The Food and Drug Administration (FDA) recently proposed guidelines that outline the small number of mobile apps the agency plans to oversee—medical apps that could present a risk to patients if the apps do not work as intended.
The agency has already cleared a handful of mobile medical apps used by health care professionals, such as a smartphone-based ultrasound app and an app for iPhones and iPads that allows physicians to view medical images and x-rays.
The agency now is proposing to oversee mobile medical apps that are used as an accessory to an FDA-regulated medical device, such as an app that could enable a health care professional to view medical images on an iPad and make a diagnosis. The guidelines also would cover apps that transform a mobile platform into a regulated medical device. An example would be an app that turns a smartphone into an electrocardiography, or ECG, machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack.
Comments on the guidelines will be accepted until October 19. For more information, visit FDA's Mobile Medical Apps page.
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