The Food and Drug Administration has proposed regulation of some medical applications that run on smartphones and other mobile computing devices that could affect the operations of other medical devices already under its governance.
The agency’s draft guidance released July 19 outlines its “current thinking” and focuses on a small subset of mobile medical apps because they can influence the performance or functionality, and potentially the safety, of currently regulated medical devices.
The mobile medical apps that FDA has in mind are those used as accessory to a medical device already regulated by the agency, such as one that enables a provider to make a diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or other mobile device.
The other set of apps under FDA’s scrutiny are those that transform a mobile communications device into a regulated medical device by using attachments, sensors or other devices. An example of this is an attachment of electrocardiograph (ECG) electrodes to a mobile platform to measure, store and display ECG signals to detect abnormal heart rhythms or if a patient is experiencing a heart attack.
FDA said that its oversight consideration does not include mobile apps that perform the functionality of an electronic health record system or personal health record system.
The agency said it seeks feedback on its oversight approach. Once the proposed guidance is published, the public may comment for 90 days. FDA will update the guidance based on that feedback.
Mobile medical apps perform a variety of functions, including monitoring calorie intake, helping people manage healthy weight, and allowing physicians to view a patient’s radiology images on their mobile communications device. The use of mobile medical apps on smart phones and tablets is revolutionizing healthcare delivery, said Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health.
“Our draft approach calls for oversight of only those mobile medical apps that present the greatest risk to patients when they don’t work as intended,” he said. FDA will continue to evaluate how these technologies might improve health care, reduce potential medical mistakes and protect patients.
Mobile medical apps could pose risks due to the unique characteristics of their platform. For example, the interpretation of radiological images on a mobile device could be adversely affected by the smaller screen size, lower contrast ratio, and uncontrolled ambient light of the mobile platform. FDA said it intends to take these limitations into account in assessing the appropriate regulatory oversight for these products.
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Examples of apps that FDA said are not part of its oversight consideration include electronic "copies" of the Physician’s Desk Reference and other medical textbooks, teaching aids or reference materials to provide clinicians with training or reinforce training previously received. However, mobile apps that allow the user to input patient-specific information along with reference material to automatically diagnose a disease or condition are considered mobile medical apps.
FDA also will not oversee mobile apps that are used to develop or maintain general health and wellness, such as dietary logs and appointment reminders, and those that automate general office operations.
Under FDA regulation, a manufacturer would register annually and list the mobile medical apps being marketed so the agency knows who is marketing what. The manufacturer also must supply certain labeling information with the product. Mobile medical app makers would have to meet quality system requirements to assure that the products are safe and effective and establish consistent methods to design, produce, and distribute their devices or software.
Finally, the mobile medical app maker would report to FDA information about serious adverse incidents related to use of their product.
