The FDA participates in new “collaborative communities” to address emerging challenges in medical devices


For immediate release:

Today, the United States Food and Drug Administration announced its participation in several new collaborative communities aimed at addressing the challenges of patient health care. Collaborative communities are an ongoing forum where representatives of the private and public sectors of the community work together on medical device challenges to achieve common goals and outcomes.

“We are pleased to report the progress we have made with participating in collaborative communities. These collaborations with various stakeholders are not only a strategic priority for the FDA’s Center for Devices and Radiological Health, they also provide much-needed forums for in-depth discussions and solution-oriented initiatives to address important issues within the organization. the medical device ecosystem, ”said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health. “The ideas and results developed by these groups will have long-term 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 pathways to accelerate and fill gaps in regulatory science and other knowledge to facilitate medical device review and oversight. They can also impact the delivery of health care and change the paradigms of clinical care.

The most recent collaborations relate to subjects such as: the development of medical devices and product quality; understanding of heart valve disease; innovations in digital pathology; reduce the rates of intentional self-harm and suicide in people with diabetes; and strategies to increase 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 Assessment System for the Collaborative Community of the Health Technology Coordination Center (NESTcc)
  • Pharmacogenomics Laboratory Practice Standardization Initiative (STRIPE) Collaborative Community
  • International Liquid Biopsy Standardization Alliance (ILSA)
  • Xavier Global Artificial Intelligence (AI) Consortium
  • Case for a quality collaborative community
  • Collaboration of heart valves (HVC)
  • Collaborative wound care community
  • Collaborative Community for Innovation in Pathology (PICC)
  • MedTech Color Collaboration Community on Diversity and Inclusion in Medical Device Product Development and Clinical Research (MedTech Color Collaboration Community)
  • Collaborative digital health measurement community (DATAcc)

“The number of collaborative communities has continued to grow, showing that, in the context of the COVID-19 pandemic, many remain committed to the idea that together they can better achieve common results, solve shared challenges and achieve using collective opportunities to improve the audience. health, ”said Michelle Tarver, MD, Ph.D., deputy director of the Office of Strategic Partnerships and Technological Innovation at the FDA’s Center for Devices and Radiological Health.

Collaborative communities are convened by interested stakeholders and can exist indefinitely, produce deliverables as needed, and address challenges with broad impacts. The FDA does not establish, direct, or operate collaborative communities, and collaborative communities are not intended to advise the FDA. Instead, the FDA can participate in the community to contribute its knowledge and perspective to discussions of public health challenges and solutions.

The FDA has met the target set under the CDRH’s 2018-2020 strategic priorities to participate in at least 10 new collaborative communities by December 31, 2020.

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The FDA, an agency of the U.S. Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of drugs, vaccines, and other biologicals for human and veterinary use, as well as medical devices. . The agency is also responsible for the safety and security of our country’s food supply, cosmetics, dietary supplements, products that emit electronic radiation, and the regulation of tobacco products.


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