Last week I wrote about mHealth technology and FDA regulation and the murkiness of such regulation. Finally, the FDA has released a set of proposed guidelines, of what mobile apps will be subject to FDA regulation. They include:
· Mobile apps that are an extension of a medical device by connecting to the device for purposes of controlling the device or displaying, storing, analyzing, or transmitting patient-specific medical device data. Examples include remote display of data from bedside monitors, display of previously stored EEG waveforms, and display of medical images directly from a Picture Archiving and Communication System (PACS) server, apps that provide the ability to control inflation and deflation of a blood pressure cuff , apps that control the delivery of insulin on an insulin pump by transmitting control signals to the pumps from the mobile platform.
· Mobile 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. Examples include attachment of a transducer to a mobile platform to function as a stethoscope, attachment of a blood glucose strip reader to a mobile platform (e.g., cell phone) to function as a glucose meter, or attachment of electrocardiograph (ECG) electrodes to a mobile platform to measure, store, and display ECG signals.
· Mobile apps that allow the user to input patient-specific information and output a patient-specific result, diagnosis, or treatment recommendation to be used in clinical practice or to assist in making clinical decisions (Offer suggestions about a patient's diagnosis or treatment). Examples include mobile apps that provide a questionnaire for collecting patient-specific lab results and compute the prognosis of a particular condition or disease, calculate dosage for a specific medication, or provide clinical recommendations that aid a clinician in making a diagnosis or selecting a specific treatment.
People have up to 90 days from publication of the proposed guidelines to submit comments and suggestions.
Draft Guidance for Industry and Food and Drug Administration Staff - Mobile Medical Applications. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm263280.htm#5