“Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff”, issued by the FDA in September 2013, provides insight to the FDA strategy for overseeing mobile medical applications. If a mobile application is classified as a medical device, it will receive the same FDA scrutiny as currently regulated medical devices, requiring appropriate validation.
There are several regulatory requirements that mobile app developers need to consider in their design, development, and marketing strategies:
How you market your app defines whether it constitutes a device.
“When the intended use of a mobile app is for the diagnosis of disease or other conditions, or the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or any function of the body of man, the mobile app is a device.”
Mobile medical apps are those having the intended use of:
FDA focus is on device functionality and risk, not on the platform. Devices subject to regulatory oversight are ones that pose a risk to patients should they fail to operate properly. Manufacturers are expected to comply with regulations for the appropriate device class, including appropriate Quality System controls, cGMP, and 21 CFR 11 requirements.
The FDA intends to focus its enforcement on medical applications with immediate potential health effects. This includes apps that measure or record patient-specific information and exhibit a high potential for risk if they don’t function properly. Example mobile medical apps that merit FDA oversight include those that:
The FDA has listed a number of mobile medical apps for which it intends to exercise “enforcement discretion” due to low risk imposed on patients. Although these may constitute devices and/or be marketed for diagnosis, cure, mitigation, treatment, or prevention of disease or other conditions, the FDA does not intend to enforce requirements under the Federal, Food, Drug, and Cosmetic Act. Example devices:
In spite of the provisions for enforcement discretion, FDA still strongly recommends adherence to Quality System regulation for all medical device software, even that which poses low patient risk. The guidance cites a nine-year FDA study indicating that over ninety percent of software-related device failures were generally due to failure to validate software prior to production.
Some apps are not regulated by the FDA. These would include apps that:
With mobile medical applications, software validation remains an important means of guaranteeing product consistency and accuracy of results. It simplifies the risk equation by actively exploring the design integrity of the application and reinforces market-readiness.