The FDA Announces Public-Private Partnership to Expedite Medical Device ApprovalsDecember 19, 2012
The U.S. Food and Drug Administration (FDA) announced Monday that it is part of the first public-private partnership to promote medical device regulatory science. The partnership will focus on speeding up the review and approval processes of new medical devices.
The new Medical Device Innovation Consortium (MDIC) is an independent, nonprofit corporation created by LifeScience Alley, a biomedical science trade association. The MDIC will receive input from industry, government and other nonprofit organizations and 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 is the science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of FDA-regulated products.
Speaking on the topic of regulatory science, FDA Commissioner Margaret Hamburg, MD, told an audience at NEHI’s Bridging the Innovation Gap conference in Boston last April that the agency needs more resources in order to speed up its processes.
“The same people that are doing the reviews are developing the guidances and going out into the communities,” said Hamburg. “They are being asked to do too many things at once. They burn out and we have rapid turnover. It’s a terrible downward spiral that will serve no one. One of the things that has been such a struggle is that the agency has been unbelievably stretched for resources.”
The MDIC may offer the additional resources need by FDA, according to Jeffrey Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health.
“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 Shuren, in a press release announcing the partnership.