FDA seeks to define, clarify mobile device application regulations

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The U.S. Food and Drug Administration (FDA) is seeking public input regarding its proposed oversight approach to mobile device applications that relate to healthcare IT.

According to draft guidelines that were released this week, the FDA would regulate a small number of devices and applications that could be used in a clinical diagnosis scenario or to modify existing clinical tools.

Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, said that “the use of mobile medical apps on smart phones and tablets is revolutionizing healthcare 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.”

Under the FDA proposals, many of the apps that are currently available would not require regulation. Applications that are intended to store, transmit and evaluate medical information would not require FDA oversight, provided that no clinical diagnoses could be based on the data that is used by the application. The FDA draft regulations focus on applications that either serve as an accessory to a regulated medical device or allow a smartphone to function as a medical device.

The guidelines further stipulate that software companies may be required to meet certain criteria when developing applications for mobile platforms under existing quality systems regulations. Developers would also be subject to FDA requests to correct errors or design flaws in medical applications under the proposed regulations to ensure patient safety.

Mobile market intelligence company Research2Guidance estimates that more than 500 million smartphone users will make use of a medical application by 2015, according to Healthcare IT News. Recent estimates suggest that more than 4,000 medical applications are currently available.