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!

Error: Please check your email address.
Rocket to Success - Your 10 Tips for Smarter ERP System Selection

Tags mobile applicationsregulationU.S. Food and Drug Administrationhealth caremobilegovernmentindustry verticals

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

Most Popular Reviews

Latest Articles

Resources

PCW Evaluation Team

Kurt Hegetschweiler

Brother PocketJet PJ-773 A4 Portable Thermal Printer

It’s perfect for mobile workers. Just take it out — it’s small enough to sit anywhere — turn it on, load a sheet of paper, and start printing.

Matthew Stivala

HP OfficeJet 250 Mobile Printer

The HP OfficeJet 250 Mobile Printer is a great device that fits perfectly into my fast paced and mobile lifestyle. My first impression of the printer itself was how incredibly compact and sleek the device was.

Armand Abogado

HP OfficeJet 250 Mobile Printer

Wireless printing from my iPhone was also a handy feature, the whole experience was quick and seamless with no setup requirements - accessed through the default iOS printing menu options.

Azadeh Williams

HP OfficeJet Pro 8730

A smarter way to print for busy small business owners, combining speedy printing with scanning and copying, making it easier to produce high quality documents and images at a touch of a button.

Andrew Grant

HP OfficeJet Pro 8730

I've had a multifunction printer in the office going on 10 years now. It was a neat bit of kit back in the day -- print, copy, scan, fax -- when printing over WiFi felt a bit like magic. It’s seen better days though and an upgrade’s well overdue. This HP OfficeJet Pro 8730 looks like it ticks all the same boxes: print, copy, scan, and fax. (Really? Does anyone fax anything any more? I guess it's good to know the facility’s there, just in case.) Printing over WiFi is more-or- less standard these days.

Ed Dawson

HP OfficeJet Pro 8730

As a freelance writer who is always on the go, I like my technology to be both efficient and effective so I can do my job well. The HP OfficeJet Pro 8730 Inkjet Printer ticks all the boxes in terms of form factor, performance and user interface.

Featured Content

Latest Jobs

Don’t have an account? Sign up here

Don't have an account? Sign up now

Forgot password?