FDA Draft Guidance Includes Medical Imaging Apps

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Medical imaging apps are included in a new U.S. Food and Drug Administration (FDA) draft guidance document covering the regulation of mobile medical applications used on smartphones and other mobile computing devices.

In the document, the FDA specifies the mobile medical applications designed for mobile computing devices and smartphones that it intends to regulate. The agency also cites those mobile medical applications that affect or could affect the performance or functionality of currently regulated medical devices; these encompass apps that are either used as an accessory to medical devices already regulated by the FDA or that 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 health care delivery," said Jeffrey Shuren, MD, 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." According to the FDA, 500 million smartphone users worldwide will be using a healthcare application by 2015.

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.Mobile medical apps subject to regulatory oversight include those that become an extension of one or more medical devices by connecting to those device(s) for the purpose of controlling them or to display, store, analyze, or transmit patient-specific medical device data. This category takes into account the display of medical images directly from a PACS or similar display functions. On the list as well are apps that transform the mobile platform, via attachments, display screens, sensors, or the inclusion of functionalities similar to those of currently regulated medical devices, into a medical device. Among examples of these apps are options that attach electrocardiograph electrodes to a mobile platform to measure, store, and display ECG signals

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As for other mobile medical apps delineated in the draft, the FDA cites those that allow users to input patient-specific information and/or output patient-specific results, diagnoses, or treatment recommendations to be used in clinical practice or to assist in making clinical decisions; examples are apps that perform calculations that result in an index or score, calculate dosage for radiation treatment, or provide recommendations that aid clinicians in making diagnoses or specifying particular treatments for given patients. Rounding out the list of radiology-related apps are those that permit users to view medical images on a mobile platform and perform analyses or processes for diagnoses; connect to DICOM medical image servers and provide processing functions such as pan, zoom, measurement, auto-contrasting, automatic detection of features, and other similar functionality; are used to display digital images, including digital mammography, for review and analysis by trained medical practitioners; wirelessly connect to medical devices with the capability of relaying or generating alarms; connect to other medical imaging devices for displaying, processing, or storing medical images; and/or act as wireless remote controls or synchronization devices for diagnostic imaging modalities.

The FDA is seeking comments and suggestions on the document, which must be submitted to the agency within 90 days from the publication date of the draft guidance (July 19).

To read the draft document, click here: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDo....