The Food and Drug Administration intends to regulate its definition of "mobile medical applications" and has issued draft guidance for industry comment during a 90-day period after publication in the Federal Register on July 21.
The FDA does not intend to regulate mobile computing devices or most applications that run on the devices. "This draft guidance when finalized will represent the Food and Drug Administration's current thinking on this topic."
A mobile medical application, according to the draft guidance, "is a mobile app that meets the definition of 'device' in section 201(h) of the Federal Food, Drug and Cosmetic Act and either is used as an accessory to a regulated medical device or transforms a mobile platform into a regulated device."
The draft guidance does not specifically address wireless safety considerations, classification and submission requirements related to clinical decision support software, or the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."
Some examples of functions that would qualify a mobile app as a mobile medical application include:
* Acting as an extension of one or more medical devices by connecting the devices for purposes of controlling the devices or displaying, storing, analyzing or transmitting patient-specific medical device data.
* Transforming the mobile platform into a medical device by using attachments, display screens, sensors, or by including other functionalities similar to currently regulated devices. These include, for instance, attaching a blood glucose strip reader to a mobile device to function as a glucose meter, or attachment of ECG electrodes to a mobile platform to measure, store and display ECG signals.
* Permitting a 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 practice or assist in making clinical decisions.
The draft guidance also gives five examples of mobile apps that the FDA does not consider to be medical mobile applications. These include:
* Apps that have electronic copies of medical textbooks, teaching aids and other materials for clinician training;
* Apps solely used to log, record, track, evaluate or make decisions or suggestions related to developing or maintaining general health and wellness;
* Apps that only automate general office functions;
* Apps with generic aids that assist users but are not commercially marketed for a specific medical indication, such as note-taking and replaying audio with amplification; and
* Apps that perform the functionality of an electronic health record or personal health record.
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