From fitness tracking to healthy eating to virtual doctor visits, mobile technology places an ever-expanding selection of health management tools and information at our fingertips. With clear benefits, it is no surprise that the Food and Drug Administration (FDA) is encouraging the development of mobile medical applications.

Yet, with patient health at stake, applying regulatory oversight to mobile apps that perform as medical devices is key to mitigating risk. In 2015, the FDA issued their amended Mobile Medical Applications Guidance for Industry and FDA Staff, placing particular attention on apps that present the greatest risks to patients if they do not work as intended.

Which mobile apps are considered regulated medical devices?

Under Section 201(h) of the FD&C Act, many mobile apps do not meet the definition of a medical device, and only a small subset of apps qualify for medical device regulation by the FDA. Mobile apps intended for the “diagnosis of disease or other conditions, or the cure, mitigation, treatment, or prevention of disease,” or those intended to “affect the structure or any function of the body of man,” are considered by the FDA to be a medical device. This includes:

• a physical accessory that can attach to a regulated medical device (eg, electrocardiographic systems used to monitor cardiac rhythms),
• software that can transform a mobile platform into a regulated medical device (eg, laboratory information management systems), or
• a combination of accessories and software.

Guidance does not address software that performs patient-specific analysis to aid or support clinical decision making.

When does the FDA require regulatory oversight?

As mentioned above, Agency regulation is driven by the level of risk patients face if the app were not to function as intended. Mobile apps that require regulatory oversight are subject to the same assignment of Class and Regulatory Controls as traditional medical devices. Each type of device (I, II, and III) is assigned to a class based on the level of control deemed necessary to assure the safety and effectiveness of the device:

• Class I General Controls: Carry minimal patient risk and may not be subject to FDA review
• Class II General Controls and Special Controls: Carry moderate patient risk
• Class II General Controls and Premarket Approval: Carry high patient risk

The Agency has expressed that they intend to focus their regulatory oversight of mobile medical apps on products that meet at least 1 of 3 main criteria:

1. Mobile apps that are an extension of one or more medical device(s), through connecting to such device(s) for the purpose of controlling the device or for use in active patient monitoring/medical data analysis.
2. Mobile apps that transform the mobile platform through attachments, display screens, or sensors, or through inclusion of functionalities similar those of currently regulated medical devices.
3. Mobile apps that perform patient-specific analysis and provide patient-specific diagnosis or treatment recommendations.

The Agency does not currently intend to regulate mobile apps that function as an electronic health record system or personal health record system.

Prescription-based mobile medical apps

One notable area of investment for companies developing mobile medical apps is digital health technologies designed to be used in conjunction with medication or behavioral interventions, or to replace treatment altogether. Examples include:

The reSET app (Pear Therapeutics), designed to increase retention in an outpatient treatment program for individuals with substance use disorder (alcohol, cocaine, marijuana, stimulant). In a multi-site, unblinded, controlled 12-week clinical trial of 399 patients, app users showed a statistically significant increase in abstinence.

The reSET-O app (Pear Therapeutics), designed to increase retention in an outpatient treatment program for individuals with opioid use disorder. In a multi-site, unblinded, controlled 12-week clinical trial of 170 patients, app users showed a statistically significant increase in abstinence.

The AKL-T01 Interactive Program (Alkali Interactive Labs), designed to improve ADHD symptoms. In a proof-of-concept study, this program showed promise for treatment, including improving attention, working memory, and inhibition in children with ADHD. Though not currently FDA-approved, Alkali is seeking 510(k) clearance as a medical device.

The De Novo classification

Unlike a traditional consumer-facing mobile app, the pathway to FDA approval for a mobile medical app (and its subsequent prescription by a medical provider) necessitates an approach that considers the regulatory approval process, much like a traditional pharmacologic therapy.

Mobile medical apps subject to regulatory oversight may qualify to utilize the FDA’s De Novo process, which classifies novel medical devices for which general controls alone (or general and special controls) provide reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate device.

Prior to submitting a De Novo request, the FDA recommends a pre-submission meeting to obtain FDA feedback.

For companies with questions about regulatory requirements for their mobile medical app, the Agency encourages developers to contact them as early as possible during the development process to gain clarity. Premier Consulting has experience supporting digital health projects, and we can help guide interactions with the FDA to advance your development program. Contact us to learn more.