How does FDA regulation impact mobile health apps?

 In User Interface Design


Smartphones have brought convenience and exciting possibilities for countless aspects of life, including tracking personal wellness and fitness. Mobile health apps offer transparency into the day-to-day well-being of patients and the effectiveness of their treatment regimens. However, apps have also raised tricky questions about the clinical uses for the information they gather and how regulators can ensure they are safe.

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 U.S. Food and Drug Administration guidelines address these software programs. Developers must pay careful attention to regulations, along with functionality and establishing a distinctive visual brand language, as they make promising leaps forward in giving consumers tools to collect and engage with their own medical information.

How are apps and devices different?

“The FDA has established a robust process for clearing new devices.”

When it comes to traditional medical devices, the FDA has established a robust process for approving or clearing new products. According to the FDA’s definition, devices are used to diagnose, cure, treat or prevent diseases and other conditions, or to affect the body’s structure or function. 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 certain mobile health apps, but only if they are used as an accessory to an already regulated medical device or cause the phone or tablet itself to act as a medical device. As of December 2016, the 21st Century Cures Act set a specific scope for what types of software would be considered a “device.” For instance, an app that uses an external sensor to continuously measure glucose levels and report trending information underwent premarket approval. Another app that works in conjunction with a Bluetooth-enabled insulin pen was cleared by the agency.

Low-risk wellness apps, on the other hand, require no approval or clearance from the FDA. These include programs intended to track the user’s diet, activity level or sleep patterns without administering any treatment or presenting a diagnosis.There is a great deal of gray area for apps to fall somewhere between these categories, and that’s why it’s important for medical product makers to consider how they will address regulation from early in development.

Regulation must be a consideration throughout development and design.Regulations must be taken into account throughout development and design.

Finding your way through the clearance process

The key questions when bringing any medical device or mobile health app to market are what claims the manufacturer is making about its use and effectiveness and whether it presents any risk to users. Depending on how the program is classified, the way forward can involve very different investments of time and resources, as well as long-term outcomes. In some cases, firms find it is best to lower their bar to entering the market by moderating the claims they make for what an app can do.

Companies that are interested in creating mobile health apps must decide the best path through regulation on a case-by-case basis. A wide variety of federal laws may apply to an app, based on its medical uses as well as the ways it collects and shares information. It’s therefore wise to consult with regulatory experts throughout the medical product design development processes.


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