Tuesday, July 19, 2011

FDA Releases Proposed Guidelines for Regulation of mHealth Technology (mobile apps)

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Draft Guidance for Industry and Food and Drug Administration Staff - Mobile Medical Applications.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


  1. >>what mobile apps will be subject to FDA regulation<<

    So I'm reading over how or what the FDA plans to regulate, and how. So here's the list...

    Class I devices: General Controls, including:

    --Establishment registration, and Medical Device listing (21 CFR Part 807);
    --Quality System (QS) regulation (21 CFR Part 820);
    --Labeling requirements (21 CFR Part 801);
    --Medical Device Reporting (21CFR Part 803);
    --Premarket notification (21CFR Part 807);
    --Reporting Corrections and Removals (21 CFR Part 806); and
    --Investigational Device Exemption (IDE) requirements for clinical studies of investigational devices (21 CFR Part 812)

    Class II devices: General Controls, Special Controls, and (for most Class II devices) Premarket Notification

    Class III devices: General Controls and Premarket Approval (21 CFR Part 814)

    ...and I'm wondering how much do all these individual regulations cost? What are the penalties for noncompliance? If a company IS fully compliant and a patient is still dissatisfied with the performance of the relevant mobile hardware or app, are they still liable in civil or criminal court?

    Food for thought.


  2. The penalties for noncompliance are having the device removed from the market which can be a huge blow to the manufacturer. The manufacturer would only be liable if some harm was caused to the patient by using their device.