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LifeScience Alley and FDA's Devices Center Sign Memorandum of Understanding to Advance Regulatory Science

Fri, 12/09/2011 - 5:33am

MINNEAPOLIS--(BUSINESS WIRE)--LifeScience Alley announced today that it has signed a memorandum of understanding (MOU) with the U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH). The MOU formalizes interactions that have been occurring between LifeScience Alley and CDRH for more than a year regarding the advancement of regulatory science. CDRH Director Dr. Jeffrey Shuren signed the MOU today just before his keynote address at the Tenth Annual LifeScience Alley Conference & Expo. 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 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 FDAs approach to regulation must be as smart and as innovative as the products we review," said 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."

In keeping with the collaborative nature of the MOU, more than 35 Minnesota medtech industry professionals recently discussed their respective research and other topics with their regulatory colleagues at CDRHs Office of Science and Engineering Laboratories. The visit, organized by LifeScience Alley and CDRH, allowed attendees to share best practices and discuss how to advance regulatory science and better test and evaluate medical devices.

LifeScience Alley will continue to engage local medtech community leaders and University of Minnesota experts in projects targeting the goals set forth by the MOU and will provide updates on all related work.

About LifeScience Alley

LifeScience Alley is an international leader in sharing best practices, and is the largest state-based life sciences trade association in the United States. With a 26-year track record of providing valuable services and results-oriented outcomes to its members, LifeScience Alley enables business success through educating workforces, influencing state and federal public policy, supporting advancement in research and technological innovation, and fostering industry connections. The Associations membership employs approximately 250,000 Minnesotans and its reach extends throughout the Midwest and Canada. www.LifeScienceAlley.org.

Posted by Sean Fenske, Editor-in-Chief, MDT

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