Minnesota Device-Makers Join Forces with FDA to Advance Regulatory Science

Posted 08 December 2011 | By

Minnesota-based medical device lobbying group, LifeScience Alley, signed a memorandum of understanding with the US Food and Drug Administration (FDA), making official a year-long partnership to continue developing best practices in regulatory science.  Center for Devices & Radiological health chief Dr. Jeffrey Shuren signed the memorandum, 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. (Mass Device)


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