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.
This guidance is separate from, but will aid to inform, a multi-agency initiative to determine the degree to which the federal government will regulate the safety and reliability of health information technology. The agencies, led by FDA, the Office of the National Coordinator for Health Information Technology and the Federal Communications Commission, expect in January 2014 to issue a proposed risk-based regulatory framework.
The FDA guidance document defines, “mobile platform,” “mobile application,” “mobile medical application,” “regulated medical device” and “mobile medical app manufacturer.” It includes multiple examples of mobile apps that the agency does not consider to meet the definition of a medical device, as well as examples of mobile apps “that MAY meet the definition of a medical device but for which the FDA intends to exercise enforcement discretion because they pose a low risk to patients.”
The guidance makes clear that FDA oversight will focus on the functionality of medical mobile apps, just as it does for conventional medical devices. “Our oversight is not determined by the platform. Under this guidance, FDA would not regulate the sale or general/conventional consumer use of smartphones or tablets. FDA’s oversight applies to mobile apps performing medical device functions, such as when a mobile medical app transforms a mobile platform into a medical device. However, as previously noted, we intend to apply this oversight authority only to those mobile apps whose functionality could pose a risk to a patient’s safety if the mobile app were not to function as intended.”
The FDA considers the following medical mobile applications, each with examples in the guidance, to be subject to regulatory oversight:
* “Mobile apps that are an extension of one or more medical devices by connecting to such devices for purposes of controlling the device(s) or displaying, storing, analyzing, or transmitting patient-specific medical device data.”
* “Mobile apps that transform the mobile platform into a regulated medical device by using attachments, display screens or sensors, or by including functionalities similar to those of currently regulated medical devices. Mobile apps that use attachments, display screens, sensors or other such similar components to transform a mobile platform into a regulated medical device are required to comply with the device classification associated with the transformed platform.”
* “Mobile apps that become a regulated medical device (software) by performing patient-specific analysis and providing patient-specific diagnosis, or treatment recommendations. These types of mobile medical apps are similar to or perform the same function as those types of software devices that have been previously cleared or approved.”
With examples, FDA will exercise enforcement discretion--meaning it does not intend to enforce requirements under the Food, Drug and Cosmetic Act--for the following types of mobile apps:
* “Mobile apps that provide or facilitate supplemental clinical care, by coaching or prompting, to help patients manage their health in their daily environment.”
* “Mobile apps that provide patients with simple tools to organize and track their health information.”
* “Mobile apps that provide easy access to information related to patients’ health conditions or treatments (beyond providing an electronic ‘copy’ of a medical reference).”
* “Mobile apps that are specifically marketed to help patients document, show or communicate to providers potential medical conditions.”
* “Mobile apps that perform simple calculations routinely used in clinical practice.”
* “Mobile apps that enable individuals to interact with PHR systems or EHR systems.”
The medical mobile apps guidance is available here.
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