Today, the U.S. Food and Drug Administration issued final guidance for developers of mobile medical
applications, or apps, which are software programs that run on mobile communication devices and
perform the same functions as traditional medical devices. The guidance outlines the FDA’s tailored
approach to mobile apps.
The agency intends to exercise enforcement discretion (meaning it will not enforce requirements
under the Federal Drug & Cosmetic Act) for the majority of mobile apps as they pose minimal risk to
consumers. The FDA intends to focus its regulatory oversight on a subset of mobile medical apps
that present a greater risk to patients if they do not work as intended.
Mobile apps have the potential to transform health care by allowing doctors to diagnose patients
with potentially life-threatening conditions outside of traditional health care settings, help
consumers manage their own health and wellness, and also gain access to useful information whenever
and wherever they need it. Mobile medical apps currently on the market can, for example, diagnose
abnormal heart rhythms, transform smart phones into a mobile ultrasound device, or function as the
“central command” for a glucose meter used by a person with insulin-dependent diabetes.
The FDA is focusing its oversight on mobile medical apps that: 1) are intended to be used as an
accessory to a regulated medical device – for example, an application that allows a health care
professional to make a specific diagnosis by viewing a medical image from a picture archiving and
communication system (PACS) on a smartphone or a mobile tablet; or 2) transform a mobile platform
into a regulated medical device – for example, an application that turns a smartphone into an
electrocardiography (ECG) machine to detect abnormal heart rhythms or determine if a patient is
experiencing a heart attack.
Mobile medical apps that undergo FDA review will be assessed using the same regulatory standards
and risk-based approach that the agency applies to other medical devices. The agency 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.” FDA has cleared about 100
mobile medical applications over the past decade; about 40 of those were cleared in the past two
years. For more information: Click Here.