FDA Medical Mobile App Guidelines: Will Apply Regulatory Oversight to Medical Device Apps

October 10, 2013

Thursday, October 10, 2013, by Christina Wheaton
At the end of last month, the U.S. Food and Drug Administration issued final guidelines regarding its regulation of mobile medical applications, or “apps.”
Mobile medical apps are often targeted at individuals seeking to maintain a healthy lifestyle, as well as those seeking to monitor a particular diagnosis. Medical mobile apps are also targeted at physicians and other medical professionals to facilitate the ease of patient care. According to FDA estimates, approximately 1,000 new medical software products are available for smart phone purchase every month.  By 2015, it is estimated that 500 million people will use medical apps for healthcare purposes. Naturally, there is a great deal of excitement about what some are calling the “mobile health revolution.”

“The FDA intends to apply its regulatory oversight to only those mobile apps . . . whose functionality could pose a risk to a patient’s safety if the mobile app were not to function as intended.”

The Federal Food, Drug and Cosmetic Act gave the FDA the authority to regulate the safety of certain devices. Under Section 201(h) of the Act, a device is defined as “an instrument, apparatus, implement, machine, contrivance . . . or other similar or related article, including any component, part or accessory which is . . . intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease.” It also includes devices intended to affect the structure or function of the body. Because of the broad definition of a “device” under the Act, a great deal of uncertainty existed in the past as to what approach the FDA planned to take regarding medical mobile apps.
In July of 2011, the FDA issued draft guidelines. The guidelines released last month represent the final revised regulations. Through its policy, the FDA intends to “protect[] patients while encouraging innovation.” Specifically, the guidelines are aimed at clarifying which medical mobile apps the FDA intends to regulate.
The FDA will only apply regulatory oversight to mobile medical apps that meet the definition of a device, and are “to be used as an accessory to a regulated medical device; or to transform a mobile platform into a regulated medical device.” Apps that come under FDA regulatory oversight belong to one of three main categories: (1) those that are an extension of a medical device, (2) those that transform a smart phone or tablet into a regulated medical device, or (3) those that become a regulated medical device by offering patient specific analysis, diagnosis and treatment. Essentially, the FDA plans to oversee only those apps that function in a similar way to the more traditional medical devices it already regulates. In addition, it clarified that it would not be regulating the smart phones or tablets using the medical apps.
The final guidelines are careful to distinguish between lower and higher risk medical device apps. “The FDA intends to apply its regulatory oversight to only those mobile apps that are medical devices and whose functionality could pose a risk to a patient’s safety if the mobile app were not to function as intended.” Thus, mobile apps that meet the criteria of a medical device, but pose low risks to public health and safety if not regulated, will not be subjected to regulatory oversight. Apps that fall into this category include those that encourage users to maintain a healthy lifestyle, track health information, or provide medical information.
Bradley Merrill Thompson, a lawyer with Epstein, Becker & Green who often represents medical device companies, praised the new regulations released by the FDA. In a statement to the Wall Street Journal, he noted the “massive changes” in the final regulations represented a “huge step forward.” He added that these regulations will allow companies that, due to a lack of guidance, “were sitting on the sidelines doing nothing” to begin developing medical mobile apps in accordance with the FDA’s standards. Only time will tell if the guidelines help to facilitate the “mobile health revolution.”