Level Up Your FDA-Required IFUs for Mobile Medical Apps

 In Medical Product Design, User Interface Design

Smartphones have brought convenience and exciting possibilities for countless aspects of life, including tracking personal wellness and fitness. And software applications that act as medical devices offer transparency into the day-to-day well-being of patients and the effectiveness of their treatment regimens. Because of this, these apps also raise tricky questions about clinical uses for the information they gather and how regulators can ensure they are safe and effective.

For makers of innovative medical devices, mobile apps present a major opportunity for creating products that involve patients more directly in their own healthcare. However, it’s important to understand how the U.S. Food and Drug Administration (FDA) guidelines address these software programs.

As apps become more sophisticated, users gain new tools to collect and engage with their medical information. For the best user experience (UX), developers must pay careful attention to regulations, along with functionality and a consistent design that supports users’ journeys with your product.

Mobile Medical Apps vs. Health Apps: What’s the Difference?

From a regulatory standpoint, not all health-related apps are created equal. To understand why mobile medical apps (MMAs) and health apps are treated differently, you need to understand the difference between the two. Which means you must first consider the definition of a medical device.

Traditional medical devices, according to the FDA, are devices used to diagnose, cure, treat or prevent diseases and other conditions, or to affect the body’s structure or function.

Mobile medical apps fall under the same umbrella. Though they may be completely contained on a phone or tablet, these software apps have the same intended purpose as a traditional device. Therefore, the FDA regulates these apps, too. In addition, some mobile medical devices have hardware components, like a blood sugar monitoring system that links to your phone and provides instant glucose readings.

Mobile health apps, on the other hand, are not used to diagnose, cure, treat, or prevent diseases or other conditions, nor do they affect the body’s structure or function. They are simply auxiliary applications that provide information or support related to health and wellness. Since these apps don’t serve the same purpose as medical devices, they don’t require regulation. Examples of mobile health apps are a food-logging program that tracks calories and macronutrients or a pedometer app that links to your smartwatch. These apps might help you understand your health, but they don’t provide or facilitate clinical care.

How the FDA Regulatory Process Applies to Different Devices

When it comes to traditional medical devices, the FDA has established a robust process for approving or clearing new products. Based on whether the product presents a low, moderate, or high risk to patients, manufacturers are required to undergo various premarket submission procedures:

  • Makers of many Class I or Class II devices – those that present low or moderate risk – must offer evidence that their new product is similar in its use, technology, and performance to a product that has already been approved.

  • Most Class III (and some Class II) devices, meanwhile, must pass premarket approval, which calls for extensive scientific evidence that the device is safe and effective.

The FDA follows the same process for MMAs, with a few caveats. If an app is used as an accessory to an already regulated medical device — or causes the phone or tablet itself to act as a medical device — it will be regulated. A mobile health app, like a step-counting app, is outside the FDA regulation parameters because it doesn’t administer a treatment or present a diagnosis. There are guidelines that set a specific scope for what types of software would be considered a “device.”

How FDA Requirements Support UX Through IFUs

Ultimately, FDA requirements are in place to ensure devices are safe and effective — which is the same basis of a good user experience. An essential part of an effective experience is solid, easily understandable instructions for use (IFUs). The FDA has requirements for labeling devices that spell out the minimum requirements for IFUs, whether printed or digital. Printed IFUs might be the only requirement in some circumstances, but those are like printed instructions for Ikea furniture. Necessary, sure, but wouldn’t a visual, interactive tutorial have a bigger impact?

There’s an opportunity to go beyond the baseline of safe and effective as guaranteed by the FDA to achieve even better user outcomes.

“UX” is a broad, catch-all term that refers to a user’s entire experience with a product or service. In the case of mobile medical apps, the user experience is the sum total of every interaction a user has with an MMA and any associated physical devices. This could include everything from unboxing, setting up a physical device, and creating a digital user profile to using an app’s software to calculate prescription dosages and diagnose injuries.

MMAs make powerful medical technology much more accessible to users by harnessing the convenience of widely owned mobile devices. Building an app that supports the technology well is an endeavor with several key considerations.

What’s the Difference Between On-Screen Help and IFUs?

To make sure users get a positive experience, it’s critical that the app provide on-screen help (OSH), also known as “in-app guidance.” OSH is a digital experience that aids users through onboarding and continued use of the MMA to make it a better and more interactive experience.

Whether this is an easily accessible help button, an overlay that demonstrates how to navigate menus, or prompts that provide the right information at the right time, a successful user experience relies on proper guidance. In addition, OSH may encompass digital IFUs, instructions for use that are either accessible within the user interface or an integrated part of the application itself.


It becomes clear to experts in UX that there’s an intersecting point at which the goals for OSH merge with the goals of IFUs. IFUs can be more than a regulatory requirement. They can be thoughtfully woven throughout the MMA graphic user interface (GUI) so users receive the information they need exactly when they need it.

How Regulations and IFUs Work Together

When developing MMAs, teams often don’t think about regulatory requirements early enough in the process. This results in an app that might work well from every other UX perspective, but lacks thorough guidance. Thus the app would fail to meet the FDA requirements for IFUs if submitted as is.

We know that many medical device companies scramble to get the basic required IFUs completed as submission deadlines draw near, creating a situation in which IFUs are often hastily written by an engineering team member rather than an technical writing expert familiar with UX design and regulatory requirements. While quick to create and technically accurate, these IFUs can result in poor UX, improper use of the product, and possibly undesired effects.

The User-Centered IFU Design Process

MPE (Formerly Mindflow Design) recommends our clients treat OSH and IFUs as a microcosm of the full design process. When done right, developing IFUs should take place concurrently with the entire design process — covering the basic requirements for FDA approval but also considering additional factors beyond that, such as:

When all of these aspects are given time and attention throughout the design process, your IFUs become a seamless and supportive part of the user experience. When done poorly, the IFUs may squeak by with only the minimum instructional guidelines and fail to meet user needs.

Go Beyond FDA Requirements for Best-in-Class UX

At the end of the day, FDA regulations and UX are rowing in the same direction.

For user experience, patient safety, and business reasons, it’s important for medical product makers to consider how they will address regulation from the earliest stages of development. Developing OSH and IFUs as an integral part of the process from the onset puts you in a good position when it’s time for FDA regulatory submission.

Your MMA’s help information should be fully integrated into your user experience by experts who are familiar with medical device and IFU development within the context of FDA regulations. Treating IFUs as a box to check for regulatory requirements just doesn’t serve the end-user. Working with experts to create a user-centered experience means you’ll be complying with the FDA requirements from onset.

Get in touch below with MPE (Formerly Mindflow Design) to understand how your medical device can benefit from carefully designed, fully integrated IFUs.


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