Checklist

FDA seeks feedback on oversight of mobile medical 'apps'

September 2011 Checklist
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The Food and Drug Administration (FDA) is seeking comments by Oct. 19 on its draft guidance for oversight of certain health care-related mobile applications. The FDA proposes oversight of a subset of mobile applications, or "apps," designed for use on smart phones and other mobile computing devices. Specifically, the FDA is concerned with apps that are "used as an accessory to [a] medical device already regulated by the FDA" and apps that "transform a mobile communications device into a regulated medical device by using attachments, sensors or other devices."

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