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The FDA’s Center for Devices and Radiological Health is participating in a growing number of public-private partnerships called “collaborative communities” that focus on overcoming device development hurdles.
Established by outside stakeholders, the communities can use a 2019 FDA toolkit that outlines best practices for them. The groups include patients and patient organizations, hospitals, professional societies, academic institutions, payers, and device or technology makers. Once established, they may ask FDA staff to participate in discussions, but the FDA doesn’t lead the groups and the groups’ work doesn’t replace traditional regulatory processes.
The communities tackle a range of topics. The Wound Care Collaborative Community aims to improve the safety of devices and drugs to treat wounds and to cut the cost patients pay for new technologies. The Reducing Suicide Rates Among Individuals With Diabetes Collaborative Community intends to better identify and help individuals with diabetes who are at risk of self-harm or suicide. The Heart Valve Collaboratory is working to fill gaps in knowledge about heart valve disease and to advocate for patients in underserved populations. Others are focused on issues including pharmacogenomic testing and laboratory practices for liquid biopsies in oncology.
“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,” Michelle Tarver, MD, PhD, deputy director of the FDA’s Office of Strategic Partnerships and Technology Innovation, said in a statement.
Kuehn BM. “Collaborative Communities” Tackle Device Development Challenges. JAMA. 2021;326(11):1000. doi:10.1001/jama.2021.15589
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