FDA Partners With Manufacturers on Medical Technology Initiative
The U.S. Food and Drug Administration (FDA) says it will join forces with medical device manufacturers in an initiative aimed at speeding up the development and review of new medical devices and technology.
The FDA is part of the new Medical Device Innovation Consortium (MDIC), which was created by LifeScience Alley (LSA), an industry group based in Minnesota, the home state of one of its members, the manufacturer Medtronic.
In announcing the partnership on Monday, FDA officials said they would provide guidance to the MDIC and collaborate with the consortium on 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,” said Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health.
The move comes as the FDA seeks to streamline its process for reviewing applications to bring new devices to market. Industry officials and Republicans on Capitol Hill have criticized the agency for having what they’ve called a slow and cumbersome review process, one that they say impedes the development of new medical technology.
Shuren described this new public-private partnership, which was in development for two years, as a win-win endeavor.
“This is about saving lives and improving care,” he said, emphasizing that the joint effort will help to bring cutting-edge and safe technologies to market sooner. As an example of what the consortium could fund and develop, FDA officials described a computer model that could be used to test an implant on a virtual patient—a move that would come before the manufacturer invests in a clinical trial.
The MDIC is an independent, nonprofit corporation. Shuren will sit on the board, along with Tamara Syrek Jensen, a deputy director with the Centers for Medicare & Medicaid Services; Peter Saltonstall, president and CEO of the National Organization for Rare Disorders; and representatives from leading manufacturers, including Medtronic, Boston Scientific Corporation, and Becton, Dickinson and Company.
FDA Commissioner Margaret Hamburg said the new consortium would serve as a “safe space” that would advance the cause of regulatory science. “It’s too expensive for anyone to do this alone,” she said.
To read the FDA’s press release about this partnership, click here. The website for the MDIC is: http://www.deviceconsortium.org/
Posted: December 4, 2012