The glacier has moved.
Today the FDA announced that it was issuing a Draft Guidance on the Oversight of Medical Applications and seeking public input into the draft. For the most part, the guidance is involved with distinguishing what is or is not going to be considered a medical app.
To that end, the agency is considering an app to be anything that (1) is used as an accessory to a regulated medical device or (2) transforms a mobile platform into a regulated medical device. Mobile platforms include the usual suspects – Droid, iPad, iPhone, etc.
The draft draws a distinction between apps that actually perform as a device, and those which are supportive of health decisions or tracking, with the former being covered and the latter not.
What is an app? “When the intended use of a mobile app is for the diagnosis of disease or other conditions, or the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or any function of the body of man, the mobile app is a device.”
What is not a medical app? These are, to name a few – those apps which appear functionary, but not diagnostic in nature – such as “log, record, track, evaluate, or make decisions or suggestions related to developing or maintaining general health and wellness. Such decisions, suggestions, or recommendations are not intended for curing, treating, seeking treatment for mitigating, or diagnosing a specific disease, disorder, patient state, or any specific, identifiable health condition. Examples of these apps include dietary tracking logs, appointment reminders, dietary suggestions based on a calorie counter, posture suggestions, exercise suggestions, or similar decision tools that generally relate to a healthy lifestyle and wellness – or that perform the functionality of an electronic health record system or personal health record system.”
In other words, my new system that has a WiFi scale for recording my weight and sending it to my iPad is probably not a medical app. But the blood pressure cuff that monitors my blood pressure and also sends it for tracking to the app probably is.
Regulatory Approach. In defining the regulatory approach, the agency appears less concerned with whether the app is mobile than whether or not it is a device – and if it is a device, then like any other device, it needs to function properly.
According to the draft – “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.“
The draft does begin by noting the history of regulating computer software going back to 1989 and which never resulted in guidance – echoing the fact that the FDA once held a public meeting on the Internet in 1996 – also with no resulting guidance. One hopes for progress on both fronts.
Mark, the most pertinent sentence in your excellent piece is, I think, “The draft does begin by noting the history of regulating computer software going back to 1989 and which never resulted in guidance – echoing the fact that the FDA once held a public meeting on the Internet in 1996 – also with no resulting guidance.”