FDA partners with manufacturers to speed medical device approval
NEWS IN BRIEF — Posted Dec. 17, 2012
The Food and Drug Administration plans to work with medical device manufacturers on a new public-private partnership aimed at speeding the development, assessment and review of new medical device technologies, the agency said on Dec. 3.
The announcement comes amid criticism by medical device manufacturers that the FDA’s system of reviewing products slows the development of important new therapies.
The partnership will be through the Medical Device Innovation Consortium, a nonprofit corporation created by LifeScience Alley, a Minnesota-based biomedical science trade association.
The consortium will receive input from industry, government and other nonprofit organizations and prioritize the regulatory science needs of the medical device community. It also plans to fund projects to simplify the process of medical device design and the pathway to market for these innovations.
The partnership will bolster the nation’s investment in regulatory science research by pooling funding, ideas, people and resources to develop new tools and methods that could be used to more efficiently evaluate new devices, the FDA said.