FDA's Public-Private Partnership Will Develop Regulatory Science for Regulating Medical Devices

December 3, 2012—The US Food and Drug Administration (FDA) announced 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.

According to the FDA, the new Medical Device Innovation Consortium (MDIC) is an independent, nonprofit corporation created by LifeScience Alley (Saint Louis Park, MN), a biomedical science trade association. The MDIC will receive input from industry, government, and other nonprofit organizations. It will prioritize the regulatory science needs of the medical device community and fund projects to help simplify the process of medical device design and the pathway to market for these innovations.

The FDA stated that the MDIC will bolster 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.

“By sharing and leveraging resources, MDIC may help industry to be better equipped to bring safe and effective medical devices to market more quickly and at a lower cost,” commented Jeffrey Shuren, MD, Director of the FDA's Center for Devices and Radiological Health.