FDA schedules workshop for mobile medical apps
The U.S. Food and Drug Administration (FDA) will hold a public workshop on its draft guidance proposal for the regulation of mobile medical applications on September 12 and 13 at its White Oak Campus in Silver Spring, MD.
The purpose of the workshop is to provide a forum for discussion with the FDA and to encourage public comment from interested stakeholders on aspects of the agency’s draft guidance document published in July 2011. Topics will also include standalone software that provides clinical decision-support functionality, and how the FDA should approach accessories and mobile medical applications that are accessories to other medical devices.
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