Sunday, December 9, 2012

FDA's New Partnership Efforts

FDA is taking part in the first public-private partnership to promote medical device regulatory science with the focus on speeding the development, assessment, and review of new medical devices. Regulatory science works to develop new tools, standards, and approaches to assess the safety, efficacy quality and performance of FDA regulated products that are critical to the medical device industry.

Advancements in regulatory science could not only improve how products are developed and evaluated but also reduce the cost and time it takes for a promising device to come to market.

The new Medical Device Innovation Consortium (MDIC) is an independent, nonprofit corporation created by LifeScience Alley (LSA), a biomedical science trade association that provides insights into current trends, regulations, research, and emerging technologies.

MDIC membership is open to representatives of organizations that are substantially involved in medical and/or medical device research, development, treatment, education, promoting public health, or have expertise in regulatory science 

MDIC will receive input from industry, government, and other nonprofit organizations and then prioritize the regulatory science needs of the medical device community. The next step will be to fund projects to help simplify the process of medical device design and the last step will be to look at commercialization possibilities.

The output from MDIC will:

  • Ensure innovative technology is readily available to patients
  • Provide industry and government with methods and tools that can be used to expedite medical device development and the regulatory process
  • Reduce the risk and expense of clinical research
  • Reduce the time and cost of medical device development
“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, M.D., J.D., Director for FDA’s Center for Devices and Radiological Health.

For more information, go to