The U.S. Food and Drug Administration intends to regulate only mobile apps that are medical devices and could pose a risk to a patient’s safety if they do not function as intended.
Some of the risks could be unique to the choice of the mobile platform. The interpretation of radiological images on a mobile device could, for example, be adversely affected by the smaller screen size, lower contrast ratio and uncontrolled ambient light of the mobile platform, the agency said in its recommendations released Monday. The FDA said it intends to take the “risks into account in assessing the appropriate regulatory oversight for these products.”
The nonbinding recommendations to developers of mobile medical apps only reflects the FDA’s current thinking on the topic, the agency said. The guidance document is being issued to clarify the small group of mobile apps which the FDA aims to scrutinize, it added.
The recommendations would leave out of FDA scrutiny a majority of mobile apps that could be classified as medical devices but pose a minimal risk to consumers, the agency said.
The FDA said it is focusing its oversight on mobile medical apps that are to be used as accessories to regulated medical devices or transform a mobile platform into a regulated medical device such as an electrocardiography machine.
“Mobile medical apps that undergo FDA review will be assessed using the same regulatory standards and risk-based approach that the agency applies to other medical devices,” the agency said.
It also clarified that its oversight would be platform neutral. Mobile apps to analyze and interpret EKG waveforms to detect heart function irregularities would be considered similar to software running on a desktop computer that serves the same function, which is already regulated.
“FDA’s oversight approach to mobile apps is focused on their functionality, just as we focus on the functionality of conventional devices. Our oversight is not determined by the platform,” the agency said in its recommendations.
The FDA has cleared about 100 mobile medical applications over the past decade of which about 40 were cleared in the past two years. The draft of the guidance was first issued in 2011.
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