By FDA Commissioner Scott Gottlieb, M.D.; Jeff Shuren, M.D., Director of FDA’s Center for Devices and Radiological Health (CDRH); and CDRH Patient Science and Engagement Program Director Michelle Tarver, M.D., Ph.D.
Collaboration. It’s a word we use a lot at the FDA — and for good reason. Collaboration is an essential element of many approaches we apply to achieve our public health mission.
Across the FDA, we work to assure patients and providers have timely and continued access to safe, effective, and high-quality medical products. At our Center for Devices and Radiological Health (CDRH) this involves engagement every day with key stakeholders, including patients, providers, and innovators.
Each of these communities rely on the FDA to develop and implement regulatory policies that outline and enforce clear standards for ensuring the safety and effectiveness of medical devices. And in turn, the agency relies on these communities to provide us with feedback that helps us continue to assure patient safety by monitoring how these products are performing in real-world settings. We use this information to take appropriate actions if medical products no longer meet our regulatory standards.
These public health obligations require us to work across the total product lifecycle of a medical device. And collaboration with diverse stakeholders is a key to achieving these goals. We know that we can achieve better outcomes in protecting public health when we integrate different perspectives, experiences, resources, and expertise from each participant in the medical device ecosystem. To advance these goals, last January we announced that a key strategic priority was the development of Collaborative Communities. The purpose is to encourage the formation of continuing forums where stakeholders can proactively work together to achieve common objectives and outcomes, solve shared challenges, and leverage collective opportunities in an environment of trust, respect, empathy, and openness.
The FDA’s commitment to Collaborative Communities recognizes that we serve the American public better when stakeholders in the medical device ecosystem, including the FDA, work together. Collaborative Communities, we believe, can contribute to improvement in areas affecting U.S. patients and healthcare and result in wide-ranging benefits for public health. We’re so committed to this concept that we included it in our feedback to Congress on how to advance a modern framework for the regulation of in vitro diagnostics. We recognize the potential benefits Collaborative Communities could offer for the future of these healthcare products, which are lab tests used to help detect and monitor the treatment of diseases and other health conditions. In this context, we see opportunities for Collaborative Communities to help evaluate evidence to support new clinical claims and new technologies, as well as develop performance criteria that would help advance an efficient approach to the oversight of more established tests.
Creating Collaborative Communities
We believe that Collaborative Communities could accelerate the development of science-based solutions to policy challenges related to assuring the safety and effectiveness of many novel areas of medical device innovation. The Collaborative Communities would typically be composed of appropriate representatives from the full range of stakeholder communities impacted by a common topic. Participants could include but are not limited to patients, caregivers, academicians, healthcare professionals, healthcare systems, payors, government agencies, international regulatory bodies, and product developers.
Distinct from task forces, working groups, and commissions — which often address narrowly-defined problems and disband after developing a final deliverable — Collaborative Communities would typically include interested stakeholders and could exist indefinitely. They could produce deliverables as needed, and tackle challenges with broad impacts. The development of consensus-oriented outcomes would be reinforced by their shared accountability for achieving common goals. CDRH has set as a key strategic priority the establishment of at least 10 new Collaborative Communities by December 31, 2020.
CDRH does not establish, lead, or operate Collaborative Communities. Nor are these Communities intended to advise CDRH. Instead CDRH may participate as a member of the Collaborative Community and consider adopting the solutions developed by the body if doing so is in the best interests of the public health and consistent with the law.
To advance these opportunities, CDRH has created a toolkit to help foster the development of Collaborative Communities. It provides helpful ideas to cultivate effective collaboration, which can result in stronger communities that are well-prepared to take on healthcare challenges. In developing this resource, FDA’s device center is relying on the feedback and input from stakeholders, including and especially patients. Stakeholders who would like to provide feedback on the toolkit and other areas related to the development of Collaborative Communities can submit their comments at https://www.regulations.gov/docket?D=FDA-2018-N-3519 by December 24, 2018.
Earlier this month, we also asked the members of the FDA’s Patient Engagement Advisory Committee for their suggestions about changes we could make to the toolkit, their experiences working in collaborative efforts that involve multiple customers, their perspectives on what specific Collaborative Communities would be helpful to the healthcare ecosystem, and what challenges they are best designed to help us address.
Issue Areas for Communities to Collaborate
While the intent is to spur ideas for Collaborative Communities outside the FDA, we already know that our work would benefit significantly from this approach, including addressing regulatory science and other knowledge gaps to aid in medical device review and oversight activities. We’ve laid the groundwork for several Collaborative Communities to more efficiently generate better evidence and standards that can serve as the basis for medical device evaluation and regulatory decision-making through a number of efforts. These include our work with the National Evaluation System for health Technology (NEST); Case for Quality, which is helping develop criteria to allow the FDA to identify device manufacturers that can consistently produce high-quality devices so we can better focus more of our resources on helping other manufacturers raise their level of quality; and pediatric medical device innovation, to support the development and availability of safe and effective pediatric medical devices.
We firmly believe in the opportunities offered by Collaborative Communities. Over the next two years, CDRH intends to make the building of Collaborative Communities part of our standard practice to solving certain challenges. In addition, as Collaborative Communities are built, we hope that they’ll attract the participation of our international colleagues who can help expand the role and approach of these bodies, helping us to find solutions that stretch across countries to reach a global scale.