The Journal of mHealth Vol 1 Issue 1 (Feb 2014) | Page 20

FDA Issues Final Guidance on Mobile Medical Apps
Continued from page 17

based approach that the agency applies to other medical
devices. The agency has stated that it does not regulate
the sale or general consumer use of smartphones or
tablets nor does it regulate mobile app distributors such
as the ‘iTunes App store” or the “Google Play store.”

Specific examples of mobile apps that FDA does not
consider to be devices and with no regulatory requirements under the current laws administered by FDA include:

1. Mobile apps that are intended to provide access to
electronic “copies” (e.g., e-books, audio books)
of medical textbooks or other reference
“We have worked hard to strike the right
materials with generic text search
balance, reviewing only the mobile apps
capabilities. These are not dethat have the potential to harm conMobile apps
vices because these apps are
sumers if they do not function
intended to be used as refhave the potential
properly,” said Shuren. “Our
erence materials and are
mobile medical app policy proto transform healthcare
not intended for use in
vides app developers with the
the diagnosis of disease
by allowing doctors to
clarity needed to support the
or other conditions, or
continued development of
diagnose patients with
in the cure, mitigation,
these important products.”
treatment, or prevention
potentially life-threatening
of disease by facilitating
The agency has cleared about
conditions outside of
a health professional’s as100 mobile medical applicasessment of a specific patraditional healthcare
tions over the past decade; about
tient, replacing the judgment
40 of those were cleared in the past
settings...
of clinical personnel, or pertwo years.
forming any clinical assessment.
Examples include mobile apps that are:
The following extracts from the guidance report sets out the type of apps that the FDA consider may meet the definition of medical device but for
which FDA intends to exercise enforcement discretion,
and those that the department will not consider to be a
medical device and therefore outside of the regulatory
scope. That is not to say that these applications will not
have to meet other regulatory requirements.
Examples of mobile apps that are NOT
considered medical devices
This extract provides a representative list of mobile app
functionalities to illustrate the types of mobile apps that
could be used in a healthcare environment, in clinical
care or patient management, but are not considered
medical devices. Because these mobile apps are not considered medical devices, FDA does not regulate them.
The FDA understands that there may be other unique
and innovative mobile apps that may not be covered in
this list that may also constitute healthcare related mobile apps. This list is not exhaustive; it is only intended
to provide clarity and assistance in identifying when a
mobile app is not considered to be a medical device.

18
February 2014

•
•

•
•
•
•

Medical dictionaries;
Electronic copies of medical textbooks or literature articles such as the Physician’s Desk Reference or Diagnostic and Statistical Manual of
Mental Disorders (DSM);
Library of clinical descriptions for diseases and
conditions;
Encyclopedia of first-aid or emergency care information;
Medical abbreviations and definitions;
Translations of medical terms across multiple
languages.

2. Mobile apps that are intended for health care providers to use as educational tools for medical training
or to reinforce training previously received. These may
have more functionality than providing an electronic
copy of text (e.g., videos, interactive diagrams), but are
not devices because they are intended generally for user
education and are not intended for use in the diagnosis
of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease by facilitating
a health professional’s assessment of a specific patient,