The Food and Drug Administration has now issued its final guide for applications of a medical and health nature.
The Food and Drug Administration (FDA) has now released a final mhealth guide that shows just how medical and health apps are going to be regulated within the United States.
The FDA has also decided that they will not be enforcing under the Federal Drug and Cosmetic App.
The FDA has come to the conclusion that the majority of health and medical apps don’t pose very much of a risk to consumers. Therefore, they will not enforce the new mhealth guidelines under the Federal Drug and Cosmetic Act. Instead, they are providing the guide for developers who are seeking to ensure that they are conforming with the FDA’s regulations. At the same time, though, the subcategory of these apps that can pose a greater risk if they do not function as intended will experience a higher level of oversight.
The FDA’s mhealth app policy will work to protect patients while attempting not to hold back tech progress.
According to Jeffrey Shuren, M.D., J.D., the director of the Center for Devices and Radiological Health at the FDA, “The FDA’s tailored policy protects patients while encouraging innovation.” This was shared within a press release. The mhealth apps that convert a mobile device into an actual form of regulated medical device – such as the form that would use a smartphone as a type of ECG machine (electrocardiography) in order to detect abnormal rhythms of the heart would, therefore be subject to greater scrutiny from the administration.
In that case, Shuren explained that “It’s not about the platform. It’s about the functionality,” and that “An ECG is an ECG.”
Mhealth apps that are meant for use as an accessory to other types of regulated medical device will also be subject to closer oversight. This includes the type that would allow a doctor to view a medical image from a picture archiving and communication system (PACS) on a tablet, for example. The FDA will not be regulating the actual sale of these applications at online marketplaces such as Google Play or the Apple App Store. Moreover, it will not be regulating calorie counters, pedometers, and other wellness apps that are considered to be very low risk.