The US Food and Drug Administration has been participating in new “collaborative communities,” according to the FDA and Imaging Technology News (ITN). One of the strategic priorities of the FDA’s Center for Devices and Radiological Health (CDRH) for 2018-2020, CDRH “believes collaborative communities can contribute to improvements in areas affecting patients and health care in the United States.’ according to the FDA website.

The CDRH defines a collaborative community as “a continuing forum in which private- and public-sector members, which can include the FDA, work together on medical device challenges to achieve common objective and outcomes. They are convened by interested stakeholders and may exist indefinitely, produce deliverables as needed and tackle challenges with broad impacts.” Collaborative communities are “established, managed, and controlled” by stakeholders outside of the FDA, according to ITN. While FDA staff members can participate in collaborative communities in ways similar to other members, they cannot chair or convene a collaborative community. “FDA staff members may participate in workstreams, as well as lend a regulatory perspective to discussions,” according to the FDA.

“’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,'” reports ITN.

Get more information about the CDRH’s participation in collaborative communities at its web page Collaborative Communities: Addressing Health Care Challenges Together. You can also download the Collaborative Communities Toolkit for an outline on creating, organizing, and managing a creative community.

Sources:

“Collaborative Communities: Addressing Health Care Challenges Together” US FDA website. Available at  https://www.fda.gov/about-fda/cdrh-strategic-priorities-and-updates/collaborative-communities-addressing-health-care-challenges-together?utm_medium=email&utm_source=govdelivery#whatis Accessed: August 19, 2021.

“FDA Participates in New ‘Collaborative Communities’ to Address Emerging Challenges in Medical Devices” Imaging Technology News. Available from August 4, 2021, at https://www.itnonline.com/content/fda-participates-new-%E2%80%98collaborative-communities%E2%80%99-address-emerging-challenges-medical-devices. Accessed August 19,2021.