CDRH identified participation in collaborative communities as a strategic priority for 2018 to 2020. The purpose of a collaborative community is to bring together medical device stakeholders in a continuing forum of private- and public-sector members, including the FDA, to achieve common outcomes, solve shared challenges, and leverage collective opportunities. Ultimately, collaborative communities seek to contribute to the improvement of areas affecting U.S. patients and healthcare.
The mission of NESTcc is to accelerate the development and translation of new and safe health technologies, leveraging real-world evidence (RWE), and innovative research. In support of this mission, NESTcc works with stakeholders across the medical device ecosystem to catalyze the timely, reliable, and cost-effective development of RWE to enhance regulatory and clinical decision-making.
NESTcc aimed to become a collaborative community as part of its 2019 strategic and operating plan, and amended its charter to align with the FDA’s Collaborative Communities Toolkit. Members of the NESTcc Governing Committee represent their own perspectives, as well as those of their larger stakeholder communities, with the intention of ensuring diverse and distributed leadership of NESTcc among patients, payers, the medical device industry, healthcare professionals and regulatory bodies.
In addition to the National Evaluation System for health Technology Coordinating Center (NESTcc) Collaborative Community, FDA announced that CDRH will also participate as a member of the Ophthalmic Imaging Collaborative Community.
For more information, see the FDA announcement.