Updated on 9 January 2013
US FDA's Center for Devices and Radiological Health (CDRH) and LifeScience Alley sign memorandum of understanding (MoU)
Singapore: The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) is joining hands with US life science industry to bring advancement in regulatory science. The apex agency has signed a memorandum of understanding (MoU) with LifeScience Alley, life sciences trade association in the US. Regulatory science refers to the tools, methods, and approaches to assessing the safety, effectiveness, performance and quality of medical products.
"This agreement represents a critical step in the process of realigning the day-to-day interactions between medical device companies and the FDA," stated Mr Dale Wahlstrom, president and CEO of LifeScience Alley and the BioBusiness Alliance of Minnesota. "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 MoU recognizes that CDRH and LifeScience Alley, which represents the industrial and academic medical technology community sectors, have shared interests in further developing regulatory science for medical devices and in enhancing the understanding of the safety, effectiveness, quality and performance of medical devices.
It also forms the basis for the development of scientific and intellectual collaborations, outreach, and educational initiatives among the FDA, LifeScience Alley, the University of Minnesota, the medical device community and eventually other partners across the country.
"The FDA's approach to regulation must be as smart and as innovative as the products we review," said Dr Shuren. "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."