FDA to Regulate Some Medical Apps

Editor’s Note:  Tomorrow’s Federal Register will include the attached notice from FDA announcing the availability of the guidance document entitled “Mobile Medical Applications.” Below is an excerpt from the Notice. 

SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled “Mobile Medical Applications.” The FDA is issuing this guidance to inform manufacturers, distributors, and other entities about how the FDA intends to apply its regulatory authorities to select software applications intended for use on mobile platforms (mobile applications or “mobile apps”). At this time, the FDA intends to apply regulatory requirements to only a small subset of mobile apps referred to in this guidance as mobile medical applications (mobile medical apps).


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