The FDA has unveiled its oversight approach for certain mobile applications specific to medicine or healthcare. The moves comes as millions of smartphone users start using apps to perform a variety of health-related functions, including monitoring calorie intake to maintain a healthy weight and allowing doctors to view a patient's radiology images on their mobile communications device.
The draft guidance defines a small subset of mobile apps that could impact the performance or functionality of currently regulated medical devices. This subset includes apps that can be used as an accessory to a medical device already regulated by the FDA, or those that can transform a mobile communications device into a regulated medical device by using attachments, sensors or other devices, the agency says in a statement.
"The use of mobile medical apps on smart phones and tablets is revolutionizing healthcare delivery," said CDRH Director Jeffrey Shuren. "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."
Already, the FDA has won praise for its proposal. "Overall we think the FDA has taken a very reasonable and sensible approach on this. They've made some clear distinctions with regards to mobile medicine. It sets the stage for continued development and gives everybody an idea of what is and is not covered under the FDA guidance," John Walls, VP of public affairs for CTIA, told PCWorld in an interview.
Several mobile medical programs have already passed FDA scrutiny, as MassDevice points out. These include two blood pressure cuffs that track and store readings on smartphones, GE's Pocket Viewer, Airstrip Technologies' Airstrip, Mobisante's MobiUs and MIM Software's Mobile MIM.
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