FDA Draft Guidance for Industry on Mobile Medical Applications Released


On July 21, 2011, the U.S. Food and Drug Administration (“FDA”) released draft guidance specifying how the FDA intends to oversee regulation of mobile medical applications for smartphones and other mobile computing devices. The guidance identifies the types of mobile medical applications that the FDA intends to focus on and requests industry comment by October 19, 2011. Although the guidance is not binding, it gives a good indication of the FDA’s current position on the regulation of mobile medical applications.

The FDA’s guidance is further evidence of the growing influence of mobile technology in the practice of medicine. While FDA oversight will be aimed at the manufacturers of mobile medical applications (which in many cases may not be medical providers) certain circumstances could render a radiology group or an imaging center a “manufacturer” for purposes of FDA oversight. The guidance explains that manufacturers include those parties that initiate specifications for a device to be manufactured by a second party for subsequent commercial distribution. This means that for groups that hire a software consultant to create an application to be used “in-house”, the group could potentially be considered a manufacturer if it decides to market the application commercially.

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