The federal Food and Drug Administration (FDA) says that it is taking a "risk-based" approach to its oversight of mobile medical apps and will focus its enforcement efforts on apps "that present a greater risk to patients if they do not work as intended." The announcement of the enforcement approach accompanied the FDA's release of its final guidance resource (.pdf) for developers of the technologies.
The guidance and enforcement information was released in draft form in July 2011, and the final document is now part of the resources available on the FDA's mobile medical applications webpage. For the most part, the agency's enforcement attention will be on apps that "are intended to be used as an accessory to a regulated medical device" or "transform a mobile platform into a regulated medical device." In addition to technologies that would monitor the heart and other organs, regulated apps would also include those that measure degree of tremor, monitor eye movement relative to balance disorders, and control settings of a neuromuscular stimulator.
Other apps that meet the FDA's definition of a "device" but do not present significant risk to the patient would likely not be subjected to review—something the FDA calls its "enforcement discretion." These would include apps that use video and games to encourage users to do physical therapy exercises at home and apps that allow users to record and evaluate activities related to exercise and diet.
According to the FDA, the guidance is an attempt to provide consumer protection services to the rapidly growing market for health-related apps, a segment of app technology that industry experts predict will be present on 50% of all smartphones and tablets by 2018.
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