The global market for mobile apps is valued at 25 billion dollars. The market for health related apps in particular is booming, the FDA predicts 500 million smartphone users will use a mobile medical app this year, and the number is expected to rise to 1.7 billion by 2018. In the past, medical software has been regulated using the same model as medical devices.
Recently, the FDA realized it needed a new and different approach to support a rising number of apps, especially those aimed at patients. In addition to the rapid growth of the market, some health app developers have made claims that can't be supported. This prompted the FDA to issue a new guidance in February of this year.
What does it all mean?
In most cases, developers aren't trying to pull a fast one on the FDA. Many developers are making the same mistake; they have not properly identified their product as one that needs regulation. Therefore, let's go through a quick refresher on the definition of medical device and other related terms.
The FDA defines a medical device as "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory" which is:
- For use in the diagnosis of disease or conditions;
- For use in the mitigation, treatment, prevention or cure of disease; or
- To affect the structure or function of the body.
Your iPhone, for example, is not a medical device; it is a prime example of a mobile platform. Not an Apple person? Your Galaxy Tab or ChromeBook falls under this definition as well.
A mobile application, on the otherhand, is software for your device—everything from social media apps like Facebook and Twitter to Medisafe Medication Reminder, a medication manager and pill reminder.
The FDA defines a mobile medical application as a mobile application that meets the definition of a device and is intended to be used as an accessory to a regulated device or to transform a mobile platform into a regulated medical device. The FDA classifies a mobile medical application as a medical device because it could pose the same risks to public health as currently regulated medical devices if they did not function as intended.
Mobile platforms and mobile applications are NOT regulated by the FDA unless they meet the definition of a mobile medical application—even if they are a "health" app. While a mobile health app like MyFitnessPal, a diet and fitness tracker, would not be regulated under this new guidance as it stands today, it would be if it included a blood pressure cuff attachment to analyze cardiac outputs during exercise.
Other types of apps that will not be regulated include:
- Disease or condition self-management apps that do not provide treatment or treatment suggestions;
- Apps that provide easy access to information related to health conditions or treatments; or
- Apps that automate simple tasks for healthcare providers.
Regulated mobile apps will include:
- Those that are an extension of a medical device and control the device for patient monitoring or analyzing medical device data;
- Ones that transform the mobile platform by using sensors, display screens, or attachments or include similar functions to currently regulated medical devices;
- Mobile apps that become a regulated medical device by performing patient-specific analysis and diagnosis, or treatment recommendations. These types of mobile medical apps are similar to types of software devices that were previously approved.
All that matters in the end...
For anyone developing or marketing a mobile medical app, we recommend spending some time visiting the corresponding guidance and medical device regulation information the FDA provides to better ensure you are headed in the right direction. As a word of caution, developers of non-regulated general wellness and health apps should avoid all claims regarding diagnosis or treatment of any condition and, to be safe, should also have a peek at the guidance to make sure that features of the app do not qualify for regulation.