Dr. Califf's opening remarks to the 26th session of the International Medical Device Regulators Forum (IMDRF) - 09/16/2024

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href="mailto:?subject=Dr.%20Califf%27s%20opening%20remarks%20to%20the%2026th%20session%20of%20the%20International%20Medical%20Device%20Regulators%20Forum%20%28IMDRF%29%20-%2009%2F16%2F2024&body=https://www.fda.gov%2Fnews-events%2Fspeeches-fda-officials%2Fdr-califfs-opening-remarks-26th-session-international-medical-device-regulators-forum-imdrf-09162024" class="lcds-share__btn lcds-share--default__btn-mail"><span class="fa icon-envelope" 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"> <div class="row inset-column" id="event-information"> <div class="col-xs-12 col-md-6"> <dl> <dt>Speech by</dt> <dd> Robert M. Califf, M.D., MACC <br/> <br/> </dd> </dl> </div> <div class="col-xs-12 col-md-6"> </div> </div> <p>Good morning.  It’s great to be with you today and help welcome all of you to this meeting of the International Medical Device Regulators Forum, or IMDRF.   </p> <p>I’m very sorry I can’t be with you in person, however, I know that you are in good hands with my colleague Jeff Shuren, who has so ably led this group over the past year. </p> <p>This is an important and impressive meeting for a number of reasons.   </p> <p>First, because it brings together such a distinguished group of medical device regulators from around the globe who share the goal of accelerating international medical device regulatory harmonization and convergence.   </p> <p>By any standard, this is an important gathering, and the work you do here and at home has an extraordinary impact on the nations and people we serve in our efforts to protect and advance public health.  </p> <p>There’s another very significant and inspiring aspect of this meeting, which is the continuing success and remarkable growth of this group.  When IMDRF was created, it was in response to a perceived need for a place where international regulators could share information and strategies and work toward common goals relating to public health in the rapidly expanding and increasingly sophisticated world of medical devices. Technologies such as digital health software a a medical device were just beginning to emerge and the founding regulatory authorities saw a need to promote an efficient and effective regulatory model for medical devices that would be responsive to emerging challenges in the sector while protecting and maximizing public health and safety and ensuring that the voice of patients is brought into the medical device ecosystem. </p> <p>But, as the founders of this group envisioned even then, to be truly effective over the long term in this work and to maximize our ability to help the greatest numbers of people from across the globe, a broad based and continually expanding membership is essential.  To your credit, you’ve focused on this important goal and I’m pleased to see how this organization’s membership has grown – both in terms of sheer numbers – from the eight founding members in 2011 to the current 32 member organizations today.  </p> <p>But even more important has been the diversification of the membership, to expand the accessibility of devices to those populations in need.  Here I’m talking particularly about nations in Africa and the Latin American region, but there are many new member nations from other regions as well. </p> <p>You are to be congratulated for growing this organization – and for expanding it in productive and beneficial ways to ensure that the regulatory systems we operate benefit and protect the people and the patients for whom they are designed.</p> <p>As a cardiologist and former intensive care unit director, I feel like devices are part of my professional identity, ranging from the complex devices like defibrillators, stents and cardiac valve deployment systems to the simplest devices like syringes and stopcocks.  Perhaps these simple devices are the most under-appreciated and taken for granted, but critical elements of basic healthcare.  Despite the amazing benefits of devices, without appropriate regulation, the field would veer too often into devices without the health benefits that we all desire—I applaud you for playing this critical and often stressful role in our societies. </p> <p>Next year, the IMDRF will be meeting in Japan, and I know that they will be an excellent host.  It has been the FDA’s great pleasure to host this group this year, and I hope that over the course of the past year and during these meetings you have had the opportunity to get to know and work with the distinguished head of the FDA’s Device Center, Jeff Shuren, and the chair of this group for the past year, who I am pleased to introduce now.   </p> <p>As some of you may know, Jeff recently announced his retirement from the FDA after a remarkable 28 years of federal service.  As we conduct a nationwide search for a permanent successor to Jeff, he will assist in the transition with the title of Center Director Emeritus until he officially leaves the FDA later this year. </p> <p>Jeff’s shoes will be hard to fill. He has served as the director of the FDA’s device center since 2009, and during that period has been a catalyst for the modernization of medical device regulation and innovator in every sense of the word. As director, he has applied a holistic, patient-centric, customer service-focused, total product life cycle approach.  </p> <p>His accomplishments are varied and numerous. Among his notable achievements are helping conceive and co-found this very group, as well as the Medical Device Innovation Consortium. He also established the Breakthrough Devices Program and Safety and Performance Based Pathway; created the first-ever Health Center of Excellence at CDRH; and piloted the Total Product Life Cycle Advisory Program, all important tools of modernizing the FDA’s regulatory oversight of medical devices.   I’m particularly excited about the new program for Home as a Healthcare Hub initiated by Jeff, together with our Acting CDRH Director, Dr. Michelle Tarver. </p> <p>Since Jeff became Director nearly 15 years ago, the number of innovative medical devices authorized annually in the U.S. has increased five-fold.  The number of authorizations of new devices in 2023 were the highest in the almost 50-year history of the medical device program.  In short, Jeff has help ensure that patients, both in this nation and abroad, will continue to have the greatest opportunities to benefit from the ever expanding and modernizing medical device ecosystem. </p> <p>Those of you who have worked with Jeff over the years know that while he may be soft spoken and certainly shies away from the spotlight, he has made enormous contributions to the advancement of medical devices and to this organization.  He will be missed. </p> <p>It is my pleasure to welcome back Dr. Jeff Shuren.  <br>  </p>   </div> <aside class="col-md-2 col-md-push-2" role="complementary"> <section id="block-entityviewcontent-4" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <div class="region region-"> <aside class="lcds-card lcds-card--border-top"> <ul role="menu" class="lcds-description-list"> <li role="menuitem" class="node-current-date lcds-description-list__item"> <div> <h2 class="lcds-description-list__item-heading">Content current as of:</h2> <p class="lcds-description-list__item-text"><time datetime="2024-10-09T00:00:00Z">10/09/2024</time> </p> </div> </li> <li role="menuitem" class="lcds-description-list__item"> <div> <h2 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Dr. Califf's opening remarks to the 26th session of the International Medical Device Regulators Forum (IMDRF) - 09/16/2024 | FDA