SILVER SPRING, Md., July 19, 2011 /PRNewswire-USNewswire/ — The
U.S. Food and Drug Administration today announced it is seeking
input on its proposed oversight approach for certain mobile
applications specific to medicine or health care called mobile
medical applications (“apps”) that are designed for use on
smartphones and other mobile computing devices. This approach
encourages the development of new apps, focuses only on a select
group of applications and will not regulate the sale or general
consumer use of smartphones or tablets.
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Today, mobile medical applications or “mobile medical apps,”
include a variety of functions, ranging from monitoring calorie
intake, helping people maintain a healthy weight, and allowing
doctors to view a patient’s radiology images on their mobile
communications device. According to Research2Guidance 2010, 500
million smartphone users worldwide will be using a health care
application by 2015.
“The use of mobile medical apps on smart phones and tablets is
revolutionizing health care delivery,” said Jeffrey Shuren, M.D.,
J.D., director of the FDA’s Center for Devices and Radiological
Health. “Our draft approach calls for oversight of only those
mobile medical apps that present the greatest risk to patients when
they don’t work as intended.”
The agency’s draft guidance defines a small subset of mobile
medical apps that impact or may impact the performance or
functionality of currently regulated medical devices. This subset
includes mobile medical apps that:
a. are used as an accessory to medical device already regulated
by the FDA
(For example, an application that allows a health care professional
to make a specific diagnosis by viewing a medical image from a
picture archiving and communication system(PACS) on a smartphone or
a mobile tablet); or
b. transform a mobile communications device into a regulated
medical device b
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