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FDA participates in new 'collaborative communities' to address emerging challenges in medical devices

Press releases may be edited for formatting or style | August 05, 2021
SILVER SPRING, Md., Aug. 4, 2021 /PRNewswire/ -- Today, the U.S. Food and Drug Administration announced participation in several new collaborative communities aimed at addressing challenges in patient health care. Collaborative communities are a continuing forum where private and public sector representatives of the community work together on medical device challenges to achieve common objectives and outcomes.

"We're pleased to announce the progress we've made with participation in collaborative communities. These collaborations with diverse stakeholders are not only a strategic priority for the FDA's Center for Devices and Radiological Health, they also provide much needed forums for deep discussion and solution-driven initiatives to tackle important issues within the medical device ecosystem," said Jeff Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health. "The insights and outcomes developed by these groups will have long-standing impacts on public health."

The FDA currently participates in 12 collaborative communities, which are established, managed and controlled by external stakeholders. Collectively these communities are charting paths to accelerate and address regulatory science and other knowledge gaps to aid in medical device review and oversight. They may also impact the delivery of healthcare and change clinical care paradigms.

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The most recent collaborations focus on topics such as: medical device development and product quality; understanding of valvular heart disease; innovations in digital pathology; reducing rates of intended self-injury and suicidal acts by people with diabetes; and strategies to increase the awareness, understanding and participation of racial and ethnic minorities in the medical technology industry. The FDA participates in these collaborative communities:

Collaborative Community on Ophthalmic Imaging
National Evaluation System for health Technology Coordinating Center (NESTcc) Collaborative Community
Standardizing Laboratory Practices in Pharmacogenomics Initiative (STRIPE) Collaborative Community
International Liquid Biopsy Standardization Alliance (ILSA)
Xavier Artificial Intelligence (AI) World Consortium
Case for Quality Collaborative Community
Heart Valve Collaboratory (HVC)
Wound Care Collaborative Community
Pathology Innovation Collaborative Community (PICC)
REducing SuiCide Rates Amongst IndividUals with DiabEtes (RESCUE) Collaborative Community

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