For medical manufacturers, compliance with the FDA regulations is paramount, as the device or product itself as well as the manufacturing process must all meet these specific standards. With the rise in mobile medical apps in the past few years, there is a growing concern about the FDA’s regulation of these devices, and it is important for all manufacturers to understand which apps are to be regulated, why, and how.

This change and the FDA issued Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff have an impact on both the FDA and your health manufacturing business.

Why are Mobile Medical Apps Being Regulated by the FDA?

According to RAPS, “Because many medical mobile applications are intended to be used ‘in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease,’ they are regulated as medical devices.” Certain mobile medical apps need to be regulated by the FDA in order to make sure that consumers are protected just as they would be in the case of other types of medical devices.

It is understood that there are specific apps that need to be regulated by the FDA and other apps that don’t. How can you tell which apps fall under the FDA-regulated category?

• Apps that are “intended to be used as an accessory to a regulated medical device” will be FDA-regulated. This describes apps that allow someone to make a diagnosis based on images it takes or through some other means.
• Apps that turn a smartphone, computer, or another platform into a medical device are also being regulated. This means that an app that turns a platform into some kind of testing device (like an ECG machine that is meant to detect abnormal heart rhythms) will be regulated.
• Apps that can be connected to another medical device and therefore become an extension of that device are being regulated.

Apps that are meant to help patients track calories, provide general health information, or regulate their conditions without making a diagnosis are not subject to the FDA’s regulations.

What Does the Rise in Mobile Medical Apps Mean for Manufacturers?

For medical manufacturers, it is important to take notice of the fact that certain mobile apps are going to be regulated with “the same risk-based approach the agency uses to assure safety and effectiveness for other medical devices,” according to the FDA itself. This process can often be costly and time-consuming, which may cause many individuals to choose not to create apps labeled as medical devices, creating fewer technological advancements in the field.

Still, the amount of mobile medical apps are on the rise. GHS states, “The number of mobile health apps will increase by a rate of 25% a year for the foreseeable future.” Not all of these apps are going to be regulated by the FDA, but many will need to be. Despite the difficulty of complying with some regulations due to cost and time, the creation of mobile medical apps is still increasing due in part to the demand for them.

This impacts the FDA as well. Not only are there stricter regulations needed for those apps which can cause issues for patients, but the FDA has been asked to “provide greater clarity related to several aspects of medical device regulation” (RAPS). The increase of mobile medical apps means that there may need to be clearer instructions and guidelines in the supervision of medical devices overall as well as more attention to the specific regulation of:

• Medical device software modules
• Medical device apps
• Accessories for medical devices
• Medical device clinical decision support software

The rise in mobile medical apps affects both the health manufacturers and the FDA, causing the need for more clear language about medical manufacturing and device regulation and the need for more supervision of a wider range of products in general. While these apps are creating new ways for individuals to receive health care, regulation is still necessary for the protection of the consumer and may be more important than ever.