Where do you feel you have the best digital user experience? A web or a mobile app? I have been a web developer for almost four years, but still, I prefer the Amazon app to order gadgets instead of the Amazon web application. Mobile devices and applications themselves are very handy because they easily fit in our pockets, their UIs show the most significant data with minimal clutter, and most importantly, they provide the same services and results as provided by web applications....

1. How to Determine if Your Mobile App is a Medical
Device?
By: Govind Yatnalkar
Where do you feel you have the best digital user experience? A web or a mobile app? I
have been a web developer for almost four years, but still, I prefer the Amazon app to order
gadgets instead of the Amazon web application. Mobile devices and applications themselves are
very handy because they easily fit in our pockets, their UIs show the most significant data with
minimal clutter, and most importantly, they provide the same services and results as provided
by web applications.
But what if you wanted to use or build a mobile application for a hospital or a laboratory?
If the application is built to host healthcare-related activities, it should be thoroughly tested to
verify the functionality as it can impact clinical data. Truly, it would be a small and rectifiable
problem if a non-healthcare application such as e-commerce or a finance app breaks down, but
if the app is utilized clinically, both data and functionality have the utmost importance as these
factors drive patient care and safety. This is the point that pushes me every time to think, the
app that I am developing, is it a medical device?
To answer this question, the FDA provided an excellent guidance document which
specifies how to categorize mobile applications as a medical device. FDA also gives examples of
apps that are not medical devices. Such examples include apps that are used only for reference
purposes such as e-books, educational tools for patients, automating general office operations
such as billing, and general-purpose applications such as note-taking apps, recording audio or
video, social messaging, or general communication such as emails.1
The most obvious way to label an app as a medical device is using its intended use. Based
on the FDA’s guidance document, an application is deemed a medical device if it is utilized in
the detection, cure, mitigation, treatment, or prevention of diseases. For example, a continuous
glucose monitoring app may collect blood-sugar data and save it in the Cloud. Based on this
collected data, the activity of adjusting and delivering insulin may be triggered. Another example
is the device that provides EKG data. If the intended use of the app is to provide
electrocardiograms and monitor them for detecting irregularities, in such a case, the app is
surely a medical device.2
1
FDA (July 2018). Examples of Mobile Apps ThatAre Not Medical Devices. Retrieved on January24th, 2020from
https://www.fda.gov/medical-devices/device-software-functions-including-mobile-medical-applications/examples-mobile-apps-
are-not-medical-devices.
2 FDA (September 2019). Policy for Device Software Functions and Mobile Medical Applications. Retrieved on January24th, 2020
from https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-device-software-functions-and-mobile-
m edical-applications.

2. Additionally, if the application is utilized in clinical assessment where the app functions
as a tracking agent by logging patient health parameters to provide medical assistance, decision,
or predictions, such an app falls under the class of medical devices. Indeed, if you do find that
your application is a medical device, as stated priorly, it should be highly precise, effective, and
above all, safe to use.3
For regulating your app, manufacturers should produce quality documentation that
documents the system design and requirements. For verifying the intended use and
functionality, they should perform scrutinized code inspections with unit testing. These steps
are also a part of verification and validation as they allow manufacturers to identify risks and
mitigate them. Surely, if the app passes through all the quality testing activities, in the end, it
achieves FDA compliance which means that is safe and qualified enough to be hosted on app
stores for industrial use.
Therefore, to sum up, my recommendation to mobile developers is to make sure you
include the “Is my phone app a medical device?” check as part of your development checklist.
As the application data and functionality directs patient safety, your mobile application or
medical device must be tested thoroughly for preciseness. Do you have a mobile medical
application, and need help with the regulatory requirements? We can help you determine if your
app is a medical device and if it is, our regulatory and software experts can guide you step-by-
step through the FDA regulatory process. Contact us at 248-987-4497 or
info@emmainternational.com for more information.
3
FDA (September2019) Policy for Device Software Functions and Mobile Medical Applications. Guidance for Industryand Food
and DrugAdministration Staff. Retrieved on January24th, 2020from https://www.fda.gov/media/80958/download.