The FDA will not be regulating the majority of medical apps because they pose very little health risk to patients, but will instead adopt a “risk-based approach.”
The U.S. Food and Drug Administration (FDA) has published its finalized guidance on regulating medical software applications that can be used on mobile devices such as smartphones and tablets.
According to a notice published on the agency's website, the FDA will not be regulating the majority of medical apps because they pose very little health risk to patients. Instead, the agency will adopt a "risk-based approach" and will concentrate on the small proportion of software apps that could potentially present a risk to users if not working properly. The FDA will regulate apps that allow mobile devices to be used to detect abnormal heart rhythm or apps which are designed to work as an accessory to another medical device that the agency regulates. Other examples given by the agency include apps that function as a mobile ultrasound device or as part of a glucose meter for patients with insulin-dependent diabetes.
Jeffrey Shuren, director of the FDA's Center for Devices for Radiological Health, explained that a tailored policy would make regulation more effective and well-balanced. The finalized guidelines are intended to encourage innovation and provide medical apps developers with the clarity they need to continue working on such important products.
According to the FDA, the popularity of medical apps is constantly growing. Over the past 10 years about 100 such apps were approved by the agency, with 40 percent of approvals granted over the past two years.
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