Table 1 Mobile Medical Applications for which FDA will apply regulatory oversight

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