This memorandum covers developing
FDA regulations of Mobile Apps. To a great extent, the future of internet
communication is via Apps. Some estimate that 80% of internet traffic will
be Mobile App mediated by the end of the decade.
Bottom Line: The time to enter the
Mobile App space may be now…
Here
is an example of a Mobile App (for Dr. Rima Laibow) described here: http://tinyurl.com/HealthFreedomApp.
FDA
Regs on Mobile Apps
Some
of the questions being considered by the regulators:
-
How the FDA should categorize mobile
apps and decides how, or whether, to regulate them as medical devices.
-
How the FDA evaluates an app's
"intended use."
-
How to interpret the FDA's promise of
"enforcement discretion" for certain types of apps.
-
Who can be considered a mobile medical
app developer and what regulations affect them.
FDA's evolving stance on Mobile Apps
sorts them into three categories:
-
Administrative health information
technology (e.g, billing, claims processing, general communication and
scheduling): This is not a medical device and not regulated by the agency.
-
Health management information technology
(e.g., medication management, data capture, electronic access to clinical
results, provider order entry): This is under FDA jurisdiction but generally so
low risk that the agency can exercise enforcement discretion and not apply
regulations.
-
Medical device health information
technology (e.g., computer-aided detection and diagnosis, robotic surgical
planning, remote display of bedside alarms, radiation treatment planning): This
is actively regulated under Class I, Class II and Class III medical device
rules.
Here is what the FDA is saying
about Mobile Apps:
The
widespread adoption and use of mobile technologies is opening new and
innovative ways to improve health and health care delivery.
Mobile
applications (apps) can help people manage their own health and wellness,
promote healthy living, and gain access to useful information when and where
they need it. These tools are being adopted almost as quickly as they can be
developed. According to industry estimates, 500 million smartphone users worldwide
will be using a health care application by 2015, and by 2018, 50 percent of the
more than 3.4 billion smartphone and tablet users will have downloaded mobile
health applications (http://www.research2guidance.com/500m-people-will
-be-using-healthcare-mobile-applications-in-2015/). These users include health
care professionals, consumers, and patients.
The
FDA encourages the development of mobile medical apps that improve health care
and provide consumers and health care professionals with valuable health
information. The FDA also has a public health responsibility to oversee the
safety and effectiveness of medical devices – including mobile medical apps.
The
FDA issued the Mobile Medical Applications Guidance for Industry and Food and
Drug Administration Staff (PDF - 269KB) on September 25, 2013, which explains
the agency’s oversight of mobile medical apps as devices and our focus only on
the apps that present a greater risk to patients if they don’t work as intended
and on apps that cause smartphones or other mobile platforms to impact the
functionality or performance of traditional medical devices.
What are mobile medical apps?
Mobile
apps are software programs that run on smartphones and other mobile
communication devices. They can also be accessories that attach to a smartphone
or other mobile communication devices, or a combination of accessories and
software.
Mobile
medical apps are medical devices that are mobile apps, meet the definition of a
medical device and are an accessory to a regulated medical device or transform
a mobile platform into a regulated medical device.
Consumers
can use both mobile medical apps and mobile apps to manage their own health and
wellness, such as to monitor their caloric intake for healthy weight
maintenance. For example, the National Institutes of Health’s LactMed app
provides nursing mothers with information about the effects of medicines on
breast milk and nursing infants.
Other
apps aim to help health care professionals improve and facilitate patient care.
The Radiation Emergency Medical Management (REMM) app gives health care
providers guidance on diagnosing and treating radiation injuries. Some mobile
medical apps can diagnose cancer or heart rhythm abnormalities, or function as
the “central command” for a glucose meter used by an insulin-dependent diabetic
patient.
How will the FDA regulate mobile
medical apps?
The FDA will apply the same
risk-based approach the agency uses to assure safety and effectiveness for
other medical devices.
The guidance document (PDF - 269KB) provides examples of how the FDA
might regulate certain moderate-risk (Class II) and high-risk (Class III)
mobile medical apps. The guidance also provides examples of mobile apps that
are not medical devices, mobile apps that the FDA intends to exercise
enforcement discretion and mobile medical apps that the FDA will regulate in
Appendix A, Appendix B and Appendix C.
We
encourage app developers to contact the FDA – as early as possible – if they
have any questions about their mobile app, its level of risk, and whether a
premarket application is required.
Mobile medical apps that the FDA
will regulate
The FDA is taking a tailored,
risk-based approach that focuses on the small subset of mobile apps that meet
the regulatory definition of “device” and that:
-
Are intended to be used as an accessory
to a regulated medical device, or
-
Transform a mobile platform into a
regulated medical device.
Mobile
apps span a wide range of health functions. While many mobile apps carry
minimal risk, those that can pose a greater risk to patients will require FDA
review.
For
a list of what is considered a mobile medical application, manufacturers and
developers of mobile applications can search FDA’s database of existing
classification by type of mobile medical application (for example diagnostic). Approved/cleared mobile medical applications
will also be listed in FDA’s 510(k) and PMA databases and on the FDA’s
Registration & Listing Database.
FDA’s
mobile medical apps policy does not require mobile medical app developers to
seek Agency re-evaluation for minor, iterative product changes.
Mobile apps for which the FDA
intends to exercise enforcement
discretion
For many mobile apps that meet the
regulatory definition of a “device” but pose minimal risk to patients and
consumers, the FDA will exercise enforcement discretions
and will not expect manufacturers to submit premarket review applications or to
register and list their apps with the FDA. This includes mobile medical apps that:
-
Help patients/users self-manage their
disease or condition without providing specific treatment suggestions;
-
Provide patients with simple tools to
organize and track their health information;
-
Provide easy access to information
related to health conditions or treatments;
-
Help patients document, show or
communicate potential medical conditions to health care providers;
-
Automate simple tasks for health care
providers; or
-
Enable patients or providers to interact
with Personal Health Records (PHR) or Electronic Health Record (EHR) systems.
Does the FDA regulate mobile
devices and mobile app stores?
FDA’s
mobile medical apps policy does not regulate the sale or general consumer use
of smartphones or tablets. FDA’s mobile medical apps policy does not consider
entities that exclusively distribute mobile apps, such as the owners and
operators of the “iTunes App store” or the “Google Play store,” to be medical
device manufacturers. FDA’s mobile medical apps policy does not consider mobile
platform manufacturers to be medical device manufacturers just because their
mobile platform could be used to run a mobile medical app regulated by FDA.
Does the guidance apply to
electronic health records?
FDA’s
mobile medical app policy does not apply to mobile apps that function as an
electronic health record (EHR) system or personal health record system.
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