The FDA has issued Mobile Medical Applications Final Guidance regarding the monitoring of Smartphone software applications with medical applications as a “medical device” under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Consistent with FDA’s existing regulatory approach that considers functionality rather than platform, the FDA intends to exercise its jurisdiction over those mobile software applications, “apps”, that fall under the definition of “medical devices”and whose functionality could present a safety risk. Thus, if a mobile app is intended for use in the “diagnosis of disease or other conditions, or the cure, mitigation, treatment, or prevention of disease” it is a medical device, regardless of the platform on which it is run. Examples of apps subject to regulation as a medical device include: apps to diagnose abnormal heart rhythms, an ultrasound device, or function as the “central command” for a glucose meter used by a person with insulin-dependent diabetes.
In the new guidance document, the FDA defines a “mobile medical app” as “a mobile app that meets the definition of device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act); and either is intended:
• to be used as an accessory to a regulated medical device; or
• to transform a mobile platform into a regulated medical device.”
Mobile apps have changed the health care industry by allowing doctors to diagnose patients outside traditional health care settings, empowering consumers with the ability to manage their own health and wellness, and making health information easily accessible at the touch of a button. The FDA says there are about 100 approved “mobile medical applications” with hundreds of others in development. Officials estimate about 500 million Smartphone users will rely on health-related apps by 2015.
The FDA will focus its regulation on manufacturers of mobile medical apps, clarifying that “[a] mobile medical app manufacturer may include anyone who initiates specifications, designs, labels, or creates a software system or application for a regulated medical device in whole or from multiple software components. This term does not include persons who exclusively distribute mobile medical apps without engaging in manufacturing functions; examples of such distributors may include owners and operators of “Google play,” “iTunes App store,” and “BlackBerry App World.”
Like all other medical devices, all mobile medical apps that fall withing the category of medical device will be classified as class I (lowest risk — general controls), class II (moderate risk — special control in addition to general controls), or class III (highest risk — premarket approval). Manufacturers will be responsible for ensuring that its mobile medical app meets the regulatory requirements for the applicable device classification.