More than two years after the United States Food and Drug Administration issued a draft of its guidance, the federal agency has finally published its final guidance for mobile medical applications.
In a public statement, the FDA reiterated that a majority of these mobile apps will not be forced to meet requirements under the Federal Drug & Cosmetic Act because “they pose minimal risk to consumers.” Instead the agency is looking to take a closer look at “a subset of mobile medical apps that present a greater risk to patients if they do not work as intended.”
The agency’s challenge was to strike the right balance that would enable innovation while at the same time ensuring patient safety.
“We have worked hard to strike the right balance, reviewing only the mobile apps that have the potential to harm consumers if they do not function properly,” Jeffrey Shuren, MD, JD, Director of the Center for Devices and Radiological Health, said in a public statement. “Our mobile medical app policy provides app developers with the clarity needed to support the continued development of these important products.”
In the final guidance, the FDA defines a mobile medial app as a device that meets one of two criteria:
• to be used as an accessory to a regulated medical device; or
• to transform a mobile platform into a regulated medical device.
The move makes clearly that the FDA’s oversight is not platform-dependent — that software can serve as a medical device in the form of a mobile app:
FDA’s oversight approach to mobile apps is focused on their functionality, just as we focus on the functionality of conventional 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.
Although the FDA has emphasized that its list of mobile apps that are and are not medical devices is not exhaustive, it has provided examples of mobile apps that will not be subject to enforcement. These include mobile apps that:
• Help patients (i.e., users) self-manage their disease or conditions without providing specific treatment or treatment suggestions;
• Provide patients with simple tools to organize and track their health information;
• Provide easy access to information related to patients’ health conditions or treatments;
• Help patients document, show, or communicate potential medical conditions to health care providers;
• Automate simple tasks for health care providers; or
• Enable patients or providers to interact with Personal Health Record (PHR) or Electronic Health Record (EHR) systems.
For manufacturers of medical mobile apps that will be regulated, the FDA is urging them to follow the Quality System regulation and be prepared to abide by the requirements associated with the applicable device classification.”