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.

Is an app 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 …

What is a mobile medical device?

The FDA defines a mobile medical device as “a mobile app that incorporates device software functionality that meets the definition of device in section 201(h) of the FD&C Act, and is either intended to be used as an accessory to a regulated medical device or to transform a mobile platform into a regulated medical …

Is an iPhone A medical device?

Your iPhone isn’t a regulated medical device. This and other insights are available in the new draft guidance: “Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types.”

Who regulates mobile health apps?

The FDA
The FDA also reserves “enforcement discretion” for all mHealth apps, meaning it retains the right to regulate what it calls low-risk medical apps [5].

Does software as a medical device require FDA approval?

Many software functions are not medical devices (meaning such software functions do not meet the definition of a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)), and FDA does not regulate them as devices.

How do I know if an app is FDA approved?

Check for Approved and Cleared Products in the Devices@FDA Database: Devices@FDA is a catalog of approved and cleared medical device information from the FDA. To search for FDA-approved or FDA-cleared products by device name or company name: Go to the Devices@FDA Database.

Does an app 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 FDA approved?

Even though these mobile apps MAY meet the definition of medical device, FDA intends to exercise enforcement discretion for these mobile apps because they pose lower risk to the public. Basically, the FDA may choose to regulate apps according to the degree of risk they pose to the public.

What qualifies as SaMD?

The term “Software as a Medical Device” (SaMD) is defined as software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device. NOTES: • SaMD is a medical device and includes in-vitro diagnostic (IVD) medical device.