FDA Mobile Medical Applications Guidance

“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.

Key Points in the Guidance

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:

1. connecting to one or more medical devices to control or otherwise extend device functionality,
2. transforming the mobile platform into a regulated medical device via connected peripherals or included medical device functionalities, or
3. converting the mobile platform into a regulated medical device by providing patient-specific analysis, diagnosis, or treatment recommendations.

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.

Qualifying Devices

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:

• use a sensor or lead connected to a mobile platform to measure and display, amplify, record, or analyze physiological parameters for diagnostic purposes. Examples: electrocardiograph (ECG), electroencephalograph (EEG), electronic stethoscope, CPR feedback monitor, nystagmograph¸ tremor transducer, limb accelerometer, blood oximeter, or glucometer
• produce controlled tones or signals using tools within the mobile platform (e.g., a speaker) intended for use in diagnostic evaluations of possible otologic disorders (e.g., an audiometer)
• present donor history questions to a potential blood donor and record/transmit responses for a collection facility to determining donor eligibility prior to collection of blood or components
• alter the function or settings of an infusion pump, blood-pressure cuff , implantable neuromuscular stimulator, cochlear implant, computed tomography (CT), or X-Ray machine
• connect to bedside (or cardiac) monitors and transfer data to a central viewing station for display and active patient monitoring

Enforcement Discretion

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:

• provide educational information, reminders,  planning, or motivational guidance in support of therapy, medication, or healthy behaviors
• use GPS information to advise of environmental risks
• track, trend, or store diet, health events, behavior triggers, symptoms, or health metrics data
• record conversations with medical professionals for later access
• use patient characteristics or symptoms to help recommend or a locate a  health provider
• initiate emergency calls or alert first responders

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:

• are not intended for medical or health-related use
• present commonly available information for general education
• present reference or review material for trained professionals
• perform or automate common office tasks
• function as generic aids or general purpose products

Final Thought

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.

Let us help you ensure safe, reliable products. Contact us to find out more about validating your mobile medical applications or with any questions you have about regulatory compliance.