Imagine your child has type 1 diabetes.  As a parent, you constantly worry about your child’s insulin level.  Your little one goes off to school and you hope they remember to check their levels and stay healthy.

Now imagine being able to track your child’s insulin with an app on your smartphone. These remote monitoring capabilities are driving the medical device market. At Morgan Hunter we have discussed the growing demand for medical device mobile apps. This industry is ready to explode, but there are certain things holding it back.

One issue is that the Federal Drug Administration guidance determining what electronic devices and apps can be considered “medical devices” was pending. If a medical product is considered a medical device, then it falls under the FDA’s jurisdiction for regulating.

After two years the wait is over. On September 26, 2013 the FDA issued a memorandum entitled “Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff” which addresses how the FDA will analyze apps to see if they fall within the definition of a medical device.

There are two broad categories of apps the FDA will regulate. One category includes devices that act as an accessory to a regulated medical device, such as a picture archiving and communication system that a physician would use to make a diagnosis. The other category includes devices that transform the mobile device into one that is already regulated. For example, if the app turns your smartphone into an electrocardiography machine, a medical device regulated by the FDA which determines when a patient is having a heart attack, then that device will be considered a medical device.

There are a myriad of wellness apps available but those are distinguishable from medical device apps. Examples of wellness apps include apps that act as pedometers or weight trackers. Those types of devices would not be a medical device in a hospital, and therefore are not medical device apps under the FDA guidelines. With these guidelines, app developers will now decide whether they are creating a non-regulated app for wellness and entertainment or for medical use as a regulated app.

App developers typically invest $24 million to get FDA approval for a moderate-risk medical monitoring device, and wait an average of 67 days for the FDA to approve the app. With the new guidelines, investors can develop apps with more clarity as to how the FDA will regulate the app.

Rely on Morgan Hunter for cutting edge medical technology information. For your company’s health care I/T assessments, project management, IMS, technology implementation, and electronic medical records needs contact Morgan Hunter Healthcare today!