The FDA made it official with LifeScience Alley, a Minnesota-based medical device lobbying group, signing a memorandum of understanding on the continued development of best practices in regulatory science.
Center for Devices & Radiological health chief Dr. Jeffrey Shuren signed the memorandum yesterday, formalizing more than a year of joint effort toward developing regulatory science – a set of tools and methods for evaluating the safety, effectiveness, quality and performance of medical devices.
If the pilot version of the program works in Minnesota, it may serve as a national model for device safety and clearance.
"This agreement represents a critical step in the process of realigning the day-to-day interactions between medical device companies and the FDA," LifeScience Alley and Alliance of Minnesota president & CEO Dale Wahlstrom said in prepared remarks. "It builds the foundation for specific projects that will improve the environment in which the medical device industry is operating, which will help to ensure the availability of life-enhancing and life-saving devices for patients."
The memorandum notes that CDRH and LifeScience Alley have shared goals in advancing regulatory science, and forms the basis for development of scientific and intellectual collaborations, education and outreach, according to a press release.
The partners recently organized a meeting of more than 35 Minnesota med-tech industry professionals to discuss their research and other matters of concern with officials from CDRH’s office of science and engineering laboratories.
"The FDA’s approach to regulation must be as smart and as innovative as the products we review," Shuren said in prepared remarks. "This MOU represents the beginning of important collaboration among industry, government and academia to strengthen the medical device industry and assure that Americans benefit from safe and effective medical products."
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