09.26.13
This week the U.S. Food and Drug Administration (FDA) issued a final guidance for developers of mobile medical applications, or apps, 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.
According to the agency, the FDA will not enforce Federal Drug & Cosmetic Act requirements across the board for apps; rather it will enforce rules with discretion, as most apps are of 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,” reads an FDA statement released on Sept. 23. “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.”
“Some mobile apps carry minimal risks to consumer or patients, but others can carry significant risks if they do not operate correctly,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “The FDA’s tailored policy protects patients while encouraging innovation.”
The FDA is focusing its oversight on mobile medical apps that:
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.
“We have worked hard to strike the right balance, reviewing only the mobile apps that have the potential to harm consumers if they do not function properly,” said Shuren. “Our mobile medical app policy provides app developers with the clarity needed to support the continued development of these important products.”
The agency has cleared about 100 mobile medical applications over the past decade; about 40 of those were cleared in the past two years.
According to the agency, the FDA will not enforce Federal Drug & Cosmetic Act requirements across the board for apps; rather it will enforce rules with discretion, as most apps are of 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,” reads an FDA statement released on Sept. 23. “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.”
“Some mobile apps carry minimal risks to consumer or patients, but others can carry significant risks if they do not operate correctly,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “The FDA’s tailored policy protects patients while encouraging innovation.”
The FDA is focusing its oversight on mobile medical apps that:
- 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
- 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.
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.
“We have worked hard to strike the right balance, reviewing only the mobile apps that have the potential to harm consumers if they do not function properly,” said Shuren. “Our mobile medical app policy provides app developers with the clarity needed to support the continued development of these important products.”
The agency has cleared about 100 mobile medical applications over the past decade; about 40 of those were cleared in the past two years.