The global market for mobile apps is valued at 25 billion dollars. The market for health 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. View the presentation to learn more about the FDA's Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff including: 1. Key points of differentiation between health apps and mobile medical apps 2. The common mistake developers make when defining their product 3. What developers of non-regulated health apps should avoid when marketing their application

1. Decoding
Mobile Medical
Application Guidance
from the FDA

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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

10. 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.

11. 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.

12. 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