Tuesday, July 10, 2012

When Does An App Need FDA's Blessing?

When Does An App Need FDA's Blessing? : Shots - Health Blog : NPR:

"As a result, the Food and Drug Administration has concluded that at least some apps should undergo review by the agency before being permitted on the market. "There are many mobile apps that are on the market that are medical devices," Dr. Jeffrey Shuren, who heads the FDA's Center for Devices and Radiological Health. "There are apps today that change a mobile platform into an EKG machine. When it's being used to diagnose patients, it's a medical device we believe subject to FDA oversight."

But Shuren stresses that the FDA has no plans to review most apps, such as those that help with wellness, healthier lifestyles. Same goes for thoseused to help patients manage their medical conditions. "The risk to patients are very, very low," he says.

Some app makers, however, say they can't be sure what's allowed. "The problem is now we live in this era of connected health where everything is being connected to everything else," said Bradley Merrill Thompson, a lawyer who represents some app makers. "So now that you've got this ecosystem where everything is connected to everything else. That's what creates this ambiguity with FDA.""

'via Blog this'

You might also be interested in:
Essentials for Medical Device Manufacturers - Recommended QSR training

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
GMP Posters by SkillsPlus Intl Inc.
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Enhanced by Zemanta

1 comment:

christine said...

When the different applications are designed as medical devices, I think that someone strict should look at them. There are some of the applications that fool people into believing that they could readily diagnose themselves with it.

From SkillsPlus International Inc.

Custom Search

Even More Resources, Books, & Things (many from Amazon.com)

FDA, GMPs, QSR, GCP, GLP, GXP:
    GMP Training Gifts & Giveaways