The FDA announced its proposed oversight approach for mobile medical
applications designed for smartphones and other mobile computing devices. The
agency is seeking input from the public on its draft guidance, which is
designed to encourage the development of new apps without regulating the sale
or general consumer use of smartphones or tablets.
medical apps currently cover a range of functions, such as helping maintain
calorie intake, maintain a healthy weight and allowing physicians to view
radiology images on mobile devices. According to the mobile research firm
research2guidance, 500 million smartphone users worldwide will be using a
health care application by 2015, FDA officials said in a press release.
“The use of mobile medical apps on smartphones and tablets is
revolutionizing health care delivery,” said Jeffrey Shuren, MD, JD,
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
The agency’s draft guidance defines a small subset of mobile
medical apps that affect or may affect the performance or functionality of
medical devices, according to the press release. This subset
includes mobile medical apps that:
- Are used as an accessory to medical devices 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 on a smartphone or a mobile tablet); or
- Transform a mobile communications device into a regulated medical
device by using attachments, sensors or other devices (for example, an
application that turns a smartphone into an electrocardiogram machine to detect
abnormal heart rhythms or determine whether a patient is experiencing a
Once the approach is posted, comments can be submitted for 90 days
online or by writing to: Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. The FDA
will update the guidance based on feedback received.