FDA: Public-Private Venture Set to Improve Regulatory Science
(HealthDay News) – The Medical Device Innovation Consortium (MDIC), the first public-private partnership to promote medical device regulatory science, has been established, according to a Dec. 3 news release issued by the U.S. Food and Drug Administration.
The MDIC, an independent nonprofit corporation created by LifeScience Alley, a biomedical trade association, will collaborate with FDA staff and receive input from industry, government, and other nonprofit organizations. The consortium aims to promote medical device regulatory science by simplifying both the process of medical device design and the pathways to market these innovations.
According to the report, the MDIC will prioritize the regulatory science needs of the medical device community, including those involved in developing new tools, standards, and approaches to evaluate the safety, efficacy, quality, and performance of FDA-regulated products. To better assess new devices, the MDIC will pool people, resources, funding, and ideas. The consortium will focus on speeding the development, evaluation, and review of new medical devices with the goal of improving the process involved and reducing the time and costs related to getting the product to market.
"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," Jeffrey Shuren, MD, JD, director of the FDA's Center for Devices and Radiological Health, said in a statement.