Mobile Medical Draft Guidance From the FDA
January 17, 2012, Medical Electronic Device Solutions Conference, Santa Clara, CA—The FDA described the latest guidelines for mobile medical devices. Bakul Patel, a policy advisor for the FDA, provided a general overview of the thought processes going into policy guidance issues.
The technology world is changing very rapidly and now consumer devices are moving into the medical area. This is good from a consumer cost perspective, but may be problematic from a regulatory view. The use of consumer devices for medical functions will help to reduce the total cost of care in the US.
The consumer devices are taking advantage of the reductions in computers and lower costs associated with mass markets. The addition of sensors and easy interface to peripherals makes these devices excellent platforms for many applications. The move to mobile computers is entering the health arena with a vengeance and has the potential to reduce costs in many areas.
About 500M people world-wide will be using health apps by ’15 and the number of apps will continue to grow. A quick check back in the App Store back in May showed 9,428 health and fitness apps and 6,848 medical apps. In October, these had increased to 17,099 health and fitness, and 8,966 medical apps. They share the characteristics of affordable and easy to use.
The challenge for the FDA is to decide which of these apps fall into the realm of regulated medical devices. The FDA defines medical devices and separate software as tools used in the diagnosis and care of patients. The regulations include software as a device due to the nearly universal availability of computers and connectivity. A device in the engineering view does something for the patient: calculate doses, imaging, treatment function, etc.
The emerging policies for using software are being driven by the latest apps. If you use an app as an electronic stethoscope to send heart sounds to your doctor, it is being used as a medical device per the regulations. One reason to separate the app from the platform is the assessment that you don’t want to regulate all of the rapidly changing smart phones.
The latest guidance describes how to use a software package as a medical device. Mobile medical apps are within the FDA scope, but they are using enforcement discretion to more strictly define those that require regulation. If the app meets the definition of a medical device, it will be reviewed and possibly regulated. If it doesn’t completely fit the device definition, it will be considered unregulated.
Mobile medical apps fit into the device definition when they are used as an accessory to some existing medical device, or if they transfer medical data through mobile communications. Health and fitness apps and information and training apps are not medical devices because they fail the definitions. When apps mimic traditional devices they become device. Grey areas are apps like medical self management or tracking and trending apps. As long as the apps don’t track or adjust medications, they are clear.
When software is an accessory, does it address multiple peripherals? Is it providing some level of diagnostics? Does it provide support for clinical decisions? If the software doesn’t change the basic use functions of device it is a non-regulated accessory, or an accessory for an extended use or a new use for those existing devices.
Clinical decision support tools access data sources and inputs, perform some type of analysis, and have some impact on a subject’s health condition or disease. The platform may matter in this case, and strict care is involved in getting medical-level acceptance and also ensuring that users can identify bad information.
The FDA is split on the “protect versus promote” public health focus. Nevertheless, they have to ensure the efficacy of mobile apps that are classified as devices while allowing general accessibility to non-regulated apps. The industry and consumers need clarity on the FDA enforcement discretion and understanding of the mobile app manufacturer expectations. Clinical devices will be reviewed under a separate document.
The general guidance will be available for public comments in the near future, and the FDA expects to finalize them later this year. They will publish the final guidance on mobile apps and another document on clinical decision support apps in the later part of this year.
