FDA Releases Guidance on Mobile Apps

The FDA has issued a final guidance for developers of mobile medical applications (“apps”), emphasizing that it will exercise enforcement discretion for the majority of mobile apps since they present minimal risk to consumers. The FDA intends, however, to apply its regulatory oversight only to “mobile medical apps” whose functionality could pose a risk to a patient’s safety if the mobile app did not function as intended.

Background

Since 1989, the FDA has offered guidance on how it defines and regulates computer-based and software-based medical devices. The FDA has formally classified certain types of software applications that meet the definition of a device and identified specific regulatory requirements that apply to these devices and their manufacturers. These software devices include products that feature one or more software components, parts, or accessories (such as electrocardiographic (ECG) systems used to monitor cardiac rhythms), as well as devices that are composed solely of software (such as laboratory information management systems).

The FDA noted that certain mobile medical apps may pose risks that are unique to the platform on which the mobile medical app is run. For example, interpreting radiological images on a mobile device could be adversely affected by the screen size, contrast ratio, and uncontrolled ambient light of the mobile platform. The FDA takes these risks into account in assessing the appropriate regulatory oversight for these products. The agency issued a draft guidance on mobile apps in July 2011; it received more than 130 comments on the draft guidance.

Final Guidance

Under the final guidance, 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 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 guidance includes definitions of “mobile platform”; “mobile application”; “mobile medical application”; “regulated medical device”; and “mobile medical app manufacturer.” The guidance also includes examples of mobile apps that are not medical devices (e.g, apps that provide access to medical textbooks or dictionaries; or apps that are used by health professionals for medical training) and those for which the FDA intends to use enforcement discretion (e.g., apps that provide motivational messages for patients with certain conditions or that use GPS technology to alert patients to local health hazards related to their condition).

The agency noted that it has cleared about 100 mobile medical applications over the past decade; about 40 in the last two years.

The FDA specifically noted in the guidance that it is not regulating the sale or consumer use of smartphones or tablets, and it is not regulating the distributors of mobile medical apps such as the iTunes App store or the Google Play store.