The Medical Device Innovation Consortium (MDIC) announced today that the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) will participate in its Case for Quality Collaborative Community (CfQcc) initiative.
The CDRH identified participation in collaborative communities as a strategic priority for 2018 to 2020. The purpose of a collaborative community is to bring together medical device stakeholders in a continuing forum of private- and public-sector members, including the FDA, to achieve common outcomes, solve shared challenges, and leverage collective opportunities. Ultimately, collaborative communities seek to contribute to the improvement of areas affecting U.S. patients and healthcare.
“The FDA is committed to working with diverse stakeholders to help ensure that patients and health care providers have access to safe, effective, and high-quality medical devices,” said Francisco Vicenty, CfQcc program manager within FDA’s CDRH. “Today’s announcement reflects the agency’s commitment to collaborative communities and builds upon existing efforts to help advance medical device quality and safety to achieve better patient outcomes. We continue to believe that collaborative communities can contribute to improvements in areas affecting patients and health care in the United States.”
The mission of the CfQcc is to convene a collaborative community of diverse stakeholders representing and serving the medical device industry with the goal of transitioning from baseline regulatory compliance to sustained, predictive practices that advance medical device quality and safety to achieve better patient outcomes. As the Convener of the CfQcc, MDIC will facilitate a neutral environment of trust and transparency, wherein a diverse group of stakeholders representing the breadth of the medical device ecosystem can collaborate openly with candor irrespective of whether they are a manufacturer, provider, patient, payor, or a member of MDIC. This initiative builds on the progress of MDIC’s Case for Quality program.
“We founded the vision and mission of the Case for Quality to reduce the risk to patients. The transformation of Case for Quality from an ecosystem program to a collaborative community really is an exciting time for us,” said Joe Sapiente, Vice President of Quality Assurance and Regulatory Affairs, Surgical, Breast, Skeletal Health, for Hologic Inc. and Chair of MDIC’s Case for Quality Steering Committee. “The formation of the Case for Quality Collaborative Community is a model for long-term success and benefit, in terms of governance, agency and industry involvement, and relationship management of our diverse stakeholders.”
In 2019, MDIC’s National Evaluation System for health Technologies Coordinating Center (NESTcc) Collaborative Community was named one of the first collaborative communities with FDA participation.
About the Medical Device Innovation Consortium
Founded in 2012, the Medical Device Innovation Consortium (MDIC) is the first public-private partnership created with the sole objective of advancing medical device regulatory science throughout the total product life cycle. MDIC’s mission is to promote public health through science and technology and to enhance trust and confidence among stakeholders. MDIC works in the pre-competitive space to facilitate the development of methods, tools, and approaches that enhance understanding and improve evaluation of product safety, quality, and