US FDA to regulate only medical apps that could be risky if malfunctioning

The FDA said the mobile platform brings its own unique risks when used for medical applications

The U.S. Food and Drug Administration intends to regulate only mobile apps that are medical devices and could pose a risk to a patient's safety if they do not function as intended.

Some of the risks could be unique to the choice of the mobile platform. The interpretation of radiological images on a mobile device could, for example, be adversely affected by the smaller screen size, lower contrast ratio and uncontrolled ambient light of the mobile platform, the agency said in its recommendations released Monday. The FDA said it intends to take the "risks into account in assessing the appropriate regulatory oversight for these products."

The nonbinding recommendations to developers of mobile medical apps only reflects the FDA's current thinking on the topic, the agency said. The guidance document is being issued to clarify the small group of mobile apps which the FDA aims to scrutinize, it added.

The recommendations would leave out of FDA scrutiny a majority of mobile apps that could be classified as medical devices but pose a minimal risk to consumers, the agency said.

The FDA said it is focusing its oversight on mobile medical apps that are to be used as accessories to regulated medical devices or transform a mobile platform into a regulated medical device such as an electrocardiography machine.

"Mobile medical apps that undergo FDA review will be assessed using the same regulatory standards and risk-based approach that the agency applies to other medical devices," the agency said.

It also clarified that its oversight would be platform neutral. Mobile apps to analyze and interpret EKG waveforms to detect heart function irregularities would be considered similar to software running on a desktop computer that serves the same function, which is already regulated.

"FDA's oversight approach to mobile apps is focused on their functionality, just as we focus on the functionality of conventional devices. Our oversight is not determined by the platform," the agency said in its recommendations.

The FDA has cleared about 100 mobile medical applications over the past decade of which about 40 were cleared in the past two years. The draft of the guidance was first issued in 2011.

John Ribeiro covers outsourcing and general technology breaking news from India for The IDG News Service. Follow John on Twitter at @Johnribeiro. John's e-mail address is john_ribeiro@idg.com

Join the newsletter!

Or

Sign up to gain exclusive access to email subscriptions, event invitations, competitions, giveaways, and much more.

Membership is free, and your security and privacy remain protected. View our privacy policy before signing up.

Error: Please check your email address.

Tags governmentmobileregulationmobile applicationsindustry verticalshealth careU.S. Food and Drug Administration

Keep up with the latest tech news, reviews and previews by subscribing to the Good Gear Guide newsletter.

John Ribeiro

IDG News Service
Show Comments

Brand Post

Win pair of MOMENTUM True Wireless

Three PC World readers will be in the running to take home a pair of MOMENTUM True Wireless which are meticulously crafted with every fine listening detail considered. *T&C's Apply

Most Popular Reviews

Latest Articles

Resources

PCW Evaluation Team

Jack Jeffries

MSI GS75

As the Maserati or BMW of laptops, it would fit perfectly in the hands of a professional needing firepower under the hood, sophistication and class on the surface, and gaming prowess (sports mode if you will) in between.

Taylor Carr

MSI PS63

The MSI PS63 is an amazing laptop and I would definitely consider buying one in the future.

Christopher Low

Brother RJ-4230B

This small mobile printer is exactly what I need for invoicing and other jobs such as sending fellow tradesman details or step-by-step instructions that I can easily print off from my phone or the Web.

Aysha Strobbe

Microsoft Office 365/HP Spectre x360

Microsoft Office continues to make a student’s life that little bit easier by offering reliable, easy to use, time-saving functionality, while continuing to develop new features that further enhance what is already a formidable collection of applications

Michael Hargreaves

Microsoft Office 365/Dell XPS 15 2-in-1

I’d recommend a Dell XPS 15 2-in-1 and the new Windows 10 to anyone who needs to get serious work done (before you kick back on your couch with your favourite Netflix show.)

Maryellen Rose George

Brother PT-P750W

It’s useful for office tasks as well as pragmatic labelling of equipment and storage – just don’t get too excited and label everything in sight!

Featured Content

Don’t have an account? Sign up here

Don't have an account? Sign up now

Forgot password?