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FDA Announces Participation in 2 Collaborative Communities to Overcome Med Tech Challenges


The communities aim to improve the quality of real-world evidence and medical devices.


The U.S. Food and Drug Administration (FDA) today announced participation in two collaborative communities — the National Evaluation System for health Technology Coordinating Center collaborative community and the Ophthalmic Imaging collaborative community — to bring together stakeholders to work on medical device challenges to achieve common objectives and outcomes.

The agency is working 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 device landscape. Sources include clinical registries, electronic health records and medical billing claims.

NEST aims to improve the quality of real-world evidence.

While the collaboration between the FDA and the NEST Coordinating Center existed prior to today’s announcement, the organization achieved recognition as a collaborative community.

The NEST Coordinating Center collaborative community is intended to help develop methodologies to decrease the time and cost of real-world data collection and analysis. The network also aims to increase the value and use of such evidence to meet the needs of patients, payers, the medical device industry, healthcare professionals and regulators.

The Ophthalmic Imaging collaborative community will identify and clarify challenges, best practices, strategies and standards and advance innovation within ophthalmic imaging. The collaborative community will help develop solutions that aid in clarifying the use of natural language processes and other emerging tech to refine the diagnosis, management and treatment of patients with eye diseases and other medical conditions.

“Part of our work assuring patients and healthcare professionals have timely and continued access to safe, effective and high-quality medical devices involves collaboration with diverse stakeholders,” said Jeff Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “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.”

Last year, the FDA announced that the collaborative communities program was a key strategic priority for the agency’s Center for Devices and Radiological Health.

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