance on Computer Software Assurance for Production - Printable Slides">Printable Slides</a>   <a href="/media/163299/download">Transcript</a></p> <p>Voluntary Improvement Program<em><strong> (Updated 10/16/24)</strong></em><br> <a href="https://youtu.be/fn2l3SNp_BQ">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="5d1f51b7-14cb-4328-adee-28516d396b9d" href="/media/182529/download?attachment" title="The Voluntary Improvement Program: How to Enroll, Opportunities, and Best Practices - Slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="81e4a357-2f3a-4884-98d9-194b9323ba6c" href="/media/182729/download?attachment" title="Transcript for Webinar - The Voluntary Improvement Program: How to Enroll, Opportunities, and Best Practices">Transcript</a></p> <hr> <p><strong>Medical Device Recalls</strong></p> <p>Introduction to Medical Device Recalls<br> <a href="https://fda.mediasite.com/mediasite/Play/1d5699afd25c4667bd51121d63ec714c1d">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="744b8d1c-7509-44ae-ab40-09de0337bdab" href="/media/181440/download?attachment" title="Introduction to Medical Device Recalls - printable slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="1b7a9ff2-f2ba-40ee-91b1-f16a920b37f8" href="/media/181441/download?attachment" title="Introduction to Medical Device Recalls - Transcript">Transcript</a></p> <p>Distinguishing Medical Device Recalls from Medical Device Enhancements<br> <a href="https://www.youtube.com/watch_popup?v=ccgE5QD7Hcg" target="_blank">Presentation</a>   <a href="/media/89896/download" target>Printable Slides</a>   <a href="/media/90355/download" target>Transcript</a></p> <p>Recall Module 21 CFR Part 806: Medical Devices; Reports of Corrections and Removals<br> <a href="http://fda.yorkcast.com/webcast/Viewer/?peid=895f808c834f49bfbc230df241fe64501d" target="_blank">Presentation</a>   <a href="/media/80614/download">Printable Slides</a></p> <p>Electronic Submission of 806 Reports of Corrections and Removals<br> <a href="/media/105706/download" target>Printable Slides</a></p> <hr> <p><strong>Medical Device Reporting (MDR)</strong></p> <p>Overview of Medical Device Reporting<br> <a href="http://fda.yorkcast.com/webcast/Play/7885da0375b648bfb080f8c54d4c88561d">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="9a4b0337-3993-47ce-a28f-b943c7d77995" href="/media/130239/download?attachment" title="Overview of Medical Device Reporting - Slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="0662bea9-49ed-4ace-9cac-94a188d1cc1a" href="/media/130238/download?attachment" title="Overview of Medical Device Reporting - Transcript">Transcript</a></p> <p>Medical Device Reporting for Mandatory Reporters<br> <a href="http://fda.yorkcast.com/webcast/Play/de5daadc3c46467eb8a9b9f1ce9e156e1d">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="f040db7c-a025-43ab-8272-aa3ffc91bca1" href="/media/130241/download?attachment" title="Medical Device Reporting for Mandatory Reporters - Slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="66202978-dde6-4398-b816-f2ee9342f952" href="/media/130240/download?attachment" title="Medical Device Reporting for Mandatory Reporters - Transcript">Transcript</a></p> <p>Electronic Medical Device Reporting (eMDR)<br> <a href="http://fda.yorkcast.com/webcast/Play/409ff7c6e65b4ad1aaf69d73762caf2e1d" target="_blank">Presentation</a>   <a href="/media/89889/download" target>Printable Slides</a>   <a href="/training-and-continuing-education/cdrhlearn/electronic-medical-device-reporting-emdr-transcript" target>Transcript</a></p> <p>Final Guidance on Medical Device Reporting for Manufacturers <br> <a href="https://www.youtube.com/watch_popup?v=Eo6uJjYKA5s" target="_blank">Presentation</a>   <a href="/media/102070/download" target>Printable Slides</a>   <a href="/media/101618/download" target>Transcript</a></p> <p>eMDR eSubmitter and WebTrader Tutorial<br> <a href="https://youtu.be/EdKy5wl8F18">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="ebc08545-6d41-4ad3-8069-282da553cac1" href="/media/153790/download?attachment" title="eMDR eSubmitter and WebTrader Tutorial Transcript">Transcript</a></p> <hr> <p><strong>Inspections - Global Harmonization</strong></p> <p>(1A) Introduction to the MDSAP Program<br> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="405bb6e7-5987-44ce-9a5b-922fe8a02439" href="/media/146941/download?attachment" title="Introduction to the MDSAP Program - Slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="2fb693d9-ace3-4550-8c66-89e64a1b0a62" href="/media/146942/download?attachment" title="Introduction to the MDSAP Program - Transcript">Transcript</a></p> <p>(1B) Overview of the MDSAP Audit Process<br> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="2d796059-441f-4bc5-8695-9f6ec7fd42ff" href="/media/146944/download?attachment" title="Overview of the MDSAP Process - Slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="f069fb71-3751-43ba-a7d5-b8ec0e38f4e4" href="/media/146943/download?attachment" title="Overview of the MDSAP Process - Transcript">Transcript</a></p> <p>(2) MDSAP: Management Process<br> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="3a525dee-f148-4333-94dd-136117e4cdc4" href="/media/147226/download?attachment" title="MDSAP: Management Process - Slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="18fd3801-f413-44c5-a742-b6d1ef0093ca" href="/media/147227/download?attachment" title="MDSAP: Management Process - Transcript">Transcript</a></p> <p>(3) MDSAP: Device Marketing Authorization and Facility Registration<br> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="d9585489-373e-44df-8e93-203a1ace11c0" href="/media/147229/download?attachment" title="MDSAP: Device Marketing Authorization and Facility Registration - Slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="2ecab45c-6b97-4348-aa15-d5f71239596d" href="/media/147228/download?attachment" title="MDSAP: Device Marketing Authorization and Facility Registration - Transcript">Transcript</a></p> <p>(4) MDSAP: Measurement, Analysis and Improvement Process <br> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="e6ca6ece-7241-4cbf-9320-e247d3fd85ab" href="/media/147372/download?attachment" title="MDSAP: Measurement, Analysis and Improvement Process">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="85c6e769-6686-4ad8-b91b-8cc1cce1268b" href="/media/147373/download?attachment" title="MDSAP: Measurement, Analysis and Improvement Process - Transcript">Transcript</a></p> <p>(5) MDSAP: Medical Device Adverse Events and Advisory Notices Reporting Process<br> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="43888546-748b-49f1-9100-ec3dd1888c0f" href="/media/147374/download?attachment" title="MDSAP: Medical Device Adverse Events and Advisory Notices Reporting">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="aaa4cf05-db8c-4730-bdc2-b74ad9610124" href="/media/147375/download?attachment" title="MDSAP: Medical Device Adverse Events and Advisory Notices Reporting - Transcript">Transcript</a></p> <p>(6) MDSAP: Design and Development Process<br> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="236ebbee-b01b-4f37-a326-b44ee5671a85" href="/media/147443/download?attachment" title="MDSAP: Design and Development Process (Slides)">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="b5a4c0d3-e65f-45b6-ad1e-aebb125d2b82" href="/media/147442/download?attachment" title="MDSAP: Design and Development Process (Transcript)">Transcript</a></p> <p>(7) MDSAP: Production and Service Controls Process, Part 1<br> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="9fe2c741-9154-4a8f-b7dd-1ed845876344" href="/media/147452/download?attachment" title="MDSAP: Production and Service Controls Process, Part 1 - Slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="2135d4b5-d481-46b7-bcd6-19212c0ad9ce" href="/media/147453/download?attachment" title="MDSAP: Production and Service Controls Process, Part 1 - Transcript">Transcript</a></p> <p>(8) MDSAP: Production and Service Controls Process: Part 2<br> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="1307a2a7-70d1-4503-8d38-96d921e0dd4b" href="/media/147549/download?attachment" title="MDSAP: Production and Service Controls Process: Part 2">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="08cec3b2-2ba4-4c82-89e6-7744015e4dd2" href="/media/147550/download?attachment" title="MDSAP: Production and Service Controls Process: Part 2 - Transcript">Transcript</a></p> <p>(9) MDSAP: Production and Service Controls Process: Part 3<br> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="74daac75-7397-4415-8bea-8a468adca783" href="/media/147554/download?attachment" title="MDSAP: Production and Service Controls Process: Part 3 - Slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="60580ad7-442e-4176-adb0-e3d411114c2a" href="/media/147553/download?attachment" title="MDSAP: Production and Service Controls Process: Part 3 - Transcript">Transcript</a></p> <p>(10) MDSAP: Purchasing Process <br> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="a2d21cd8-fa30-4efd-9e14-5b853312eb89" href="/media/152336/download?attachment" title="MDSAP Purchasing Process Slides">Printable Slides</a> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="a8f9b5dc-58ea-4984-bbed-55e15a6a54f7" href="/media/152335/download?attachment" title="MDSAP Purchasing Process">Transcript</a></p> </div> </div> </div> <div class="panel panel-default"> <div class="panel-heading"> <h4 class="panel-title"><a class="toggle collapsed" data-parent="#accordion" data-toggle="collapse" href="#collapseIVD">In Vitro Diagnostics - <em>(Updated 10/29/24)</em></a></h4> <em>IVD Development, CLIA, and Virtual Town Hall Series</em></div> <div class="panel-collapse collapse" id="collapseIVD"> <div class="panel-body"> <p>3D Printed Swabs<br> <a href="https://www.youtube.com/watch?v=M20v7UF7c5E">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="ca01b320-52e9-4103-b8e3-7786f494f57b" href="/media/138309/download?attachment" title="Virtual Town Hall - 3D Printed Swabs - Slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="82e6b357-9c0b-4ce2-ba35-d99dc48e881b" href="/media/138310/download?attachment" title="Virtual Town Hall - 3D Printed Swabs - Transcript">Transcript</a></p> <p>Antimicrobial Susceptibility Test System Devices - Updating Breakpoints in Device Labeling<br> <a href="https://youtu.be/dnoKzEbNlK0">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="a65c5c1b-5183-4758-9244-b65750c44de3" href="/media/174440/download?attachment" title="Slides for Webinar - Immediately-in-effect guidance: Antimicrobial Susceptibility Test System Devices - Updating Breakpoints in Device Labeling">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="2788005d-7c7a-440a-996e-b9518ca5e9f8" href="/media/174917/download?attachment" title="Transcript - Webinar - Immediately-in-effect guidance: Antimicrobial Susceptibility Test System Devices - Updating Breakpoints in Device Labeling">Transcript</a></p> <p>CLIA Waiver Applications Draft Guidances<br> <a href="https://youtu.be/SuP_RmQUJhA">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="50511a7e-c7ff-4f96-a75e-5d2e2b2e7c5d" href="/media/119676/download?attachment" title="CLIA Waiver Applications Draft Guidances - Slides ">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="0973201d-abd7-46c5-9346-3596b255f29b" href="/media/119747/download?attachment" title="CLIA Webinar Transcript January 9 2019 ">Transcript</a></p> <p>Clinical Laboratory Improvement Amendments (CLIA)<br> <a href="https://www.accessdata.fda.gov/cdrh_docs/presentations/video/clia.mp3" target="_blank">Presentation</a>   <a href="/media/87817/download">Printable Slides</a>   <a href="/media/87955/download">Transcript</a></p> <p>Clinical Laboratory Improvement Amendments (CLIA) Waiver Applications Final Guidances<br> <a href="https://youtu.be/YAsLgjzrz-k ">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="a0626254-cd1b-45d2-ac0c-997f07df54ee" href="/media/136948/download?attachment" title="Webinar - Clinical Laboratory Improvement Amendments (CLIA) Waiver Applications Final Guidances - Slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="811b897e-627f-45e3-9537-86b5f51bad0b" href="/media/137166/download?attachment" title="CLIA Transcripts">Transcript</a></p> <p>Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices<br> <a href="https://www.youtube.com/watch_popup?v=Yir2AkTvr6s">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="d3425fc1-a658-4d92-98b4-669747f19cbb" href="/media/120319/download?attachment" title="Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices - Slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="19657f5f-0537-4c5f-b185-1dce832df89d" href="/media/120360/download?attachment" title="Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices - Transcript">Transcript</a></p> <p>Electromagnetic Compatibility (EMC) of In Vitro Diagnostic Devices<br> <a href="https://youtu.be/Zm6UzrtYeXw">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="048d179f-ca50-49b4-917b-c6dba63b5001" href="/media/165025/download?attachment" title="Webinar Slides - Electromagnetic Compatibility (EMC) of In Vitro Diagnostic Devices">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="2d629534-88d9-4662-a0eb-976d066b507c" href="/media/165423/download?attachment" title="Webinar Transcript - Electromagnetic Compatibility (EMC) of In Vitro Diagnostic Devices">Transcript</a></p> <p>Enforcement Policies for Certain In Vitro Diagnostic Devices - Draft Guidances <em><strong>(Updated 6/11/2024)</strong></em><br> <a href="https://youtu.be/PdICiG1Zeqg">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="d7bb8ad7-b1db-4121-bdfd-44a93c223792" href="/media/179149/download?attachment" title="Slides for Webinar - Enforcement Policies for Certain In Vitro Diagnostic Devices - Draft Guidances">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="1abb4cd0-1781-4543-9b94-0624131a7e2c" href="/media/179286/download?attachment" title="Enforcement Policies for Certain In Vitro Diagnostic Devices - Draft Guidances - Transcript">Transcript</a></p> <p>Final Guidances on Next Generation Sequencing-based Tests<br> <a href="https://www.youtube.com/watch_popup?v=_X3bHrBNmk4" target="_blank">Presentation</a>   <a href="https://web.archive.org/web/20180725103022/https://www.fda.gov/downloads/Training/CDRHLearn/UCM608434.pdf" target>Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="58f3e5e0-d0d9-4ae3-9b01-d93838d197b6" href="/media/113511/download?attachment" target title="Final Guidances on Next Generation Sequencing-based Tests - Transcript">Transcript</a></p> <p>In Vitro Diagnostic Product (IVD): Classification <em><strong>(Updated 8/18/2024)</strong></em><br> <a href="https://youtu.be/-Qhb96v5toA">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="d74b47ba-a669-40f2-a9c4-c721a62eeb1a" href="/media/180085/download?attachment" title="In Vitro Diagnostic Product (IVD): Classification - slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="f89dee15-9689-4117-9b77-838ebdfe74e0" href="/media/180195/download?attachment" title="In Vitro Diagnostic Product (IVD): Classification - transcript">Transcript</a></p> <p>In Vitro Diagnostic Products (IVDs) - MDR Requirements, Correction and Removal Reporting Requirements, and Quality System Complaint Requirements<em><strong> (Updated 8/27/2024)</strong></em><br> <a href="https://youtu.be/PNG87J0Hh9o">Presentation</a>  <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="a4099b65-a7f2-41e0-910d-0f3c866da84e" href="/media/181138/download?attachment" title="In Vitro Diagnostic Products (IVDs) - MDR Requirements, Correction and Removal Reporting Requirements, and Quality System Complaint Requirements - August 22, 2024 - slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="4024a9dd-6e9b-4006-a346-c410f7f0e4fb" href="/media/181314/download?attachment" title="Transcript: In Vitro Diagnostic Products (IVDs) - MDR Requirements, Correction and Removal Reporting Requirements, and Quality System Complaint Requirements, August 22, 2024">Transcript</a></p> <p>Labeling Requirements for In Vitro Diagnostic Products (IVD), Including LDTs, Under 21 CFR 809.10(b) <em><strong>(Updated 9/27/2024)</strong></em><br> <a href="https://youtu.be/pQuMn5gLfSw">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="3ee61290-f348-478e-a1cf-63d022c573a3" href="/media/182155/download?attachment" title="Slides for Webinar - Labeling Requirements for In Vitro Diagnostic Products (IVD), Including LDTs, Under 21 CFR 809.10(b)">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="fe93f939-df7a-49fc-b6e4-1816f676ce74" href="/media/182283/download?attachment" title="Transcript: CDRH Webinar IVD LDT Labeling 9-24-2024">Transcript</a></p> <p>Laboratory Developed Tests; Medical Devices: Final Rule <strong><em>(Updated 5/20/24)</em></strong><br> <a href="https://youtu.be/d3N9VuSqirY">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="0a7da654-a4e5-4ad4-ab1d-03a6b4249eb2" href="/media/178581/download?attachment" title="Slides - Final Rule: Medical Devices; Laboratory Developed Tests">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="a9eca833-d7a5-46a9-9063-58283b8e2d02" href="/media/178736/download?attachment" title="Webinar - Final Rule: Medical Devices; Laboratory Developed Tests - Transcript">Transcript</a></p> <p>Laboratory Developed Tests; Medical Devices: Proposed Rule<br> <a href="https://youtu.be/WG_YKHTzTjw">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="7c827d78-faf5-4f11-bdaa-2aeeb8240bef" href="/media/173457/download?attachment" title="Proposed Rule: Medical Devices; Laboratory Developed Tests Webinar - Slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="4f0a64d5-9b24-4033-86c4-54cef9f8765c" href="/media/173623/download?attachment" title="Webinar Transcript - Proposed Rule: Medical Devices; Laboratory Developed Tests">Transcript</a></p> <p>Oncology Drug Products Used with Certain In Vitro Diagnostic Tests: Pilot Program<br> <a href="https://www.youtube.com/watch?v=z9uHjAE9lWI">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="0a95e987-7bf1-413e-b2c8-48957b272bdd" href="/media/174678/download?attachment" title="CDRH Webinar - Oncology Drug Products Used with Certain In Vitro Diagnostic Tests: Pilot Program - Prinatable Slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="63d11a92-7ee5-4740-bc43-96844cc06b8b" href="/media/174948/download?attachment" title="Webinar Transcript - Oncology Drug Products Used with Certain In Vitro Diagnostic Tests: Pilot Program">Transcript</a></p> <p>Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product<br> <a href="http://www.accessdata.fda.gov/cdrh_docs/presentations/video/codevelopmentwebinar.wmv" target="_blank">Presentation</a>   <a href="/media/99790/download" target>Printable Slides</a>   <a href="/media/99690/download" target>Transcript</a></p> <p>Total Product Life Cycle Approach to In Vitro Diagnostic Products (IVDs) <strong>(<em>Updated 10/29/2024</em>)</strong><br> <a href="https://youtu.be/JiddyVgdoFM">Presentation</a>  <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="ddc6c92b-1c03-4444-aed2-db4786f3be2e" href="/media/183011/download?attachment" title="Printable Slides CDRH Webinar IVD TPLC 10-24-2024">Printable Slides</a>    <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="0acfd40b-6f32-4c0a-ad74-cac3824a555d" href="/media/183184/download?attachment" title="Transcript - FDA’s Total Product Life Cycle Approach to In Vitro Diagnostic Products (IVDs) - October 24, 2024">Transcript</a></p> <p>Virtual Town Hall Series</p> <div class="lcds-datatable lcds-datatable--ckeditor"> <table aria-readonly="true" class="table" data-column-defs="[{ "targets": 2, "type": "date" }]" data-order="[ 2, "desc" ]" data-page-length="10" data-paging="true" data-searching="false" role="grid" summary="Previous Town Hall Materials"> <thead> <tr role="row"> <th scope="col">Series<br> Number</th> <th scope="col">Topic</th> <th scope="col">Date</th> <th scope="col">Materials</th> </tr> </thead> <tbody> <tr role="row"> <td><b>0</b></td> <td> </td> <td>03/02/2020</td> <td><a href="https://www.youtube.com/watch?v=qPqaI-jg-14">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="be9adf98-242a-4ae9-a1b0-db27f4d1490e" href="/media/135916/download?attachment" title="COVID-19 Lab Tests Webinar - Transcript">Transcript</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="96c23e18-fcae-4c2b-97d1-303148568e04" href="/media/135707/download?attachment" title="COVID-19 Lab Tests Webinar - Slides">Slides</a></td> </tr> <tr role="row"> <td><b>00</b></td> <td> </td> <td>03/06/2020</td> <td><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="c2685a89-4143-4e4f-8b33-58823138a978" href="/media/136703/download?attachment" title="Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing - Transcript">Transcript</a></td> </tr> <tr role="row"> <td><strong>01</strong></td> <td> </td> <td>03/25/2020</td> <td><a href="https://www.youtube.com/watch?v=D38ZteEsiOI">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="ac27d03b-d10e-422e-91b0-acea2273871a" href="/media/136518/download?attachment" title="Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - March 25, 2020 - Transcript">Transcript</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="e5c487e1-ba75-432d-a384-b0b1bbdfd718" href="/media/136439/download?attachment" title="Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - March 25, 2020 - Slides">Slides</a></td> </tr> <tr role="row"> <td><strong>02</strong></td> <td> </td> <td>04/01/2020</td> <td><a href="https://www.youtube.com/watch?v=C5R8CJMo878">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="b36cd1ee-4a2f-4ab6-9d83-4c656dd3ba8c" href="/media/136681/download?attachment" title="Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - April 1, 2020 - Transcript">Transcript</a></td> </tr> <tr role="row"> <td><strong>03</strong></td> <td> </td> <td>04/08/2020</td> <td><a href="https://www.youtube.com/watch?v=qpmRhUgrfTA">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="dbd9eb4a-cc46-4b00-a261-8448d005ee9b" href="/media/136833/download?attachment" title="Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - April 8, 2020 - Transcript">Transcript</a></td> </tr> <tr role="row"> <td><strong>04</strong></td> <td> </td> <td>04/15/2020</td> <td><a href="https://www.youtube.com/watch?v=yQMxmUhvwjA">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="d843412b-371d-4c05-a3b9-81731d1d7071" href="/media/137136/download?attachment" title="Virtual Town Hall - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - April 15, 2020 - Transcript">Transcript</a></td> </tr> <tr role="row"> <td><strong>05</strong></td> <td> </td> <td>04/22/2020</td> <td><a href="https://www.youtube.com/watch?v=bo40H5RSmGg">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="d54a13c6-6989-4602-b21c-b9f0cba0672f" href="/media/137426/download?attachment" title="FDA Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - April 22, 2020 - Transcript">Transcript</a></td> </tr> <tr role="row"> <td><strong>06</strong></td> <td> </td> <td>04/29/2020</td> <td><a href="https://www.youtube.com/watch?v=VwEudYZrmuA">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="cda200c0-09eb-4dd1-862d-5f8b7a630e94" href="/media/137764/download?attachment" title="April 29, 2020 - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - Transcript">Transcript</a></td> </tr> <tr role="row"> <td><strong>07</strong></td> <td> </td> <td>05/06/2020</td> <td><a href="https://www.youtube.com/watch?v=4J2HEZvqjT4">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="06f1c3db-c9ad-42cd-be64-e26ceb49f405" href="/media/137986/download?attachment" title="May 6, 2020 - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - Transcript">Transcript</a></td> </tr> <tr role="row"> <td><strong>08</strong></td> <td> </td> <td>05/13/2020</td> <td><a href="https://www.youtube.com/watch?v=UTy2_QxxqSA">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="ba8baccc-e0d3-4944-a8ef-4bb333640c02" href="/media/138240/download?attachment" title="May 13, 2020 - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - Transcript">Transcript</a></td> </tr> <tr role="row"> <td><strong>09</strong></td> <td> </td> <td>05/20/2020</td> <td><a href="https://www.youtube.com/watch?v=FnlXijt3WK4">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="43cfd34a-4ade-4ec7-a7ce-574314059084" href="/media/138382/download?attachment" title="May 20, 2020 - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - Transcript">Transcript</a></td> </tr> <tr role="row"> <td><strong>10</strong></td> <td> </td> <td>05/27/2020</td> <td><a href="https://www.youtube.com/watch?v=8KJcbGBPNns">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="b9ebb480-1e26-461b-a8f1-21e7e5e6bd42" href="/media/138555/download?attachment" title="May 27, 2020 - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - Transcript">Transcript</a></td> </tr> <tr role="row"> <td><strong>11</strong></td> <td> </td> <td>06/03/2020</td> <td><a href="https://youtu.be/zTu0ayDklOQ">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="661ef7a5-cc2a-42cf-9209-528928f39a6c" href="/media/138802/download?attachment" title="Transcript of Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - June 3, 2020">Transcript</a></td> </tr> <tr role="row"> <td><strong>12</strong></td> <td> </td> <td>06/10/2020</td> <td><a href="https://www.youtube.com/watch?v=olMCL9P27BE">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="bc0fe6e1-3e3c-4bc7-ac47-15defc84d03e" href="/media/139488/download?attachment" title="Virtual Town Hall 12 - Transcript">Transcript</a></td> </tr> <tr role="row"> <td><strong>13</strong></td> <td> </td> <td>06/17/2020</td> <td><a href="https://www.youtube.com/watch?v=aT5C5Hm7CoI">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="af62cf16-645d-4b18-ba5b-f813e321ea7d" href="/media/139489/download?attachment" title="Virtual Town Hall 13 - Transcript">Transcript</a></td> </tr> <tr role="row"> <td><strong>14</strong></td> <td> </td> <td>06/24/2020</td> <td><a href="https://www.youtube.com/watch?v=LL1IAEz1Wls">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="e0adee37-c727-440e-b7a2-8c07c1571397" href="/media/139618/download?attachment" title="June 24, 2020 - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - Transcript">Transcript</a></td> </tr> <tr role="row"> <td><strong>15</strong></td> <td> </td> <td>07/01/2020</td> <td><a href="https://youtu.be/k1v3eBHSDO8">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="2d146ef5-6a98-4620-a87a-fe145fc1ffcd" href="/media/139775/download?attachment" title="Transcript - FDA Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - July 1, 2020">Transcript</a></td> </tr> <tr role="row"> <td><strong>16</strong></td> <td> </td> <td>07/08/2020</td> <td><a href="https://www.youtube.com/watch?v=BqsgtxKv2OU">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="807bf974-e17f-4fcc-a1ec-a4e43722b1fe" href="/media/140218/download?attachment" title="July 8, 2020 - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - Transcript">Transcript</a></td> </tr> <tr role="row"> <td><strong>17</strong></td> <td> </td> <td>07/15/2020</td> <td><a href="https://youtu.be/kUH1u1SCxIY">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="d94045e7-d25f-46f2-b3a8-4242bd41a63c" href="/media/140326/download?attachment" title="July 15, 2020 - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - Transcript">Transcript</a></td> </tr> <tr role="row"> <td><strong>18</strong></td> <td> </td> <td>07/22/2020</td> <td><a href="https://youtu.be/Inj5GgQHI6c">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="ce36d77b-320d-4987-acfa-8070863a1bfa" href="/media/140462/download?attachment" title="July 22, 2020 - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - Transcript">Transcript</a></td> </tr> <tr role="row"> <td><strong>19</strong></td> <td> </td> <td>07/29/2020</td> <td><a href="https://www.youtube.com/watch?v=j1rZ4neSeNE">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="a29d8492-88c4-487b-8f60-f4c1d6dac4ce" href="/media/140847/download?attachment" title="July 29, 2020 - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - Transcript">Transcript</a></td> </tr> <tr role="row"> <td><strong>20</strong></td> <td> </td> <td>08/05/2020</td> <td><a href="https://www.youtube.com/watch?v=0aR05y2HRoI">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="33ac8cb3-06a6-412b-b88c-c2c109fc3c19" href="/media/140975/download?attachment" title="Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - August 5, 2020 - Transcript">Transcript</a></td> </tr> <tr role="row"> <td><strong>21</strong></td> <td> </td> <td>08/12/2020</td> <td><a href="https://youtu.be/Nb5ECJq7yu4">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="859dcd2d-9b1d-43b9-8f44-5ee99209a248" href="/media/141317/download?attachment" title="August 12, 2020 - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - Transcript">Transcript</a></td> </tr> <tr role="row"> <td><strong>22</strong></td> <td> </td> <td>08/19/2020</td> <td><a href="https://www.youtube.com/watch?v=x957vZbGEmg">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="f905c3cd-a546-4743-b7e5-ecf9b1508fd7" href="/media/141606/download?attachment" title="August 19, 2020 - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests">Transcript</a></td> </tr> <tr role="row"> <td><strong>23</strong></td> <td> </td> <td>08/26/2020</td> <td><a href="https://www.youtube.com/watch?v=_95PepFJz1c">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="d2a66af6-0f47-4c0e-8187-52d9d1b42fda" href="/media/141817/download?attachment" title="August 26, 2020 - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - transcript">Transcript</a></td> </tr> <tr role="row"> <td><strong>24</strong></td> <td> </td> <td>09/02/2020</td> <td><a href="https://youtu.be/1Nycu3Xm15M">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="8f7b2fb7-5075-41cb-ba1c-88a840029f7b" href="/media/141952/download?attachment" title="September 2, 2020 - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests">Transcript</a></td> </tr> <tr role="row"> <td><strong>25</strong></td> <td> </td> <td>09/09/2020</td> <td><a href="https://www.youtube.com/watch?v=wR5TPPb00SQ">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="ecd719e5-c484-4fd9-94aa-68a821c69d71" href="/media/142352/download?attachment" title="September 9, 2020 - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests">Transcript</a></td> </tr> <tr role="row"> <td><strong>26</strong></td> <td> </td> <td>09/16/2020</td> <td><a href="https://youtu.be/PfakNcEmaXs">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="e858445d-0eff-4130-a139-681953ac4229" href="/media/142312/download?attachment" title="September 16, 2020 - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests">Transcript</a></td> </tr> <tr role="row"> <td><strong>27</strong></td> <td> </td> <td>09/23/2020</td> <td><a href="https://youtu.be/gpU26VT95KA">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="38c9a8fb-8593-45bf-b585-fa20b53e254a" href="/media/142511/download?attachment" title="September 23, 2020 - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests Town Hall Transcript">Transcript</a></td> </tr> <tr role="row"> <td><strong>28</strong></td> <td> </td> <td>09/30/2020</td> <td><a href="https://www.youtube.com/watch?v=Va4Mvy2kU5Q">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="d702e9db-cec8-4361-817a-0288bfbbd307" href="/media/142810/download?attachment" title="September 30, 2020 - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - Transcript">Transcript</a></td> </tr> <tr role="row"> <td><strong>29</strong></td> <td> </td> <td>10/07/2020</td> <td><a href="https://www.youtube.com/watch?v=E4Stcl0yivQ">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="988d841b-2485-40f5-acbc-5d28b9578f2e" href="/media/143084/download?attachment" title="Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - October 7, 2020 - Transcript">Transcript</a></td> </tr> <tr role="row"> <td><strong>30</strong></td> <td> </td> <td>10/14/2020</td> <td><a href="https://www.youtube.com/watch?v=dKrhkQrUx7U">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="fc7a8cbd-041b-4da3-8b5c-552b7dda800b" href="/media/143085/download?attachment" title="Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - October 14, 2020 - Transcript">Transcript</a></td> </tr> <tr role="row"> <td><strong>31</strong></td> <td> </td> <td>10/21/2020</td> <td><a href="https://www.youtube.com/watch?v=zAAWmiaSf10">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="b6cb54cd-b56a-468c-a0bc-32c23a438f4a" href="/media/143327/download?attachment" title="Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - October 21, 2020">Transcript</a></td> </tr> <tr role="row"> <td><strong>32</strong></td> <td> </td> <td>10/28/2020</td> <td><a href="https://www.youtube.com/watch?v=w6m16qnTuVI">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="0021c4c0-05f2-44c8-bbeb-966f5368822e" href="/media/143596/download?attachment" title="Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - October 28, 2020 - Transcript">Transcript</a></td> </tr> <tr role="row"> <td><strong>33</strong></td> <td> </td> <td>11/04/2020</td> <td><a href="https://www.youtube.com/watch?v=BshSehtRZ9g">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="3b57d08d-b9be-4534-9cb7-c24b085e02c8" href="/media/143958/download?attachment" title="Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - November 4, 2020 - Transcript">Transcript</a></td> </tr> <tr role="row"> <td><strong>34</strong></td> <td> </td> <td>11/18/2020</td> <td><a href="https://www.youtube.com/watch?v=kk-tOG1M18c">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="b0748e30-1fce-40d0-a556-0627506195be" href="/media/143957/download?attachment" title="Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - November 18, 2020 - Transcript">Transcript</a></td> </tr> <tr role="row"> <td><strong>35</strong></td> <td> </td> <td>12/02/2020</td> <td><a href="https://www.youtube.com/watch?v=ZUJn4q1CEHo">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="178290e0-7b24-4068-a2e6-b0ad13f660c2" href="/media/147778/download?attachment" title="Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - December 2, 2020">Transcript</a></td> </tr> <tr role="row"> <td><strong>36</strong></td> <td> </td> <td>12/09/2020</td> <td><a href="https://www.youtube.com/watch?v=VNrwrH0N0dY">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="a625aeed-be01-4828-87b1-d3389433ebf4" href="/media/144566/download?attachment" title="Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - December 9, 2020 - Transcript">Transcript</a></td> </tr> <tr role="row"> <td><strong>37</strong></td> <td> </td> <td>12/16/2020</td> <td><a href="https://www.youtube.com/watch?v=KJZRyFhDyY8">Presentation</a>   <a href="/media/144735/download">Transcript </a></td> </tr> <tr role="row"> <td><strong>38</strong></td> <td> </td> <td>01/06/2021</td> <td><a href="https://www.youtube.com/watch?v=dS5IkneoAgU">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="5efc3abd-4edd-4d46-9a6f-853caf772f56" href="/media/145096/download?attachment" title="Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - January 6, 2021 - Transcript">Transcript </a></td> </tr> <tr role="row"> <td><strong>39</strong></td> <td> </td> <td>01/13/2021</td> <td><a href="https://www.youtube.com/watch?v=52aSLUaK9jI">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="de16d038-39be-4c92-acf6-9a041f6e9bb4" href="/media/145290/download?attachment" title="Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - January 13, 2021 - transcript">Transcript </a></td> </tr> <tr role="row"> <td><strong>40</strong></td> <td> </td> <td>01/27/2021</td> <td><a href="https://www.youtube.com/watch?v=xpubAY5rT_g">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="35c7b903-0087-4446-b885-246d7a076965" href="/media/145571/download?attachment" title="Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - January 27, 2021 - Transcript">Transcript </a></td> </tr> <tr role="row"> <td><strong>41</strong></td> <td> </td> <td>02/03/2021</td> <td><a href="https://www.youtube.com/watch?v=SkNByAteggE">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="91a594d0-005c-46a2-ae1c-770a704a8dab" href="/media/145756/download?attachment" title="Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - February 3, 2021 - Transcript">Transcript </a></td> </tr> <tr role="row"> <td><strong>42</strong></td> <td> </td> <td>02/10/2021</td> <td><a href="https://www.youtube.com/watch?v=qd29CjG9cWQ">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="eee05ba0-f7df-4baa-ad71-e93a171730d1" href="/media/146012/download?attachment" title="Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - February 10, 2021 - Transcript">Transcript</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="f430168e-7910-48d6-a5eb-78fb89e6aae5" href="/media/145829/download?attachment" title="Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - February 10, 2021 - Slides">Slides</a></td> </tr> <tr role="row"> <td><strong>43</strong></td> <td> </td> <td>02/17/2021</td> <td><a href="https://www.youtube.com/watch?v=LOrfZ9BjiVI">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="da8952cb-bc57-4783-8b79-1471be078287" href="/media/146226/download?attachment" title="Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - February 17, 2021 - Transcript">Transcript</a></td> </tr> <tr role="row"> <td><strong>44</strong></td> <td> </td> <td>02/24/2021</td> <td><a href="https://www.youtube.com/watch?v=owdGSBGw7hw">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="ed3f423e-ffb2-4d90-b935-4e3eee165fc1" href="/media/146427/download?attachment" title="Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - February 24, 2021 - Transcript">Transcript</a></td> </tr> <tr role="row"> <td><strong>45</strong></td> <td> </td> <td>03/03/2021</td> <td><a href="https://youtu.be/RlTrIOGV-3Q">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="ad40e518-429b-4818-b0ef-3fd3bca0bc0c" href="/media/146615/download?attachment" title="Transcript for Virtual Town Hall Series #45 - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - March 3, 2021">Transcript</a></td> </tr> <tr role="row"> <td><strong>46</strong></td> <td> </td> <td>03/10/2021</td> <td><a href="https://www.youtube.com/watch?v=os69KDMI4RY">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="450b2c6d-2fe9-48fa-bd8f-aace8b41fc3a" href="/media/146811/download?attachment" title="Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - March 10, 2021 - Transcript">Transcript</a></td> </tr> <tr role="row"> <td><strong>47</strong></td> <td> </td> <td>03/17/2021</td> <td><a href="https://www.youtube.com/watch?v=4I-KHMcaeug">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="3a139986-945a-444d-985d-0aa08e7c1e71" href="/media/146819/download?attachment" title="Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - March 17, 2021 - Transcript">Transcript</a></td> </tr> <tr role="row"> <td><strong>48</strong></td> <td> </td> <td>03/24/2021</td> <td><a href="https://www.youtube.com/watch?v=6crM00c06jg">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="3467c175-75f9-486e-b345-a61741efa76f" href="/media/147211/download?attachment" title="Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - March 24, 2021 - transcript">Transcript</a></td> </tr> <tr role="row"> <td><strong>49</strong></td> <td> </td> <td>03/31/2021</td> <td><a href="https://www.youtube.com/watch?v=ONvIVEmXj0k">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="8d6c2090-d2cc-41a9-8383-6ef4208acb0c" href="/media/147394/download?attachment" title="Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - March 31, 2021 - Transcript">Transcript</a></td> </tr> <tr role="row"> <td><strong>50</strong></td> <td> </td> <td>04/07/2021</td> <td><a href="https://www.youtube.com/watch?v=OcVci-fTFrQ">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="2e4e370c-0132-4db4-87fa-177f587d515c" href="/media/147489/download?attachment" title="Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - April 7, 2021 - Transcript">Transcript</a></td> </tr> <tr role="row"> <td><strong>51</strong></td> <td> </td> <td>04/14/2021</td> <td><a href="https://www.youtube.com/watch?v=NM8edzTUIKE">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="a3a7a3ca-24aa-4a5c-a6ee-cfeb0f519bdd" href="/media/147771/download?attachment" title="Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - April 14, 2021 - Transcript">Transcript</a></td> </tr> <tr role="row"> <td><strong>52</strong></td> <td> </td> <td>04/21/2021</td> <td><a href="https://www.youtube.com/watch?v=B7-kUBycPAM">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="9800033f-708e-4821-a9ac-75208bbbbbe0" href="/media/147952/download?attachment" title="Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - April 21, 2021 - Transcript">Transcript</a></td> </tr> <tr role="row"> <td><strong>53</strong></td> <td> </td> <td>04/28/2021</td> <td><a href="https://www.youtube.com/watch?v=txFUTJy6wA8">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="2a0b6f87-872e-4231-a25f-d07d8b4d8a78" href="/media/148253/download?attachment" title="Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - April 28, 2021 - Transcript">Transcript</a></td> </tr> <tr role="row"> <td><strong>54</strong></td> <td> </td> <td>05/05/2021</td> <td><a href="https://www.youtube.com/watch?v=wDFoF8T80cU">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="d6296d13-08af-467e-b748-100b79326e55" href="/media/148505/download?attachment" title="Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - May 5, 2021 - Transcript">Transcript</a></td> </tr> <tr role="row"> <td><strong>55</strong></td> <td> </td> <td>05/12/2021</td> <td><a href="https://www.youtube.com/watch?v=toEiWI_d-m8">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="ade2837a-d36e-4780-b9b2-e00a83e0d76c" href="/media/148740/download?attachment" title="Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - May 12, 2021 - Transcript ">Transcript</a></td> </tr> <tr role="row"> <td><strong>56</strong></td> <td> </td> <td>05/19/2021</td> <td><a href="https://youtu.be/H8YuL2_OjzE">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="f8c3c8ff-cff0-4c42-be49-695417db291d" href="/media/149074/download?attachment" title="FDA Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - May 19, 2021 - Transcript">Transcript</a></td> </tr> <tr role="row"> <td><strong>57</strong></td> <td> </td> <td>05/26/2021</td> <td><a href="https://www.youtube.com/watch?v=VTWoHUB1_R8">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="24e382c3-5759-495e-8865-b609e37a4ecd" href="/media/149660/download?attachment" title="Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - May 26, 2021 - Transcript">Transcript</a></td> </tr> <tr role="row"> <td><strong>58</strong></td> <td> </td> <td>06/02/2021</td> <td><a href="https://www.youtube.com/watch?v=sjlWdzvzCAk">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="321d27ad-7b48-42a0-9c0a-e31cb7a3d2a1" href="/media/149980/download?attachment" title="Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - June 2, 2021 - Transcript">Transcript</a></td> </tr> <tr role="row"> <td><strong>59</strong></td> <td> </td> <td>06/09/2021</td> <td><a href="https://www.youtube.com/watch?v=RIXvWGrvphM">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="1c260a73-ad6c-4a06-bfbb-bad8612ad8e7" href="/media/150145/download?attachment" title="Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - June 9, 2021 - Transcript">Transcript</a></td> </tr> <tr role="row"> <td><strong>60</strong></td> <td> </td> <td>06/16/2021</td> <td><a href="https://youtu.be/59Ni_qSGAtc">Presentation</a>   <a href="/media/150355/download">Transcript</a></td> </tr> <tr role="row"> <td><strong>61</strong></td> <td> </td> <td>06/23/2021</td> <td><a href="https://youtu.be/abHlnbQVODk">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="ad56af5c-cfb2-4cb3-9f01-97bf9a15248e" href="/media/150378/download?attachment" title="Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - June 23, 2021 - Transcript">Transcript</a></td> </tr> <tr role="row"> <td><strong>62</strong></td> <td> </td> <td>06/30/2021</td> <td><a href="https://www.youtube.com/watch?v=75p98DjMicg">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="04da8865-5b8a-4cc0-900a-da2a9e9cef6b" href="/media/150621/download?attachment" title="Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - June 30, 2021 - Transcript">Transcript</a></td> </tr> <tr role="row"> <td><strong>63</strong></td> <td> </td> <td>07/14/2021</td> <td><a href="https://www.youtube.com/watch?v=I51a6gqPhUk">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="1ce9669f-4acf-4c3e-8b4c-fcd33f7c8251" href="/media/151119/download?attachment" title="Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - July 14, 2021 - Transcript">Transcript</a></td> </tr> <tr role="row"> <td><strong>64</strong></td> <td> </td> <td>07/28/2021</td> <td><a href="https://www.youtube.com/watch?v=7SPxK1XILIg">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="60e13153-6706-4d8b-9792-61ff84d1051d" href="/media/151330/download?attachment" title="Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - July 28, 2021 - Transcript">Transcript</a></td> </tr> <tr role="row"> <td><strong>65</strong></td> <td> </td> <td>08/04/2021</td> <td><a href="https://youtu.be/poscLohPQNs">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="c7a39616-4c60-41c0-8056-a189863d153e" href="/media/151937/download?attachment" title="Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - August 4, 2021 - Transcript">Transcript</a></td> </tr> <tr role="row"> <td><strong>66</strong></td> <td> </td> <td>08/11/2021</td> <td><a href="https://youtu.be/Y1hj6AdPaHk">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="edc8c036-bc1b-4bcb-945b-e90caeb369dd" href="/media/151938/download?attachment" title="Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - August 11, 2021 - Transcript">Transcript</a></td> </tr> <tr role="row"> <td><strong>67</strong></td> <td> </td> <td>08/18/2021</td> <td><a href="https://youtu.be/sPuLvzIyUkk">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="589af8b9-c2a9-4fbd-a12c-df0e84af464f" href="/media/152560/download?attachment" title="COVID IVD Virtual Town Hall 67 8-18-21 Transcript">Transcript</a></td> </tr> <tr role="row"> <td><strong>68</strong></td> <td> </td> <td>08/25/2021</td> <td><a href="https://youtu.be/C5a3GkRTztA">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="de7e72d6-9de4-4b56-b3c8-9a49ec567c22" href="/media/152561/download?attachment" title="COVID IVD Virtual Town Hall 68 8-25-21 Transcript">Transcript</a></td> </tr> <tr role="row"> <td><strong>69</strong></td> <td> </td> <td>09/08/2021</td> <td><a href="https://youtu.be/XwF2qXapzBc">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="76ca743e-3410-43ff-a7bd-d3804935f18a" href="/media/152755/download?attachment" title="Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - September 8, 2021 - Transcript">Transcript</a></td> </tr> <tr role="row"> <td><strong>70</strong></td> <td> </td> <td>09/22/2021</td> <td><a href="https://youtu.be/C2bwFnORLFI">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="da4b072b-1439-4cb0-bbc6-00b91ded0c5d" href="/media/152888/download?attachment" title="Virtual IVD Town Hall 70 - September 22, 2021">Transcript</a></td> </tr> <tr role="row"> <td><strong>71</strong></td> <td> </td> <td>10/06/2021</td> <td><a href="https://www.youtube.com/watch?v=f7Xrxgrkh4U">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="c63aba04-9941-40b9-bb91-b1199be2f0fb" href="/media/153122/download?attachment" title="Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - October 6, 2021 - Transcript">Transcript</a></td> </tr> <tr role="row"> <td><strong>72</strong></td> <td> </td> <td>10/20/2021</td> <td><a href="https://www.youtube.com/watch?v=TieDF76P7yY">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="c2c0772e-cc0d-41a8-8145-446142cafa4e" href="/media/153914/download?attachment" title="Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - October 20, 2021">Transcript</a></td> </tr> <tr> <td><strong>73</strong></td> <td> </td> <td>11/17/2021</td> <td><a href="https://youtu.be/lUMMzaD8XCY">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="51f8c835-f4aa-4232-9605-8b838342a7ee" href="/media/154706/download?attachment" title="Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - November 17, 2021 - Transcript">Transcript</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="ade19c92-e672-47cf-bea3-ffa658a5c5e6" href="/media/155292/download?attachment" title="Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - November 17, 2021 - Slides">Slides</a></td> </tr> <tr> <td><strong>74</strong></td> <td> </td> <td>12/01/2021</td> <td><a href="https://youtu.be/A8dPnkA_QKk">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="4eb5377f-2fa2-4123-b7a1-9dbecfc3bf90" href="/media/155063/download?attachment" title="Coronavirus (COVID-19) Test Development and Validation Virtual Town Hall Series (December 1, 2021) Number 74 - Transcript">Transcript</a></td> </tr> <tr> <td><strong>75</strong></td> <td> </td> <td>12/15/2021</td> <td><a href="https://youtu.be/Bng-X7wRXQE">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="b9396467-f0e4-4885-b654-4e07dc086c99" href="/media/155156/download?attachment" title=" Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - December 15, 2021 - Transcript">Transcript</a></td> </tr> <tr> <td><strong>76</strong></td> <td>COVID-19</td> <td>01/12/2022</td> <td><a href="https://youtu.be/otDWtDNNHzY">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="1de31454-3900-4a5a-8ef0-e82abb35b04f" href="/media/155886/download?attachment" title="Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - January 12, 2022 - Transcript">Transcript</a></td> </tr> <tr> <td><strong>77</strong></td> <td>COVID-19</td> <td>01/26/2022</td> <td><a href="https://youtu.be/hp5ceXLlpd0">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="28e983f5-bbb5-40cc-91df-afc05d609936" href="/media/156146/download?attachment" title="Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - January 26, 2022 - Transcript">Transcript</a></td> </tr> <tr> <td><strong>78</strong></td> <td>COVID-19</td> <td>02/09/2022</td> <td><a href="https://youtu.be/Rk3TU1jwrJ0">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="36a1ac41-753e-4006-8a32-d2cc6aecc3c7" href="/media/156422/download?attachment" title="CDRH Virtual IVD Town Hall - February 9, 2022">Transcript</a></td> </tr> <tr> <td><strong>79</strong></td> <td>COVID-19</td> <td>02/23/2022</td> <td><a href="https://youtu.be/Zj-FfWEV0ZU">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="807f80e4-4a37-4299-b28c-5999830d1df2" href="/media/156735/download?attachment" title="Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - February 23, 2022 - Transcript">Transcript</a></td> </tr> <tr> <td><strong>80</strong></td> <td>COVID-19</td> <td>03/09/2022</td> <td><a href="https://youtu.be/RalX62b6AJ0">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="44ae4348-a4ff-45a3-bbba-0bd0036d2a13" href="/media/157014/download?attachment" title="Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - March 9, 2022 - Transcript">Transcript</a></td> </tr> <tr> <td><strong>81</strong></td> <td>COVID-19</td> <td>03/23/2022</td> <td><a href="https://youtu.be/E3GehMsbvpY">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="032793c1-dbbc-4b45-bbe4-9afc8ef900da" href="/media/157366/download?attachment" title="Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - March 23, 2022 - Transcript">Transcript</a></td> </tr> <tr> <td><strong>82</strong></td> <td>COVID-19</td> <td>04/06/2022</td> <td><a href="https://youtu.be/TNSjg6dO9wI">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="346e8f2d-329e-4c7f-8a4f-1da717046799" href="/media/157771/download?attachment" title="CDRH IVD Virtual Town Hall 82 - April 6, 2022">Transcript</a></td> </tr> <tr> <td><strong>83</strong></td> <td>COVID-19</td> <td>04/20/2022</td> <td><a href="https://youtu.be/_et0g3tjz74">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="6f1e0bf0-2b1c-4101-8236-ca4ac3dbe633" href="/media/158032/download?attachment" title="Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - April 20, 2022 - Transcript">Transcript</a></td> </tr> <tr> <td><strong>84</strong></td> <td>COVID-19</td> <td>05/04/2022</td> <td><a href="https://youtu.be/CF73LTLm4vg">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="3719ec85-f622-4b5f-8e0e-ba29eb4be249" href="/media/158336/download?attachment" title="Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation Transcript- May 4, 2022">Transcript</a></td> </tr> <tr> <td><strong>85</strong></td> <td>COVID-19</td> <td>05/18/2022</td> <td><a href="https://youtu.be/UZOPxUDd2K4">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="e19b99cb-7ef6-48b3-a39f-778e2760dc5b" href="/media/158755/download?attachment" title="Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - May 18, 2022 - Transcript">Transcript</a></td> </tr> <tr> <td><strong>86</strong></td> <td>COVID-19</td> <td>06/01/2022</td> <td><a href="https://youtu.be/G4T_6quIfYg">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="21b36e85-ca4a-4008-b3a5-9785031eaece" href="/media/159024/download?attachment" title="FDA Virtual Town Hall 86 Series – Coronavirus (COVID-19) Test Development and Validation Transcript">Transcript</a></td> </tr> <tr> <td><strong>87</strong></td> <td>COVID-19</td> <td>06/15/2022</td> <td><a href="https://youtu.be/VQvzMIFgzzs">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="a73345f7-2967-4b8d-94ef-42fecc104761" href="/media/159486/download?attachment" title="CDRH IVD Virtual Town Hall Series Number 87 - June 15 2022">Transcript</a></td> </tr> <tr> <td><strong>88</strong></td> <td>COVID-19</td> <td>06/29/2022</td> <td><a href="https://youtu.be/_Rhgjx4ZX1k">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="cf21eb2c-8952-417c-aa26-7385b59cf010" href="/media/159787/download?attachment" title="CDRH IVD Virtual Town Hall Series Number 88 - June 29, 2022">Transcript</a></td> </tr> <tr> <td><strong>89</strong></td> <td>COVID-19</td> <td>07/27/2022</td> <td><a href="https://youtu.be/-F6wlrzBLvk">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="3913c19f-95a0-43cd-8a2f-331ab11ec8e4" href="/media/160670/download?attachment" title="CDRH IVD Virtual Town Hall Series Number 89 - July 27, 2022">Transcript</a></td> </tr> <tr> <td><strong>90</strong></td> <td>COVID-19</td> <td>08/24/2022</td> <td><a href="https://youtu.be/CjmdF7mDC4M">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="edc2c1a1-3cf0-4ed9-90d5-0dcf2f586313" href="/media/161382/download?attachment" title="CDRH IVD Virtual Town Hall Number 90 - Transcript">Transcript</a></td> </tr> <tr> <td><strong>91</strong></td> <td>Monkeypox</td> <td>09/14/2022</td> <td><a href="https://youtu.be/TJAOAiSbtxg">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="26d24218-e7e7-4d0e-99f1-48f81dc7d6b2" href="/media/161668/download?attachment" title="Transcript for CDRH Webinar: Policy for Monkeypox Test 9-14-2022">Transcript</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="ad8e693f-02c8-40aa-9dcd-f939d933cc1f" href="/media/161580/download?attachment" title="CDRH Webinar: Policy for Monkeypox Tests to Address the Public Health Emergency">Printable Slides</a></td> </tr> <tr> <td><strong>92</strong></td> <td>Monkeypox</td> <td>09/21/2022</td> <td><a href="https://youtu.be/ty5ZlLYo_qY">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="54fb67f6-81a4-4bb6-b3b5-7c9e5478c19f" href="/media/161863/download?attachment" title="Virtual Town Hall Series - Monkeypox Test Development and Validation September 21, 2022">Transcript</a></td> </tr> <tr> <td><strong>93</strong></td> <td>COVID-19 and Monkeypox</td> <td>09/28/2022</td> <td><a href="https://www.youtube.com/watch?v=R43Hd0KnIhs">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="de3336d9-2c4d-4d5e-87d3-3c3d48b26050" href="/media/162060/download?attachment" title="CDRH Virtual Town Hall 93 Monkeypox and COVID Test Development and Validation Transcript - September 28, 2022">Transcript</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="3117f067-c1ec-41bb-86a8-3720300411d5" href="/media/162061/download?attachment" title="CDRH Virtual Town Hall 93 Monkeypox and COVID Test Development and Validation Slides - September 28, 2022">Printable Slides</a></td> </tr> <tr> <td><strong>94</strong></td> <td>Monkeypox</td> <td>10/05/2022</td> <td><a href="https://youtu.be/PkXysd2ETok">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="83dd5573-3114-4946-a63e-bd89d0db67ab" href="/media/162254/download?attachment" title="CDRH Virtual Town Hall 94 Monkeypox and COVID Test Development and Validation Transcript - October 5, 2022">Transcript</a></td> </tr> <tr> <td><strong>95</strong></td> <td>Monkeypox</td> <td>10/12/2022</td> <td><a href="https://youtu.be/dhGbn0IDcG4">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="81b5b3df-ccb4-41a9-a091-1f53645f0667" href="/media/162587/download?attachment" title="CDRH Virtual Town Hall #95 - Transcript">Transcript</a></td> </tr> <tr> <td><strong>96</strong></td> <td>COVID-19 and Monkeypox</td> <td>10/26/2022</td> <td><a href="https://youtu.be/krO1uOKkcZg">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="2737e7ef-9a4c-4342-9215-79cc4a5246dd" href="/media/162887/download?attachment" title="CDRH Virtual Town Hall 96 Monkeypox and COVID‐19 Test Development and Validation - October 26, 2022">Transcript</a></td> </tr> <tr> <td><strong>97</strong></td> <td>Monkeypox</td> <td>11/09/2022</td> <td><a href="https://youtu.be/bW12jfr0ecw">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="58eec819-51df-4c7e-84d9-51c6431efd41" href="/media/163255/download?attachment" title="CDRH Virtual Town Hall 97 Monkeypox Test Development and Validation - November 9, 2022">Transcript</a></td> </tr> <tr> <td><strong>98</strong></td> <td>Monkeypox and COVID-19</td> <td>11/30/2022</td> <td><a href="https://youtu.be/mJNdpZt5OMo">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="132877e4-e57d-46ac-932b-7d6c9ce422a0" href="/media/163860/download?attachment" title="CDRH Virtual Town Hall - Monkeypox and COVID‐19 Test Development and Validation Transcript - November 30, 2022">Transcript</a></td> </tr> <tr> <td><strong>99</strong></td> <td>Monkeypox (mpox) and COVID-19</td> <td>12/14/2022</td> <td><a href="https://youtu.be/AX9iyqOJ0qU">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="56c3f4ba-5ca5-4a48-a5b3-e684c4d10d29" href="/media/164110/download?attachment" title="CDRH Virtual Town Hall - Monkeypox and COVID‐19 Test Development and Validation Transcript - December 14, 2022">Transcript</a></td> </tr> <tr> <td><strong>100</strong></td> <td>Monkeypox (mpox) and COVID-19</td> <td>01/11/2023</td> <td><a href="https://youtu.be/JzlxverAjpM">Presentation </a>  <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="0884ce7c-eaa3-45b7-88ba-5df2175a2a0f" href="/media/164637/download?attachment" title="CDRH IVD Town Hall 100 MPX COVID19 Transcript 01-11-23">Transcript</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="4d6d9b1f-5da8-4ee4-9c22-00db67d0b686" href="/media/164638/download?attachment" title="CDRH IVD Town Hall 100 MPX COVID19 Printable Slides 01-11-23">Printable Slides</a></td> </tr> <tr> <td><strong>101</strong></td> <td>Monkeypox (mpox) and COVID-19</td> <td>02/15/2023</td> <td><a href="https://youtu.be/tIoLtx8__Ew">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="ac3ea0e3-7e88-4f40-888e-95a2c32e62f6" href="/media/165573/download?attachment" title="CDRH Virtual Town Hall 101 - Mpox and COVID-19 Test Development and Validation Transcript - February 15, 2023">Transcript</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="58a438b8-55a8-49d9-a01d-a09c214c946d" href="/media/165572/download?attachment" title="CDRH Virtual Town Hall 101 - Mpox and COVID-19 Test Development and Validation Slides - February 15, 2023">Printable Slides</a></td> </tr> <tr> <td><strong>102</strong></td> <td>Monkeypox (mpox) and COVID-19</td> <td>03/22/2023</td> <td><a href="https://youtu.be/DsKd5harDO4">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="a3eed06a-7384-4620-9607-40e6ddbc6889" href="/media/166605/download?attachment" title="CDRH Virtual Town Hall 102 Mpox and COVID-19 Test Development and Validation March 22, 2023 - Transcript">Transcript</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="7b160cc6-7ac9-43e1-b77b-ff9ea53a1072" href="/media/166606/download?attachment" title="CDRH Virtual Town Hall 102 Mpox and COVID-19 Test Development and Validation March 22, 2023 - Slides">Printable Slides</a></td> </tr> <tr> <td><strong>103</strong></td> <td>COVID-19</td> <td>04/26/2023</td> <td><a href="https://youtu.be/NF6t6Rk5YeQ">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="d38c11ac-500b-4675-a7fa-5e22344c0462" href="/media/167914/download?attachment" title="CDRH Webinar IVD Town Hall 103 Transcript">Transcript</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="2290f951-fabd-4dc6-be76-9f413decc6fe" href="/media/167915/download?attachment" title="CDRH Webinar IVD Town Hall 103 Printable-Slides">Printable Slides</a></td> </tr> </tbody> </table> </div> <p>2021 and 2020 virtual town hall presentations and transcripts are <a href="https://public4.pagefreezer.com/browse/FDA/01-01-2022T01:12/https:/www.fda.gov/training-and-continuing-education/cdrh-learn">archived</a> and located in the Specialty Technical Topics section as: Coronavirus (COVID-19) Test Development and Validation Virtual Town Hall Series.</p> </div> </div> </div> <div class="panel panel-default"> <div class="panel-heading"> <h4 class="panel-title"><a class="toggle collapsed" data-parent="#accordion" data-toggle="collapse" href="#collapseFour">Unique Device Identification (UDI) System</a></h4> </div> <div class="panel-collapse collapse" id="collapseFour"> <div class="panel-body"> <p>1. Unique Device Identification (UDI) System Regulatory Overview<br> <a href="http://fda.yorkcast.com/webcast/Play/455307461f76415ead204eeb03dedad61d" target="_blank">Presentation</a>   <a href="/media/96818/download" target>Printable Slides</a>   <a href="/media/96825/download" target>Transcript</a></p> <p>2. Global Unique Device Identification Database (GUDID) Account Request: Preparation and Process<br> <a href="http://fda.yorkcast.com/webcast/Play/c3f1d47f147e4865937b6a0f8f1dcdc21d" target="_blank">Presentation</a>   <a href="/media/96828/download" target>Printable Slides</a>   <a href="/media/96834/download" target>Transcript</a></p> <p>3. The GUDID Device Identifier (DI) Record<br> <a href="http://fda.yorkcast.com/webcast/Play/3e1557a3ba4a4de1aac3d07bf8cdf0ee1d" target="_blank">Presentation</a>   <a href="/media/96842/download" target>Printable Slides</a>   <a href="/media/96850/download" target>Transcript</a></p> <p>4. GUDID HL7 SPL Submission Option<br> <a href="http://fda.yorkcast.com/webcast/Play/2c41f519e6f34e28b2c784795e5ab57a1d">Presentation</a>   <a href="/media/96855/download" target>Printable Slides</a>   <a href="/media/96863/download" target>Transcript</a></p> <p>5. Optimizing GUDID Data Quality<br> <a href="https://www.youtube.com/watch_popup?v=HPnpf_toQtc" target="_blank">Presentation</a>   <a href="/media/106776/download" target>Printable Slides</a>   <a href="/media/106752/download" target>Transcript</a></p> <p>6. Unique Device Identification: Direct Marking of Devices Final Guidance<br> <a href="https://www.youtube.com/watch_popup?v=g1iz8ocqe-4" target="_blank">Presentation</a>   <a href="/media/109503/download" target>Printable Slides</a>   <a href="/media/109657/download" target>Transcript</a></p> <p>7. Unique Device Identification: Convenience Kits, Final Guidance<br> <a href="https://www.youtube.com/watch?v=8LmOUxZpkvE">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="7c53c29d-f1c0-49f6-a8fe-ae3a6dd467ce" href="/media/125417/download?attachment" title="Webinar - Unique Device Identification: Convenience Kits Final Guidance - May 21, 2019 - Printable Slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="0f012c80-86aa-4b69-8be9-5bcc8936b85e" href="/media/126826/download?attachment" title="Webinar - Unique Device Identification: Convenience Kits Final Guidance - May 21, 2019 - Transcript ">Transcript</a></p> </div> </div> </div> <div class="panel panel-default"> <div class="panel-heading"> <h4 class="panel-title"><a class="toggle collapsed" data-parent="#accordion" data-toggle="collapse" href="#collapseFive">Specialty Technical Topics - <em>(Updated 11/19/24)</em></a></h4> </div> <div class="panel-collapse collapse" id="collapseFive"> <div class="panel-body"> <p><strong>COVID-19 Transition Policy</strong></p> <p>COVID-19 Transition Policy for Devices, Final Guidances<br> <a href="https://youtu.be/ux3IEMewEzE">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="58355e78-ebc5-41ac-9e64-c0ec04b6edf3" href="/media/167168/download?attachment" title="COVID-19 Transition Policy for Devices, Final Guidances - Printable Slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="4bf60d3d-97ab-48ab-98a2-9aa030aa7f8b" href="/media/167604/download?attachment" title="Transcript for Webinar - COVID-19 Transition Policy for Devices, Final Guidances">Transcript</a></p> <p><strong>Device-Specific Topics</strong></p> <p>Dental Devices Premarket Submissions<br> <a href="https://www.youtube.com/watch_popup?v=FL7nh3C2zwo">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="467b2912-cc43-4324-9847-fc04be9ea010" href="/media/131294/download?attachment" title="Dental Devices Premarket Submissions - slides ">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="538c3873-646f-4399-b021-a847c897ff6f" href="/media/131709/download?attachment" title="Dental Devices Premarket Submissions - Transcript ">Transcript</a></p> <p>Final Guidance on "General Wellness: Policy for Low-Risk Devices"<br> <a href="https://www.youtube.com/watch_popup?v=_1PQas0YzZ4" target="_blank">Presentation</a>   <a href="/media/100032/download" target>Printable Slides</a>   <a href="/media/99809/download" target>Transcript</a></p> <p>Digital Health Software Precertification (PreCert) Pilot Program<br> <a href="https://www.youtube.com/watch_popup?v=PXxsyqX-A_Q" target="_blank">Presentation</a>   <a href="/media/106563/download" target>Printable Slides</a>   <a href="/media/106978/download" target>Transcript</a></p> <p>Hearing Aids and Personal Sound Amplification Products<br> <a href="https://youtu.be/Kv3YnMSV4n8">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="575311a2-0e5b-45b0-959b-2f90f588d336" href="/media/155019/download?attachment" title="Webinar - Hearing Aids and Personal Sound Amplification Products (December 7, 2021) - Prinatble Slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="75e674ee-3386-49bc-92a8-29767b144199" href="/media/155020/download?attachment" title="Webinar - Hearing Aids and Personal Sound Amplification Products (December 7, 2021) - Transcript">Transcript</a></p> <p>Overview of the Final Order calling for PMAs for AEDs<br> <a href="https://www.youtube.com/watch_popup?v=yHOuoazjb7k" target="_blank">Presentation</a>   <a href="/media/90729/download" target>Printable Slides</a>   <a href="/media/91164/download" target>Transcript</a></p> <p>Self Monitoring Blood Glucose Systems for Over-the-Counter Use & Blood Glucose Monitoring Systems for Prescription Point-of-Care Use <br> <a href="https://www.youtube.com/watch_popup?v=Y1MhpTIoW7U" target="_blank">Presentation</a>   <a href="/media/101886/download" target>Printable Slides</a>   <a href="/media/102002/download" target>Transcript</a></p> <hr> <p><strong>Animal-Related Policy</strong></p> <p>Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices) Final Guidance<br> <a href="https://www.youtube.com/watch_popup?v=ZWAuyH8IvBw">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="87832b00-5ebe-48ac-b133-3ba5b34f5698" href="/media/123373/download?attachment" title="Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices) Final Guidance - Slides ">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="a276bdf5-00f1-44d1-ab38-19d5e1fa614f" href="/media/124252/download?attachment" title="Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices) Final Guidance - Transcript ">Transcript</a></p> <hr> <p><strong>Biocompatibility</strong></p> <p>Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process” - Final Guidance [2023]<br> <a href="https://youtu.be/RJPj2anMAO4">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="241cf55a-3c5e-4f4a-a64b-57596691cc47" href="/media/172951/download?attachment" title="Webinar - Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" - Final Guidance - Printable Slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="c92e6875-5f1f-43be-ae93-75e912f381b2" href="/media/173290/download?attachment" title="Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process” - Final Guidance - Transcript">Transcript</a></p> <p>Final Guidance on "Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" [2016]<br> <a href="https://www.youtube.com/watch_popup?v=Vor3EYNFHBg" target="_blank">Presentation</a>   <a href="/media/99426/download" target>Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="c7e2b409-cc54-4239-8fbc-95f6fd03f8b1" href="/media/99026/download?attachment" target title="Final Guidance on “Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" - Transcript">Transcript</a></p> <p>Color Additives<br> <a href="https://www.youtube.com/watch_popup?v=v3BKT79VdcI" target="_blank">Presentation</a>   <a href="/media/95929/download">Printable Slides</a>   <a href="/media/96047/download" target>Transcript</a></p> <hr> <p><strong>Collaboration</strong></p> <p>Collaborative Communities: Addressing Healthcare Challenges Together<br> <a href="https://www.youtube.com/watch_popup?v=zdQRfNSDn5E">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="74a05f7f-fc08-472e-9cd4-04a2b0085df0" href="/media/132048/download?attachment" title="Collaborative Communities: Addressing Healthcare Challenges Together - slides ">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="7f4afc40-a285-4c03-a89b-02e1bd624c71" href="/media/132327/download?attachment" title="Collaborative Communities: Addressing Healthcare Challenges Together - Transcript ">Transcript</a></p> <hr> <p><strong>Custom Devices</strong></p> <p>Custom Device Exemption<br> <a href="http://fda.yorkcast.com/webcast/Play/3f15ac0fee9441bc9dde831b3cb321ae1d" target="_blank">Presentation</a>   <a href="/media/89996/download" target>Printable Slides</a>   <a href="/media/89641/download" target>Transcript</a></p> <p>Technical Considerations for Additive Manufactured Medical Devices<br> <a href="https://www.youtube.com/watch_popup?v=ZbyU5c7IDOs" target="_blank">Presentation</a>   <a href="/media/110152/download" target>Printable Slides</a>   <a href="/media/110519/download" target>Transcript</a></p> <hr> <p><strong>Digital Health</strong></p> <p>Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act: Final Guidance<br> <a href="https://www.youtube.com/watch?v=2Rvw9zmVsww">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="77005dd5-291a-4073-b3f8-a1ebcf9fa012" href="/media/132527/download?attachment" title="Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act: Final Guidance - Slides ">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="fac7b854-3fd0-4c3f-8d08-3ad5ae532c87" href="/media/132870/download?attachment" title="Transcript - Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act: Final Guidance - November 14, 2019">Transcript</a></p> <p>Clinical Decision Support Software, Final Guidance <br> <a href="https://www.youtube.com/watch?v=TqUaHbt_OHI" target="_blank">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="00e586b3-1f91-4cda-ba67-2c93710e72a3" href="/media/162345/download?attachment" title="CDRH Webinar: Final Guidance on Clinical Decision Support Software October 18 2022 - Printable Slides ">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="ebcb8ebb-3bc6-416f-831e-31c5e261547d" href="/media/162880/download?attachment" title="Clinical Decision Support Software, Final Guidance - Transcript">Transcript</a></p> <p>Content of Premarket Submissions for Device Software Functions, Final Guidance<br> <a href="https://youtu.be/DwFW_24-T8w">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="d2764c8c-4263-495e-81c8-23ccf93fdd86" href="/media/170328/download?attachment" title="Printable Slides: CDRH Webinar Premarket Software Final Guidance">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="5efa6981-3297-4c44-b63b-ad936b084322" href="/media/170714/download?attachment" title="Final Guidance: Content of Premarket Submissions for Device Software Functions Webinar Transcript - July 20, 2023">Transcript</a></p> <p>Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions - Final Guidance<br> <a href="https://youtu.be/mQlD7jYWjOY">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="accc1929-6139-440e-904a-7daf8570c8b5" href="/media/173516/download?attachment" title="Webinar - Final Guidance: Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions - Slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="cd6a2939-f251-4173-bed8-14963c8024fb" href="/media/173984/download?attachment" title="Webinar Transcript - Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions - Final Guidance">Transcript</a></p> <p>Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices Final Guidance<br> <a href="https://www.youtube.com/watch_popup?v=Yhu3RXKaseY" target="_blank">Presentation</a>   <a href="/media/108238/download" target>Printable Slides</a>   <a href="/media/108774/download" target>Transcript</a></p> <p>Digital Health<br> <a href="https://www.youtube.com/watch_popup?v=PlCt-xOLwRQ" target="_blank">Presentation</a>   <a href="/media/90800/download" target>Printable Slides</a>   <a href="/media/90974/download" target>Transcript</a></p> <p>Digital Health Center of Excellence Listening Session #1<br> <a href="https://www.youtube.com/watch?v=aZwIbH-HzQc">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="84957202-bae9-494c-b61b-981051b9d324" href="/media/143078/download?attachment" title="Webinar - Digital Health Center of Excellence Listening Session 1 - Slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="69b969be-e834-452f-8a5d-a49cffab0fd4" href="/media/143387/download?attachment" title="Webinar - Digital Health Center of Excellence Listening Session 1 - Transcript">Transcript</a></p> <p>Digital Health Center of Excellence Listening Session #2 <br> <a href="https://www.youtube.com/watch?v=PiFVO7Af4ms">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="9134a561-da15-4cb9-b1c4-ab66b2e22b0a" href="/media/143712/download?attachment#2" title="Webinar - Digital Health Center of Excellence Listening Session #2 - Slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="1def8563-710e-4976-99f0-35044f8bab7f" href="/media/143908/download?attachment" title="Webinar - Digital Health Center of Excellence Listening Session 2 - Transcript">Transcript</a></p> <p>Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions <br> <a href="https://youtu.be/J26TfajAeSo">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="de14a4b1-cedb-4366-8f2c-cea7dd3dec0e" href="/media/167069/download?attachment" title="Printable Slides - Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="b49fe1de-88eb-4cf7-9551-75c8c26b1ba9" href="/media/167353/download?attachment" title="Webinar Transcript - Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence / Machine Learning-Enabled Device Software Functions Draft Guidance">Transcript</a></p> <p>Postmarket Management of Cybersecurity in Medical Devices Final Guidance <br> <a href="https://www.youtube.com/watch_popup?v=b4wIuFK6Kf4" target="_blank">Presentation</a>   <a href="/media/102583/download" target>Printable Slides</a>   <a href="/media/102731/download" target>Transcript</a></p> <p>Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act, Draft Guidance (New Module 5/9/2024)<br> <a href="https://youtu.be/DtGVyZmSoVo">Presentation</a>   <a href="/media/178134/download">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="25b26af0-a90e-4f19-b9d6-3440dac61e25" href="/media/178547/download?attachment" title="Transcript Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act, Draft Guidance - April 30, 2024">Transcript</a></p> <hr> <p><strong>Human Factors</strong></p> <p>Applying Human Factors and Usability Engineering to Medical Devices<br> <a href="https://www.youtube.com/watch_popup?v=mhBlEiO5Yyc" target="_blank">Presentation</a>   <a href="/media/96064/download" target>Printable Slides</a>   <a href="/media/96507/download" target>Transcript</a></p> <hr> <p><strong>Home Use</strong></p> <p>FDA's Home Use Medical Device Initiative<br> <a href="http://fda.yorkcast.com/webcast/Viewer/?peid=46b4288ad2a34b71a9d1ff0b9afbd92d1d" target="_blank">Presentation</a>   <a href="/media/81569/download">Printable Slides</a></p> <p>Promoting Patient Safety with Home Use Devices<br> <a href="http://fda.yorkcast.com/webcast/Viewer/?peid=8c13f3459ca54e84884a78d67a591b3f1d" target="_blank">Presentation</a>   <a href="/media/81576/download">Printable Slides</a></p> <p>Home Use Medical Devices: New Risks<br> <a href="http://fda.yorkcast.com/webcast/Viewer/?peid=a8124bbeb8c34aa4904dbc83bdf4e5771d" target="_blank">Presentation</a>   <a href="/media/81582/download">Printable Slides</a></p> <p>Medical Devices in the Home: Design Considerations and Guidance for Industry<br> <a href="https://www.youtube.com/watch_popup?v=yYMMse5792E" target="_blank">Presentation</a>   <a href="/media/89757/download" target>Printable Slides</a>   <a href="/media/89874/download" target>Transcript</a></p> <hr> <p><strong>Medical Device Development Tools</strong></p> <p>Qualification of Medical Device Development Tools: Final Guidance<br> <a href="https://www.youtube.com/watch?v=JG_pTNBVslQ">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="b407a00b-10dd-49a4-a543-8df11c661a14" href="/media/107112/download?attachment" title="Qualification of Medical Device Development Tools: Final Guidance - Printable Slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="2ce40c29-a463-44ca-87e4-c65fb75e2ae9" href="/media/172287/download?attachment" title="Qualification of Medical Device Development Tools: Final Guidance - Transcript">Transcript</a></p> <hr> <p><strong>Medical Imaging</strong></p> <p>Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment <br> <a href="https://www.youtube.com/watch?v=sEru8IJSJWU">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="57370c3f-2372-4bb6-bf91-8064770da547" href="/media/150328/download?attachment" title="Webinar - Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment - Slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="e1911596-803a-46b5-8364-d3100262ff31" href="/media/150519/download?attachment" title="Webinar - Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment - Transcript">Transcript</a></p> <hr> <p><strong>Neurological Devices</strong></p> <p>Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder: Draft Guidance<br> <a href="https://youtu.be/3ObasCr4cEM">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="b56de02a-3b4a-4f31-933a-afaea8200368" href="/media/171950/download?attachment" title="Slides - Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder: Draft Guidance">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="f13e6c1e-ab51-4227-8671-f3db3cfa1a1e" href="/media/172288/download?attachment" title="Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder: Draft Guidance - Transcript">Transcript</a></p> <p>Regulatory Advice for Investigators and Sponsors of Neurological Devices and the Path to Initiating Human Studies<br> <a href="https://www.youtube.com/watch_popup?v=LJVmlwYsSO4" target="_blank">Presentation</a>   <a href="/media/100581/download" target>Printable Slides</a>   <a href="/media/100145/download" target>Transcript</a></p> <p>Regulatory Overview for Developers and Sponsors of Neurological Devices: An Introduction to Premarket Approvals <br> <a href="https://www.youtube.com/watch_popup?v=6cswbe_UGCI" target="_blank">Presentation</a>   <a href="/media/106128/download" target>Printable Slides</a>   <a href="/media/106715/download" target>Transcript</a></p> <p>Regulatory Overview for Developers and Sponsors of Neurological and Physical Medicine Devices: An Introduction to the De Novo Pathway<br> <a href="https://www.youtube.com/watch?v=SchDJfh3ddo">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="a649d95e-cbb3-46ed-9485-e40d8e634bea" href="/media/141603/download?attachment" title="Webinar - Regulatory Overview for Developers and Sponsors of Neurological and Physical Medicine Devices: An Introduction to the De Novo Pathway - Slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="8c58e66f-e28e-4d43-ab16-d52ee95d6778" href="/media/142008/download?attachment" title="Webinar - Regulatory Overview for Developers and Sponsors of Neurological and Physical Medicine Devices: An Introduction to the De Novo Pathway - Transcript">Transcript</a></p> <p>Regulatory Overview for Developers and Sponsors of Neurological Devices: An Introduction to Humanitarian Device Exemptions (HDEs) <br> <a href="https://www.youtube.com/watch_popup?v=6zndHTZuxyI" target="_blank">Presentation</a>   <a href="/media/89805/download" target>Printable Slides</a>   <a href="/media/110283/download" target>Transcript</a></p> <p>FDA Innovation Challenge: Devices to Prevent and Treat Opioid Use Disorder<br> <a href="https://www.youtube.com/watch_popup?v=XaI1InkeMmI" target="_blank">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="8a4edf47-8c63-46cf-8ba1-4c6b62d13fb3" href="/media/115312/download?attachment" target title="FDA Innovation Challenge: Devices to Prevent and Treat Opioid Use Disorder - Slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="4426d978-e93b-4c5c-86ac-781d64baac52" href="/media/114911/download?attachment" target title="FDA Innovation Challenge: Devices to Prevent and Treat Opioid Use Disorder - Transcript">Transcript</a></p> <p>Implanted BCI Devices for Patients with Paralysis or Amputation - Non-clinical Testing and Clinical Considerations Final Guidance<br> <a href="https://youtu.be/vZorRbrWL_M">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="baafb2b7-af1a-4ca0-8c59-40105715a49b" href="/media/151115/download?attachment" title="Implanted BCI Devices for Patients with Paralysis or Amputation - Non-clinical Testing and Clinical Considerations Final Guidance - Webinar Slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="83d3a0f9-eadf-4b7b-aa98-902cef8e2971" href="/media/159568/download?attachment" title="Implanted BCI Devices for Patients with Paralysis or Amputation - Non-clinical Testing and Clinical Considerations Final Guidance - Transcript">Transcript</a></p> <hr> <p><strong>Patient Engagement</strong></p> <p>Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use In Medical Device Evaluation, Final Guidance<br> <a href="https://youtu.be/9OiV8I2z6ts">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="ab0cec9c-8a6a-42b3-8dab-149c3ae6d7b5" href="/media/156530/download?attachment" title="Webinar - Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation - Final Guidance - Slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="66b8b87a-0ae0-482e-9f9e-2fefcdd3cdeb" href="/media/156929/download?attachment" title="Webinar Transcript: PRO Final Guidance March 1, 2022">Transcript</a></p> <p>Patient Engagement in the Design and Conduct of Medical Device Clinical Studies, Final Guidance<br> <a href="https://youtu.be/Arme0k7lsQU">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="563f7903-2fd1-4d53-aaab-1367a424b890" href="/media/157068/download?attachment" title="Slides - Patient Engagement in the Design and Conduct of Medical Device Clinical Studies - Final Guidance">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="5ea1fa91-1349-40a0-baca-861f014c72ef" href="/media/157370/download?attachment" title="Transcript - Patient Engagement in the Design and Conduct of Medical Device Clinical Studies - Final Guidance">Transcript</a></p> <hr> <p><strong>Personal Protective Equipment (PPE)</strong></p> <p>Enforcement Policy for Personal Protective Equipment (PPE) During COVID-19: Immediately in Effect Guidance - April 6, 2020<br> <a href="https://www.youtube.com/watch?v=_WG_bVWaLq8">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="d9c75157-635c-42a9-ab88-9c4b0f87ab1b" href="/media/136704/download?attachment" title="Enforcement Policy for Personal Protective Equipment (PPE) During COVID-19: Immediately in Effect Guidance">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="8082d9c7-d9ec-4bfe-bab4-9838bcfca8ad" href="/media/136903/download?attachment" title="Webinar - Enforcement Policy for Personal Protective Equipment (PPE) During COVID-19: Immediately in Effect Guidance - Transcript">Transcript</a></p> <p>Respirators for Health Care Personnel Use during COVID-19 Pandemic - June 9, 2020<br> <a href="https://www.youtube.com/watch?v=g2lyuRbEfUk">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="39b69ccd-2a3a-4370-8100-a627b200f0a9" href="/media/138740/download?attachment" title="Webinar Series - Respirators for Health Care Personnel Use during COVID-19 Pandemic June 9, 2020 - Slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="c6ef0be0-2ac7-4c0f-a9b9-cc42ec80685d" href="/media/139155/download?attachment" title="Webinar Series - Respirators for Health Care Personnel Use during COVID-19 Pandemic - Transcript">Transcript</a></p> <p>Respirators for Health Care Personnel Use during COVID-19 Pandemic - June 23, 2020<br> <a href="https://www.youtube.com/watch?v=5ZaZZkb0rlo">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="0e2ee7c7-a413-4ce3-99f9-ec6ca9da491c" href="/media/139403/download?attachment" title="Webinar Series - Respirators for Health Care Personnel Use during COVID-19 Pandemic - Slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="5c1a7eac-65b8-4f29-9b0c-cf3f1796d707" href="/media/139666/download?attachment" title="Webinar Series - Respirators for Health Care Personnel Use during COVID-19 Pandemic - Transcript June 23 2020">Transcript</a> </p> <p>Respirators for Health Care Personnel Use during COVID-19 Pandemic - July 7, 2020<br> <a href="https://www.youtube.com/watch?v=iKY0zPI7TPM">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="6d0033cb-d00b-408c-b698-e8095994d357" href="/media/139774/download?attachment" title="Printable Slides - Respirators for Health Care Personnel Use during COVID-19 Pandemic - July 7, 2020">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="78c6aca8-3f50-4330-83d4-2714111b1473" href="/media/140219/download?attachment" title="July 7, 2020 - Respirators for Health Care Personnel Use - Transcript">Transcript</a></p> <p>Respirators for Health Care Personnel Use during COVID-19 Pandemic - July 21, 2020<br> <a href="https://www.youtube.com/watch?v=-G_SOEI5oKI">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="57511fc7-6452-4517-a7e4-1fad38b7949e" href="/media/140639/download?attachment" title="July 21, 2020 - Respirators for Health Care Personnel Use - transcript">Transcript</a></p> <p>Regulation of Face Masks and Surgical Masks During the COVID-19 Pandemic - August 4, 2020<br> <a href="https://youtu.be/4z5WllV-Z8s">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="6ebf4bac-2df8-482a-907a-3a747457c93e" href="/media/141086/download?attachment" title="FDA Webinar Series- FDA’s Regulation of Face Masks and Surgical Masks During the COVID-19 Pandemic (August 4, 2020)">Transcript</a></p> <p>FDA's Surgical Masks Umbrella EUA - August 18, 2020<br> <a href="https://www.youtube.com/watch?v=kpO1K5ujcdY">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="715e8c08-7450-4b75-825e-be136e1309ab" href="/media/141609/download?attachment" title="Augusut 18, 2020 - FDA's Surgical Masks EUA Umbrella - transcript">Transcript</a></p> <p>CDC/NIOSH's Surgical N95 Respirator Guidance - September 1, 2020<br> <a href="https://www.youtube.com/watch?v=KmPVciyxSN0">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="eefc185b-c5ef-42e3-ac69-a9623cc5be55" href="/media/141689/download?attachment" title="Webinar Series - CDC/NIOSH's Surgical N95 Respirator Guidance - Slides - September 1, 2020">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="f47c0498-983b-4e58-b371-f68597c7ea1f" href="/media/142116/download?attachment" title="Transcript for CDC/NIOSH's Surgical N95 Respirator Guidance - September 1, 2020">Transcript</a></p> <p>Gowns and Other Apparel for Use by Health Care Personnel in COVID-19 Pandemic<br> <a href="https://www.youtube.com/watch?v=i3_ri_AmB5I">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="bb69701e-595c-4558-b4fe-0d9e5f8940e2" href="/media/142176/download?attachment" title="Webinar Series - Gowns and Other Apparel for Use by Health Care Personnel in COVID-19 Pandemic - Slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="9b130fdf-09c5-4ec6-a4d1-deeb4d6916df" href="/media/142429/download?attachment" title="September 15, 2020 - Gowns and Other Apparel for Use by Health Care Personnel in COVID-19 Pandemic - Transcript">Transcript</a></p> <p>Respirators and Other PPE for Health Care Personnel Use <br> <a href="https://www.youtube.com/watch?v=x-cXRE81LwE">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="4a609aef-8d4d-406b-b17b-b5e56f35e54d" href="/media/142979/download?attachment" title="Respirators and Other PPE for Health Care Personnel Use Webinar - Transcript">Transcript</a></p> <p>Protective Barrier Enclosure Emergency Use Authorizations (EUAs)<br> <a href="https://www.youtube.com/watch?v=eyMSOe0rkDM">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="f77fa649-cb19-4299-b89d-2056136e74c8" href="/media/142934/download?attachment" title="Protective Barrier Enclosures Webinar October 13, 2020">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="d5f9de9c-d6a0-490f-a728-a4152450ca1d" href="/media/143242/download?attachment" title="Protective Barrier Enclosure Emergency Use Authorizations (EUAs) - Transcript">Transcript</a></p> <p>Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic<br> <a href="https://youtu.be/ihyyV7SH6RQ">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="1adb7fb7-3d65-41f4-bbdb-afdfdc6f8ffd" href="/media/143317/download?attachment" title="Webinar Series - Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic - October 27, 2020 - Slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="b87f5073-2921-4791-a294-d41d2d22f0ac" href="/media/143546/download?attachment" title="Transcript for Recommendations for Surgical Mask Premarket Notifications, or 510(k)s - October 27, 2020">Transcript</a></p> <p>Gowns - Regulatory Responsibilities<br> <a href="https://www.youtube.com/watch_popup?v=XKPeaJtcfcE" target="_blank">Presentation</a>   <a href="/media/95910/download" target>Printable Slides</a>   <a href="/media/95908/download" target>Transcript</a></p> <p>Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic<br> <a href="https://www.youtube.com/watch?v=B6z2wCtJGWo">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="45fcff8e-218d-47c3-858e-b921f3abc166" href="/media/144236/download?attachment" title="Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic - December 8, 2020">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="82699568-2a9d-430b-be83-3ec2741ff917" href="/media/144565/download?attachment" title="Webinar Series - Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic - December 8, 2020 - Transcript">Transcfript</a></p> <p>Enforcement Policy for Bioburden Reduction Systems Using Dry Heat to Support Single-User Reuse of Certain Filtering Facepiece Respirators during the COVID-19 Pandemic<br> <a href="https://www.youtube.com/watch?v=ncHGPaBBeow">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="ef7253ff-9dc5-4b23-971a-7e9807a10b9f" href="/media/145432/download?attachment" title="Webinar Slides: Enforcement Policy for Bioburden Reduction Systems Using Dry Heat to Support Single-User Reuse of Certain Filtering Facepiece Respirators during the COVID-19 Pandemic">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="871eb841-2165-4527-bb29-0c04e2b5a6fe" href="/media/145699/download?attachment" title="Enforcement Policy for Bioburden Reduction Systems Using Dry Heat to Support Single-User Reuse of Certain Filtering Facepiece Respirators during the COVID-19 Pandemic - Transcript">Transcript</a></p> <p>Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic<br> <a href="https://www.youtube.com/watch?v=v4Rq22negIw">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="8f32dcdf-a977-42da-8c6a-e0e8817d8735" href="/media/146204/download?attachment" title="Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic - Slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="550c80be-1cfa-4da4-9f4a-e90bac3f6d7d" href="/media/146512/download?attachment" title="Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic - Transcript">Transcript</a></p> <p>Transitioning from the Use of Decontaminated Disposable Respirators<br> <a href="https://www.youtube.com/watch?v=ieEoIwFxDBw">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="69f92e61-e3d2-4154-8a57-c6704acb4aa4" href="/media/147882/download?attachment" title="Transitioning from the Use of Decontaminated Disposable Respirators - Slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="5ec53627-93cc-466f-af75-910f6578c80f" href="/media/148737/download?attachment" title="Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic - April 27, 2021 - Transcript">Transcript</a></p> <p>Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic<br> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="d433effe-93e6-4377-9fe3-0f2c136149f4" href="/media/149953/download?attachment" title="Webinar Series - Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic - June 8, 2021 - Slides">Printable Slides</a></p> <p>Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic <br> <a href="https://www.youtube.com/watch?v=3NQgVaouQpY">Presentation</a>   <a href="http://wcms-internet.fda.gov/media/150715/download">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="4c903017-4891-457d-8727-8b0236623508" href="/media/151348/download?attachment" title="Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic - July 13, 2021 - Transcript">Transcript</a></p> <hr> <p><strong>Regulatory Science Tools</strong></p> <p>Targeted Box and Blocks Test (tBBT)<br> <a href="https://www.youtube.com/watch?v=3jWBZDbEYMU">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="6cf6e2d8-a590-4358-bd72-833de668a01c" href="/media/163894/download?attachment" title="Targeted Box and Blocks Test (tBBT) - Transcript">Transcript</a></p> <p>Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions, Final Guidance<br> <a href="https://youtu.be/ylG5RmAGShM">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="ae4e36f7-e415-4b30-9528-0e1ed924657c" href="/media/175363/download?attachment" title="Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions Final Guidance - Slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="a62d388d-49ba-4701-b308-b58db99c0ddb" href="/media/175618/download?attachment" title="Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions, Final Guidance - Transcript">Transcript</a></p> <hr> <p><strong>Reprocessing</strong></p> <p>Webinar - Duodenoscope Sampling and Culturing<br> <a href="https://www.youtube.com/watch_popup?v=9TkLWpMm3so" target="_blank">Presentation</a>   <a href="/media/111677/download" target>Printable Slides</a>   <a href="/media/112402/download" target>Transcript</a></p> <p>Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling<br> <a href="https://www.youtube.com/watch_popup?v=6ISXatMmmws" target="_blank">Presentation</a>   <a href="/media/91922/download" target>Printable Slides</a>   <a href="/media/91913/download" target>Transcript</a></p> <hr> <p><strong>Sterility</strong></p> <p>FDA Innovation Challenges: Identify Sterilization Alternatives and Reduce Ethylene Oxide Emissions<br> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="50c25c31-aaf8-4927-93be-db115cfe7a28" href="/media/129798/download?attachment" title="Webinar- FDA Innovation Challenges: Identify Sterilization Alternatives and Reduce Ethylene Oxide Emissions – August 13, 2019 – Printable Slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="90156ed3-ad10-4d70-8533-1132b4e298e6" href="/media/130169/download?attachment" title="Webinar - FDA Innovation Challenges: Identify Sterilization Alternatives and Reduce Ethylene Oxide Emissions - August 13, 2019 - Transcript ">Transcript</a></p> <p>Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile Final Guidance<br> <a href="https://www.youtube.com/watch_popup?v=tT0QeKTWZWM" target="_blank">Presentation</a>   <a href="/media/95770/download" target>Printable Slides</a>   <a href="/media/96493/download" target>Transcript</a></p> <p>Medical Device Sterilization Town Hall Series <em><strong>(Updated 11/19/24)</strong></em></p> <div class="lcds-datatable lcds-datatable--ckeditor"> <table aria-readonly="true" class="table" data-column-defs="[{ "targets": 2, "type": "date" }]" data-order="[ 0, "asc" ]" role="grid"> <thead> <tr role="row"> <th scope="col">Series<br> Number</th> <th scope="col">Topic</th> <th scope="col">Date</th> <th scope="col">Materials</th> </tr> </thead> <tbody> <tr role="row"> <td><strong>01</strong></td> <td>Medical Device Sterilization Town Hall Overview</td> <td>01/10/2024</td> <td><a href="https://youtu.be/rhIPMr0bwKg">Presentation</a> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="70b99959-2125-44d4-acfa-bf6448690111" href="/media/175543/download?attachment?attachment" title="Medical Device Sterilization Town Hall Overview - Transcript">Transcript</a> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="d08c6015-04a6-4cfa-b65e-2fc770f4c3e6" href="/media/175360/download?attachment?attachment" title="Medical Device Sterilization Town Hall: Overview of Sterilization Landscape and Role of Ethylene Oxide - Slides">Slides</a></td> </tr> <tr role="row"> <td><strong>02</strong></td> <td>FDA’s Sterilization Related Activities</td> <td>01/26/2024</td> <td><a href="https://youtu.be/5DjPHyYZBTM">Presentation</a> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="07e22ca7-5886-4c49-8346-25ef76ac9d9f" href="/media/175952/download?attachment?attachment" title="Medical Device Sterilization Town Hall: FDA Activities and Challenges in Reducing Reliance on Ethylene Oxide (EtO) - Transcript">Transcript</a> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="e0688616-a437-4447-a16d-ef01dd470f15" href="/media/175737/download?attachment?attachment" title="Medical Device Sterilization Town Hall: FDA Activities and Challenges in Reducing Reliance on Ethylene Oxide (EtO) - Slides">Slides</a></td> </tr> <tr role="row"> <td><strong>03</strong></td> <td>Premarket Pt 1: New submissions & considerations</td> <td>02/07/2024</td> <td><a href="https://youtu.be/NkmVKMMVI64">Presentation</a> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="7df6b6b5-acf1-4a72-8fa7-38772be59daf" href="/media/176351/download?attachment" title="Transcript for Medical Device Sterilization Town Hall: Discussion of Premarket Submission Expectations and Additional Considerations for Sterility Review - February 7, 2024">Transcript</a> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="53006459-51c9-419a-8585-02b54310ebbc" href="/media/176017/download?attachment?attachment" title="Medical Device Sterilization Town Hall: Discussion of Premarket Submission Expectations and Additional Considerations for Sterility Review - Slides">Slides</a></td> </tr> <tr> <td><strong>04</strong></td> <td>Premarket Pt 2: Modifications and Master Files</td> <td>02/29/2024</td> <td><a href="https://youtu.be/Ctoz9yqPen8">Presentation</a> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="013e2b53-50bb-489b-8acf-b1a495671ce5" href="/media/176867/download?attachment" title="Transcript Medical Device Sterilization Town Hall 02-29-2024">Transcript</a> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="e53d622a-995c-4ee2-ab94-45cceecc16a8" href="/media/176614/download?attachment" title="Medical Device Sterilization Town Hall: FDA’s Modifications Guidances and the Use of Device Master Files in Reviews - Slides">Slides</a></td> </tr> <tr> <td><strong>05</strong></td> <td>Premarket Pt 3: Use of Standards & Standards Development</td> <td>03/21/2024</td> <td><a href="https://youtu.be/xKceHYiDeWc">Presentation</a> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="ab97e35b-1f29-4f2c-9947-bbfbb7c86f00" href="/media/177399/download?attachment" title="Transcript: Medical Device Sterilization Town Hall: The Value and Use of Recognized Consensus Standards in Premarket Submissions - March 21, 2024">Transcript</a> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="33ed57f7-d5c0-46fb-b126-6241ee806aa4" href="/media/177141/download?attachment" title="Slides - Medical Device Sterilization Town Hall: The Value and Use of Recognized Consensus Standards in Premarket Submissions - March 21, 2024">Slides</a></td> </tr> <tr> <td><strong>06</strong></td> <td>Topics and Formats for the Continuing Town Hall Series</td> <td>04/29/2024</td> <td><a href="https://youtu.be/TdnYIlkMQq4">Presentation</a> <a href="/media/178548/download">Transcript</a> <a href="/media/178042/download">Slides</a></td> </tr> <tr> <td><strong>07</strong></td> <td>Sterilization Method Selection</td> <td>05/23/2024</td> <td><a href="https://youtu.be/Ln1Zz_N6O18">Presentation</a> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="835dc93d-9b3f-40e5-9796-25c89d421dcf" href="/media/179030/download?attachment" title="Transcript for Medical Device Sterilization Town Hall: Sterilization Method Selection for New and Existing Devices - May 23, 2024">Transcript</a> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="cdd96374-aa58-49bc-a31f-194d7f02b442" href="/media/178837/download?attachment" title="Slides for Medical Device Sterilization Town Hall: Sterilization Method Selection for New and Existing Devices">Slides</a></td> </tr> <tr> <td><strong>08</strong></td> <td>Sterilization Open Q&A</td> <td>06/12/2024</td> <td><a href="https://youtu.be/XLxC71BPrPo">Presentation</a> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="46183f89-2a60-48f0-8122-c39dd931a1ce" href="/media/179463/download?attachment" title="Transcript for Medical Device Sterilization Town Hall: Sterilization Open Q&A - June 12, 2024">Transcript</a> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="07621a0e-889c-4f20-8c51-44f06fbf87ed" href="/media/179262/download?attachment" title="Slides for Medical Device Sterilization Town Hall: Sterilization Open Q&A">Slides</a></td> </tr> <tr> <td><strong>09</strong></td> <td>Mock Pre-Submission for Sterilization Method Change</td> <td>07/10/2024</td> <td><a href="https://youtu.be/xQCYpaswH-I">Presentation</a> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="e38d21a6-2dc0-46df-bed1-ce10de152613" href="/media/180254/download?attachment" title="Transcript - Medical Device Sterilization Town Hall: Mock Pre-Submission on Implementing a Change in Sterilization Method - July 10, 2024">Transcript</a> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="8dd9e1cd-9295-4215-a4c6-2f5b1f281a12" href="/media/179911/download?attachment" title="Medical Device Sterilization Town Hall: Mock Pre-Submission on Implementing a Change in Sterilization Method - slides">Slides</a></td> </tr> <tr> <td><strong>10</strong></td> <td>Bioburden, bacterial endotoxin and packaging integrity testing for sterile medical devices</td> <td>08/07/2024</td> <td><a href="https://youtu.be/w0U1QxUWcrU">Presentation</a> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="62873e33-9718-4086-a37c-be658375261c" href="/media/181116/download?attachment" title="Transcript - Medical Device Sterilization Town Hall: Sterilization Short Topics and Open Q&A - August 7, 2024">Transcript </a><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="cf538836-da81-4fe5-8e2e-063b468c2fed" href="/media/180606/download?attachment" title="Slides for Medical Device Sterilization Town Hall: Sterilization Short Topics and Open Q&A - August 7, 2024">Slides</a></td> </tr> <tr> <td><strong>11</strong></td> <td>Effective use of Sterility Master Files</td> <td>09/11/2024</td> <td><a href="https://youtu.be/9Lo6ZK2jlfs">Presentation</a> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="c600b7dd-0797-41aa-ac56-2f3944f3667b" href="/media/181977/download?attachment" title="Transcript - Medical Device Sterilization Town Hall: Sterility Master files and Effective Use in Premarket Submissions, September 11, 2024">Transcript</a> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="2c170bde-8b23-4941-8895-22635314434e" href="/media/181681/download?attachment" title="Medical Device Sterilization Town Hall: Sterility Master Filesand Effective Use in Premarket Submissions - 9/11/24 - Printable Slides">Slides</a></td> </tr> <tr> <td><strong>12</strong></td> <td>Predetermined Change Control Plans (PCCPs)</td> <td>10/09/2024</td> <td><a href="https://youtu.be/q-8B7RKAmbU">Presentation</a> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="e573c5bd-32a0-4e64-836d-b74dcbb16bfa" href="/media/182769/download?attachment" title="Transcript: Medical Device Sterilization Town Hall: Sterilization Short Topics and Open Q&A October 9, 2024">Transcript</a> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="34b6cd53-de80-4da6-b996-3bcdeeedd437" href="/media/182563/download?attachment" title="Printable Slides: Medical Device Sterilization Town Hall: Sterilization Short Topic and Open Q&A October 9, 2024">Slides</a></td> </tr> <tr> <td><strong>13</strong></td> <td>Supporting medical device innovators and bundling sterility submissions</td> <td>10/30/2024</td> <td><a href="https://youtu.be/w8M6_L4OhyA">Presentation</a> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="0db5e9f7-0ec2-4bd6-a566-1e4c28126132" href="/media/183416/download?attachment" title="Medical Device Sterilization Town Hall: Sterilization Short Topics and Open Q&A - Transcript">Transcript</a> <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="7cd20610-4abf-41ef-9921-a7435656c0d6" href="/media/183140/download?attachment" title="Medical Device Sterilization Town Hall: Sterilization Short Topics and Open Q&A - Slides">Slides</a></td> </tr> <tr> <td><strong>14</strong></td> <td>Recognized consensus standards and biocompatibility assessment considerations</td> <td>11/20/2024</td> <td><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="e7a6b4f9-53af-4c96-af69-f9fb1114aa88" href="/media/183682/download?attachment" title="Medical Device Sterilization Town Hall 14: Sterilization Short Topics and Open Q&A">Slides</a></td> </tr> </tbody> </table> </div> </div> </div> </div> <div class="panel panel-default"> <div class="panel-heading"> <h4 class="panel-title"><a class="toggle collapsed" data-parent="#accordion" data-toggle="collapse" href="#collapseSix">Radiation-Emitting Products</a></h4> </div> <div class="panel-collapse collapse" id="collapseSix"> <div class="panel-body"> <p>How to Get Your Electronic Product on the U.S. Market<br> <a href="https://youtu.be/Z1CKFatezFs">Presentation</a>   <a href="/media/88417/download" target>Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="4417dccc-f51c-4048-80fc-bf601d116547" href="/media/117234/download?attachment" title="How to Get Your Electronic Product on the U.S. Market - Transcript">Transcript</a></p> <p>Electronic Product Certification and Quality Testing Programs<br> <a href="http://fda.yorkcast.com/webcast/Play/770a8b516a164761a0df6779abd1706c1d">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="13b3c4c4-ac4c-4991-84de-447b05c4ec02" href="/media/134142/download?attachment" title="Electronic Product Certification and Quality Control Testing Programs - Slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="7a040def-fd4e-4979-8fca-607fde09248b" href="/media/134143/download?attachment" title="Electronic Product Certification and Quality Control Testing Programs - Transcript">Transcript</a></p> <p>Marketing Clearance of Diagnostic Ultrasound Systems and Transducers: Final Guidance<br> <a href="https://youtu.be/xvcze_wxP1Y ">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="14683c75-60fe-4de4-8a8d-a9590a741d0b" href="/media/130212/download?attachment" title="Marketing Clearance of Diagnostic Ultrasound Systems and Transducers Final Guidance - Slides ">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="42f078e8-6b4b-4870-9394-49120986b265" href="/media/130352/download?attachment" title="Marketing Clearance of Diagnostic Ultrasound Systems and Transducers Final Guidance-Transcript ">Transcript</a></p> <p>Pediatric Information for X-ray Imaging Device Premarket Notifications<br> <a href="https://www.youtube.com/watch_popup?v=2VnR2zEPu48" target="_blank">Presentation</a>   <a href="/media/110025/download" target>Printable Slides</a>   <a href="/media/110534/download" target>Transcript</a></p> <p>Phantom Image Scoring (For MQSA Inspectors)<br> <a href="https://fda.mediasite.com/mediasite/Play/9c227d4915894f82a204de812d6bd3a51d" target="_blank">Presentation</a></p> <p>eSubmitter Tutorial Presentations<br> <a href="/industry/fda-esubmitter/esubmitter-tutorial-videos">eSubmitter Tutorial Presentations</a>   <a href="https://www.youtube.com/watch_popup?v=--JvaQDRG24" target="_blank">Radiological Health Report Tutorial</a></p> </div> </div> </div> <div class="panel panel-default"> <div class="panel-heading"> <h4 class="panel-title"><a class="toggle collapsed" data-parent="#accordion" data-toggle="collapse" href="#collapseSeven">510(k) Third Party Review Program (for Third Party Review Organizations)</a></h4> </div> <div class="panel-collapse collapse" id="collapseSeven"> <div class="panel-body"> <p>510(k) Third Party Review Program: Overview<strong> </strong><br> <a href="http://fda.yorkcast.com/webcast/Play/c4789ff2e8464d4aaadc0f331df75eaa1d">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="37d8fadf-7a72-4256-a688-20b6271a1bba" href="/media/117250/download?attachment" title="510(k) Third Party Review Program Overview - transcript">Transcript</a></p> <p>X-Ray Systems<br> <a href="http://fda.yorkcast.com/webcast/Play/d93d85815e7d456a83f4ff4b09a776b71d">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="4805db69-4273-4e3c-8ee1-5a9acfbe3e2f" href="/media/117251/download?attachment" title="X-Ray Systems - Slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="aed8c77a-0561-4e80-a661-1ebd36e739c5" href="/media/117252/download?attachment" title="X-Ray Systems - transcript">Transcript</a></p> <p>510(k) Third Party Review Program: Final Guidance510(k) Third Party Review Program: Final Guidance<br> <a href="https://www.youtube.com/watch?v=v8b-L44A528">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="8b060eb0-cac7-4260-af27-1372a6b2828f" href="/media/137038/download?attachment" title="Webinar Slides 510(k) Third Party Review Program: Final Guidance ">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="71a4902c-a811-4abc-88ff-c27f124402e7" href="/media/137765/download?attachment" title="Webinar - 510(k) Third Party Review Program: Final Guidance - Transcript">Transcript</a></p> <p>Overview of the 510(k) Process: Guide for Third Party Reviewers<br> <a href="http://fda.yorkcast.com/webcast/Play/f97b4486c68045e3986c7dc90729717d1d">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="60948736-5d9c-4025-9130-6aaac88e8887" href="/media/135138/download?attachment" title="Overview of the 510(k) Process: Guide for Third Party Reviewers - Slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="4b3a5ee5-683c-4f1e-bfd9-2aed59b492f1" href="/media/135139/download?attachment" title="Overview of the 510(k) Process: Guide for Third Party Reviewers - Transcript">Transcript</a></p> <p>Deficiency Writing for Third Party Reviewers<br> <a href="http://fda.yorkcast.com/webcast/Play/8310d14837e84a2b9b0c29adb6d438fb1d">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="0ebe12f2-9be7-442d-9fd1-aacffa5c5d9b" href="/media/135140/download?attachment" title="Deficiency Writing for Third Party Reviewers - Slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="bb781f06-a42b-4d6b-a322-abc1f3fe0d8e" href="/media/135141/download?attachment" title="Deficiency Writing for Third Party Reviewers - Transcript">Transcript</a></p> <p>Deficiency Writing for Third Party Reviewers: Examples<br> <a href="http://fda.yorkcast.com/webcast/Play/601bf9dfedf2480a9868e9ca8c52e6941d">Presentation</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="a16c758a-9acd-426e-810d-cd0b76a266cd" href="/media/135142/download?attachment" title="Deficiency Writing for Third Party Reviewers: Examples - Slides">Printable Slides</a>   <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="6d59a677-e85d-4bbf-83e0-61faa7f294c2" href="/media/135143/download?attachment" title="Deficiency Writing for Third Party Reviewers: Examples - Transcript">Transcript</a></p> </div> </div> </div> <div class="panel panel-default"> <div class="panel-heading"> <h4 class="panel-title"><a class="toggle collapsed" data-parent="#accordion" data-toggle="collapse" href="#collapseEight">Industry Basics Workshop Series</a></h4> </div> <div class="panel-collapse collapse" id="collapseEight"> <div class="panel-body"> <p><strong>November 2022 Industry Basics Workshop: Understanding Risk Management with Medical Devices </strong><br> <a href="https://fda.yorkcast.com/webcast/Play/4aecf454d2d54039a1d5a6a3001d78c31d">Full Presentation</a>   <a href="https://public4.pagefreezer.com/browse/FDA/28-12-2023T13:10/https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/virtual-public-workshop-cdrh-industry-basics-understanding-risk-medical-devices-11152022">Workshop Page</a></p> <p><strong>April 2021 Industry Basics Workshop: Consensus Standards and the Accreditation Scheme for Conformity Assessment (ASCA) Pilot</strong><br> <a href="https://fda.yorkcast.com/webcast/Play/2f3dce7e06d140c4a769666418af58e91d" onclick="return __pf_external_resource_alert();" target="_blank">Full Presentation</a>   <a href="https://public4.pagefreezer.com/browse/FDA/28-12-2023T13:10/https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/cdrh-industry-basics-workshop-consensus-standards-and-accreditation-scheme-conformity-assessment">Workshop Page</a></p> <p><strong>November 2019 Industry Basics Workshop: 513(g) Requests for Information and Custom Device Exemption</strong><br> <a href="http://fda.yorkcast.com/webcast/Play/626be66734eb406f986cdda0005a306a1d">Full Presentation</a>   <a href="https://wayback.archive-it.org/7993/20201220013445/https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/cdrh-industry-basics-workshop-513g-requests-information-and-custom-device-exemption-november-5-2019">Workshop Page</a></p> <p><strong>November 2018 Industry Basics Workshop: Production and Process Controls; and Documents, Change Control, and Records</strong><br> <a href="http://fda.yorkcast.com/webcast/Play/7906e1c71eca47b79e75f2d87252d7941d">Full Presentation</a>   <a href="https://wayback.archive-it.org/7993/20201220013458/https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/cdrh-industry-basics-workshop-production-and-process-controls-and-documents-change-control-and">Workshop Page</a></p> <p><strong>November 2017 Industry Basics Workshop: Quality System - Nonconforming Product and Complaint Files</strong><br> <a href="http://fda.yorkcast.com/webcast/Play/745573f2bbba46d4a001d77d30dadc601d" target="_blank">Full Presentation</a>   <a href="https://wayback.archive-it.org/7993/20201220013515/https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/cdrh-industry-basics-workshop-nonconforming-product-and-complaint-files-november-7th-2017" target>Workshop Page</a>   <a href="/media/109424/download" target>Transcript</a></p> <p><strong>November 2016 Industry Basics Workshop: Quality System - Management Controls and Design Controls </strong><br> <a href="http://fda.yorkcast.com/webcast/Play/5909f81acb4e44fa8a0acf2d2cdc95f91d" target="_blank">Full Presentation</a>   <a href="https://wayback.archive-it.org/7993/20201220004710/https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-cdrh-industry-basics-workshop-quality-system-november-3-2016" target>Workshop Page</a><br> <i>To view specific chapters of the video presentation, select the circular "Chapters" icon in the lower left-hand corner of the window. Click on the desired chapter and press play. To close chapter view, click the X in the upper right-hand corner.</i></p> <p><strong>March 2016 Industry Basics Workshop: Unique Device Identification (UDI) Part II, Submitting Information to GUDID</strong><em> </em><br> <a href="http://fda.yorkcast.com/webcast/Play/a21960fcc6d44a3380eba129a069cfd81d" target="_blank">Full Presentation</a>   <a href="http://wayback.archive-it.org/7993/20161022055430/http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm486935.htm">Workshop Page</a><br> <br> <strong>January 2016 Industry Basics Workshop: Unique Device Identification (UDI) Part I</strong><br> <a href="http://fda.yorkcast.com/webcast/Play/06c7017ec9bd4ef3973cc7872339633b1d" target="_blank">Full Presentation</a>   <a href="http://wayback.archive-it.org/7993/20161022062057/http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm480237.htm">Workshop Page</a></p> <p><strong>November 2015 Industry Basics Workshop: Purchasing Controls and Process Validation</strong><br> <a href="http://fda.yorkcast.com/webcast/Play/85b72f2be2a941648962fc46ccb81aa41d" target="_blank">Full Presentation</a>   <a href="http://wayback.archive-it.org/7993/20161022062059/http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm468246.htm">Workshop Page with Presentation in Segments</a></p> <p><strong>November 2014 Industry Basics Workshop: IDE, 510(k), de novo, CAPA, eMDR</strong><br> <a href="http://fda.yorkcast.com/webcast/play/c369da3174e945db99747267beeb2a551d" target="_blank">Full Presentation</a>   <a href="http://wayback.archive-it.org/7993/20161022062100/http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm419120.htm">Workshop Page with Presentation in Segments</a>  </p> <p> </p> </div> </div> </div> </div> <p class="text-align-center"><span contenteditable="false" tabindex="-1"><span contenteditable="false" tabindex="-1"><a class="btn btn-primary btn-lg" data-widget="btbutton" href="https://www.research.net/r/CDRHLearnSurvey"><span class="text">Take the CDRH Learn Survey</span></a></span></span></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" >Resources</h2> </header> <div class="lcds-card-deck__body"> <a href="/medical-devices/device-advice-comprehensive-regulatory-assistance" title="Device Advice"> <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/2020-08-27-WEB-WEB-3DLaptopScreens_0.jpg?itok=LCyrrJ-v 380w" media="all and (max-width: 320px)" type="image/jpeg" sizes="100vw" width="380" height="200"/> <source srcset="/files/styles/thunbnail_3/public/2020-08-27-WEB-WEB-3DLaptopScreens_0.jpg?itok=LCyrrJ-v 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/2020-08-27-WEB-WEB-3DLaptopScreens_0.jpg?itok=5Emfkk_y 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/2020-08-27-WEB-WEB-3DLaptopScreens_0.jpg?itok=5Emfkk_y 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/2020-08-27-WEB-WEB-3DLaptopScreens_0.jpg?itok=5Emfkk_y 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/2020-08-27-WEB-WEB-3DLaptopScreens_0.jpg?itok=5Emfkk_y 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/2020-08-27-WEB-WEB-3DLaptopScreens_0.jpg?itok=5Emfkk_y" width="420" height="220" alt="Laptop Screens" class="img-responsive" /> </picture> </div> </div> <div class="lcds-card__body"> <h3 class="lcds-card__title">Device Advice</h3> <p class="lcds-card__text">Device Advice is CDRH's premier text-based resource for comprehensive regulatory education that explains medical device laws, regulations, guidances, and policies, across the entire product life cycle.</p> </div> </article> </a> <a href="/medical-devices/medical-devices-news-and-events/cdrh-events" title="CDRH Webinars"> <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/Medical-Device-Webinars-for-Industry.jpg?itok=2GN8MbA2 380w" media="all and (max-width: 320px)" type="image/jpeg" sizes="100vw" width="380" height="200"/> <source srcset="/files/styles/thunbnail_3/public/Medical-Device-Webinars-for-Industry.jpg?itok=2GN8MbA2 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/Medical-Device-Webinars-for-Industry.jpg?itok=p-c7lSks 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/Medical-Device-Webinars-for-Industry.jpg?itok=p-c7lSks 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/Medical-Device-Webinars-for-Industry.jpg?itok=p-c7lSks 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/Medical-Device-Webinars-for-Industry.jpg?itok=p-c7lSks 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/Medical-Device-Webinars-for-Industry.jpg?itok=p-c7lSks" width="420" height="220" alt="Webinar Feature Graphic" class="img-responsive" /> </picture> </div> </div> <div class="lcds-card__body"> <h3 class="lcds-card__title">CDRH Webinars</h3> <p class="lcds-card__text">CDRH Webinars feature FDA presentations and live stakeholder question and answer discussions about timely medical device laws, regulations, guidances, or programs.</p> </div> </article> </a> </div> </section></div> <div class="field--item"> <section class="lcds-contact"> <div class="lcds-contact__contact lcds-contact__contact--subtopic bg-blue txt-light"> <h2 class="lcds-contact__heading sr-only" > <div class="field field--name-field-title-contact-us field--type-string field--label-above"> <div class="field--label">Paragraph Header</div> <div class="field--item">Contact Us</div> </div> </h2> <div class="field field--name-field-contact-point field--type-entity-reference field--label-above"> <div class="field--label">Contact Point</div> <div class="field--item"><div> <div class="field field--name-field-contact-point-description- field--type-string-long field--label-hidden field--item">Division of Industry and Consumer Education<br /> Center for Devices and Radiological Health<br /> Food and Drug Administration<br /> 10903 New Hampshire Ave<br /> Silver Spring, MD 20993<br /> </div> <p> <div class="field field--name-field-email field--type-email field--label-hidden field--item"><a href="mailto:DICE@fda.hhs.gov">DICE@fda.hhs.gov</a></div> </p> <p> <div class="field field--name-field-phone field--type-string field--label-hidden field--item">(800) 638-2041</div> <div class="field field--name-field-phone-2 field--type-string field--label-hidden field--item">(301) 796-7100</div> </p> <p> </p> <p> <div class="field field--name-field-hours-available field--type-entity-reference-revisions field--label-above"> <div class="field--label">Hours Available</div> <div class="field--items"> <div class="field--item"> </div> </div> </div> </p> <p> <div class="field field--name-field-office-ext-org-committee field--type-entity-reference field--label-hidden field--items"> <div class="field--item"> <div class="field field--name-field-office-name field--type-string field--label-hidden field--item">Office of Communication, Information Disclosure, Training and Education</div> </div> </div> </p> </div></div> </div> </div> </section> </div> </div> </div> <br> </div> <aside 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