FDA announces public-private partnership to develop regulatory science that will speed patient access to new medical device technologies

FDA: Dec. 3, 2012
The U.S. Food and Drug Administration announced today 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 (LSA), 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.
Regulatory science – the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products – is critical to the medical device industry and to public health. Advancements in regulatory science not only aim to improve how products are developed and evaluated, but also could reduce the cost and time it takes for a promising device to come to market. For example, a computer model might be developed to test an implant on a virtual patient before a manufacturer spends the time and budget to study that product in a clinical trial. Read More