The FDA announces that it is part of the first public-private partnership to promote medical device regulatory science with a focus on speeding the development, assessment, and review of new medical devices.
The new Medical Device Innovation Consortium (MDIC) is an independent, nonprofit corporation, created by LifeScience Alley, a biomedical science trade association. The MDIC will receive input from industry, government, and other nonprofit organizations. MDIC will prioritize the regulatory science needs of the medical device community and fund projects to help simplify the process of medical device design and pathway to market for these innovations.
According to the FDA, regulatory science—the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products—represents a critical component of the medical device industry and public health. Advancements in regulatory science aim to improve how products are developed and evaluated and they can also reduce the cost and time it takes for a promising device to come to market.
The MDIC will augment the country’s investment in regulatory science research by pooling people, funding, resources, and ideas to develop new tools, models, and methods that may be utilized to better and more efficiently evaluate new devices. FDA staff may collaborate with the MDIC on MDIC-supported research and other projects.