The FDA has released, for comment purposes, draft guidance on mobile medical applications. The 29-page draft, issued July 21, contains nonbinding recommendations “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,” the draft stated.
The draft includes definitions of mobile platforms, mobile applications, mobile medical applications, regulated medical devices and mobile medical application manufacturers, as well as the scope of the FDA’s plans, regulatory approach for mobile apps and regulatory requirements.
The FDA plans to focus only on a subset of mobile apps that either have traditionally been considered medical devices or affect the performance or functionality of a currently regulated medical device.
This subset, which the agency is calling mobile medical apps, includes only those that meet the statutory definition of a device; and either are used as an accessory to a regulated medical device, or to transform a mobile platform into a regulated medical device.
“This guidance does not specifically address wireless safety considerations, classification and submission requirements related to clinical decision support software or the application of quality systems to software. The FDA intends to address these topics through separate guidance(s),” the draft stated.
The following examples represent mobile apps that the FDA considers to be subject to its regulatory oversight:
- Mobile apps that are an extension of one or more medical device(s) by connecting 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 wave forms, and display of medical images directly from a PACS server; or similar display functions that meet the definition of an MDDS.
- 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.
Click here to see the draft guidelines.