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FDA Releases Final Guidance for Mobile Medical Applications

The US Food and Drug Administration (FDA) has released its much-anticipated final guidance outlining how it intends to oversee developers of mobile medical applications that run on mobile phones and tablets.

The final guidance was released on September 23 and was scheduled for publication in the Federal Register on September 25. The FDA, one of many federal agencies that have some responsibility for the oversight of mobile health devices and applications, first circulated the draft guidance in July 2011. During the intervening two years, mHealth issues have gained visibility among consumers and regulators, as demonstrated by task forces convened by the Federal Communications Commission and the Office of the National Coordinator for Health Information Technology, as well as hearings on Capitol Hill, and a rapid growth in revenues.

According to the agency, the final guidance is directed to industry participants and FDA employees and “should be viewed only as recommendations.” The final guidance starts by emphasizing that the FDA does not regulate the sale or general consumer use of smartphones or tablets. Rather, it targets manufacturers of mobile medical apps. The guidance does not reach entities like Apple’s iTunes App Store or Google’s Play Store so long as they only distribute mobile medical apps.

Even for those applications that technically fit within the agency’s oversight, the FDA intends to focus its enforcement efforts only on the subset of applications that present a greater risk to patient health and safety. For mobile medical applications that present low risk to consumers, the FDA stated that it intends to exercise its “discretion” not to enforce FDA legal requirements. The final guidance provides several examples of low-risk mobile applications, including:

  • applications that help patients self-manage their medical condition according to treatments provided by a licensed medical provider;
  • tools to organize personal health information or review electronic health records; and
  • tools that automate simple tasks for health care providers.

The FDA will, on the other hand, engage in regulatory oversight and enforcement actions for mobile medical apps that have the potential to harm consumers if they do not function as intended. Several examples of these types of applications are also provided in the guidance, and include:

  • applications intended to be used as an accessory to a regulated medical device, such as an application that allows a health care professional to make a specific diagnosis by viewing a medical image;
  • applications that transform a mobile platform into a regulated medical device, such as an application that turns a smartphone into an electrocardiography (ECG) machine to detect abnormal heart rhythms; and
  • any application that purports to provide patient-specific analysis or diagnosis.

Mobile medical applications that fit within the categories subject to FDA enforcement will be assessed using the same regulatory standards and risk-based approach that the agency applies to other medical devices, which may include the need for FDA approval before the device is marketed.

The final guidance is available here. For more information about the regulation of mHealth devices, including the FDA’s draft guidance, please contact any member of the Arent Fox mHealth team.


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