The U.S. Food and Drug Administration (FDA) has included medical imaging apps in a new draft guidance document for its regulation of mobile medical applications used on smartphones and other mobile computing devices.
The draft guidance document defines the mobile medical applications designed for mobile computing devices and smartphones that the agency intends to regulate, and delineates mobile medical applications that affect or could affect the performance or functionality of currently regulated medical devices. These include mobile medical apps that are either used as an accessory to medical devices already regulated by the FDA or which transform a mobile communications device into a regulated medical device. A number of medical imaging categories are included in the draft.
"The use of mobile medical apps on smartphones and tablets is revolutionizing healthcare delivery," said Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, in a statement. "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." The FDA cited a projection that by 2015, 500 million smartphone users worldwide will be using a healthcare application.
For the subset of mobile medical apps subject to FDA regulatory oversight, manufacturers must meet the requirements associated with the applicable device classification. If the mobile medical app falls within a medical device classification, its manufacturer is subject to the requirements associated with that classification.
The FDA has typically expected that the manufacturer of an accessory would meet the requirements associated with the classification of a connected device. The agency stated that this approach may not be well suited for mobile medical apps that serve as an accessory to another medical device because of the wide variety of functions these apps can potentially perform. Therefore, it is seeking comment on how it should approach the regulation of these accessory apps so that safety and effectiveness can be reasonably assured.
Mobile medical apps subject to regulatory oversight include:
Apps that are an extension of one or more medical devices by connecting to the device(s) for the purpose of controlling the device, or for the purpose of displaying, storing, analyzing, or transmitting patient-specific medical device data. These include display of medical images directly from a PACS or similar display functions.
Apps that transform the mobile platform into a medical device by using attachments, display screens, or sensors, or by including functionalities similar to those of currently regulated medical devices. These include apps that attach electrocardiograph (ECG) electrodes to a mobile platform to measure, store, and display ECG signals.
Apps that allow the user to input patient-specific information and/or output a patient-specific result, diagnosis, or treatment recommendations to be used in clinical practice or to assist in making clinical decisions. These include apps that perform calculations that result in an index or score, that calculate dosage for radiation treatment, or that provide recommendations that aid a clinician in making a diagnosis or selecting a specific treatment for a patient.
Examples of other mobile medical apps specifically related to radiology cited in the draft guidance document include:
- Apps that allow a user to view medical images on a mobile platform and perform an analysis or process for diagnosis
- Apps that connect to DICOM medical image servers and provide processing functions such as pan, zoom, measurement, autocontrasting, automatic detection of features, and other similar functionality
- Apps used to display digital images, including digital mammography, for review and analysis by trained medical practitioners
- Apps that wirelessly connect to medical devices with the capability of relaying or generating alarms
- Apps that connect to other medical imaging devices for displaying, processing, or storing medical images
- Apps that act as wireless remote controls or synchronization devices for diagnostic imaging modalities
The document may be accessed in its entirety here. Comments and suggestions may be submitted to the FDA within 90 days from the date of publication on July 19 of this draft guidance.
