FDA recently issued final guidance for developers of mobile medical applications, or apps, the software programs that run on mobile communication devices and perform the same functions as traditional medical devices. According to FDA, the agency intends to exercise enforcement discretion (ie, it will not enforce requirements under the Federal Drug & Cosmetic Act) for the majority of mobile apps as they pose a low risk to consumers. Instead, the agency will 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.
“Some mobile apps carry minimal risks to consumer or patients, but others can carry significant risks if they do not operate correctly. The FDA’s tailored policy protects patients while encouraging innovation,” explains Jeffrey Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health.
Under the final guidance, FDA will focus its oversight on mobile medical apps that:
- are intended to be used as an accessory to a regulated medical device – ie, 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;
- 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 FDA applies to other medical devices. The agency has cleared about 100 mobile medical applications over the past ten years and about 40 of those were cleared in the past 2 years.
Since the draft guidance was issued in July 2011, FDA received more than 130 comments. The majority of respondents supported the FDA’s tailored, risk-based approach, according to the agency. “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,” says Shuren. “Our mobile medical app policy provides app developers with the clarity needed to support the continued development of these important products.”
