Designed to protect consumer safety while supporting innovation, the U.S. Food and Drug Administration (FDA) issued final guidance for developers of mobile medical applications, or apps.
The agency will not enforce requirements under the Federal Drug & Cosmetic Act, but instead exercise discretion for the majority of mobile apps as they pose minimal risk to consumers. Medical apps are software programs that run on mobile communication devices and perform the same functions as traditional medical devices.
The FDA will focus regulatory oversight on a subset of mobile medical apps that present a greater risk to patients if they do not work as intended, including the following:
- Apps used as accessories to regulated medical devices — for example, applications that allow healthcare professionals 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
- Apps that transform a mobile platform into a regulated medical device — for example, applications that turn 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 currently on the market can diagnose abnormal heart rhythms, transform smartphones into a mobile ultrasound device, or function as the “central command” for a glucose meter used by a person with insulin-dependent diabetes.
They have the potential to transform healthcare by allowing doctors to diagnose patients with potentially life-threatening conditions outside of traditional healthcare settings, help consumers manage their own health and wellness, and also gain access to useful information whenever and wherever they need it, FDA officials say.
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 The FDA received more than 130 comments on the draft guidance issued in July 2011. Respondents overwhelmingly supported the FDA’s tailored, risk-based approach.
The agency has cleared about 100 mobile medical applications over the past decade; about 40 of those were cleared in the past two years.
Source: U.S. Food and Drug Administration (FDA), September 23, 2013
2013 Healthcare Benchmarks: Mobile Health delivers a snapshot of mobile health (mHealth) trends, including current and planned mHealth initiatives, types and purpose of mHealth interventions, targeted populations and health conditions, and challenges, impact and results from mHealth efforts.