FDA Participates in New 'Collaborative Communities' to Address Emerging Challenges in Medical Devices

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Aug 04, 2021, 13:12 ET

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.

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
MedTech Color Collaborative Community on Diversity and Inclusion in Medical Device Product Development and Clinical Research (MedTech Color Collaborative Community)
Digital Health Measurement Collaborative Community (DATAcc)

"The number of collaborative communities has continued to grow, showing that, amidst the backdrop of the COVID-19 pandemic, many remain dedicated to the idea that together, they can better achieve common outcomes, solve shared challenges and leverage collective opportunities to improve public health," said Michelle Tarver, M.D., Ph.D., deputy director of the Office of Strategic Partnerships and Technology Innovation in the FDA's Center for Devices and Radiological Health.

Collaborative communities are convened by interested stakeholders and may exist indefinitely, produce deliverables as needed and tackle challenges with broad impacts. The FDA does not establish, lead or operate collaborative communities, nor are collaborative communities intended to advise the FDA. Instead, the FDA may participate in the community in order to contribute its knowledge and perspective to discussions of public health challenges and solutions.

The FDA reached the goal set as part of CDRH's 2018-2020 Strategic Priorities of participating in at least 10 new collaborative communities by December 31, 2020.

Additional Resources:

Media Contact: Lauren-Jei McCarthy, 240-702-3940
Consumer Inquiries: Email, 888-INFO-FDA

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.

SOURCE U.S. Food and Drug Administration