As more and more mobile medical apps (applications) enter the market, the FDA (Food and Drug Administration) has said today it seeks feedback on its proposed oversight approach. These apps are designed for smartphone and other mobile computing device usage.

The FDA says it would like to focus just on a certain number of apps and will not become involved in regulating apps for consumer use.

Mobile medical apps have a variety of functions today, including helping people maintain a healthy body weight, keeping an eye on their calorie consumption, or allowing physicians to see a patient’s imaging scans on a mobile device. By 2015 over 500 million smartphone users are expected to be using a health care app.

Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health, said:

“The use of mobile medical apps on smart phones and tablets is revolutionizing health care delivery. 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 FDA would like to supervise a small subset of mobile medical apps that might impact the functionality or performance of currently regulated medical devices. For example:

  • Apps that are currently used as an accessory to already FDA-regulated medical devices. These may include apps that allow a doctor to view a scanned image from a PACS (archiving communication system) on a smartphone or mobile tablet.
  • Apps that can turn a mobile communications device into an FDA-regulated medical device by using sensors, attachments or other devices. For example, some smartphones can turn into an ECG device.

The FDA is asking for public feedback on its proposed approach. Comments, once posted, can be submitted for 90 days online, or by post to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

The Agency says it will update the draft guidance according to feedback it receives.

“FDA: Draft Guidance for Industry and Food and Drug Administration Staff – Mobile Medical Applications”

“FDA: Consumer Update – FDA Proposes Health ‘App’ Guidelines”

Written by Christian Nordqvist