The US Food and Drug Administration (FDA) has issued draft guidelines about how it intends to regulate mobile apps. Given the growth in mobile health-inspired apps, the FDA wanted to clarify over which apps it intends to cast its regulatory authority.  The administration says it will only regulate those that fall under its definition of “mobile medical apps”.

It gives three examples of those apps that fall into this category. Firstly, those apps that are designed to control a medical device so that it can display, store, analyse or transmit patient-specific medical data. An example of this category is the remote display of data from bedside monitors.  A second category is those apps that transform a mobile platform into a medical platform “by using attachments, display screens, or sensors or by including functionalities similar to those of currently regulated medical devices”. An example is the attachment of a transducer to a mobile platform so that it functions like a stethoscope. The third category is apps that allow a user to input patient-specific information and as a result receive a diagnosis or treatment recommendation.  In this area, examples include mobile apps offering questionnaires for collecting patient-specific lab results.

The FDA’s guidelines are only draft and it is open to a response from interested parties. It is open to comments on its proposals until mid-October. The administration’s final guidance will not establish legally enforceable responsibilities.  Instead, it offers a view of the administration’s current thinking and should be taken as recommendations unless “specific regulatory or statutory requirements are cited”.

The fast growth in mobile apps is a challenge to regulators, such as the FDA. The great concern is that apps are coming to market without going through the same regulatory oversight that is applied to medical devices that perform a similar function. The publication of its draft guidance is an attempt to fill that gap.