The Food and Drug Administration (FDA) is issuing this draft guidance document to inform manufacturers, distributors, and other entities about how the FDA intends to apply its regulatory authorities to select software applications intended for use on mobile platforms (mobile applications or “mobile apps”).
Given the rapid expansion and broad applicability of mobile apps, the FDA is issuing this draft guidance document to clarify the types of mobile apps to which the FDA intends to apply its authority. At this time, the FDA intends to apply its regulatory requirements solely to a subset of mobile apps that it is calling mobile medical applications or “mobile medical apps.”
FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word “should” in Agency guidances means that something is suggested or recommended, but not required.
The following examples represent mobile apps FDA considers mobile medical apps and that will be subject to its regulatory oversight:
- Mobile apps that are an extension of one or more medical device(s) by connecting17 to such device(s) for purposes of controlling the device(s) or displaying, storing, analyzing, or transmitting patient-specific medical device data. Examples of displays of patient-specific medical device data 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, or similar display functions that meet the definition of an MDDS. Examples of mobile apps that control medical devices include apps that provide the ability to control inflation and deflation of a blood pressure cuff through a mobile platform and mobile 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 a mobile app that uses a mobile platform for medical device functions, such as 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, or attachment of electrocardiograph (ECG) electrodes to a mobile platform to measure, store, and display ECG signals; or, a mobile app that uses the built-in accelerometer on a mobile platform to collect motion information for monitoring sleep apnea.
- Mobile apps that allow the user to input patient-specific information and - using 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. Examples include mobile apps that provide a questionnaire for collecting patient-specific lab results and compute the prognosis of a particular condition or disease, perform calculations that result in an index or score, calculate dosage for a specific medication or radiation treatment, or provide recommendations that aid a clinician in making a diagnosis or selecting a specific treatment for a patient.