The Food and Drug Administration has issued final guidance on its current thinking about the regulation of medical mobile applications.
“This guidance explains the FDA’s intentions to focus its oversight on a subset of mobile apps,” according to the document. “Mobile medical apps as defined in section III include only those mobile apps that meet the statutory definition of a device and either are intended to be used as an assessor to a regulated medical device or to transform a mobile platform into a regulated medical device.” This means some mobile apps will fall under the 510(k) premarket notification process and require approval from the agency before marketing. Other mobile apps could be subject to some level of oversight at the FDA’s discretion, while others will receive no oversight.
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