Decoding Mobile Medical

Application Guidance from the FDA

Mobile Medical Application Guidance

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.

Mobile Medical Application Guidance

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.

What Does It All Mean? 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.

What Does It All Mean? 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 other hand, is software for your device—everything from social media apps like Facebook and Twitter to the Medisafe Medication Reminder, a medication manager and

pill reminder.

What Does It All Mean? 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.

What Does It All Mean? 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.

What Does It All Mean? 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

What Does It All Mean? Regulated mobile apps 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… 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.

Grey Matter Marketing is a full-service, award-winning marketing agency working exclusively with medical technology companies. We provide the marketing architecture to build strong connections with providers and patients to drive adoption of innovative technology that improves lives. We have a proven track record in developing both traditional and digital plans that create compelling marketing experiences and drive business results. Our strength is finding the important truth in any communication effort, and translating that truth into something your customer understands, and more importantly, feels. Armed with this knowledge and insight, we roll up our sleeves and do what we do best: work hard, think strategically and deliver.

IF YOU ARE INTERESTED IN LEARNING MORE ABOUT ABOUT MOBILE MEDICAL APPLICATION GUIDANCE EMAIL US AT INFO@GREYMATTERMARKETING.COM