The global mobile medical app market is expected to reach 17.61 billion by 2027 with a robust revenue CAGR of 22.9%, according to Emergen Research. Thanks to a boost in digital healthcare forced by the pandemic and an ever-expanding market of wearable medical tech, this market holds almost unlimited potential.
But finding success with a mobile medical app is not simply a matter of having the right idea and the best software. In order to find success in the American market, you also need to understand FDA regulations concerning this field. Given that not all medical-related mobile applications are regulated by the FDA, this isn’t always an easy task.
In this article, we’ll look at what defines an app as a mobile medical application (MMA) and how the FDA regulates software that falls into this category. We’ll also discuss examples of MMA that fall into a gray area where FDA enforcement may or may not occur. And lastly, we’ll look at why it is important to understand these differences and how to move forward in line with FDA regulations.
What Are Mobile Medical Apps?
Mobile medical apps are applications for smartphones and tablets that support doctors and patients. These apps aid or support in the diagnosis, treatment, and/or monitoring of an ailment or disease. MMAs can be stand-alone software or a combination of an accessory that attaches to the mobile device and software used to interpret and utilize the data from the accessory.
In more technical terms, mobile medical applications are (as defined by the FDA):
Medical devices that are mobile apps, that incorporate device software functionality that meet the definition of a device in section 201(h) of the Food, Drug & Cosmetic Act, and are an accessory to a regulated medical device or transform a mobile platform into a regulated medical device.
What this means is that MMAs are medical devices, which means they fall under the same regulating guidelines as insulin pumps, continuous glucose monitors, and other medical hardware. For this reason, it is just as important to design your stand-alone or supporting medical app in line with governing regulations as you would any tangible medical device.
But the nonspecific definition of MMAs can make it difficult to know with certainty whether the FDA will regard your application as a medical device or as a simple mobile app untouched by this type of regulation. Or, as is often the case, something that lands in the gray area between these two potentialities.
FDA Regulation
One way to gain a better understanding of how the FDA views MMAs and what to expect in terms of oversight is to look at examples of different mobile applications that fall into distinct regulatory categories. Here, the FDA offers plenty of help.
Examples of FDA-Regulated MMAs
If any part of the MMA is deemed a regulated medical device (i.e. any software function that supports or aids in disease diagnosis, treatment, or monitoring) then the entire application becomes a medical device and is subject to government regulation.
The FDA lists many examples of regulated device software functions that would be subject to oversight on their webpage. These specific examples fall into three major categories:
- Software functions that transform a mobile platform into a medical device. Given examples include sensors attached to the mobile platform or tools within the mobile platform to measure physiological parameters and the use of mathematical algorithms to interpret physiological data. Real-world applications that fall into this category include connected CGM apps and meal trackers that calculate insulin dosing information.
- Software functions that connect to an existing device in order to control its operation, function, or energy source. Given examples include apps that alter the function of an infusion pump and calibrate, change, or control the settings of a medical device. Real-world applications that fall into this category include insulin pump apps and apps that allow for the calibration of CGMs.
- Software functions used in active patient monitoring or to analyze patient-specific medical device data. Given examples include apps that use patient-specific data to identify medical anomalies and those that process physiological signals of connected monitors. Real-world examples include applications that allow doctors to view CGM reports and live data and apps that alert caregivers via connected apps when a patient is experiencing low or high blood sugar.
MMAs That Fall Into an FDA Gray Area
The above represents the more obvious cases of MMAs that qualify as medical apps. It is easy to see how any software falling into those three categories works to treat, monitor, or diagnose disease. It is when you step out of these clear definitions and begin looking at software that is meant to be used by those with medical problems but that does not directly aid in treating the condition that the questions begin to arise.
The FDA refers to these types of MMAs as medical devices but of which they intend to “exercise enforcement discretion.” In other words, while these apps are considered medical devices and therefore fall under the category of MMAs, they do not expect manufacturers to submit premarket review applications or register and list their software with the FDA.
Some examples from the FDA’s list of enforcement discretion instances that may pertain to apps developed for people living with diabetes include:
- Software functions that provide periodic educational information, reminders, or motivational guidance.
- Software functions that prompt the user to enter herbs/drugs they would like to take concurrently and provide information on interactions.
- Software functions that use patient characteristics such as age, sex, and behavioral risk factors to provide patient-specific preventive recommendations.
- Software functions that track medications and provide user-configured reminders for improved medication adherence.
- Software functions that provide historical trending and comparisons of blood sugar levels.
- Software functions that provide prediabetes patients with guidance/tools to help develop better eating habits or increase physical activity.
While each of these examples allows patients to better manage their health or condition, none offer treatment advice, diagnostic information, or active monitoring of physiological parameters.
The list above represents examples of software as a medical device (SaMD) that is not typically regulated by the FDA. It is also possible to create mobile applications for disease support and education that fall completely outside the definition of MMA and therefore are not considered mobile medical devices at all.
Designing Apps In Line with FDA Regulations
Regardless of which category your software falls into, it is always prudent to understand FDA regulations and develop your application in line with these guidelines. This assures that, as laws and regulations change with respect to what is considered an MMA, your software will be ready for certification if necessary.
If you aren’t sure if your software falls cleanly into the category of a medical device or not, the FDA recommends you email them as early on in the process as possible to get answers. They can help you determine your product’s risk and tell you whether a premarket application is required.
If you do find your MMA falls into the category of a regulated medical device or floats somewhere in the gray, we recommend working with a partner that has a broad knowledge of SaMD development to bring your app to market. Here at Sequenex, we have an in-depth understanding of ISO 13485, global medical technology guidelines, and the many other considerations that go into designing successful SaMD.
If you need help understanding your future product’s place in the MMA market or designing that software in line with FDA regulations, contact us today.