Medical devices in the App Store? US regulation of mobile medical applications | Lippes Mathias Wexler Friedman
Since the start of the COVID-19 pandemic, more people than ever have downloaded and used mobile apps or apps to communicate with their doctors, manage prescriptions, and streamline much of the healthcare activities traditionally performed in hospitals. hospitals and clinics. “Vaccine passports” included in a mobile phone’s digital wallet may soon become the norm for checking its vaccination status for international travel or attending major events. What once seemed new is now commonplace as “digital health” technology has exploded in the United States and Canada.
With the proliferation of mobile medical apps on the market, it would be hard to find someone who hasn’t used an app to count their steps, track their sleep, manage their diet, or improve their overall health and well-being. . Technological growth has allowed applications to do more and more each year. The Canadian digital health market has seen unprecedented growth, with Canadian digital health startups raising significantly more funds in 2020 than in 2019.
However, it is essential that developers and manufacturers assess whether their applications are not just unregulated software functions, but rather regulated medical devices.
As often happens, as technological growth proliferates, laws and regulations struggle to catch up. Rather than creating entirely new regulatory regimes, the US Food and Drug Administration (“FDA”) and Health Canada have attempted to integrate software functions, including mobile medical applications, into their existing regulatory structures. This created confusion given the broad definitions of “medical devices” of the two agencies.
Although the classification of a device varies between the United States and Canada, both define a “medical device” broadly as an instrument intended for the diagnosis, treatment or prevention of a disease which does not affect not its primary purpose by chemical action. Many, if not all, mobile medical applications could fit into this definition, no matter how harmless they are. After the passage of the 21st Century Cures Act, the United States exempted several software functions from the definition of “medical device”, including those intended to maintain or encourage a healthy lifestyle unrelated to diagnosis, cure. , alleviation, prevention or treatment of a disease or condition. However, it would be impossible to list all potential software functions in the law.
To alleviate industry and consumer confusion, the FDA and Health Canada released guidance documents in 2019 outlining their respective approaches to the regulatory interpretation of “device software functions”, including software. as a medical device, software in a medical device, and mobile medical applications. In an effort to improve harmonization, the two countries have joined as members of the International Forum of Medical Device Regulators (“IMDRF”) and adopted the IMDRF’s definition of “software as a medical device” as “a software intended to be used for one or more medical purposes that fulfill those purposes without being part of a physical medical device.
The FDA has taken a streamlined regulatory approach, classifying software functions into three distinct groups: (1) not a medical device; (2) a medical device, but not subject to FDA enforcement; and (3) a medical device subject to FDA enforcement. The FDA only intends to apply regulatory oversight to software functions that are medical devices. and the functionality of which could pose a risk to patient safety if the device does not perform as intended. It is then possible that an application is a medical device, but the FDA has chosen to exercise its discretion by not regulating it as such.
For software functions considered to be medical devices, specific FDA regulations focus on software functions that:
- are an extension of one or more medical devices by connecting to those devices for the purpose of controlling the device or analyzing device data (for example, mobile apps that control insulin delivery) ;
- transforming the mobile platform into a regulated medical device by using accessories, display screens or sensors, or by including functionality similar to these regulated medical devices (for example, a glucometer accessory on a mobile phone); and
- become a regulated medical device by performing or providing patient-specific analysis, diagnosis or treatment recommendations (for example, a device that calculates or creates a dosage plan for radiation therapy).
If the FDA chooses to regulate a company’s software function as a medical device, the company will need to obtain approval, clearance, or clearance from the appropriate agency before marketing the device. The company may also have to meet specific registration and registration requirements, as well as any other regulatory requirements applicable to the manufacturer or distributor of a device. Failure to follow these steps could pose a significant risk to consumers and result in FDA enforcement activity, such as issuing a warning letter, foreclosure, injunction, or even legal action. lawsuits. For particularly egregious violations of federal food, drug and cosmetic law, tort fines can reach $ 500,000.
The FDA’s interest in regulating software functions has grown significantly in recent years. More than 250 digital health products have been authorized, approved or approved by the FDA since 2017. The FDA has created a pre-certification program for software technologies through its Center of Excellence in Digital Health to inform development a more streamlined regulatory model going forward. In April 2021, the FDA cleared the commercialization of an artificial intelligence (“AI”) device that uses machine learning in
colon cancer screening. Likewise, a law passed in 2019 gave Health Canada a “regulatory sandbox” through which the agency can experiment with the intricacies of regulating AI.
For companies whose devices fall into a gray area of regulatory enforcement, it is important that they seek help in assessing the regulatory status of the device and the potential risks associated with marketing it to consumers. No matter what the future holds, mobile medical apps are here to stay, and as businesses and products evolve, so will the regulatory landscape.
Key points to remember
- Unprecedented growth. Digital health technologies, and mobile medical applications in particular, are experiencing unprecedented growth and are here to stay.
- Regulatory landscape. The United States and Canada have released guidance documents and provided application examples in an attempt to clarify a large and confusing regulatory space.
- Marketing questions. An app that “treats” or “diagnoses” or “cures” a specific disease or condition will be regulated differently from an app that “improves” or “tracks” overall health and well-being.
- Risk awareness. If misuse or malfunction of the app could cause a significant risk to the health and well-being of a user, then it is likely that it will be treated as a regulated device.
- Watch out for the border. While the FDA and Health Canada have published numerous examples of the types of software functions that may be subject to regulation, the two agencies have left ambiguity in their respective regulatory approaches. As you move from the Canadian market to the US market, it is important to assess if and how your product will be regulated in each country.