Does the FDA regulate mobile medical apps?

This list provides examples of mobile app functionalities to illustrate the types of mobile apps that could be used in a healthcare environment, in clinical care or patient management, but are not considered medical devices. Because these mobile apps are not considered medical devices, FDA does not regulate them.

Do medical apps need FDA approval?

Short Answer: You need approval if it’s used as a medical tool. If the app is used as a medical tool, it needs FDA approval. If it’s used to aid memory, automate processes, or complete some other non-medical task, it probably does not need FDA approval.

Can an app be considered a medical device?

According to the FDA, the targeted mobile medical apps are either “intended to be used as an accessory to a regulated medical device” or “intended to transform a mobile platform into a regulated medical device.” Apps can be considered “medical devices” and subject to FDA regulation if they are “intended for use in the …

Can an app be FDA approved?

It can take years for an app to be approved, and the FDA might approve a specific function of the app rather than the app in its entirety.

Are mobile apps regulated?

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.

What are mobile health apps?

An “mHealth App” is an app offered by a healthcare organization to their patients. Patients use these mHealth Apps to access self-service tools such as pay my bill, schedule an appointment, send a message to my provider, access my lab results, find a physician and view my medical records.

What are medical mobile apps?

Mobile medical apps are medical devices that are mobile apps, meet the definition of a medical device, and are an accessory to a regulated medical device or transform a mobile platform into a regulated medical device.

Are health apps regulated?

The FDA regulates some of these products as medical devices, but the majority of apps that are meant to be used only for monitoring and recording symptoms — not treating disease — are not regulated. But the FDA regulates and approves devices as final products.

What are examples of mobile health?

Smartphones are being used as medical devices in prenatal care, cancer care, ophthalmology, and infectiology, to name just a few examples. Other mobile devices, such as tablets, wearable sensors, and portable biomedical systems are increasingly used not just by patients, but by health professionals as well.

How many mobile health apps are there?

The report found there are now more than 350,000 digital health apps available to consumers. While many are geared toward general wellness or fitness, and some are middling in quality, specific disease management apps are increasing in number.

What are 3 different types of applications for medical devices submitted to the FDA?

Types of Applications

• Investigational New Drug (IND)
• New Drug Application (NDA)
• Abbreviated New Drug Application (ANDA)
• Over-the-Counter Drugs (OTC)
• Biologic License Application (BLA)