September 19, 2019
“Part of our work assuring patients and health care professionals have timely and continued access to safe, effective and high-quality medical devices involves collaboration with diverse stakeholders. We know we can achieve better outcomes in protecting and promoting public health when key stakeholder groups work together to achieve shared outcomes and solve shared problems. This is why last year we announced the collaborative communities program as a key strategic priority for the FDA’s Center for Devices and Radiological Health,” said Jeff Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “Since our announcement, we’ve integrated feedback from members of the health care ecosystem into resources developed for emerging collaborative communities seeking to generate solutions that can be used to protect and improve public health. Today we’re excited to announce our participation as members in the first two collaborative communities: NEST Coordinating Center (NESTcc) Collaborative Community and the Ophthalmic Imaging Collaborative Community. We firmly believe in the opportunities offered by participating in collaborative communities, and we recognize that we serve the American public better when stakeholders in the medical device ecosystem, including the FDA, work together.”
Today the U.S. Food and Drug Administration announced participation in the first two collaborative communities; the National Evaluation System for health Technology Coordinating Center (NESTcc) Collaborative Community and the Ophthalmic Imaging Collaborative Community. A collaborative community is a continuing forum where private and public sector members, including the FDA, work together on medical device challenges to achieve common objectives and outcomes. They are convened by interested stakeholders and may exist indefinitely, produce deliverables as needed and tackle challenges with broad impacts.
The FDA is collaborating with medical device stakeholders to build the National Evaluation System for health Technology (NEST), which will link and synthesize data from different sources across the medical device landscape, including clinical registries, electronic health records and medical billing claims, to help improve the quality of real-world evidence. The NESTcc was established in 2016 to provide governance for the NEST ecosystem, oversee infrastructure building, promote standards, and monitor progress. While this is an existing collaboration, today’s announcement highlights that NESTcc has achieved recognition as a Collaborative Community as described in CDRH’s 2018-2020 Strategic Priorities. The NESTcc Collaborative Community is a national network intended to help develop methodologies designed to drive down the time and cost of real-world data collection and analysis and increase the value and use of real-world evidence to meet the needs of patients, payers, the medical device industry, health care professionals and regulatory bodies. The members in this Collaborative Community include stakeholders that reflect the entire NEST ecosystem. As members, individuals will represent their own perspectives as well as those of their larger communities’, such as the professional organization to which they belong.
The Ophthalmic Imaging Collaborative Community will seek to identify and clarify important challenges, clarify best practices, strategies and standards and advance innovation within the general area of ophthalmic imaging. This collaborative community has domestic and international stakeholders from the health care ecosystem committed to developing scientific solutions that can aid in clarifying the use of natural language processing and other emerging technological advances that can refine the diagnosis, management and treatment of patients with eye diseases as well as other medical conditions.
The FDA does not establish, lead or operate collaborative communities, nor are collaborative communities intended to advise the FDA. Instead, the FDA 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 interest of the public health and is consistent with the law.
The agency is actively engaging with medical device stakeholders to encourage the formation of more collaborative communities by others as part of the Center for Devices and Radiological Health’s strategic priority to establish participation in at least 10 collaborative communities by Dec. 31, 2020.Collaborative communities are invited to use a toolkit, developed with public feedback as well as input from the FDA’s Patient Engagement Advisory Committee, to establish themselves and to encourage effective collaboration to take on health care challenges.
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.