FDA Releases Guidelines for Mobile Medical Apps

The mobile development industry has created a wide range of apps related to health and medicine without knowing whether or how those apps would be regulated. Now the Food and Drug Administration (FDA) has issued some guidance about its plans.

The FDA says it won’t look at calorie counters and similar apps that aid in personal fitness, but will only regulate apps that function like a medical device, such as an ultrasound. “We have worked hard to strike the right balance, reviewing only the mobile apps that have the potential to harm consumers if they do not function properly,” said Dr. Jeffrey Shuren with the FDA.

Apps will be approved on a case by case basis, and approval won’t require costly clinical trials as long as the apps resemble devices that are already on the market. The FDA has approved approximately 40 apps in the last two years.

View article

Share the Post:
Share on facebook
Share on twitter
Share on linkedin


The Latest

your company's audio

4 Areas of Your Company Where Your Audio Really Matters

Your company probably relies on audio more than you realize. Whether you’re creating a spoken text message to a colleague or giving a speech, you want your audio to shine. Otherwise, you could cause avoidable friction points and potentially hurt your brand reputation. For example, let’s say you create a

chrome os developer mode

How to Turn on Chrome OS Developer Mode

Google’s Chrome OS is a popular operating system that is widely used on Chromebooks and other devices. While it is designed to be simple and user-friendly, there are times when users may want to access additional features and functionality. One way to do this is by turning on Chrome OS

homes in the real estate industry

Exploring the Latest Tech Trends Impacting the Real Estate Industry

The real estate industry is changing thanks to the newest technological advancements. These new developments — from blockchain and AI to virtual reality and 3D printing — are poised to change how we buy and sell homes. Real estate brokers, buyers, sellers, wholesale real estate professionals, fix and flippers, and beyond may