The FDA publishes a guide to regulate healthcare mobile apps

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This guide sets a legal framework to determine which apps can be branded as “medical” in the USA


USA's Food and Drug Administration, the oficial agency for the regulation of all perisable and non-perishable foods as well as medicines, has published a guide that contains its opinions and positions towards medical and healthcare mobile apps, with the goal of establishing a regulatory frame that determines the requisites that an app must have to be branded as “medical”.

This document states that true medical/healthcare apps should meet the following criteria: a) play a complementary role with another device that has already been approved by the FDA, or  b) to transform a movile device into a regulated medical device. On the side of the apps themselves, their goals must be: to diagnose diseases and medical conditions or to heal, mitigate, treat or prevent a disease.

The FDA considers that the success of mobile apps in the field of healthcare presents the need to officially regulate and classify them within the market of healthcare tech. Thus, the FDA draws the line between apps that can officially me considered medical devices and those who don´t, and promotes the adoption and use of the first category of apps, which are branded as “mobile medical applications”.

 Read here the official guide published by the FDA