Table 1

Mobile Medical Applications for which FDA will apply regulatory oversight

Description

Examples


Mobile applications that are an extension of one or more medical device(s) or displaying, storing, analyzing, or transmitting patient-specific medical device data

Remote display of data from bedside monitors

Display of previously stored EEG waveforms

Display of medical images directly from a Picture Archiving and Communication System (PACS) server

Control of inflation/deflation of a blood pressure cuff

Control of the delivery of insulin by an insulin pump


Mobile applications 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

Attachment of a transducer to a mobile platform to function as a stethoscope

Attachment of a blood glucose strip reader to a mobile platform to function as a glucose meter

Attachment of electrocardiograph (ECG) electrodes to a mobile platform to measure, store, and display ECG signals


Mobile applications that allow the user to input patient-specific information and through the use of formulae or processing algorithms, output a patient-specific result, diagnosis, or treatment recommendation to be used in clinical practice or to assist in making clinical decisions

Mobile applications that provide a questionnaire for collecting patient-specific lab results and either: (1) compute the prognosis of a particular condition or disease; (2) perform calculations that result in an index or score; (3) calculate dosage for a specific medication or radiation treatment; or (4) provide recommendations that aid a clinician in making a diagnosis or selecting a specific treatment for a patient


Adapted from: Draft Guidance for Industry and Food and Drug Administration Staff - Mobile Medical Applications http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm263280.htm webcite

The FDA defines a mobile medical application as one that meets the definition of a device ('... an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent' that is 'intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man...' or '... intended to affect the structure or any function of the body of a man or other animals...') and is either 'used as an accessory to a regulated medical device or transforms a mobile platform into a regulated medical device'. This table summarizes information about the mobile medical applications that will be subjected to regulation by the FDA. The table describes the mobile applications of interest and then provides specific examples of devices that would fall under the regulation.

Barton BMC Medicine 2012 10:46   doi:10.1186/1741-7015-10-46

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